Effects of Inhibiting Early Inflammation in Kidney Transplant Patients

• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT02495077
• Collaborator: Clinical Trials in Organ Transplantation (Other), Rho Federal Systems Division, Inc. (Industry)
• Enrollment: 290
• Locations: 15
• Arms: 2
• Actual Duration (Months): 68.7
• Patients Per Site: 19.3
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

During transplant surgery, there is a period of time when a donated kidney is removed from a donor's body and stored until the time of the transplant surgery. The storage procedure results in buildup of various proteins within the kidney that can injure the donated kidney after it is transplanted. One of these proteins is tumor necrosis factor-alpha (TNF-alpha).

The purpose of this study is to evaluate whether taking infliximab, which blocks tumor necrosis factor alpha (TNF-alpha), just prior to transplant surgery, along with usual transplant medicines will protect the donated kidney from damage caused by TNF-alpha and help keep the transplanted kidney healthy for a longer period of time.

Condition or Disease	Intervention/Treatment	Phase
Kidney Transplant	Biological: Infliximab; Drug: Methylprednisolone; Drug: Mycophenolate Mofetil; Drug: Tacrolimus; Biological: Thymoglobulin®; Drug: Acetaminophen; Drug: Loratadine; Biological: Placebo for Infliximab; Drug: Prednisone; Drug: Diphenhydramine	Phase 2

Detailed Description

This is a Phase 2, multicenter, randomized, double blind (masked), placebo-controlled, 2-arm clinical trial of 300 deceased donor kidney transplant recipients. Participants will be randomized (1:1) to the experimental or control arm (150 subjects per arm).

Study Design

• Study Type: Interventional
• Actual Enrollment: 290 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Randomized Controlled Trial of Infliximab (Remicade®) Induction Therapy for Deceased Donor Kidney Transplant Recipients (CTOT-19)
• Actual Study Start Date: Nov 2, 2015
• Actual Primary Completion Date: Jul 23, 2021
• Actual Study Completion Date: Jul 23, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental rATG is co-administered with anti-TNFa (infliximab/Remicade®) plus maintenance therapy with tacrolimus, a mycophenolic acid derivative (either MMF or enteric coated MPA) and prednisone.	Biological: Infliximab; A single dose, of 3mg/kg infusion; Other Names: Remicade® ; Drug: Methylprednisolone; 500mg will be Initiated just prior to or at the initiation of transplant surgery and prior to Infliximab and thymoglobulin infusion; Other Names: Solu-Medrol ; Drug: Mycophenolate Mofetil; Administered at a target dose of 2000mg daily, as tolerated, until study closure; Other Names: MMF CellCept® ; Drug: Tacrolimus; Administered at a target dose of 0.1mg/kg BID, post-op, then adjusted to target trough levels of 8-12ng/ml during 1st 3-months post-op and finally adjusted to target trough levels of 5-8ng/ml until study closure; Other Names: FK-506 FR-900506 Prograf® ; Biological: Thymoglobulin®; Administered daily for 5 days with the intention of achieving a total dose of 4.5 to 6.0 mg/kg, as tolerated; Other Names: Antithymocyte Globulin [Rabbit] Rabbit ATG ; Drug: Acetaminophen; 30 to 60 minutes prior to the start of the infusion Tylenol, 600 to 1000mg by mouth or Suppository form; Other Names: Tylenol® ; Drug: Loratadine; 30 to 60 minutes prior to the start of the infusion Claritin (Loratadine) 10mg by mouth or Benadryl (Diphenhydramine) 25 or 50 mg by mouth; Other Names: Claritin® ; Drug: Prednisone; Prednisone will be administered peri-operatively according to center practice. Prednisone should be gradually tapered to no less than 5 mg/day or 10 mg every other day by 3 months post-transplant thereafter until study closure.; Drug: Diphenhydramine; 30 to 60 minutes prior to the start of the infusion Claritin (Loratadine) 10mg by mouth or Benadryl (Diphenhydramine) 25 or 50 mg by mouth; Other Names: Benadryl
Active Comparator: Control Rabbit anti-thymocyte globulin (rATG/Thymoglobulin®) plus placebo (Sterile normal saline) induction followed by maintenance therapy with tacrolimus, a mycophenolic acid derivative (either MMF or enteric coated MPA) and prednisone.	Drug: Methylprednisolone; 500mg will be Initiated just prior to or at the initiation of transplant surgery and prior to Infliximab and thymoglobulin infusion; Other Names: Solu-Medrol ; Drug: Mycophenolate Mofetil; Administered at a target dose of 2000mg daily, as tolerated, until study closure; Other Names: MMF CellCept® ; Drug: Tacrolimus; Administered at a target dose of 0.1mg/kg BID, post-op, then adjusted to target trough levels of 8-12ng/ml during 1st 3-months post-op and finally adjusted to target trough levels of 5-8ng/ml until study closure; Other Names: FK-506 FR-900506 Prograf® ; Biological: Thymoglobulin®; Administered daily for 5 days with the intention of achieving a total dose of 4.5 to 6.0 mg/kg, as tolerated; Other Names: Antithymocyte Globulin [Rabbit] Rabbit ATG ; Drug: Acetaminophen; 30 to 60 minutes prior to the start of the infusion Tylenol, 600 to 1000mg by mouth or Suppository form; Other Names: Tylenol® ; Drug: Loratadine; 30 to 60 minutes prior to the start of the infusion Claritin (Loratadine) 10mg by mouth or Benadryl (Diphenhydramine) 25 or 50 mg by mouth; Other Names: Claritin® ; Biological: Placebo for Infliximab; A single dose is volume matched to Infliximab (250mL) infusion; Drug: Prednisone; Prednisone will be administered peri-operatively according to center practice. Prednisone should be gradually tapered to no less than 5 mg/day or 10 mg every other day by 3 months post-transplant thereafter until study closure.; Drug: Diphenhydramine; 30 to 60 minutes prior to the start of the infusion Claritin (Loratadine) 10mg by mouth or Benadryl (Diphenhydramine) 25 or 50 mg by mouth; Other Names: Benadryl

