SOCRATES: Steroid or Cyclosporine Removal After Transplantation Using Everolimus

• Sponsor: Novartis Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00371826
• Collaborator: (none)
• Enrollment: 126
• Locations: 7
• Arms: 3
• Duration (Months): 75
• Patients Per Site: 18
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The aim of this study is to assess the safety and efficacy of corticosteroid discontinuation versus cyclosporine micro emulsion discontinuation in recipients receiving reduced exposure cyclosporine micro emulsion and corticosteroids plus enteric-coated mycophenolate sodium (EC-MPS) initially, changed to everolimus at 2 weeks post-transplant. These two groups will be compared to a third control group, who will receive treatment consisting of cyclosporine micro emulsion, enteric-coated mycophenolate sodium (EC-MPS) and steroids.

Condition or Disease	Intervention/Treatment	Phase
Renal Transplanted Recipients	Drug: Everolimus (RAD001); Drug: Cyclosporine (Calcineurin Inhibitor (CNI)); Drug: Methylprednisone/prednisone; Drug: Mycophenolate sodium (MPA)	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 126 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective, Open-label, Controlled Multicenter Trial to Assess the Efficacy and Safety of an Induction Regimen of Cyclosporine Micro Emulsion, Enteric-coated Mycophenolate Sodium (EC-MPS) and Corticosteroids, Followed by Administration of Everolimus and Enteric-coated Mycophenolate Sodium (EC-MPS), With Either the Withdrawal of Cyclosporine Micro Emulsion or Corticosteroids in de Novo Kidney Transplant Recipients
• Study Start Date: Mar 1, 2006
• Actual Primary Completion Date: Jun 1, 2012
• Actual Study Completion Date: Jun 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Calcineurin Inhibitor (CNI) Withdrawal Every randomized patient in this group received Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day	Drug: Everolimus (RAD001); Other Names: Certican® ; Drug: Cyclosporine (Calcineurin Inhibitor (CNI)); Other Names: Neoral® ; Drug: Methylprednisone/prednisone; Drug: Mycophenolate sodium (MPA); Other Names: myfortic®
Experimental: Steroid Withdrawal Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120. Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol	Drug: Everolimus (RAD001); Other Names: Certican® ; Drug: Cyclosporine (Calcineurin Inhibitor (CNI)); Other Names: Neoral® ; Drug: Methylprednisone/prednisone; Drug: Mycophenolate sodium (MPA); Other Names: myfortic®
Active Comparator: CNI+MPA+ Steroid Patients randomized to this group received: Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36.	Drug: Cyclosporine (Calcineurin Inhibitor (CNI)); Other Names: Neoral® ; Drug: Methylprednisone/prednisone; Drug: Mycophenolate sodium (MPA); Other Names: myfortic®

Outcome Measures

Primary Outcome Measures

1. Calculated Glomerular Filtration Rate (cGFR) After Kidney Transplant to Evaluate Kidney Function (12 Months Analysis) [At Month 12]

   The glomerular filtration rate (GFR) was calculated by the Nankivell formula: GFR = 6.7 / Scr + BW / 4 - Surea / 2-100 / (height)^ 2 + C where Scr is the serum creatinine concentration expressed in mmol/L, BW the body weight in kg, Surea the serum urea in mmol/L, height in m, and the constant C is 35 for male and 25 for female patients.

Secondary Outcome Measures

1. Calculated Glomerular Filtration Rate (cGFR) After Kidney Transplant to Evaluate Kidney Function (36 Months Analysis) [At Month 24 and 36]

   The glomerular filtration rate (GFR) was calculated by the Nankivell formula: GFR = 6.7 / Scr + BW / 4 - Surea / 2-100 / (height)^ 2 + C where Scr is the serum creatinine concentration expressed in mmol/L, BW the body weight in kg, Surea the serum urea in mmol/L, height in m, and the constant C is 35 for male and 25 for female patients.

2. Number of Participants With Biopsy Proven Acute Rejection (BPAR) Per Treatment Group (12 Months Analysis) [At Month 12]

   A biopsy-proven acute rejection is defined as a biopsy graded IA, IB, IIA, IIB, or III as per Banff 97 classification.

3. Number of Participants With Biopsy Proven Acute Rejection (BPAR) Per Treatment Group (36 Months Analysis) [At Month 12, 24 and 36]

   A biopsy-proven acute rejection is defined as a biopsy graded IA, IB, IIA, IIB, or III as per Banff 97 classification.

4. Number of Participants With Composite Endpoint of Treatment Failure (12 Months Analysis) [Month 12]

   Composite endpoint of treatment failure includes biopsy-proven acute rejection (BPAR), graft loss, death and loss-to-follow-up. A BPAR is defined as a biopsy graded IA, IB, IIA, IIB, or III as per Banff 97 classification. The allograft was presumed to be lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis. If the patient underwent a graft nephrectomy, then the day of nephrectomy was the day of graft loss.

5. Number of Participants With Composite Endpoint of Treatment Failure (36 Months Analysis) [At Month 12, 24 and 36]

   Composite endpoint of treatment failure includes biopsy-proven acute rejection (BPAR), graft loss, death and loss-to-follow-up. A BPAR is defined as a biopsy graded IA, IB, IIA, IIB, or III as per Banff 97 classification. The allograft was presumed to be lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis. If the patient underwent a graft nephrectomy, then the day of nephrectomy was the day of graft loss.

6. Number of Participants With Histological Evidence Chronic Allograft Nephropathy (CAN) (12 Months Analysis) [At Month 12]

   A per-protocol biopsy was performed at Baseline and Month 12 and read by an independent blinded pathologist in order to assess chronic allograft nephropathy. Chronic rejection is characterized by a slow progressive decline in renal function and is typically preceded by the histological picture of chronic allograft nephropathy. The presence of biopsy confirmed Grade I, II or III chronic allograft nephropathy by Banff 97 criteria was assessed on all optional biopsies obtained for clinical suspicion of chronic rejection. Data summarized by 3 categories. "Yes" - Patients with histological evidence of CAN ; "No" - Patients with histological evidence of CAN and "Not Done" - Central protocol defined kidney allograft biopsies were not done.

7. Number of Participants With Histological Evidence Chronic Allograft Nephropathy (CAN) (36 Months Analysis) [At Month 36]

   Chronic rejection is characterized by a slow progressive decline in renal function and is typically preceded by the histological picture of chronic allograft nephropathy. The presence of biopsy confirmed Grade I, II or III chronic allograft nephropathy by Banff 97 criteria was assessed on all optional biopsies obtained for clinical suspicion of chronic rejection. Data summarized by 3 categories. "Yes" - Patients with histological evidence of CAN ; "No" - Patients with histological evidence of CAN and "Not Done" - Central protocol defined kidney allograft biopsies were not done.

8. Number of Participants With Sub Clinical Acute Rejection (12 Months Analysis) [At Month 12]

   Based on Banff 97 criteria, sub clinical acute rejection can be: GRADE IA - Cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of moderate tubulitis (>4 mononuclear cells/tubular cross section or group of 10 tubular cells). GRADE IB - Cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of moderate tubulitis (>10 mononuclear cells/tubular cross section or group of 10 tubular cells). GRADE IIA - Cases with significant interstitial infiltration and mild to moderate intimal arteritis (v1). GRADE IIB - Cases with moderate to severe intimal arteritis comprising >25% of the luminal area (v2). GRADE III - Cases with "transmural" arteritis or fibrinoid change and necrosis of medial smooth muscle cells (v3). "Borderline" category is used when no intimal arteritis is present, but there are foci of mild tubulitis (1 to 4 mononuclear cells/tubular cross section).

9. Number of Participants With Sub Clinical Acute Rejection (36 Months Analysis) [At Month 36]

   Based on Banff 97 criteria, sub clinical acute rejection can be: GRADE IA - Cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of moderate tubulitis (>4 mononuclear cells/tubular cross section or group of 10 tubular cells). GRADE IB - Cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of moderate tubulitis (>10 mononuclear cells/tubular cross section or group of 10 tubular cells). GRADE IIA - Cases with significant interstitial infiltration and mild to moderate intimal arteritis (v1). GRADE IIB - Cases with moderate to severe intimal arteritis comprising >25% of the luminal area (v2). GRADE III - Cases with "transmural" arteritis or fibrinoid change and necrosis of medial smooth muscle cells (v3). "Borderline' category is used when no intimal arteritis is present, but there are foci of mild tubulitis (1 to 4 mononuclear cells/tubular cross section).

10. Mean Serum Creatinine (12 Months Analysis) [At Month 12]

11. Mean Serum Creatinine (36 Months Analysis) [At Month 12, 18, 24 and 36]

12. Creatinine Clearance (CrCl) Calculated by the Cockcroft-Gault Formula (12 Months Analysis) [At Month 12]

    Creatinine clearance were calculated according to the Cockcroft-Gault formula: CrCl (males) = (140-A) × BW/(72 × Cr) CrCl (females) = CrCl (males) × 0.85 where A is age [years], BW is body weight [kg], and Cr is the serum concentration of creatinine [mg/dL]. The Cockcroft-Gault formula estimates creatinine clearance based on serum creatinine level, body weight, and age.

13. Creatinine Clearance Calculated by the Cockcroft-Gault Formula (36 Months Analysis) [At Month 12, 24 and 36]

    Creatinine clearance were calculated according to the Cockcroft-Gault formula: CrCl (males) = (140-A) × BW/(72 × Cr) CrCl (females) = CrCl (males) × 0.85 where A is age [years], BW is body weight [kg], and Cr is the serum concentration of creatinine [mg/dL]. The Cockcroft-Gault formula estimates creatinine clearance based on serum creatinine level, body weight, and age.

14. Mean Urine Albumin/Creatinine Ratio (ACR) as Measurement of Proteinuria (12 Months Analysis) [At Month 12]

    Proteinuria is measured by spot morning urine Albumin/Creatinine Ratio [ACR]. When the ACR is more than or equal to 30 mg/mmol then it is known as proteinuria.

15. Mean Urine Albumin/Creatinine Ratio [ACR] as Measurement of Proteinuria (36 Months Analysis) [At Month 12, 18, 24 and 36]

    Proteinuria is measured by spot morning urine Albumin/Creatinine Ratio [ACR]. When the ACR is more than or equal to 30 mg/mmol then it is known as proteinuria.

16. Number of Participants With Post Transplant Diabetes Mellitus (PTDM) and Impaired Fasting Glucose (12 Months Analysis) [At Month 12]

    The symptoms of post transplant diabetes mellitus (PTDM) and impaired fasting glucose are defined as any of the following conditions: Patients receiving glucose lowering treatment Fasting plasma glucose (FPG) >= 126 mg/dL on 2 separate occasions Hemoglobin subtype A1c (HbA1c) > 6.5% Diabetes reported as treatment emergent AE with end date > Day 15

17. Number of Participants With New Onset Diabetes Mellitus After Transplantation (NODAT) and Impaired Fasting Glucose (36 Months Analysis) [At Month 36]

    The symptoms of new onset diabetes mellitus after transplantation (NODAT) and impaired fasting glucose are defined as any of the following conditions: Patients receiving glucose lowering treatment 2 fasting plasma glucose (FPG) values >= 126 mg/dL or 2 random plasma glucose (RPG) values >= 200 mg/dL or FPG value >= 126 mg/dL and 1 RPG value >= 200 mg/dL Diabetes reported as treatment emergent AE with end date > Day 15

18. Number of Participants With Notable Abnormal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as Measurement of Effect of Treatment on Cardiovascular Health (12 Months Analysis) [Baseline, Overall post-baseline up to 12 month]

    Notable abnormal systolic blood pressure is defined as : Either an increase of >=30 that results in >=180 or >200 (mm/Hg) OR a decrease of >=30 that results in <=90 or <75 (mm/Hg)from baseline Notable abnormal diastolic blood pressure is defined as : Either an increase of >=20 that results in >=105 or >115 (mm/Hg) OR a decrease of >=20 that results in <=50 or <40 (mm/Hg) from baseline

19. Number of Participants With Notable Abnormal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as Measurement of Effect of Treatment on Cardiovascular Health (36 Months Analysis) [Baseline, Overall post baseline up to Month 36]

    Notable abnormal systolic blood pressure is defined as : Either an increase of >=30 that results in >=180 or >200 (mm/Hg) OR a decrease of >=30 that results in <=90 or <75 (mm/Hg) from baseline Notable abnormal diastolic blood pressure is defined as : Either an increase of >=20 that results in >=105 or >115 (mm/Hg) OR a decrease of >=20 that results in <=50 or <40 (mm/Hg) from baseline

20. Number of Participants With Erythropoietin Usage (12 Months Analysis) [Month 12]

21. Number of Participants With Erythropoietin Usage (36 Months Analysis) [Month 36]

22. Mean Short-form 36 Health Survey (SF-36) Score as a Measure of Quality of Life Assessment (12 Months Analysis) [At Month 12]

    SF-36 measures impact of disease on overall quality of life (QoL). 36-item survey has 8 subscales. The 8 subscales are: Physical functioning (PF), Role-physical (RP), Bodily pain (BP), General health (GH), Vitality (VT), Social functioning (SF), Role-emotional (RE) and Mental health (MH). Score for eash sub-scale has been standardized with the use of norm-based methods based on assessment of the general U.S. population free of chronic conditions. Scores range from 1-100 with a mean=50 and a standard deviation=10. A higher score indicates less impact on QoL.