Outcome Measures

Primary Outcome Measures

1. The Difference Between the Mean eGFR (Modified MDRD) in the Experimental vs. Control Groups. [24-Month post-transplantation]

   Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Modification of Diet in Renal Disease (MDRD) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. eGFR values from months 1, 3, 6, 12, 18, and 24 were used to generate an estimate of the month 24 eGFR for each treatment group.

Secondary Outcome Measures

1. Percent of Participants With Biopsy Proven Acute Cellular Rejection (BPAR) [6 month post-transplantation]

   Acute cellular rejection was defined based on central lab pathology interpretation using the Banff 2007 criteria. Participants with a Banff grade of greater than or equal to IA with or without clinical symptoms within 6 months of transplant were determined to have met the endpoint. Severity is graded as IA, IB, IIA, IIB, or III, with IA being the mildest form of cellular rejection and III being the most severe form of cellular rejection.Criteria include: IA-significant interstitial infiltration and foci of moderate tubulitis; IB-significant interstitial infiltration and foci of severe tubulitis; IIA-mild to moderate intimal arteritis; IIB-severe intimal arteritis; III-transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation.

2. Percent of Participants With Biopsy Proven Acute Cellular Rejection (BPAR). [24 months post-transplantation]

   Acute cellular rejection was defined based on central lab pathology interpretation using the Banff 2007 criteria. Participants with a Banff grade of greater than or equal to IA with or without clinical symptoms within 24 months of transplant were determined to have met the endpoint. Severity is graded as IA, IB, IIA, IIB, or III, with IA being the mildest form of cellular rejection and III being the most severe form of cellular rejection. Criteria include: IA-significant interstitial infiltration and foci of moderate tubulitis; IB-significant interstitial infiltration and foci of severe tubulitis; IIA-mild to moderate intimal arteritis; IIB-severe intimal arteritis; III-transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation.

3. BANFF Grades of First Acute Cellular Rejections (ACR). [6 month post-transplantation]

   Acute cellular rejection was defined based on central lab pathology interpretation using the Banff 2007 criteria. Participants with a Banff grade of greater than or equal to IA with or without clinical symptoms within 6 months of transplant were determined to have met the endpoint. Severity is graded as IA, IB, IIA, IIB, or III, with IA being the mildest form of cellular rejection and III being the most severe form of cellular rejection.Criteria include: IA-significant interstitial infiltration and foci of moderate tubulitis; IB-significant interstitial infiltration and foci of severe tubulitis; IIA-mild to moderate intimal arteritis; IIB-severe intimal arteritis; III-transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation.

4. Percent of Participants With Biopsy Proven Acute Cellular Rejection (BPAR) or Borderline Rejection. [6 months post-transplantation]

   Acute cellular rejection was defined based on central lab pathology interpretation using the Banff 2007 criteria. Participants with a Banff grade of borderline or greater than or equal to IA with or without clinical symptoms within 6 months of transplant were determined to have met the endpoint. Severity is graded as Borderline, IA, IB, IIA, IIB, or III, with borderline representing possible cellular rejection, IA being the mildest form of cellular rejection, and III being the most severe form of cellular rejection.Criteria include: Borderline-no intimal arteritis is present but foci of mild tubulitis; IA-significant interstitial infiltration and foci of moderate tubulitis; IB-significant interstitial infiltration and foci of severe tubulitis; IIA-mild to moderate intimal arteritis; IIB-severe intimal arteritis; III-transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation.

5. Percent of Participants With Biopsy Proven Acute Cellular Rejection (BPAR) or Borderline Rejection [24 months post-transplantation]

   Acute cellular rejection was defined based on central lab pathology interpretation using the Banff 2007 criteria. Participants with a Banff grade of borderline or greater than or equal to IA with or without clinical symptoms within 24 months of transplant were determined to have met the endpoint. Severity is graded as Borderline, IA, IB, IIA, IIB, or III, with borderline representing possible cellular rejection, IA being the mildest form of cellular rejection, and III being the most severe form of cellular rejection. Criteria include: Borderline-no intimal arteritis is present but foci of mild tubulitis; IA-significant interstitial infiltration and foci of moderate tubulitis; IB-significant interstitial infiltration and foci of severe tubulitis; IIA-mild to moderate intimal arteritis; IIB-severe intimal arteritis; III-transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation.

6. Percent of Participants With Biopsy Proven Acute Antibody Mediated Rejection (AMR) [6 months post-transplantation]

   Antibody mediated rejection (AMR) was defined based on central lab pathology interpretation using the Banff 2013 criteria. Participants with a Banff finding of AMR within 6 months of transplant were determined to have met the endpoint. AMR is classified as acute/active, chronic/active, or C4d staining positive.Criteria include: acute/active-histologic evidence of acute tissue injury, evidence of current/recent antibody interaction with vascular endothelium, and serologic evidence of donor-specific antibodies (DSAs); chronic/active-morphologic evidence of chronic tissue injury, evidence of current/recent antibody interaction with vascular endothelium, and serologic evidence of DSAs; C4d staining positive-linear C4d staining in peritubular capillaries, glomerulitis=0, peritubular capillary=0, chronic glomerulopathy=0, no acute cell-mediated rejection or borderline changes.

7. Percent of Participants With Biopsy Proven Acute Antibody Mediated Rejection (AMR). [24 months post-transplantation]

   Antibody mediated rejection (AMR) was defined based on central lab pathology interpretation using the Banff 2013 criteria. Participants with a Banff finding of AMR within 24 months of transplant were determined to have met the endpoint. AMR is classified as acute/active, chronic/active, or C4d staining positive. Criteria include: acute/active-histologic evidence of acute tissue injury, evidence of current/recent antibody interaction with vascular endothelium, and serologic evidence of donor-specific antibodies (DSAs); chronic/active-morphologic evidence of chronic tissue injury, evidence of current/recent antibody interaction with vascular endothelium, and serologic evidence of DSAs; C4d staining positive-linear C4d staining in peritubular capillaries, glomerulitis=0, peritubular capillary=0, chronic glomerulopathy=0, no acute cell-mediated rejection or borderline changes.

8. Percent of Participants With Biopsy Proven Acute Antibody Mediated Rejection AMR or Suspicious for AMR [6 months post-transplantation]

   Antibody mediated rejection (AMR) was defined based on central lab pathology interpretation using the Banff 2013 criteria. Participants with a Banff finding of AMR or suspicious for AMR within 6 months of transplant were determined to have met the endpoint. AMR is classified as acute/active, chronic/active, C4d staining positive, or suspicious. Criteria include: acute/active-histologic evidence of acute tissue injury, evidence of current/recent antibody interaction with vascular endothelium, and serologic evidence of donor-specific antibodies (DSAs); chronic/active-morphologic evidence of chronic tissue injury, evidence of current/recent antibody interaction with vascular endothelium, and serologic evidence of DSAs; C4d staining positive-linear C4d staining in peritubular capillaries, glomerulitis=0, peritubular capillary=0, chronic glomerulopathy=0, no acute cell-mediated rejection or borderline changes; suspicious-when 2 of 3 factors for acute/active are present.