23. Mean Short-form 36 Health Survey (SF-36) Score as a Measure of Quality of Life Assessment (36 Months Analysis) [At Month 24]

    SF-36 measures impact of disease on overall quality of life (QoL). 36-item survey has 8 subscales. The 8 subscales are : Physical functioning (PF), Role-physical (RP), Bodily pain (BP), General health (GH), Vitality (VT), Social functioning (SF), Role-emotional (RE) and Mental health (MH). Score for each sub-scale has been standardized with the use of norm-based methods based on assessment of the general U.S. population free of chronic conditions. Scores range from 1-100 with a mean=50 and a standard deviation=10. A higher score indicates less impact on QoL.

24. Number of Participants Hospitalized for Reasons Other Than Primary Transplantation (12 Months Analysis) [Month 12]

    This analysis is reporting number of participants hospitalized for reasons (such as acute rejection, infection, gastrointestinal (GI) events, cardiovascular event, metabolic disorder and Other) other than primary transplantation.

25. Number of Participants Hospitalized for Reasons Other Than Primary Transplantation (36 Months Analysis) [Month 36]

    This analysis is reporting number of participants hospitalized for reasons (such as acute rejection, infection, gastrointestinal (GI) events, cardiovascular event, metabolic disorder and Other) other than primary transplantation.

26. Number of Participants With Employment Status (12 Months Analysis) [At screening (at day 0 +/- 7 days ), At Month 12]

    The various employment status reported are: Employed/self employed full time Employed part time Unemployed Homemaker Volunteer Permanently disabled Non-permanently disable Retired Other

27. Number of Participants With Employment Status (36 Months Analysis) [At screening (at day 0 +/- 7 days ), At Month 36]

    The various employment status reported are: Employed/self employed full time Employed part time Unemployed Homemaker Volunteer Permanently disabled Non-permanently disable Retired Other

28. Number of Participants With Wound Problems(12 Months Analysis) [At Month 12]

    Patients with any wound healing problem such as infection related to kidney surgery, dehiscence, lymphocele, hernia, seroma, hematoma, ureteral anastomotic complication and other were reported in this analysis.

29. Number of Participants With Any Wound Problems (36 Months Analysis) [At Month 12, 24 and 36]

    Patients with any wound healing problem such as infection related to kidney surgery, dehiscence, lymphocele, hernia, seroma, hematoma, ureteral anastomotic complication and other were reported in this analysis.

30. Number of Participants With Notable Abnormalities in Total Cholesterol and Triglycerides as Measurement of Effect of Treatment on Cardiovascular Health (12 Months Analysis) [Overall post baseline up to month 12]

    Notable abnormal total cholesterol is defined as : High: >= 9.1 mmol/L , normal range is 0.00 - 5.17 mmol/L Notable abnormal triglycerides is defined as : High: >= 8.5 mmol/L, normal range is 0.30 - 2.00 mmol/L

31. Number of Participants With Notable Abnormalities in Total Cholesterol and Triglycerides as Measurement of Effect of Treatment on Cardiovascular Health (36 Months Analysis) [Overall Post Baseline up to month 36]

    Notable abnormal total cholesterol is defined as : High: >= 9.1 mmol/L , normal range is 0.00 - 5.17 mmol/L Notable abnormal triglycerides is defined as : High: >= 8.5 mmol/L, normal range is 0.30 - 2.00 mmol/L

32. Number of Participants With Antibody-mediated Rejection Per Treatment Group (12 Months Analysis) [At Month 12]

33. Number of Participants With Antibody-mediated Rejection Per Treatment Group (36 Months Analysis) [At Month 12, 24 and 36]

34. Number of Participants With Biopsy Proven Acute Rejection (BPAR) Influenced by Demographic Characteristics and Morbidities (12 Months Analysis) [At Month 12]

    The influence of demographic characteristics and comorbidities on incidence of BPAR were analyzed in the following way: Demographic characteristics were age (<55 years, ≥55 years), Expanded criteria Donor (ECD) organ (donor age >60 years or donor non heart-beating and donor age >50), gender, living vs. deceased donor, Body Mass Index (BMI) classes (underweight <18.5, normal 18.5 - <25.0, overweight 25.0 - <30.0, obesity 30.0 and above), years on dialysis before transplantation (<1, 1-5, >5 years). Comorbidities were diabetes, hypertension, cardiovascular diseases/events, nephrosclerosis, glomerulonephritis/glomerular disease, polycystic disease, and Cytomegalovirus status.

35. Number of Participants With Biopsy Proven Acute Rejection (BPAR) Influenced by Demographic Characteristics and Morbidities (36 Months Analysis) [At Month 36]

    The influence of demographic characteristics and comorbidities on incidence of BPAR were analyzed in the following way: Demographic characteristics were age (<55 years, ≥55 years), Expanded Criteria Donor [ECD] organ (donor age >60 years or donor non heart-beating and donor age >50), gender, living vs. deceased donor, Body Mass Index (BMI) classes (underweight <18.5, normal 18.5 - <25.0, overweight 25.0 - <30.0, obesity 30.0 and above), years on dialysis before transplantation (<1, 1-5, >5 years). Comorbidities were diabetes, hypertension, cardiovascular diseases/events, nephrosclerosis, glomerulonephritis/glomerular disease, polycystic disease, and Cytomegalovirus status.

36. Number of Patient Survival and Graft Survival (12 Months Analysis) [At Month 12]

37. Number of Patient Survival and Graft Survival (36 Months Analysis) [At Month 12, 24 and 36]

38. Change in Bone Mineral Density Between Week 2 and Month 24 (36 Months Analysis) [Week 2, Month 24]

    Measurements of bone mineral density (BMD) by Dual Energy X-ray Absorptiometry (DEXA) were done at Week 2 and Month 24. Change in BMD between week 2 and Month 24 were done for neck of femur and lumbar spine.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion criteria

1. Males and females aged 18-65 years inclusive.

2. First time recipients of cadaveric, living unrelated or living related donor kidney transplants.

3. Patients who are willing and able to participate in the study and from whom written informed consent has been obtained.

Exclusion criteria

1. Patients who are recipients of multiple organ transplants, including more than one kidney, kidney and pancreas, or previous transplant with any organ other than kidney.

2. Patients at high immunological risk of graft loss, indicated by peak PRA >50% or loss of a previous renal allograft within the first 6 months of transplantation due to acute rejection.

3. Patients who have received an investigational drug within 4 weeks prior to the screening visit.

4. Presence of any severe allergy or hypersensitivity to drugs similar to everolimus (e.g. antibiotics such as Clindamycin)

Other protocol-defined inclusion/exclusion criteria may applied

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Royal Prince Alfred Hospital	NSW		Australia
2	Westmead Hospital	NSW		Australia
3	Princess Alexandra Hospital	QLD		Australia
4	Monash Medical Centre	Sale		Australia
5	Queen Elizabeth Hospital	Sale		Australia
6	Royal Melbourne Hospital	VIC		Australia
7	Sir Charles Gairdner Hospital	WA		Australia

Sponsors and Collaborators

• Novartis Pharmaceuticals

Investigators

• Study Director: Novartis, Novartis

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT00371826
• Other Study ID Numbers: CRAD001A2421
• First Posted: Sep 4, 2006
• Last Update Posted: Aug 19, 2013
• Last Verified: Jun 1, 2013

• Keywords provided by Novartis Pharmaceuticals: Renal transplantation; everolimus; Immunosuppressants
• Additional relevant MeSH terms: Cyclosporine; Mycophenolic Acid; Prednisone; Everolimus; Cyclosporins; Calcineurin Inhibitors

Study Results

Participant Flow

Arm/Group Title	Calcineurin Inhibitor (CNI) Withdrawal	CNI+MPA+ Steroid	Steroid Withdrawal
Arm/Group Description	Every randomized patient in this group received Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day	Patients randomized to this group received: Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36.	Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120. Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol
Period Title: Core Phase (12 Months)
STARTED	49	47	30
Modified Intent to Treat (mITT)- Add	46	44	20
Modified Intent to Treat (mITT)	27	39	6
COMPLETED	25	39	6
NOT COMPLETED	24	8	24
Period Title: Core Phase (12 Months)
STARTED	23	39	5
Intention to Treat - Extenstion (ITT-Ex)	23	39	4
Safety Set	22	40	5
COMPLETED	18	29	3
NOT COMPLETED	5	10	2

Baseline Characteristics

Arm/Group Title	Calcineurin Inhibitor (CNI) Withdrawal	CNI+MPA+ Steroid	Steroid Withdrawal	Total
Arm/Group Description	Every randomized patient in this group received Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day	Patients randomized to this group received: Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36.	Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120. Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol	Total of all reporting groups
Overall Participants	49	47	30	126
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	48.4 (10.17)	45.8 (10.83)	43.5 (10.66)	46.3 (10.63)
Sex: Female, Male (Count of Participants)
Female	17 34.7%	13 27.7%	6 20%	36 28.6%
Male	32 65.3%	34 72.3%	24 80%	90 71.4%

Outcome Measures

1. Primary Outcome

Title	Calculated Glomerular Filtration Rate (cGFR) After Kidney Transplant to Evaluate Kidney Function (12 Months Analysis)
Description	The glomerular filtration rate (GFR) was calculated by the Nankivell formula: GFR = 6.7 / Scr + BW / 4 - Surea / 2-100 / (height)^ 2 + C where Scr is the serum creatinine concentration expressed in mmol/L, BW the body weight in kg, Surea the serum urea in mmol/L, height in m, and the constant C is 35 for male and 25 for female patients.
Time Frame	At Month 12

Outcome Measure Data

Analysis Population Description

Modified intent-to-treat (mITT)-Add population: All ITT patients who had a calculated GFR value recorded at Month 12 post-randomization including those collected after discontinuation of study medication and retrospectively collected creatinine and urea data

Arm/Group Title	Calcineurin Inhibitor (CNI) Withdrawal	CNI+MPA+ Steroid	Steroid Withdrawal
Arm/Group Description	Every randomized patient in this group received Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day	Patients randomized to this group received: Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36.	Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120. Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol
Measure Participants	46	44	20
Mean (Standard Deviation) [mL/min per 1.73 m^2]	65.2 (15.52)	69.3 (15.18)	66.9 (16.22)

2. Secondary Outcome

Title	Calculated Glomerular Filtration Rate (cGFR) After Kidney Transplant to Evaluate Kidney Function (36 Months Analysis)
Description	The glomerular filtration rate (GFR) was calculated by the Nankivell formula: GFR = 6.7 / Scr + BW / 4 - Surea / 2-100 / (height)^ 2 + C where Scr is the serum creatinine concentration expressed in mmol/L, BW the body weight in kg, Surea the serum urea in mmol/L, height in m, and the constant C is 35 for male and 25 for female patients.
Time Frame	At Month 24 and 36

Outcome Measure Data

Analysis Population Description

Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period. Missing values were imputed by last observation carried forward (LOCF) using values beyond Month 6

Arm/Group Title	Calcineurin Inhibitor (CNI) Withdrawal	CNI+MPA+ Steroid	Steroid Withdrawal
Arm/Group Description	Every randomized patient in this group received Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day	Patients randomized to this group received: Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36.	Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120. Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol
Measure Participants	23	36	4
Month 24 (n= 23, 36, 4)	69.5 (12.60)	71.8 (16.37)	67.0 (14.72)
Month 36 (n= 19, 35, 3)	71.6 (17.50)	69.1 (14.77)	61.0 (11.36)

3. Secondary Outcome

Title	Number of Participants With Biopsy Proven Acute Rejection (BPAR) Per Treatment Group (12 Months Analysis)
Description	A biopsy-proven acute rejection is defined as a biopsy graded IA, IB, IIA, IIB, or III as per Banff 97 classification.
Time Frame	At Month 12

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication.

Arm/Group Title	Calcineurin Inhibitor (CNI) Withdrawal	CNI+MPA+ Steroid	Steroid Withdrawal
Arm/Group Description	Every randomized patient in this group received Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day	Patients randomized to this group received: Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36.	Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120. Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol
Measure Participants	49	47	30
Number [Participants]	15 30.6%	6 12.8%	5 16.7%

4. Secondary Outcome

Title	Number of Participants With Biopsy Proven Acute Rejection (BPAR) Per Treatment Group (36 Months Analysis)
Description	A biopsy-proven acute rejection is defined as a biopsy graded IA, IB, IIA, IIB, or III as per Banff 97 classification.
Time Frame	At Month 12, 24 and 36

Outcome Measure Data

Analysis Population Description

Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period. This population includes also all patients who were randomized but were not treated with study medication.

Arm/Group Title	Calcineurin Inhibitor (CNI) Withdrawal	CNI+MPA+ Steroid	Steroid Withdrawal
Arm/Group Description	Every randomized patient in this group received Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day	Patients randomized to this group received: Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36.	Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120. Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol
Measure Participants	23	39	4
At Month 12	4 8.2%	4 8.5%	0 0%
At Month 24	5 10.2%	5 10.6%	0 0%
At Month 36	6 12.2%	8 17%	0 0%

5. Secondary Outcome

Title	Number of Participants With Composite Endpoint of Treatment Failure (12 Months Analysis)
Description	Composite endpoint of treatment failure includes biopsy-proven acute rejection (BPAR), graft loss, death and loss-to-follow-up. A BPAR is defined as a biopsy graded IA, IB, IIA, IIB, or III as per Banff 97 classification. The allograft was presumed to be lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis. If the patient underwent a graft nephrectomy, then the day of nephrectomy was the day of graft loss.
Time Frame	Month 12

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication.

Arm/Group Title	Calcineurin Inhibitor (CNI) Withdrawal	CNI+MPA+ Steroid	Steroid Withdrawal
Arm/Group Description	Every randomized patient in this group received Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day	Patients randomized to this group received: Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36.	Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120. Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol
Measure Participants	49	47	30
Number [Participants]	16 32.7%	8 17%	11 36.7%

6. Secondary Outcome

Title	Number of Participants With Composite Endpoint of Treatment Failure (36 Months Analysis)
Description	Composite endpoint of treatment failure includes biopsy-proven acute rejection (BPAR), graft loss, death and loss-to-follow-up. A BPAR is defined as a biopsy graded IA, IB, IIA, IIB, or III as per Banff 97 classification. The allograft was presumed to be lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis. If the patient underwent a graft nephrectomy, then the day of nephrectomy was the day of graft loss.
Time Frame	At Month 12, 24 and 36

Outcome Measure Data

Analysis Population Description

Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period. This population includes also all patients who were randomized but were not treated with study medication.

Arm/Group Title	Calcineurin Inhibitor (CNI) Withdrawal	CNI+MPA+ Steroid	Steroid Withdrawal
Arm/Group Description	Every randomized patient in this group received Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day	Patients randomized to this group received: Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36.	Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120. Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol
Measure Participants	23	39	4
At Month 12	4 8.2%	4 8.5%	0 0%
At Month 24	6 12.2%	6 12.8%	0 0%
At Month 36	7 14.3%	10 21.3%	0 0%

7. Secondary Outcome

Title	Number of Participants With Histological Evidence Chronic Allograft Nephropathy (CAN) (12 Months Analysis)
Description	A per-protocol biopsy was performed at Baseline and Month 12 and read by an independent blinded pathologist in order to assess chronic allograft nephropathy. Chronic rejection is characterized by a slow progressive decline in renal function and is typically preceded by the histological picture of chronic allograft nephropathy. The presence of biopsy confirmed Grade I, II or III chronic allograft nephropathy by Banff 97 criteria was assessed on all optional biopsies obtained for clinical suspicion of chronic rejection. Data summarized by 3 categories. "Yes" - Patients with histological evidence of CAN ; "No" - Patients with histological evidence of CAN and "Not Done" - Central protocol defined kidney allograft biopsies were not done.
Time Frame	At Month 12

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication. For this analysis, only patients with available data were included. The analysis included biopsies of Month 12 visit that were done beyond month 12 cut-off date.

Arm/Group Title	Calcineurin Inhibitor (CNI) Withdrawal	CNI+MPA+ Steroid	Steroid Withdrawal
Arm/Group Description	Every randomized patient in this group received Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day	Patients randomized to this group received: Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36.	Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120. Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol
Measure Participants	30	40	10
YES	8 16.3%	6 12.8%	2 6.7%
NO	15 30.6%	26 55.3%	5 16.7%
Not Done	7 14.3%	8 17%	3 10%

8. Secondary Outcome

Title	Number of Participants With Histological Evidence Chronic Allograft Nephropathy (CAN) (36 Months Analysis)
Description	Chronic rejection is characterized by a slow progressive decline in renal function and is typically preceded by the histological picture of chronic allograft nephropathy. The presence of biopsy confirmed Grade I, II or III chronic allograft nephropathy by Banff 97 criteria was assessed on all optional biopsies obtained for clinical suspicion of chronic rejection. Data summarized by 3 categories. "Yes" - Patients with histological evidence of CAN ; "No" - Patients with histological evidence of CAN and "Not Done" - Central protocol defined kidney allograft biopsies were not done.
Time Frame	At Month 36

Outcome Measure Data

Analysis Population Description

Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period. Patients with data available at month 36 were included in this analysis.

Arm/Group Title	Calcineurin Inhibitor (CNI) Withdrawal	CNI+MPA+ Steroid	Steroid Withdrawal
Arm/Group Description	Every randomized patient in this group received Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day	Patients randomized to this group received: Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36.	Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120. Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol
Measure Participants	18	31	3
YES	2 4.1%	1 2.1%	1 3.3%
NO	8 16.3%	16 34%	1 3.3%
Not Done	8 16.3%	14 29.8%	1 3.3%

9. Secondary Outcome

Title	Number of Participants With Sub Clinical Acute Rejection (12 Months Analysis)
Description	Based on Banff 97 criteria, sub clinical acute rejection can be: GRADE IA - Cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of moderate tubulitis (>4 mononuclear cells/tubular cross section or group of 10 tubular cells). GRADE IB - Cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of moderate tubulitis (>10 mononuclear cells/tubular cross section or group of 10 tubular cells). GRADE IIA - Cases with significant interstitial infiltration and mild to moderate intimal arteritis (v1). GRADE IIB - Cases with moderate to severe intimal arteritis comprising >25% of the luminal area (v2). GRADE III - Cases with "transmural" arteritis or fibrinoid change and necrosis of medial smooth muscle cells (v3). "Borderline" category is used when no intimal arteritis is present, but there are foci of mild tubulitis (1 to 4 mononuclear cells/tubular cross section).
Time Frame	At Month 12

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication. For this analysis, only patients with available data were included. The analysis included biopsies of Month 12 visit that were done beyond month 12 cut-off date.

Arm/Group Title	Calcineurin Inhibitor (CNI) Withdrawal	CNI+MPA+ Steroid	Steroid Withdrawal
Arm/Group Description	Every randomized patient in this group received Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day	Patients randomized to this group received: Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36.	Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120. Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol
Measure Participants	30	40	10
NO	20 40.8%	29 61.7%	5 16.7%
Borderline	2 4.1%	2 4.3%	2 6.7%
Grade IA	1 2%	0 0%	0 0%
Grade IB	0 0%	1 2.1%	0 0%
Grade IIA	0 0%	0 0%	0 0%
Grade IIB	0 0%	0 0%	0 0%
Grade III	0 0%	0 0%	0 0%
Not Done	7 14.3%	8 17%	3 10%

10. Secondary Outcome

Title	Number of Participants With Sub Clinical Acute Rejection (36 Months Analysis)
Description	Based on Banff 97 criteria, sub clinical acute rejection can be: GRADE IA - Cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of moderate tubulitis (>4 mononuclear cells/tubular cross section or group of 10 tubular cells). GRADE IB - Cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of moderate tubulitis (>10 mononuclear cells/tubular cross section or group of 10 tubular cells). GRADE IIA - Cases with significant interstitial infiltration and mild to moderate intimal arteritis (v1). GRADE IIB - Cases with moderate to severe intimal arteritis comprising >25% of the luminal area (v2). GRADE III - Cases with "transmural" arteritis or fibrinoid change and necrosis of medial smooth muscle cells (v3). "Borderline' category is used when no intimal arteritis is present, but there are foci of mild tubulitis (1 to 4 mononuclear cells/tubular cross section).
Time Frame	At Month 36

Outcome Measure Data

Analysis Population Description

Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period.

Arm/Group Title	Calcineurin Inhibitor (CNI) Withdrawal	CNI+MPA+ Steroid	Steroid Withdrawal
Arm/Group Description	Every randomized patient in this group received Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day	Patients randomized to this group received: Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36.	Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120. Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol
Measure Participants	18	31	3
Month 36: NO	9 18.4%	15 31.9%	2 6.7%
Month 36: Borderline	1 2%	1 2.1%	0 0%
Month 36: Grade IA	0 0%	1 2.1%	0 0%
Month 36: Grade IB	0 0%	0 0%	0 0%
Month 36: Grade IIA	0 0%	0 0%	0 0%
Month 36: Grade IIB	0 0%	0 0%	0 0%
Month 36: Grade III	0 0%	0 0%	0 0%
Month 36: Not Done	8 16.3%	14 29.8%	1 3.3%

11. Secondary Outcome

Title	Mean Serum Creatinine (12 Months Analysis)
Time Frame	At Month 12

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication. Patients with 12 month data on serum creatinine were included in this analysis.

Arm/Group Title	Calcineurin Inhibitor (CNI) Withdrawal	CNI+MPA+ Steroid	Steroid Withdrawal
Arm/Group Description	Every randomized patient in this group received Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day	Patients randomized to this group received: Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36.	Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120. Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol
Measure Participants	33	43	11
Mean (Standard Deviation) [umol/L]	118.9 (31.59)	161.0 (169.22)	148.6 (76.84)

12. Secondary Outcome

Title	Mean Serum Creatinine (36 Months Analysis)
Time Frame	At Month 12, 18, 24 and 36

Outcome Measure Data

Analysis Population Description

Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period. Patients with data on creatinine serum creatinine were included in this analysis. Last observation carried forward (LOCF) imputation technique was used.

Arm/Group Title	Calcineurin Inhibitor (CNI) Withdrawal	CNI+MPA+ Steroid	Steroid Withdrawal
Arm/Group Description	Every randomized patient in this group received Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day	Patients randomized to this group received: Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36.	Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120. Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol
Measure Participants	23	39	4
At Month 12 (n= 23, 39, 4)	112.7 (33.38)	123.0 (33.10)	146.8 (89.36)
At Month 18 (n= 22, 36, 4)	113.6 (34.56)	121.4 (35.78)	146.3 (89.16)
At Month 24 (n = 23, 36, 4)	119.9 (36.83)	123.7 (35.20)	146.5 (78.20)
At Month 36 (n= 19, 35, 3)	119.4 (47.50)	131.8 (42.30)	176.0 (87.28)

13. Secondary Outcome

Title	Creatinine Clearance (CrCl) Calculated by the Cockcroft-Gault Formula (12 Months Analysis)
Description	Creatinine clearance were calculated according to the Cockcroft-Gault formula: CrCl (males) = (140-A) × BW/(72 × Cr) CrCl (females) = CrCl (males) × 0.85 where A is age [years], BW is body weight [kg], and Cr is the serum concentration of creatinine [mg/dL]. The Cockcroft-Gault formula estimates creatinine clearance based on serum creatinine level, body weight, and age.
Time Frame	At Month 12

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication. Patients with 12 month data on creatinine clearance were included in this analysis.

Arm/Group Title	Calcineurin Inhibitor (CNI) Withdrawal	CNI+MPA+ Steroid	Steroid Withdrawal
Arm/Group Description	Every randomized patient in this group received Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day	Patients randomized to this group received: Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36.	Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120. Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol
Measure Participants	33	43	11
Mean (Standard Deviation) [mL/min]	66.1 (19.37)	67.8 (21.85)	63.2 (21.73)

14. Secondary Outcome

Title	Creatinine Clearance Calculated by the Cockcroft-Gault Formula (36 Months Analysis)
Description	Creatinine clearance were calculated according to the Cockcroft-Gault formula: CrCl (males) = (140-A) × BW/(72 × Cr) CrCl (females) = CrCl (males) × 0.85 where A is age [years], BW is body weight [kg], and Cr is the serum concentration of creatinine [mg/dL]. The Cockcroft-Gault formula estimates creatinine clearance based on serum creatinine level, body weight, and age.
Time Frame	At Month 12, 24 and 36

Outcome Measure Data

Analysis Population Description

Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period. Patients with data on creatinine clearance were included in this analysis. Last observation carried forward (LOCF) imputation technique was used.