9. Percent of Participants With Biopsy Proven Acute Antibody Mediated Rejection AMR or Suspicious for AMR. [24 months post-transplantation]

   Antibody mediated rejection (AMR) was defined based on central lab pathology interpretation using the Banff 2013 criteria. Participants with a Banff finding of AMR or suspicious for AMR within 24 months of transplant were determined to have met the endpoint. AMR is classified as acute/active, chronic/active, C4d staining positive, or suspicious. Criteria include: acute/active-histologic evidence of acute tissue injury, evidence of current/recent antibody interaction with vascular endothelium, and serologic evidence of donor-specific antibodies (DSAs); chronic/active-morphologic evidence of chronic tissue injury, evidence of current/recent antibody interaction with vascular endothelium, and serologic evidence of DSAs; C4d staining positive-linear C4d staining in peritubular capillaries, glomerulitis=0, peritubular capillary=0, chronic glomerulopathy=0, no acute cell-mediated rejection or borderline changes; suspicious-when 2 of 3 factors for acute/active are present

10. BANFF Grades of First AMR. [6 months post-transplantation]

    Antibody mediated rejection (AMR) was defined based on central lab pathology interpretation using the Banff 2013 criteria. Participants with a Banff finding of AMR within 6 months of transplant were determined to have met the endpoint. AMR is classified as acute/active, chronic/active, or C4d staining positive. Criteria include: acute/active-histologic evidence of acute tissue injury, evidence of current/recent antibody interaction with vascular endothelium, and serologic evidence of donor-specific antibodies (DSAs); chronic/active-morphologic evidence of chronic tissue injury, evidence of current/recent antibody interaction with vascular endothelium, and serologic evidence of DSAs; C4d staining positive-linear C4d staining in peritubular capillaries, glomerulitis=0, peritubular capillary=0, chronic glomerulopathy=0, no acute cell-mediated rejection or borderline changes.

11. Percent of Participants With BANFF Chronicity Scores > or Equal 2 on the 24 Month Biopsy. [24 months post-transplantation]

    The Banff 2013 classification involves scoring numerous characteristics of renal biopsy specimens. The ci (interstitial fibrosis) and ct (tubular atrophy) scores are two such characteristics. The scores can take values of 0, 1, 2, or 3 for each characteristic (ci and ct), indicating increasing severity of disease as the scores increase. Participants are considered to have met this endpoint if their ci + ct score on the 24 month biopsy summed to be > or equal to 2.

12. Change in BANFF Chronicity Scores Between Implantation and the 24 Month Biopsy. [24 months post-transplantation]

    The Banff 2013 classification involves scoring numerous characteristics of renal biopsy specimens. The ci (interstitial fibrosis) and ct (tubular atrophy) scores are two such characteristics. The scores can take values of 0, 1, 2, or 3 for each characteristic (ci and ct), indicating increasing severity of disease as the scores increase. For this endpoint, the sum of ci+ct scores from the implantation biopsy was subtracted from the sum of the ci+ct scores from the month 24 biopsy and the difference between the two time points was classified as 0, 1, 2, or 3+. Higher values of this difference indicate more severe disease.

13. Percent of Participants With Locally Treated Rejection, Defined as Treatment Administered for Rejection Based on Clinical Signs or Biopsy Findings. [6 months post-transplantation]

    Biopsies were read by the local pathologist at the hospital where the participant was a patient. These local reads informed clinical care for the participant, which may or may not include prescribing/administering medication to the participant to help with clinical concerns or findings noted on a biopsy. Participants were considered to have met this endpoint if they have a report of receiving treatment for clinical or biopsy-proven rejection during the first 6 months post-transplant.