Arm/Group Title	Calcineurin Inhibitor (CNI) Withdrawal	CNI+MPA+ Steroid	Steroid Withdrawal
Arm/Group Description	Every randomized patient in this group received Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day	Patients randomized to this group received: Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36.	Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120. Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol
Measure Participants	23	39	4
At Month 12 (n= 23, 39, 4)	69.8 (19.90)	71.7 (17.68)	63.7 (10.33)
At Month 18 (n=22, 36, 4)	69.9 (20.16)	73.7 (19.34)	66.2 (12.28)
At Month 24 (n= 23, 36, 4)	65.6 (18.83)	72.8 (20.86)	63.7 (5.76)
At Month 36 (n= 23, 39, 4)	66.3 (22.30)	67.5 (16.01)	62.7 (16.58)

15. Secondary Outcome

Title	Mean Urine Albumin/Creatinine Ratio (ACR) as Measurement of Proteinuria (12 Months Analysis)
Description	Proteinuria is measured by spot morning urine Albumin/Creatinine Ratio [ACR]. When the ACR is more than or equal to 30 mg/mmol then it is known as proteinuria.
Time Frame	At Month 12

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication. Patients with 12 month data on Proteinuria were included in this analysis.

Arm/Group Title	Calcineurin Inhibitor (CNI) Withdrawal	CNI+MPA+ Steroid	Steroid Withdrawal
Arm/Group Description	Every randomized patient in this group received Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day	Patients randomized to this group received: Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36.	Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120. Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol
Measure Participants	22	32	4
Mean (Standard Deviation) [mg/mg]	0.2 (0.27)	0.1 (0.12)	0.1 (0.02)

16. Secondary Outcome

Title	Mean Urine Albumin/Creatinine Ratio [ACR] as Measurement of Proteinuria (36 Months Analysis)
Description	Proteinuria is measured by spot morning urine Albumin/Creatinine Ratio [ACR]. When the ACR is more than or equal to 30 mg/mmol then it is known as proteinuria.
Time Frame	At Month 12, 18, 24 and 36

Outcome Measure Data

Analysis Population Description

Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment in extension period. This also includes all patients who were randomized but were not treated with study medication. Patients with ACR data at particular time point were included for analysis.

Arm/Group Title	Calcineurin Inhibitor (CNI) Withdrawal	CNI+MPA+ Steroid	Steroid Withdrawal
Arm/Group Description	Every randomized patient in this group received Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day	Patients randomized to this group received: Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36.	Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120. Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol
Measure Participants	18	32	2
At 12 Month (n = 18, 32, 2)	23.5 (31.51)	8.1 (13.40)	4.8 (3.80)
At 18 Month (n= 17, 31, 2)	28.2 (47.78)	8.1 (12.00)	5.3 (4.12)
At 24 Month ( n= 16, 29, 1)	30.0 (51.72)	6.6 (14.69)	7.0 (NA)
At 36 Month ( n= 15, 25, 0)	30.6 (40.18)	23.4 (66.51)	NA (NA)

17. Secondary Outcome

Title	Number of Participants With Post Transplant Diabetes Mellitus (PTDM) and Impaired Fasting Glucose (12 Months Analysis)
Description	The symptoms of post transplant diabetes mellitus (PTDM) and impaired fasting glucose are defined as any of the following conditions: Patients receiving glucose lowering treatment Fasting plasma glucose (FPG) >= 126 mg/dL on 2 separate occasions Hemoglobin subtype A1c (HbA1c) > 6.5% Diabetes reported as treatment emergent AE with end date > Day 15
Time Frame	At Month 12

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication. Patients with 12 month data on PTDM were included in this analysis.

Arm/Group Title	Calcineurin Inhibitor (CNI) Withdrawal	CNI+MPA+ Steroid	Steroid Withdrawal
Arm/Group Description	Every randomized patient in this group received Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day	Patients randomized to this group received: Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36.	Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120. Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol
Measure Participants	38	42	25
Glucose lowering treatment	10 20.4%	9 19.1%	5 16.7%
FPG >= 126 mg/dL on 2 separate occasions	6 12.2%	0 0%	5 16.7%
HbA1c > 6.5%	12 24.5%	3 6.4%	5 16.7%
Diabetes as treatment emergent AE	8 16.3%	2 4.3%	3 10%
Any of the above symptoms	19 38.8%	10 21.3%	8 26.7%

18. Secondary Outcome

Title	Number of Participants With New Onset Diabetes Mellitus After Transplantation (NODAT) and Impaired Fasting Glucose (36 Months Analysis)
Description	The symptoms of new onset diabetes mellitus after transplantation (NODAT) and impaired fasting glucose are defined as any of the following conditions: Patients receiving glucose lowering treatment 2 fasting plasma glucose (FPG) values >= 126 mg/dL or 2 random plasma glucose (RPG) values >= 200 mg/dL or FPG value >= 126 mg/dL and 1 RPG value >= 200 mg/dL Diabetes reported as treatment emergent AE with end date > Day 15
Time Frame	At Month 36

Outcome Measure Data

Analysis Population Description

Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period. This also includes patients who were randomized but were not treated with study drug.

Arm/Group Title	Calcineurin Inhibitor (CNI) Withdrawal	CNI+MPA+ Steroid	Steroid Withdrawal
Arm/Group Description	Every randomized patient in this group received Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day	Patients randomized to this group received: Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36.	Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120. Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol
Measure Participants	23	39	4
Glucose lowering treatment	5 10.2%	10 21.3%	2 6.7%
FPG or RPG	3 6.1%	2 4.3%	1 3.3%
Diabetes as treatment emergent AE	5 10.2%	4 8.5%	2 6.7%
Any of the above symptoms	6 12.2%	11 23.4%	2 6.7%

19. Secondary Outcome

Title	Number of Participants With Notable Abnormal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as Measurement of Effect of Treatment on Cardiovascular Health (12 Months Analysis)
Description	Notable abnormal systolic blood pressure is defined as : Either an increase of >=30 that results in >=180 or >200 (mm/Hg) OR a decrease of >=30 that results in <=90 or <75 (mm/Hg)from baseline Notable abnormal diastolic blood pressure is defined as : Either an increase of >=20 that results in >=105 or >115 (mm/Hg) OR a decrease of >=20 that results in <=50 or <40 (mm/Hg) from baseline
Time Frame	Baseline, Overall post-baseline up to 12 month

Outcome Measure Data

Analysis Population Description

Safety population (SAF): All patients in whom transplantation was performed and who were treated with at least one dose of study medication and had at least one safety/tolerability assessment after randomization. Patients with baseline and overall post baseline up to 12 month assessment for this analysis were included.

Arm/Group Title	Calcineurin Inhibitor (CNI) Withdrawal	CNI+MPA+ Steroid	Steroid Withdrawal
Arm/Group Description	Every randomized patient in this group received Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day	Patients randomized to this group received: Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36.	Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120. Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol
Measure Participants	49	47	30
SBP: >=180 mm/Hg or 200 mm/Hg	5 10.2%	5 10.6%	7 23.3%
SBP: < = 90 mm/Hg or < 200 mm/Hg	1 2%	0 0%	0 0%
DBP : >=105 mm/Hg or >115 mm/Hg	3 6.1%	6 12.8%	5 16.7%
DBP: <=50 mm/Hg or <40 mm/Hg	1 2%	4 8.5%	0 0%

20. Secondary Outcome

Title	Number of Participants With Notable Abnormal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as Measurement of Effect of Treatment on Cardiovascular Health (36 Months Analysis)
Description	Notable abnormal systolic blood pressure is defined as : Either an increase of >=30 that results in >=180 or >200 (mm/Hg) OR a decrease of >=30 that results in <=90 or <75 (mm/Hg) from baseline Notable abnormal diastolic blood pressure is defined as : Either an increase of >=20 that results in >=105 or >115 (mm/Hg) OR a decrease of >=20 that results in <=50 or <40 (mm/Hg) from baseline
Time Frame	Baseline, Overall post baseline up to Month 36

Outcome Measure Data

Analysis Population Description

Safety population extension (SAF-EX): All patients who entered the extension period, treated with at least one dose of study medication during the extension period and had at least one safety/tolerability assessment after entering the extension period. Patients with baseline and overall post baseline up to month 36 assessment were included.

Arm/Group Title	Calcineurin Inhibitor (CNI) Withdrawal	CNI+MPA+ Steroid	Steroid Withdrawal
Arm/Group Description	Every randomized patient in this group received Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day	Patients randomized to this group received: Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36.	Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120. Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol
Measure Participants	22	40	5
SBP: >=180 mm/Hg or 200 mm/Hg	3 6.1%	4 8.5%	1 3.3%
SBP: < = 90 mm/Hg or < 200 mm/Hg	1 2%	0 0%	0 0%
DBP : >=105 mm/Hg or >115 mm/Hg	2 4.1%	5 10.6%	1 3.3%
DBP: <=50 mm/Hg or <40 mm/Hg	1 2%	4 8.5%	0 0%

21. Secondary Outcome

Title	Number of Participants With Erythropoietin Usage (12 Months Analysis)
Time Frame	Month 12

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication.

Arm/Group Title	Calcineurin Inhibitor (CNI) Withdrawal	CNI+MPA+ Steroid	Steroid Withdrawal
Arm/Group Description	Every randomized patient in this group received Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day	Patients randomized to this group received: Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36.	Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120. Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol
Measure Participants	49	47	30
Number [participants]	20 40.8%	10 21.3%	8 26.7%

22. Secondary Outcome

Title	Number of Participants With Erythropoietin Usage (36 Months Analysis)
Time Frame	Month 36

Outcome Measure Data

Analysis Population Description

Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period. This also includes patients who were randomized but were not treated with study drug.

Arm/Group Title	Calcineurin Inhibitor (CNI) Withdrawal	CNI+MPA+ Steroid	Steroid Withdrawal
Arm/Group Description	Every randomized patient in this group received Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day	Patients randomized to this group received: Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36.	Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120. Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol
Measure Participants	23	39	4
Number [participants]	5 10.2%	7 14.9%	2 6.7%

23. Secondary Outcome

Title	Mean Short-form 36 Health Survey (SF-36) Score as a Measure of Quality of Life Assessment (12 Months Analysis)
Description	SF-36 measures impact of disease on overall quality of life (QoL). 36-item survey has 8 subscales. The 8 subscales are: Physical functioning (PF), Role-physical (RP), Bodily pain (BP), General health (GH), Vitality (VT), Social functioning (SF), Role-emotional (RE) and Mental health (MH). Score for eash sub-scale has been standardized with the use of norm-based methods based on assessment of the general U.S. population free of chronic conditions. Scores range from 1-100 with a mean=50 and a standard deviation=10. A higher score indicates less impact on QoL.
Time Frame	At Month 12

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication. Only those patients who had completed the QoL assessment for Month 12 were included in this analysis.

Arm/Group Title	Calcineurin Inhibitor (CNI) Withdrawal	CNI+MPA+ Steroid	Steroid Withdrawal
Arm/Group Description	Every randomized patient in this group received Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day	Patients randomized to this group received: Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36.	Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120. Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol
Measure Participants	24	37	5
Physical functioning (PF)	78.7 (26.53)	76.9 (30.08)	82.0 (34.93)
Role-physical (RP)	72.9 (40.99)	78.2 (33.98)	100.0 (0.00)
Bodily pain (BP)	73.6 (30.60)	81.5 (19.21)	96.8 (7.16)
General health (GH)	67.1 (22.41)	71.2 (15.75)	86.8 (12.91)
Vitality (VT)	62.7 (23.64)	72.4 (15.88)	85.0 (9.35)
Social Functioning (SF)	74.5 (30.72)	81.1 (21.97)	97.5 (5.59)
Role-emotional (RE)	72.2 (40.13)	81.1 (34.73)	100.0 (0.00)
Mental health (MH)	73.3 (21.02)	79.1 (14.58)	92.8 (7.69)

24. Secondary Outcome

Title	Mean Short-form 36 Health Survey (SF-36) Score as a Measure of Quality of Life Assessment (36 Months Analysis)
Description	SF-36 measures impact of disease on overall quality of life (QoL). 36-item survey has 8 subscales. The 8 subscales are : Physical functioning (PF), Role-physical (RP), Bodily pain (BP), General health (GH), Vitality (VT), Social functioning (SF), Role-emotional (RE) and Mental health (MH). Score for each sub-scale has been standardized with the use of norm-based methods based on assessment of the general U.S. population free of chronic conditions. Scores range from 1-100 with a mean=50 and a standard deviation=10. A higher score indicates less impact on QoL.
Time Frame	At Month 24

Outcome Measure Data

Analysis Population Description

Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period. This also includes patients who were randomized but were not treated with study drug. Patients with completed SF-36 assessment were included in this analysis.