14. Percent of Participants With Locally Treated Rejection, Defined as Treatment Administered for Rejection Based on Clinical Signs or Biopsy Findings. [24 months post-transplantation]

    Biopsies were read by the local pathologist at the hospital where the participant was a patient. These local reads informed clinical care for the participant, which may or may not include prescribing/administering medication to the participant to help with clinical concerns or findings noted on a biopsy. Participants were considered to have met this endpoint if they have a report of receiving treatment for clinical or biopsy-proven rejection during the 24 month post-transplant follow-up.

15. Change in eGFR Between 3 Months and 24 Months as Measured by MDRD [3 months and 24 months post-transplantation]

    Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Modification of Diet in Renal Disease (MDRD) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. The change in eGFR between months 3 and 24 was calculated as the month 24 eGFR minus the month 3 eGFR for each participant. A window of +/- 14 days was used for month 3 and +/- 1 month was used for month 24.

16. Change in eGFR Between 3 Months and 24 Months as Measured by CKD-EPI [3 months and 24 months post-transplantation]

    Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. The change in eGFR between months 3 and 24 was calculated as the month 24 eGFR minus the month 3 eGFR for each participant. A window of +/- 14 days was used for month 3 and +/- 1 month was used for month 24.

17. Change in eGFR Between Post-transplant Nadir and 24 Months as Measured by MDRD [6 months and 24 months post-transplantation]

    Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Modification of Diet in Renal Disease (MDRD) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. Post-transplant nadir was defined as the lowest value of eGFR from the first 6 months post-transplant. The change in eGFR between nadir and month 24 was calculated as the month 24 eGFR minus the nadir eGFR for each participant. A window of +/- 21 days was used for month 6 and +/- 1 month was used for month 24.

18. Change in eGFR Between Post-transplant Nadir and 24 Months as Measured by CKD-EPI [6 months and 24 months post-transplantation]

    Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. Post-transplant nadir was defined as the lowest value of eGFR from the first 6 months post-transplant. The change in eGFR between nadir and month 24 was calculated as the month 24 eGFR minus the nadir eGFR for each participant. A window of +/- 21 days was used for month 6 and +/- 1 month was used for month 24.

19. Change in eGFR Between 6 Months and 24 Months as Measured by MDRD [6 months and 24 months post-transplantation]

    Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Modification of Diet in Renal Disease (MDRD) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. The change in eGFR between months 6 and 24 was calculated as the month 24 eGFR minus the month 6 eGFR for each participant. A window of +/- 21 days was used for month 6 and +/- 1 month was used for month 24.

20. Change in eGFR Between 6 Months and 24 Months as Measured by CKD-EPI [6 months and 24 months post-transplantation]

    Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. The change in eGFR between months 6 and 24 was calculated as the month 24 eGFR minus the month 6 eGFR for each participant. A window of +/- 21 days was used for month 6 and +/- 1 month was used for month 24.

21. eGFR Values as Measured by MDRD [Day 7 post-transplantation]

    Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Modification of Diet in Renal Disease (MDRD) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. eGFR values from day 7 and months 1, 3, 6, 12, 18, and 24 were used to generate an estimate of the eGFR at each time point of interest for each treatment group.

22. eGFR Values as Measured by MDRD [Days 30, 60, and 180 post-transplantation]

    Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Modification of Diet in Renal Disease (MDRD) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. eGFR values from day 7 and months 1, 3, 6, 12, 18, and 24 were used to generate an estimate of the eGFR at each time point of interest for each treatment group.

23. eGFR Values as Measured by CKD-EPI [Day 7 post-transplantation]

    Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. eGFR values from day 7 and months 1, 3, 6, 12, 18, and 24 were used to generate an estimate of the eGFR at each time point of interest for each treatment group.

24. eGFR Values as Measured by CKD-EPI [Days 30, 90, and 180 post-transplantation]

    Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. eGFR values from day 7 and months 1, 3, 6, 12, 18, and 24 were used to generate an estimate of the eGFR at each time point of interest for each treatment group.

25. Percent of Participants With Death or Graft Failure. [24 months post-transplantation]

    Participants who died or experienced graft failure were considered to have met this endpoint. Graft failure was defined as the need for post-transplant dialysis for more than 56 days.

26. Percent of Participants With Only Graft Failure. [24 months post-transplantation]

    Participants who experienced graft failure were considered to have met this endpoint. Graft failure was defined as the need for post-transplant dialysis for more than 56 days.

27. Percent of Participants That Required at Least One Dialysis Treatment. [1 week post-transplantation]

    Dialysis within the first week post-transplant is used in the setting of delayed graft function (DGF). Participants are considered to have had DGF if they had at least one dialysis treatment in the first week post-transplant.

28. Number of Dialysis Sessions. [8 weeks post-transplantation]

    The number of dialysis sessions a person had during their first 8 weeks post-transplant was used for this endpoint.

29. Duration of Delayed Graft Function (DGF), Defined as Time From Transplantation to the Last Required Dialysis Treatment. [First post-transplant dialysis treatment to last post-transplant dialysis treatment]

    Participants are considered to have had DGF if they had at least one dialysis treatment in the first week post-transplant. For this endpoint, duration was calculated as the date of last post-transplant dialysis treatment minus the date of the first post-transplant dialysis treatment.

30. Percent of Participants With Primary Non-Function (PNF), Defined as Dialysis-dependency for More Than 3 Months. [Transplantation through at least month 3 up to month 24]

    Post-transplant dialysis is sometimes required in the setting of kidney transplant. If such dialysis continues for more than 3 months, the participant is considered to have PNF and, as such, meets this endpoint definition.

31. Change From Baseline (Immediately After Surgery) in Serum Creatinine. [24, 48 and 72 hours post-transplantation]

    Serum creatinine (mg/dL) is used to measure kidney function. A normal result is 0.7 to 1.3 mg/dL for men and 0.6 to 1.1 mg/dL for women. Higher results indicate poorer kidney function, as creatinine is removed from the body by the kidneys. eGFR values from 24, 48, and 72 hours post-transplant (i.e., days 1, 2, and 3) were used to generate an estimate of the serum creatinine at each time point of interest for each treatment group.

32. Days From Transplantation Until Event (ACR, AMR, or Hospitalization for Infection and/or Malignancy) [24 months post-transplantation]

    Participants are considered to have met this endpoint if they experienced biopsy-proven T-cell mediated rejection (ACR) or antibody mediated rejection (AMR) based on central pathology reading or were hospitalized for infection and/or malignancy. For participants who met one or more of these three components, the earliest event date of the three components was used as the time of meeting the endpoint. Participants who did not meet any of the three components were censored at their last date of follow-up. Event (or censor) day was calculated as event (or censor) date minus transplant date.

33. The Percent of Participants With a Serum Creatinine of More Than 3 mg/dL. [Day 5 post-transplantation]

    Serum creatinine (mg/dL) is used to measure kidney function. A normal result is 0.7 to 1.3 mg/dL for men and 0.6 to 1.1 mg/dL for women. Higher results indicate poorer kidney function, as creatinine is removed from the body by the kidneys. This endpoint is ascertaining slow graft function in the immediate days post-transplant. A participant was considered to have met this endpoint if their day 5 serum creatinine was greater than 3 mg/dL.

34. Creatinine Reduction Ratio (CRR), Defined as the First Creatinine on Day 2 Divided by he First Creatinine After Surgery [Day 2 post-transplantation]

    Serum creatinine (mg/dL) is used to measure kidney function. A normal result is 0.7 to 1.3 mg/dL for men and 0.6 to 1.1 mg/dL for women. Higher results indicate poorer kidney function, as creatinine is removed from the body by the kidneys. CRR was calculated as the day 1 post-transplant creatinine value minus the day 2 creatinine value divided by the day 1 creatinine value and multiplied by 100, resulting in a percentage. Higher numbers indicate a greater reduction in serum creatinine and, thus, potentially better kidney function.

35. Creatinine Reduction Ratio (CRR), Defined as the First Creatinine on Day 5 Divided by the First Creatinine After Surgery. [Day 5 post-transplantation]

    Serum creatinine (mg/dL) is used to measure kidney function. A normal result is 0.7 to 1.3 mg/dL for men and 0.6 to 1.1 mg/dL for women. Higher results indicate poorer kidney function, as creatinine is removed from the body by the kidneys. CRR was calculated as the day 1 post-transplant creatinine value minus the day 5 creatinine value divided by the day 1 creatinine value and multiplied by 100, resulting in a percentage. Higher numbers indicate a greater reduction in serum creatinine and, thus, potentially better kidney function.