Arm/Group Title	Calcineurin Inhibitor (CNI) Withdrawal	CNI+MPA+ Steroid	Steroid Withdrawal
Arm/Group Description	Every randomized patient in this group received Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day	Patients randomized to this group received: Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36.	Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120. Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol
Measure Participants	16	31	2
Physical functioning (PF)	84.3 (24.20)	87.6 (17.70)	90.0 (7.07)
Role-physical (RP)	75.0 (39.79)	77.4 (33.76)	100.0 (0.00)
Bodily pain (BP)	81.6 (20.57)	85.0 (21.18)	84.0 (0.00)
General health (GH)	71.6 (24.45)	69.8 (16.46)	67.0 (0.00)
Vitality (VT)	70.0 (23.59)	72.7 (13.59)	60.0 (14.14)
Social Functioning (SF)	85.9 (20.35)	80.6 (23.46)	68.8 (26.52)
Role-emotional (RE)	72.9 (30.35)	83.9 (29.65)	33.3 (0.00)
Mental health (MH)	77.5 (18.35)	77.9 (16.37)	62.0 (8.49)

25. Secondary Outcome

Title	Number of Participants Hospitalized for Reasons Other Than Primary Transplantation (12 Months Analysis)
Description	This analysis is reporting number of participants hospitalized for reasons (such as acute rejection, infection, gastrointestinal (GI) events, cardiovascular event, metabolic disorder and Other) other than primary transplantation.
Time Frame	Month 12

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication.

Arm/Group Title	Calcineurin Inhibitor (CNI) Withdrawal	CNI+MPA+ Steroid	Steroid Withdrawal
Arm/Group Description	Every randomized patient in this group received Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day	Patients randomized to this group received: Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36.	Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120. Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol
Measure Participants	49	47	30
Number [Participants]	34 69.4%	31 66%	13 43.3%

26. Secondary Outcome

Title	Number of Participants Hospitalized for Reasons Other Than Primary Transplantation (36 Months Analysis)
Description	This analysis is reporting number of participants hospitalized for reasons (such as acute rejection, infection, gastrointestinal (GI) events, cardiovascular event, metabolic disorder and Other) other than primary transplantation.
Time Frame	Month 36

Outcome Measure Data

Analysis Population Description

Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period.

Arm/Group Title	Calcineurin Inhibitor (CNI) Withdrawal	CNI+MPA+ Steroid	Steroid Withdrawal
Arm/Group Description	Every randomized patient in this group received Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day	Patients randomized to this group received: Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36.	Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120. Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol
Measure Participants	23	39	4
Number [Participants]	16 32.7%	30 63.8%	1 3.3%

27. Secondary Outcome

Title	Number of Participants With Employment Status (12 Months Analysis)
Description	The various employment status reported are: Employed/self employed full time Employed part time Unemployed Homemaker Volunteer Permanently disabled Non-permanently disable Retired Other
Time Frame	At screening (at day 0 +/- 7 days ), At Month 12

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication.

Arm/Group Title	Calcineurin Inhibitor (CNI) Withdrawal	CNI+MPA+ Steroid	Steroid Withdrawal
Arm/Group Description	Every randomized patient in this group received Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day	Patients randomized to this group received: Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36.	Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120. Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol
Measure Participants	49	47	30
Screening visit: Employed/self employed full time	18 36.7%	21 44.7%	9 30%
Month 12: Employed/self employed full time	6 12.2%	14 29.8%	2 6.7%
Screening visit: Employed part time	9 18.4%	7 14.9%	4 13.3%
Month 12: Employed part time	3 6.1%	5 10.6%	0 0%
Screening visit: Unemployed	10 20.4%	8 17%	10 33.3%
Month 12: Unemployed	6 12.2%	1 2.1%	6 20%
Screening visit: Homemaker	3 6.1%	5 10.6%	5 16.7%
Month 12 : Homemaker	2 4.1%	5 10.6%	2 6.7%
Screening visit: Volunteer	1 2%	0 0%	0 0%
Month 12: Volunteer	1 2%	0 0%	0 0%
Screening visit: Permanently disabled	2 4.1%	2 4.3%	0 0%
Month 12: Permanently disabled	1 2%	2 4.3%	0 0%
Screening visit: Non-permanently disabled	1 2%	2 4.3%	0 0%
Month 12: Non-permanently disabled	1 2%	0 0%	0 0%
Screening visit: Retired	4 8.2%	2 4.3%	1 3.3%
Month 12: Retired	1 2%	2 4.3%	0 0%
Screening visit: Other	1 2%	0 0%	1 3.3%
Month 12: Other	1 2%	0 0%	0 0%

28. Secondary Outcome

Title	Number of Participants With Employment Status (36 Months Analysis)
Description	The various employment status reported are: Employed/self employed full time Employed part time Unemployed Homemaker Volunteer Permanently disabled Non-permanently disable Retired Other
Time Frame	At screening (at day 0 +/- 7 days ), At Month 36

Outcome Measure Data

Analysis Population Description

Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period. This population includes also all patients who were randomized but were not treated with study medication.

Arm/Group Title	Calcineurin Inhibitor (CNI) Withdrawal	CNI+MPA+ Steroid	Steroid Withdrawal
Arm/Group Description	Every randomized patient in this group received Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day	Patients randomized to this group received: Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36.	Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120. Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol
Measure Participants	23	39	4
Screening visit: Employed/self employed full time	5 10.2%	10 21.3%	1 3.3%
Month 36: Employed/self employed full time	4 8.2%	10 21.3%	1 3.3%
Screening visit: Employed part time	4 8.2%	7 14.9%	0 0%
Month 36: Employed part time	3 6.1%	4 8.5%	0 0%
Screening visit: Unemployed	5 10.2%	7 14.9%	1 3.3%
Month 36: Unemployed	3 6.1%	6 12.8%	0 0%
Screening visit: Homemaker	3 6.1%	3 6.4%	1 3.3%
Month 36 : Homemaker	3 6.1%	3 6.4%	1 3.3%
Screening visit: Permanently disabled	0 0%	1 2.1%	0 0%
Month 36: Permanently disabled	0 0%	1 2.1%	0 0%
Screening visit: Non-permanently disabled	0 0%	1 2.1%	0 0%
Month 36: Non-permanently disabled	0 0%	1 2.1%	0 0%
Screening visit: Retired	0 0%	2 4.3%	0 0%
Month 36: Retired	0 0%	2 4.3%	0 0%
Screening visit: Other	1 2%	0 0%	0 0%
Month 36: Other	1 2%	0 0%	0 0%

29. Secondary Outcome

Title	Number of Participants With Wound Problems(12 Months Analysis)
Description	Patients with any wound healing problem such as infection related to kidney surgery, dehiscence, lymphocele, hernia, seroma, hematoma, ureteral anastomotic complication and other were reported in this analysis.
Time Frame	At Month 12

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication.

Arm/Group Title	Calcineurin Inhibitor (CNI) Withdrawal	CNI+MPA+ Steroid	Steroid Withdrawal
Arm/Group Description	Every randomized patient in this group received Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day	Patients randomized to this group received: Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36.	Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120. Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol
Measure Participants	49	47	30
Any wound healing problem	16 32.7%	15 31.9%	9 30%
Infection related to kidney surgery	2 4.1%	4 8.5%	3 10%
Dehiscence	3 6.1%	2 4.3%	2 6.7%
Lymphocele	3 6.1%	4 8.5%	3 10%
Hernia	3 6.1%	2 4.3%	1 3.3%
Seroma	4 8.2%	9 19.1%	3 10%
Hematoma	4 8.2%	0 0%	2 6.7%
Ureteral anastomotic complication	2 4.1%	1 2.1%	1 3.3%
Other	3 6.1%	1 2.1%	0 0%

30. Secondary Outcome

Title	Number of Participants With Any Wound Problems (36 Months Analysis)
Description	Patients with any wound healing problem such as infection related to kidney surgery, dehiscence, lymphocele, hernia, seroma, hematoma, ureteral anastomotic complication and other were reported in this analysis.
Time Frame	At Month 12, 24 and 36

Outcome Measure Data

Analysis Population Description

Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period.

Arm/Group Title	Calcineurin Inhibitor (CNI) Withdrawal	CNI+MPA+ Steroid	Steroid Withdrawal
Arm/Group Description	Every randomized patient in this group received Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day	Patients randomized to this group received: Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36.	Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120. Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol
Measure Participants	23	39	4
At Month 12	6 12.2%	11 23.4%	2 6.7%
At Month 24	9 18.4%	13 27.7%	2 6.7%
At Month 36	10 20.4%	13 27.7%	2 6.7%

31. Secondary Outcome

Title	Number of Participants With Notable Abnormalities in Total Cholesterol and Triglycerides as Measurement of Effect of Treatment on Cardiovascular Health (12 Months Analysis)
Description	Notable abnormal total cholesterol is defined as : High: >= 9.1 mmol/L , normal range is 0.00 - 5.17 mmol/L Notable abnormal triglycerides is defined as : High: >= 8.5 mmol/L, normal range is 0.30 - 2.00 mmol/L
Time Frame	Overall post baseline up to month 12

Outcome Measure Data

Analysis Population Description

Safety population (SAF): All patients in whom transplantation was performed and who were treated with at least one dose of study medication and had at least one safety/tolerability assessment after randomization. Patients with serum lipid assessment anytime post baseline up to 12 month were included in this analysis.

Arm/Group Title	Calcineurin Inhibitor (CNI) Withdrawal	CNI+MPA+ Steroid	Steroid Withdrawal
Arm/Group Description	Every randomized patient in this group received Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day	Patients randomized to this group received: Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36.	Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120. Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol
Measure Participants	48	47	30
Total Cholesterol: High (n = 48, 47,30)	6 12.2%	0 0%	3 10%
Triglycerides : High (n= 48, 46, 30)	1 2%	0 0%	0 0%

32. Secondary Outcome

Title	Number of Participants With Notable Abnormalities in Total Cholesterol and Triglycerides as Measurement of Effect of Treatment on Cardiovascular Health (36 Months Analysis)
Description	Notable abnormal total cholesterol is defined as : High: >= 9.1 mmol/L , normal range is 0.00 - 5.17 mmol/L Notable abnormal triglycerides is defined as : High: >= 8.5 mmol/L, normal range is 0.30 - 2.00 mmol/L
Time Frame	Overall Post Baseline up to month 36

Outcome Measure Data

Analysis Population Description

Safety population extension (SAF-EX): All patients who entered the extension period, treated with at least one dose of study medication during the extension period and had at least one safety/tolerability assessment after entering the extension period. Patients with serum lipid assessment anytime post baseline up to 36 month were included .

Arm/Group Title	Calcineurin Inhibitor (CNI) Withdrawal	CNI+MPA+ Steroid	Steroid Withdrawal
Arm/Group Description	Every randomized patient in this group received Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day	Patients randomized to this group received: Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36.	Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120. Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol
Measure Participants	22	40	5
Total Cholesterol: High	6 12.2%	0 0%	1 3.3%
Triglycerides : High	0 0%	1 2.1%	0 0%

33. Secondary Outcome

Title	Number of Participants With Antibody-mediated Rejection Per Treatment Group (12 Months Analysis)
Time Frame	At Month 12

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication.

Arm/Group Title	Calcineurin Inhibitor (CNI) Withdrawal	CNI+MPA+ Steroid	Steroid Withdrawal
Arm/Group Description	Every randomized patient in this group received Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day	Patients randomized to this group received: Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36.	Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120. Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol
Measure Participants	49	47	30
Number [Participants]	5 10.2%	2 4.3%	2 6.7%

34. Secondary Outcome

Title	Number of Participants With Antibody-mediated Rejection Per Treatment Group (36 Months Analysis)
Time Frame	At Month 12, 24 and 36

Outcome Measure Data

Analysis Population Description

Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period. This population includes also all patients who were randomized but were not treated with study medication.

Arm/Group Title	Calcineurin Inhibitor (CNI) Withdrawal	CNI+MPA+ Steroid	Steroid Withdrawal
Arm/Group Description	Every randomized patient in this group received Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day	Patients randomized to this group received: Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36.	Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120. Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol
Measure Participants	23	39	4
At Month 12	1 2%	0 0%	0 0%
At Month 24	1 2%	0 0%	0 0%
At Month 36	1 2%	2 4.3%	0 0%

35. Secondary Outcome

Title	Number of Participants With Biopsy Proven Acute Rejection (BPAR) Influenced by Demographic Characteristics and Morbidities (12 Months Analysis)
Description	The influence of demographic characteristics and comorbidities on incidence of BPAR were analyzed in the following way: Demographic characteristics were age (<55 years, ≥55 years), Expanded criteria Donor (ECD) organ (donor age >60 years or donor non heart-beating and donor age >50), gender, living vs. deceased donor, Body Mass Index (BMI) classes (underweight <18.5, normal 18.5 - <25.0, overweight 25.0 - <30.0, obesity 30.0 and above), years on dialysis before transplantation (<1, 1-5, >5 years). Comorbidities were diabetes, hypertension, cardiovascular diseases/events, nephrosclerosis, glomerulonephritis/glomerular disease, polycystic disease, and Cytomegalovirus status.
Time Frame	At Month 12

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication.