36. The Percent of Participants Whose Day 5 Serum CRR Was Less Than 70%. [Day 5 post-transplantation]

    Serum creatinine (mg/dL) is used to measure kidney function. A normal result is 0.7 to 1.3 mg/dL for men and 0.6 to 1.1 mg/dL for women. Higher results indicate poorer kidney function, as creatinine is removed from the body by the kidneys. CRR was calculated as the day 1 post-transplant creatinine value minus the day 5 creatinine value divided by the day 1 creatinine value and multiplied by 100, resulting in a percentage. Higher numbers indicate a greater reduction in serum creatinine and, thus, potentially better kidney function. A participant was considered to have met this endpoint if their day 5 serum CRR was less than 70%.

37. The Percent of Participants Whose Day 2 Serum CRR Was Less Than 30%. [Day 2 post-transplantation]

    Serum creatinine (mg/dL) is used to measure kidney function. A normal result is 0.7 to 1.3 mg/dL for men and 0.6 to 1.1 mg/dL for women. Higher results indicate poorer kidney function, as creatinine is removed from the body by the kidneys. CRR was calculated as the day 1 post-transplant creatinine value minus the day 2 creatinine value divided by the day 1 creatinine value and multiplied by 100, resulting in a percentage. Higher numbers indicate a greater reduction in serum creatinine and, thus, potentially better kidney function. A participant was considered to have met this endpoint if their day 2 serum CRR was less than 30%.

38. The Percent of Participants Who Need Dialysis After Week 1. [1 week to 24 months post-transplantation]

    Participants who needed dialysis after the first week post-transplant were considered to have met this endpoint.

39. Percent of Participants With de Novo DSA. [24 months post-transplantation]

    Donor specific antibody (DSA) can be formed post-transplant as part of the recipient's alloimmune response to the transplanted organ. DSA was determined by a central laboratory. Participants with newly developed DSA (i.e., de novo) following transplant were considered to have met this endpoint.

40. Percent of Participants With Any Infection Requiring Hospitalization or Resulting in Death. [24 months post-transplantation]

    Participants were considered to have met this endpoint if they had an infection that required hospitalization or resulted in death.

41. Percent of Participants With Mycobacterial or Fungal Infections [24 months post-transplantation]

    Participants were considered to have met this endpoint if they had at least one mycobacterial of fungal infection.

42. Percent of Participants With CMV Viremia That Require a Change in Immunosuppression or Anti-viral Treatment as Per Standard of Care at the Site [24 months post-transplantation]

    Participants were considered to have met this endpoint if they had a reported case of CMV viremia that required a change in their existing immunosuppression or the use of anti-viral therapy.

43. Percent of Participants With BK Viremia That Require a Change in Immunosuppression or Anti-viral Treatment as Per Standard of Care at the Site. [24 months post-transplantation]

    Participants were considered to have met this endpoint if they had a reported case of BK viremia that required a change in their existing immunosuppression or the use of anti-viral therapy.

44. Percent of Participants With Malignancy. [24 months post-transplantation]

    Participants were considered to have met this endpoint if they had a reported case of malignancy.

45. Percent of Participants With Impaired Wound Healing Manifested by Wound Dehiscence, Wound Infection, or Hernia at the Site of the Transplant Incision [24 months post-transplantation]

    Participants were considered to have met this endpoint if they had a reported case of impaired wound healing at the site of the transplant incision manifested by one wound dehiscence, wound infection, or hernia.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Adult (>18 years of age) male and female recipients (all races and ethnicities)

2. Subject must be able to understand and provide consent

3. Recipients of deceased donor kidney transplants (including re-transplants)

4. Negative crossmatch, actual or virtual, or a PRA of 0% on historic and current sera as determined by each participating study center

5. Donor kidneys from deceased donors and donors after cardiac death (DCD) with Kidney Donor Profile Indices (KDPI) ranging from ≥20 to <95

6. Female participants of childbearing potential must have a negative pregnancy test upon study entry

7. Subjects must have a negative test result for latent tuberculosis (TB) infection (PPD,

QuantiFERON, ELISPOT):

• Subjects who have a negative test result for latent TB infection within 1 year of transplant date are eligible for enrollment and no further action is required

• Subjects who have a negative test for latent TB infection that is greater than 1 year old are eligible for enrollment but are required to have a repeat test prior to transplantation.