Arm/Group Title	Calcineurin Inhibitor (CNI) Withdrawal	CNI+MPA+ Steroid	Steroid Withdrawal
Arm/Group Description	Every randomized patient in this group received Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day	Patients randomized to this group received: Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36.	Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120. Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol
Measure Participants	49	47	30
Age < 55 years	11 22.4%	5 10.6%	4 13.3%
Age > = 55 years	4 8.2%	1 2.1%	1 3.3%
ECD Organ	3 6.1%	0 0%	2 6.7%
NO ECD Organ	12 24.5%	6 12.8%	3 10%
Male	11 22.4%	6 12.8%	4 13.3%
Female	4 8.2%	0 0%	1 3.3%
Living donor	9 18.4%	6 12.8%	2 6.7%
Deceased donor	6 12.2%	0 0%	3 10%
BMI < 18.5	0 0%	1 2.1%	0 0%
BMI 18.5 - <25	5 10.2%	2 4.3%	3 10%
BMI 25 - <30	8 16.3%	3 6.4%	1 3.3%
BMI >= 30	2 4.1%	0 0%	1 3.3%
Years on dialysis before transplantation: None	1 2%	0 0%	0 0%
< 1 Year on dialysis before transplantation	3 6.1%	3 6.4%	1 3.3%
1 - 5 Years on dialysis before transplantation	8 16.3%	1 2.1%	2 6.7%
> 5 Years on dialysis before transplantation	3 6.1%	2 4.3%	2 6.7%
Diabetes mellitus: No	10 20.4%	4 8.5%	4 13.3%
Diabetes mellitus: Yes	5 10.2%	2 4.3%	1 3.3%
Hypertension: No	2 4.1%	1 2.1%	0 0%
Hypertension: Yes	13 26.5%	5 10.6%	5 16.7%
Cardiovascular disease : No	4 8.2%	3 6.4%	2 6.7%
Cardiovascular disease: Yes	11 22.4%	3 6.4%	3 10%
Nephrosclerosis: No	15 30.6%	6 12.8%	4 13.3%
Nephrosclerosis: Yes	0 0%	0 0%	1 3.3%
Glomerulonephritis/glomerular disease : No	8 16.3%	5 10.6%	3 10%
Glomerulonephritis/glomerular disease: Yes	7 14.3%	1 2.1%	2 6.7%
Cytomegalovirus : Negative	2 4.1%	2 4.3%	0 0%
Cytomegalovirus : Positive	13 26.5%	4 8.5%	5 16.7%

36. Secondary Outcome

Title	Number of Participants With Biopsy Proven Acute Rejection (BPAR) Influenced by Demographic Characteristics and Morbidities (36 Months Analysis)
Description	The influence of demographic characteristics and comorbidities on incidence of BPAR were analyzed in the following way: Demographic characteristics were age (<55 years, ≥55 years), Expanded Criteria Donor [ECD] organ (donor age >60 years or donor non heart-beating and donor age >50), gender, living vs. deceased donor, Body Mass Index (BMI) classes (underweight <18.5, normal 18.5 - <25.0, overweight 25.0 - <30.0, obesity 30.0 and above), years on dialysis before transplantation (<1, 1-5, >5 years). Comorbidities were diabetes, hypertension, cardiovascular diseases/events, nephrosclerosis, glomerulonephritis/glomerular disease, polycystic disease, and Cytomegalovirus status.
Time Frame	At Month 36

Outcome Measure Data

Analysis Population Description

Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period. This population includes also all patients who were randomized but were not treated with study medication

Arm/Group Title	Calcineurin Inhibitor (CNI) Withdrawal	CNI+MPA+ Steroid	Steroid Withdrawal
Arm/Group Description	Every randomized patient in this group received Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day	Patients randomized to this group received: Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36.	Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120. Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol
Measure Participants	23	39	4
Age < 55 years	6 12.2%	7 14.9%	0 0%
Age > = 55 years	0 0%	1 2.1%	0 0%
ECD Organ	0 0%	0 0%	0 0%
NO ECD Organ	6 12.2%	8 17%	0 0%
Male	4 8.2%	7 14.9%	0 0%
Female	2 4.1%	1 2.1%	0 0%
Living donor	5 10.2%	6 12.8%	0 0%
Deceased donor	1 2%	2 4.3%	0 0%
BMI < 18.5	1 2%	0 0%	0 0%
BMI 18.5 - <25	1 2%	3 6.4%	0 0%
BMI 25 - <30	4 8.2%	4 8.5%	0 0%
BMI >= 30	0 0%	1 2.1%	0 0%
Years on dialysis before transplantation: None	0 0%	1 2.1%	0 0%
< 1 Year on dialysis before transplantation	3 6.1%	4 8.5%	0 0%
1 - 5 Years on dialysis before transplantation	2 4.1%	2 4.3%	0 0%
> 5 Years on dialysis before transplantation	1 2%	1 2.1%	0 0%
Diabetes mellitus: No	3 6.1%	6 12.8%	0 0%
Diabetes mellitus: Yes	3 6.1%	2 4.3%	0 0%
Hypertension: No	1 2%	1 2.1%	0 0%
Hypertension: Yes	5 10.2%	7 14.9%	0 0%
Cardiovascular disease : No	3 6.1%	5 10.6%	0 0%
Cardiovascular disease: Yes	3 6.1%	3 6.4%	0 0%
Nephrosclerosis: No	6 12.2%	7 14.9%	0 0%
Nephrosclerosis: Yes	0 0%	1 2.1%	0 0%
Glomerulonephritis/glomerular disease : No	4 8.2%	7 14.9%	0 0%
Glomerulonephritis/glomerular disease: Yes	2 4.1%	1 2.1%	0 0%
Cytomegalovirus : Negative	1 2%	4 8.5%	0 0%
Cytomegalovirus : Positive	5 10.2%	4 8.5%	0 0%

37. Secondary Outcome

Title	Number of Patient Survival and Graft Survival (12 Months Analysis)
Time Frame	At Month 12

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population: All patients who were randomized. This population also included all patients who were randomized but were not treated with study medication.

Arm/Group Title	Calcineurin Inhibitor (CNI) Withdrawal	CNI+MPA+ Steroid	Steroid Withdrawal
Arm/Group Description	Every randomized patient in this group received Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day	Patients randomized to this group received: Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36.	Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120. Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol
Measure Participants	49	47	30
Patient Survival	49 100%	46 97.9%	30 100%
Graft Survival	49 100%	45 95.7%	30 100%

38. Secondary Outcome

Title	Number of Patient Survival and Graft Survival (36 Months Analysis)
Time Frame	At Month 12, 24 and 36

Outcome Measure Data

Analysis Population Description

Intent-to-treat population extension (ITT-EX): All patients who were randomized, entered the extension period, and had at least one efficacy assessment after entering the extension period. This population includes also all patients who were randomized but were not treated with study medication.

Arm/Group Title	Calcineurin Inhibitor (CNI) Withdrawal	CNI+MPA+ Steroid	Steroid Withdrawal
Arm/Group Description	Every randomized patient in this group received Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day	Patients randomized to this group received: Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36.	Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120. Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol
Measure Participants	23	39	4
Month 12: Patient Survival	23 46.9%	39 83%	4 13.3%
Month 12: Graft Survival	23 46.9%	39 83%	4 13.3%
Month 24: Patient Survival	23 46.9%	39 83%	4 13.3%
Month 24: Graft Survival	23 46.9%	39 83%	4 13.3%
Month 36: Patient Survival	23 46.9%	39 83%	4 13.3%
Month 36: Graft Survival	23 46.9%	39 83%	4 13.3%

39. Secondary Outcome

Title	Change in Bone Mineral Density Between Week 2 and Month 24 (36 Months Analysis)
Description	Measurements of bone mineral density (BMD) by Dual Energy X-ray Absorptiometry (DEXA) were done at Week 2 and Month 24. Change in BMD between week 2 and Month 24 were done for neck of femur and lumbar spine.
Time Frame	Week 2, Month 24

Outcome Measure Data

Analysis Population Description

Safety population extension (SAF-EX): All patients who entered the extension period, who were treated with at least one dose of study medication during the extension period and had at least one safety/tolerability assessment after entering the extension period. Patients with week 2 and month 24 assessment for this analysis were included.

Arm/Group Title	Calcineurin Inhibitor (CNI) Withdrawal	CNI+MPA+ Steroid	Steroid Withdrawal
Arm/Group Description	Every randomized patient in this group received Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day	Patients randomized to this group received: Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36.	Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120. Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol
Measure Participants	19	33	2
Neck of Femur (Month 24- Week 2)	0.2 (0.91)	-0.1 (0.06)	-0.1 (0.05)
Lumbar Spine (Month 24 - Week 2)	-0.0 (0.14)	-0.1 (0.10)	-0.0 (0.07)

Adverse Events

Time Frame	36 months
Adverse Event Reporting Description	Safety set includes all patients in whom transplantation was performed and treated with at least one dose of study drug,had at least one safety assessment after randomization. One patient mis-randomised to "CNI withdrawal" arm but treated in control regimen (CNI+MPA+Steroid), evaluated for safety in control arm.
Arm/Group Title	Calcineurin Inhibitor (CNI) Withdrawal		CNI+MPA+ Steroid		Steroid Withdrawal
Arm/Group Description	Every randomized patient in this group received Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day		Patients randomized to this group received: Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36.		Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120. Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol
All Cause Mortality
	Calcineurin Inhibitor (CNI) Withdrawal		CNI+MPA+ Steroid		Steroid Withdrawal
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Calcineurin Inhibitor (CNI) Withdrawal		CNI+MPA+ Steroid		Steroid Withdrawal
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	33/48 (68.8%)		36/48 (75%)		16/30 (53.3%)
Blood and lymphatic system disorders
Anaemia	2/48 (4.2%)		0/48 (0%)		3/30 (10%)
Febrile neutropenia	0/48 (0%)		1/48 (2.1%)		0/30 (0%)
Polycythaemia	1/48 (2.1%)		0/48 (0%)		0/30 (0%)
Thrombocytopenia	1/48 (2.1%)		0/48 (0%)		0/30 (0%)
Cardiac disorders
Atrial fibrillation	1/48 (2.1%)		2/48 (4.2%)		0/30 (0%)
Cardiac valve disease	0/48 (0%)		1/48 (2.1%)		0/30 (0%)
Mitral valve incompetence	1/48 (2.1%)		0/48 (0%)		0/30 (0%)
Myocardial infarction	0/48 (0%)		0/48 (0%)		1/30 (3.3%)
Myocardial ischaemia	1/48 (2.1%)		0/48 (0%)		0/30 (0%)
Tachycardia	2/48 (4.2%)		0/48 (0%)		0/30 (0%)
Ventricular tachycardia	0/48 (0%)		1/48 (2.1%)		0/30 (0%)
Endocrine disorders
Hyperparathyroidism	1/48 (2.1%)		1/48 (2.1%)		0/30 (0%)
Hyperparathyroidism tertiary	0/48 (0%)		1/48 (2.1%)		0/30 (0%)
Eye disorders
Cataract	0/48 (0%)		1/48 (2.1%)		0/30 (0%)
Gastrointestinal disorders
Abdominal pain	2/48 (4.2%)		2/48 (4.2%)		0/30 (0%)
Abdominal pain lower	1/48 (2.1%)		0/48 (0%)		0/30 (0%)
Colitis ischaemic	1/48 (2.1%)		0/48 (0%)		0/30 (0%)
Diarrhoea	4/48 (8.3%)		1/48 (2.1%)		0/30 (0%)
Dyspepsia	0/48 (0%)		1/48 (2.1%)		0/30 (0%)
Gastrointestinal hypomotility	0/48 (0%)		1/48 (2.1%)		0/30 (0%)
Gastrointestinal necrosis	1/48 (2.1%)		0/48 (0%)		0/30 (0%)
Ileitis	1/48 (2.1%)		0/48 (0%)		0/30 (0%)
Ileus paralytic	1/48 (2.1%)		0/48 (0%)		0/30 (0%)
Inguinal hernia	1/48 (2.1%)		0/48 (0%)		0/30 (0%)
Intestinal obstruction	1/48 (2.1%)		0/48 (0%)		0/30 (0%)
Large intestine perforation	0/48 (0%)		1/48 (2.1%)		0/30 (0%)
Localised intraabdominal fluid collection	1/48 (2.1%)		0/48 (0%)		0/30 (0%)
Small intestinal obstruction	1/48 (2.1%)		0/48 (0%)		0/30 (0%)
Vomiting	0/48 (0%)		1/48 (2.1%)		0/30 (0%)
General disorders
Adverse drug reaction	0/48 (0%)		1/48 (2.1%)		0/30 (0%)
Catheter site haemorrhage	0/48 (0%)		1/48 (2.1%)		0/30 (0%)
Chest discomfort	0/48 (0%)		1/48 (2.1%)		0/30 (0%)
Chest pain	0/48 (0%)		1/48 (2.1%)		0/30 (0%)
Chills	0/48 (0%)		1/48 (2.1%)		0/30 (0%)
Cyst	0/48 (0%)		1/48 (2.1%)		0/30 (0%)
Device occlusion	0/48 (0%)		1/48 (2.1%)		0/30 (0%)
Fatigue	1/48 (2.1%)		0/48 (0%)		0/30 (0%)
Localised oedema	1/48 (2.1%)		0/48 (0%)		0/30 (0%)
Malaise	1/48 (2.1%)		0/48 (0%)		0/30 (0%)
Oedema peripheral	2/48 (4.2%)		0/48 (0%)		0/30 (0%)
Pain	2/48 (4.2%)		0/48 (0%)		0/30 (0%)
Pyrexia	4/48 (8.3%)		4/48 (8.3%)		1/30 (3.3%)
Hepatobiliary disorders
Cholelithiasis	0/48 (0%)		1/48 (2.1%)		0/30 (0%)
Immune system disorders
Transplant rejection	7/48 (14.6%)		4/48 (8.3%)		1/30 (3.3%)
Infections and infestations
Abscess intestinal	0/48 (0%)		1/48 (2.1%)		0/30 (0%)
Aspergillosis	0/48 (0%)		1/48 (2.1%)		0/30 (0%)
Bacteraemia	1/48 (2.1%)		0/48 (0%)		0/30 (0%)
Bacterascites	2/48 (4.2%)		0/48 (0%)		0/30 (0%)
Cellulitis	3/48 (6.3%)		1/48 (2.1%)		0/30 (0%)
Cytomegalovirus oesophagitis	0/48 (0%)		0/48 (0%)		1/30 (3.3%)
Device related infection	0/48 (0%)		1/48 (2.1%)		0/30 (0%)
Diabetic foot infection	1/48 (2.1%)		0/48 (0%)		0/30 (0%)
Escherichia bacteraemia	1/48 (2.1%)		0/48 (0%)		0/30 (0%)
Febrile infection	0/48 (0%)		1/48 (2.1%)		0/30 (0%)
Fungal peritonitis	0/48 (0%)		1/48 (2.1%)		0/30 (0%)
Gastroenteritis	4/48 (8.3%)		1/48 (2.1%)		0/30 (0%)
H1N1 influenza	0/48 (0%)		1/48 (2.1%)		0/30 (0%)
Herpes zoster	0/48 (0%)		2/48 (4.2%)		1/30 (3.3%)
Infected skin ulcer	1/48 (2.1%)		0/48 (0%)		0/30 (0%)
Localised infection	0/48 (0%)		1/48 (2.1%)		0/30 (0%)
Lower respiratory tract infection	0/48 (0%)		2/48 (4.2%)		0/30 (0%)
Perinephric abscess	1/48 (2.1%)		0/48 (0%)		0/30 (0%)
Pneumocystis jiroveci pneumonia	0/48 (0%)		1/48 (2.1%)		0/30 (0%)
Pneumonia	0/48 (0%)		2/48 (4.2%)		0/30 (0%)
Pneumonia cytomegaloviral	1/48 (2.1%)		2/48 (4.2%)		1/30 (3.3%)
Pneumonia klebsiella	1/48 (2.1%)		0/48 (0%)		0/30 (0%)
Pneumonia mycoplasmal	1/48 (2.1%)		0/48 (0%)		0/30 (0%)
Pyelonephritis	0/48 (0%)		0/48 (0%)		1/30 (3.3%)
Respiratory tract infection	1/48 (2.1%)		0/48 (0%)		0/30 (0%)
Salmonellosis	1/48 (2.1%)		0/48 (0%)		0/30 (0%)
Sepsis	1/48 (2.1%)		3/48 (6.3%)		0/30 (0%)
Septic shock	1/48 (2.1%)		0/48 (0%)		0/30 (0%)
Staphylococcal infection	1/48 (2.1%)		0/48 (0%)		0/30 (0%)
Upper respiratory tract infection	0/48 (0%)		2/48 (4.2%)		0/30 (0%)
Urinary tract infection	4/48 (8.3%)		1/48 (2.1%)		1/30 (3.3%)
Urinary tract infection fungal	1/48 (2.1%)		0/48 (0%)		0/30 (0%)
Urosepsis	1/48 (2.1%)		2/48 (4.2%)		0/30 (0%)
Varicella	1/48 (2.1%)		0/48 (0%)		0/30 (0%)
Viral infection	2/48 (4.2%)		0/48 (0%)		0/30 (0%)
Wound infection	2/48 (4.2%)		3/48 (6.3%)		1/30 (3.3%)
Injury, poisoning and procedural complications
Anastomotic haemorrhage	1/48 (2.1%)		0/48 (0%)		0/30 (0%)
Cervical vertebral fracture	1/48 (2.1%)		0/48 (0%)		0/30 (0%)
Chronic allograft nephropathy	0/48 (0%)		0/48 (0%)		1/30 (3.3%)
Complications of transplanted kidney	2/48 (4.2%)		1/48 (2.1%)		0/30 (0%)
Drug toxicity	0/48 (0%)		0/48 (0%)		1/30 (3.3%)
Fall	1/48 (2.1%)		0/48 (0%)		0/30 (0%)
Fibula fracture	1/48 (2.1%)		0/48 (0%)		0/30 (0%)
Graft complication	1/48 (2.1%)		0/48 (0%)		0/30 (0%)
Graft haemorrhage	1/48 (2.1%)		0/48 (0%)		0/30 (0%)
Graft loss	0/48 (0%)		1/48 (2.1%)		0/30 (0%)
Hand fracture	1/48 (2.1%)		0/48 (0%)		0/30 (0%)
Incisional hernia	3/48 (6.3%)		1/48 (2.1%)		0/30 (0%)
Joint dislocation	1/48 (2.1%)		0/48 (0%)		0/30 (0%)
Muscle rupture	1/48 (2.1%)		0/48 (0%)		0/30 (0%)
Perirenal haematoma	1/48 (2.1%)		0/48 (0%)		1/30 (3.3%)
Post procedural haemorrhage	0/48 (0%)		1/48 (2.1%)		0/30 (0%)
Procedural pain	1/48 (2.1%)		0/48 (0%)		0/30 (0%)
Rib fracture	1/48 (2.1%)		0/48 (0%)		0/30 (0%)
Road traffic accident	2/48 (4.2%)		0/48 (0%)		0/30 (0%)
Sternal fracture	1/48 (2.1%)		0/48 (0%)		0/30 (0%)
Subdural haematoma	1/48 (2.1%)		0/48 (0%)		0/30 (0%)
Tendon rupture	0/48 (0%)		1/48 (2.1%)		0/30 (0%)
Therapeutic agent toxicity	0/48 (0%)		0/48 (0%)		1/30 (3.3%)
Tibia fracture	1/48 (2.1%)		0/48 (0%)		0/30 (0%)
Toxicity to various agents	0/48 (0%)		0/48 (0%)		1/30 (3.3%)
Traumatic liver injury	1/48 (2.1%)		0/48 (0%)		0/30 (0%)
Wound dehiscence	1/48 (2.1%)		0/48 (0%)		0/30 (0%)
Wound secretion	0/48 (0%)		2/48 (4.2%)		1/30 (3.3%)
Investigations
Blood creatinine increased	7/48 (14.6%)		4/48 (8.3%)		3/30 (10%)
Blood pressure increased	1/48 (2.1%)		0/48 (0%)		0/30 (0%)
Drug level above therapeutic	1/48 (2.1%)		0/48 (0%)		0/30 (0%)
Hepatic enzyme increased	0/48 (0%)		0/48 (0%)		1/30 (3.3%)
Oxygen saturation decreased	0/48 (0%)		0/48 (0%)		1/30 (3.3%)
Urine output decreased	2/48 (4.2%)		0/48 (0%)		0/30 (0%)
Weight increased	1/48 (2.1%)		0/48 (0%)		0/30 (0%)
Metabolism and nutrition disorders
Dehydration	3/48 (6.3%)		1/48 (2.1%)		0/30 (0%)
Diabetic foot	1/48 (2.1%)		0/48 (0%)		0/30 (0%)
Diabetic ketoacidosis	1/48 (2.1%)		0/48 (0%)		0/30 (0%)
Electrolyte imbalance	2/48 (4.2%)		0/48 (0%)		0/30 (0%)
Hyperglycaemia	1/48 (2.1%)		0/48 (0%)		0/30 (0%)
Hyperkalaemia	2/48 (4.2%)		0/48 (0%)		0/30 (0%)
Hypokalaemia	1/48 (2.1%)		0/48 (0%)		0/30 (0%)
Hypomagnesaemia	1/48 (2.1%)		0/48 (0%)		0/30 (0%)
Musculoskeletal and connective tissue disorders
Arthritis	0/48 (0%)		1/48 (2.1%)		0/30 (0%)
Costochondritis	1/48 (2.1%)		0/48 (0%)		0/30 (0%)
Neck pain	1/48 (2.1%)		0/48 (0%)		0/30 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma	0/48 (0%)		4/48 (8.3%)		0/30 (0%)
Fibroadenoma of breast	0/48 (0%)		0/48 (0%)		1/30 (3.3%)
Squamous cell carcinoma	3/48 (6.3%)		2/48 (4.2%)		0/30 (0%)
Nervous system disorders
Dizziness	1/48 (2.1%)		0/48 (0%)		0/30 (0%)
Lethargy	1/48 (2.1%)		1/48 (2.1%)		0/30 (0%)
Loss of consciousness	1/48 (2.1%)		0/48 (0%)		0/30 (0%)
Partial seizures	1/48 (2.1%)		0/48 (0%)		0/30 (0%)
Somnolence	1/48 (2.1%)		0/48 (0%)		0/30 (0%)
Psychiatric disorders
Confusional state	1/48 (2.1%)		0/48 (0%)		0/30 (0%)
Depression	0/48 (0%)		1/48 (2.1%)		0/30 (0%)
Depression suicidal	0/48 (0%)		1/48 (2.1%)		0/30 (0%)
Hallucination	1/48 (2.1%)		0/48 (0%)		0/30 (0%)
Paranoia	0/48 (0%)		1/48 (2.1%)		0/30 (0%)
Renal and urinary disorders
Bladder disorder	0/48 (0%)		0/48 (0%)		1/30 (3.3%)
Cystitis haemorrhagic	0/48 (0%)		1/48 (2.1%)		0/30 (0%)
Dysuria	1/48 (2.1%)		0/48 (0%)		0/30 (0%)
Focal segmental glomerulosclerosis	1/48 (2.1%)		0/48 (0%)		0/30 (0%)
Glomerular vascular disorder	1/48 (2.1%)		0/48 (0%)		0/30 (0%)
Haematuria	4/48 (8.3%)		2/48 (4.2%)		1/30 (3.3%)
Hydronephrosis	3/48 (6.3%)		1/48 (2.1%)		0/30 (0%)
Obstructive uropathy	1/48 (2.1%)		0/48 (0%)		0/30 (0%)
Proteinuria	1/48 (2.1%)		0/48 (0%)		0/30 (0%)
Renal artery stenosis	1/48 (2.1%)		0/48 (0%)		1/30 (3.3%)
Renal failure acute	2/48 (4.2%)		0/48 (0%)		0/30 (0%)
Renal tubular necrosis	1/48 (2.1%)		1/48 (2.1%)		0/30 (0%)
Renal vein thrombosis	0/48 (0%)		1/48 (2.1%)		0/30 (0%)
Tubulointerstitial nephritis	0/48 (0%)		0/48 (0%)		1/30 (3.3%)
Ureteric obstruction	1/48 (2.1%)		1/48 (2.1%)		1/30 (3.3%)
Ureteric stenosis	1/48 (2.1%)		0/48 (0%)		0/30 (0%)
Reproductive system and breast disorders
Pelvic fluid collection	1/48 (2.1%)		0/48 (0%)		0/30 (0%)
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema	1/48 (2.1%)		0/48 (0%)		1/30 (3.3%)
Dyspnoea	1/48 (2.1%)		1/48 (2.1%)		0/30 (0%)
Interstitial lung disease	0/48 (0%)		1/48 (2.1%)		0/30 (0%)
Pulmonary oedema	0/48 (0%)		0/48 (0%)		1/30 (3.3%)
Respiratory arrest	1/48 (2.1%)		1/48 (2.1%)		0/30 (0%)
Tachypnoea	1/48 (2.1%)		0/48 (0%)		0/30 (0%)
Skin and subcutaneous tissue disorders
Diabetic foot	1/48 (2.1%)		0/48 (0%)		0/30 (0%)
Skin ulcer	1/48 (2.1%)		0/48 (0%)		0/30 (0%)
Vascular disorders
Deep vein thrombosis	2/48 (4.2%)		0/48 (0%)		2/30 (6.7%)
Haematoma	1/48 (2.1%)		0/48 (0%)		0/30 (0%)
Hypertension	0/48 (0%)		0/48 (0%)		1/30 (3.3%)
Hypotension	3/48 (6.3%)		0/48 (0%)		0/30 (0%)
Hypovolaemic shock	1/48 (2.1%)		1/48 (2.1%)		0/30 (0%)
Ischaemia	0/48 (0%)		0/48 (0%)		1/30 (3.3%)
Lymphocele	2/48 (4.2%)		2/48 (4.2%)		0/30 (0%)
Other (Not Including Serious) Adverse Events
	Calcineurin Inhibitor (CNI) Withdrawal		CNI+MPA+ Steroid		Steroid Withdrawal
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	47/48 (97.9%)		48/48 (100%)		30/30 (100%)
Blood and lymphatic system disorders
Anaemia	15/48 (31.3%)		13/48 (27.1%)		7/30 (23.3%)
Leukopenia	2/48 (4.2%)		5/48 (10.4%)		1/30 (3.3%)
Pancytopenia	0/48 (0%)		3/48 (6.3%)		0/30 (0%)
Thrombocytopenia	2/48 (4.2%)		3/48 (6.3%)		1/30 (3.3%)
Cardiac disorders
Arrhythmia	0/48 (0%)		2/48 (4.2%)		2/30 (6.7%)
Bradycardia	2/48 (4.2%)		4/48 (8.3%)		0/30 (0%)
Palpitations	4/48 (8.3%)		3/48 (6.3%)		1/30 (3.3%)
Tachycardia	4/48 (8.3%)		5/48 (10.4%)		1/30 (3.3%)
Endocrine disorders
Cushingoid	1/48 (2.1%)		3/48 (6.3%)		0/30 (0%)
Hyperparathyroidism	0/48 (0%)		4/48 (8.3%)		0/30 (0%)
Eye disorders
Vision blurred	1/48 (2.1%)		4/48 (8.3%)		0/30 (0%)
Gastrointestinal disorders
Abdominal discomfort	3/48 (6.3%)		7/48 (14.6%)		1/30 (3.3%)
Abdominal distension	5/48 (10.4%)		5/48 (10.4%)		3/30 (10%)
Abdominal pain	4/48 (8.3%)		2/48 (4.2%)		0/30 (0%)
Abdominal pain lower	1/48 (2.1%)		5/48 (10.4%)		0/30 (0%)
Constipation	22/48 (45.8%)		29/48 (60.4%)		15/30 (50%)
Diarrhoea	19/48 (39.6%)		12/48 (25%)		5/30 (16.7%)
Dyspepsia	7/48 (14.6%)		2/48 (4.2%)		0/30 (0%)
Epigastric discomfort	2/48 (4.2%)		3/48 (6.3%)		0/30 (0%)
Gastrooesophageal reflux disease	4/48 (8.3%)		4/48 (8.3%)		0/30 (0%)
Haemorrhoids	2/48 (4.2%)		8/48 (16.7%)		1/30 (3.3%)
Mouth ulceration	6/48 (12.5%)		3/48 (6.3%)		3/30 (10%)
Nausea	24/48 (50%)		19/48 (39.6%)		7/30 (23.3%)
Paraesthesia oral	3/48 (6.3%)		0/48 (0%)		0/30 (0%)
Vomiting	14/48 (29.2%)		16/48 (33.3%)		4/30 (13.3%)
General disorders
Chest discomfort	1/48 (2.1%)		4/48 (8.3%)		0/30 (0%)
Chest pain	3/48 (6.3%)		8/48 (16.7%)		2/30 (6.7%)
Oedema	8/48 (16.7%)		8/48 (16.7%)		4/30 (13.3%)
Oedema peripheral	21/48 (43.8%)		17/48 (35.4%)		3/30 (10%)
Pain	5/48 (10.4%)		6/48 (12.5%)		0/30 (0%)
Pyrexia	6/48 (12.5%)		8/48 (16.7%)		6/30 (20%)
Immune system disorders
Transplant rejection	7/48 (14.6%)		5/48 (10.4%)		0/30 (0%)
Infections and infestations
Cellulitis	3/48 (6.3%)		3/48 (6.3%)		1/30 (3.3%)
Gastroenteritis	0/48 (0%)		3/48 (6.3%)		1/30 (3.3%)
Herpes simplex	0/48 (0%)		3/48 (6.3%)		0/30 (0%)
Herpes zoster	1/48 (2.1%)		3/48 (6.3%)		0/30 (0%)
Nasopharyngitis	1/48 (2.1%)		8/48 (16.7%)		2/30 (6.7%)
Oral candidiasis	3/48 (6.3%)		1/48 (2.1%)		0/30 (0%)
Upper respiratory tract infection	9/48 (18.8%)		22/48 (45.8%)		3/30 (10%)
Urinary tract infection	13/48 (27.1%)		15/48 (31.3%)		6/30 (20%)
Wound infection	3/48 (6.3%)		4/48 (8.3%)		1/30 (3.3%)
Injury, poisoning and procedural complications
Complications of transplanted kidney	13/48 (27.1%)		5/48 (10.4%)		6/30 (20%)
Contusion	2/48 (4.2%)		4/48 (8.3%)		0/30 (0%)
Drug toxicity	2/48 (4.2%)		5/48 (10.4%)		3/30 (10%)
Laceration	0/48 (0%)		4/48 (8.3%)		0/30 (0%)
Perinephric collection	0/48 (0%)		4/48 (8.3%)		1/30 (3.3%)
Procedural pain	14/48 (29.2%)		11/48 (22.9%)		2/30 (6.7%)
Skin laceration	2/48 (4.2%)		4/48 (8.3%)		0/30 (0%)
Toxicity to various agents	0/48 (0%)		7/48 (14.6%)		1/30 (3.3%)
Wound complication	10/48 (20.8%)		6/48 (12.5%)		4/30 (13.3%)
Wound dehiscence	3/48 (6.3%)		1/48 (2.1%)		1/30 (3.3%)
Wound secretion	4/48 (8.3%)		6/48 (12.5%)		1/30 (3.3%)
Investigations
Alanine aminotransferase increased	4/48 (8.3%)		0/48 (0%)		0/30 (0%)
Blood cholesterol increased	2/48 (4.2%)		4/48 (8.3%)		1/30 (3.3%)
Blood creatinine increased	12/48 (25%)		13/48 (27.1%)		7/30 (23.3%)
Blood glucose increased	4/48 (8.3%)		5/48 (10.4%)		2/30 (6.7%)
Blood magnesium decreased	3/48 (6.3%)		0/48 (0%)		0/30 (0%)
Blood phosphorus decreased	5/48 (10.4%)		1/48 (2.1%)		2/30 (6.7%)
Hepatic enzyme increased	3/48 (6.3%)		3/48 (6.3%)		2/30 (6.7%)
Urine output decreased	9/48 (18.8%)		13/48 (27.1%)		7/30 (23.3%)
Weight increased	8/48 (16.7%)		6/48 (12.5%)		2/30 (6.7%)
White blood cell count decreased	1/48 (2.1%)		4/48 (8.3%)		1/30 (3.3%)
Metabolism and nutrition disorders
Acidosis	0/48 (0%)		3/48 (6.3%)		1/30 (3.3%)
Dehydration	1/48 (2.1%)		3/48 (6.3%)		2/30 (6.7%)
Diabetes mellitus	9/48 (18.8%)		5/48 (10.4%)		4/30 (13.3%)
Fluid overload	4/48 (8.3%)		10/48 (20.8%)		2/30 (6.7%)
Glucose tolerance impaired	2/48 (4.2%)		3/48 (6.3%)		1/30 (3.3%)
Hypercalcaemia	0/48 (0%)		6/48 (12.5%)		2/30 (6.7%)
Hypercholesterolaemia	12/48 (25%)		9/48 (18.8%)		2/30 (6.7%)
Hyperglycaemia	7/48 (14.6%)		10/48 (20.8%)		2/30 (6.7%)
Hyperkalaemia	11/48 (22.9%)		15/48 (31.3%)		7/30 (23.3%)
Hyperlipidaemia	10/48 (20.8%)		9/48 (18.8%)		3/30 (10%)
Hypertriglyceridaemia	3/48 (6.3%)		3/48 (6.3%)		0/30 (0%)
Hypocalcaemia	9/48 (18.8%)		10/48 (20.8%)		5/30 (16.7%)
Hypokalaemia	7/48 (14.6%)		6/48 (12.5%)		0/30 (0%)
Hypomagnesaemia	0/48 (0%)		7/48 (14.6%)		0/30 (0%)
Hyponatraemia	1/48 (2.1%)		7/48 (14.6%)		0/30 (0%)
Hypophosphataemia	4/48 (8.3%)		5/48 (10.4%)		1/30 (3.3%)
Hypovolaemia	3/48 (6.3%)		1/48 (2.1%)		0/30 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	8/48 (16.7%)		5/48 (10.4%)		6/30 (20%)
Back pain	3/48 (6.3%)		9/48 (18.8%)		2/30 (6.7%)
Joint swelling	6/48 (12.5%)		1/48 (2.1%)		4/30 (13.3%)
Muscle spasms	2/48 (4.2%)		3/48 (6.3%)		0/30 (0%)
Muscular weakness	2/48 (4.2%)		3/48 (6.3%)		1/30 (3.3%)
Musculoskeletal pain	1/48 (2.1%)		6/48 (12.5%)		0/30 (0%)
Myalgia	0/48 (0%)		3/48 (6.3%)		0/30 (0%)
Neck pain	1/48 (2.1%)		3/48 (6.3%)		0/30 (0%)
Osteoporosis	2/48 (4.2%)		2/48 (4.2%)		2/30 (6.7%)
Pain in extremity	5/48 (10.4%)		9/48 (18.8%)		0/30 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma	0/48 (0%)		3/48 (6.3%)		1/30 (3.3%)
Nervous system disorders
Dizziness	8/48 (16.7%)		10/48 (20.8%)		2/30 (6.7%)
Headache	10/48 (20.8%)		19/48 (39.6%)		2/30 (6.7%)
Hypoaesthesia	2/48 (4.2%)		4/48 (8.3%)		0/30 (0%)
Lethargy	5/48 (10.4%)		6/48 (12.5%)		0/30 (0%)
Paraesthesia	6/48 (12.5%)		1/48 (2.1%)		0/30 (0%)
Tremor	3/48 (6.3%)		8/48 (16.7%)		1/30 (3.3%)
Psychiatric disorders
Anxiety	3/48 (6.3%)		6/48 (12.5%)		0/30 (0%)
Depression	3/48 (6.3%)		2/48 (4.2%)		1/30 (3.3%)
Insomnia	10/48 (20.8%)		8/48 (16.7%)		3/30 (10%)
Renal and urinary disorders
Bladder spasm	6/48 (12.5%)		2/48 (4.2%)		4/30 (13.3%)
Dysuria	5/48 (10.4%)		8/48 (16.7%)		6/30 (20%)
Haematuria	8/48 (16.7%)		7/48 (14.6%)		4/30 (13.3%)
Hydronephrosis	3/48 (6.3%)		2/48 (4.2%)		1/30 (3.3%)
Pollakiuria	2/48 (4.2%)		1/48 (2.1%)		3/30 (10%)
Polyuria	2/48 (4.2%)		6/48 (12.5%)		0/30 (0%)
Renal tubular necrosis	6/48 (12.5%)		2/48 (4.2%)		4/30 (13.3%)
Reproductive system and breast disorders
Menorrhagia	4/48 (8.3%)		1/48 (2.1%)		0/30 (0%)
Respiratory, thoracic and mediastinal disorders
Cough	16/48 (33.3%)		12/48 (25%)		5/30 (16.7%)
Dyspnoea	8/48 (16.7%)		7/48 (14.6%)		3/30 (10%)
Oropharyngeal pain	4/48 (8.3%)		6/48 (12.5%)		1/30 (3.3%)
Productive cough	1/48 (2.1%)		4/48 (8.3%)		2/30 (6.7%)
Rhinorrhoea	8/48 (16.7%)		9/48 (18.8%)		1/30 (3.3%)
Skin and subcutaneous tissue disorders
Acne	4/48 (8.3%)		4/48 (8.3%)		4/30 (13.3%)
Actinic keratosis	3/48 (6.3%)		3/48 (6.3%)		1/30 (3.3%)
Hirsutism	1/48 (2.1%)		6/48 (12.5%)		2/30 (6.7%)
Night sweats	2/48 (4.2%)		1/48 (2.1%)		2/30 (6.7%)
Pruritus	3/48 (6.3%)		4/48 (8.3%)		3/30 (10%)
Psoriasis	3/48 (6.3%)		0/48 (0%)		0/30 (0%)
Rash	3/48 (6.3%)		6/48 (12.5%)		2/30 (6.7%)
Skin lesion	3/48 (6.3%)		3/48 (6.3%)		0/30 (0%)
Vascular disorders
Hypertension	24/48 (50%)		22/48 (45.8%)		10/30 (33.3%)
Hypotension	7/48 (14.6%)		9/48 (18.8%)		1/30 (3.3%)
Lymphocele	3/48 (6.3%)		3/48 (6.3%)		2/30 (6.7%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.