Exclusion Criteria:

1. Inability or unwillingness of a participant to give written informed consent or comply with study protocol

2. Recipients of living donor transplants

3. Presence of other transplanted solid organ (heart, lung, liver, pancreas, small intestines) or co-transplanted organ

4. Human immunodeficiency virus positive (HIV+) recipients

5. Epstein-Barr virus Immunoglobulin G (EBV IgG) negative recipients

6. Hepatitis B surface antigen positive kidney transplant recipients

7. Hepatitis B core antibody positive kidney transplant recipients

8. Hepatitis B negative kidney transplant recipients that receive transplants from Hepatitis B core antibody positive donor

9. Hepatitis C Virus positive (HCV+) patients who are either untreated or have failed to demonstrate sustained viral remission for more than 12 months after anti-viral treatment

10. Recipients with a previous history of active TB

11. Recipients with a positive test for latent TB infection (PPD, QuantiFERON, ELISPOT), regardless of previous therapy

12. Any severe infection at the time of transplantation.

--Note: Severe infection determination will be made by the local site investigator.

1. Severe congestive heart failure (NYHA functional class III or higher)

2. Subjects with a known hypersensitivity to any murine/ mouse proteins

3. Subjects with any history of receiving any anti-tumor necrosis factor (anti- TNF) products

4. Subjects in whom rabbit anti-thymocyte globulin (Thymoglobulin®) or infliximab might not be tolerated

5. Subjects with a white blood cell count less than 3000/mm^3

6. Subjects with a platelet count less than 100,000/mm^3

7. Subjects with systolic blood pressure <100 mm/Hg

8. Subjects with symptomatic orthostatic hypotension or currently requiring Midodrine for blood pressure support

9. Subjects from, or who have traveled, to endemic areas with a history of active histoplasmosis or, with a chest x-ray consistent with previous active histoplasmosis (no serological testing required) :

--Endemic regions determined by site based on local standard of care.

1. Subjects currently or formerly residing in regions of the United States that are highly endemic for coccidioidomycosis, and who have a positive serologic test for coccidioidomycosis:

--Endemic regions determined by site based on local standard of care.

1. Recipients are excluded if the local site decides to treat the recipient with fluconazole because of diagnosis or suspicion of fungal infection the donor

2. Subjects that receive IVIG treatment within 3 months of transplant or planned intravenous immunoglobulin (IVIG) treatment peri-transplant

3. Use of an investigational agent within 4-weeks prior to study entry.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294
2	University of California, Los Angeles	Los Angeles	California	United States	90024
3	University of California, San Francisco	San Francisco	California	United States	94143
4	Yale University	New Haven	Connecticut	United States	06511
5	Emory University	Atlanta	Georgia	United States	30322
6	University of Maryland	Baltimore	Maryland	United States	21201
7	Johns Hopkins University	Baltimore	Maryland	United States	21287
8	University of Michigan	Ann Arbor	Michigan	United States	48109
9	Washington University School of Medicine in St. Louis	Saint Louis	Missouri	United States	63110
10	Mount Sinai Medical Center	New York	New York	United States	10029
11	Cleveland Clinic	Cleveland	Ohio	United States	44106
12	University Hospitals of Cleveland	Cleveland	Ohio	United States	44106
13	University of Wisconsin	Madison	Wisconsin	United States	53792
14	University of Manitoba	Winnipeg	Manitoba	Canada	R3A 1R9
15	Toronto General Hospital	Toronto	Ontario	Canada	M5G 2C4

Sponsors and Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID)
• Clinical Trials in Organ Transplantation
• Rho Federal Systems Division, Inc.

Investigators

• Principal Investigator: Peter S. Heeger, MD, Icahn School of Medicine at Mount Sinai, Recanati Miller Transplant Institute
• Study Chair: Donald E Hricik, MD, University Hospitals of Cleveland, Division of Nephrology & Hypertension

Study Documents (Full-Text)

• Study Protocol - Apr 27, 2020
• Statistical Analysis Plan - Dec 14, 2021

More Information

Additional Information:

• Division of Allergy, Immunology, and Transplantation (DAIT)
• National Institute of Allergy and Infectious Diseases (NIAID)
• Clinical Trials in Organ Transplantation (CTOT)

Publications

None provided.

• Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
• ClinicalTrials.gov Identifier: NCT02495077
• Other Study ID Numbers: DAIT CTOT-19; U01AI063594; NIAID CRMS ID#: 20678
• First Posted: Jul 13, 2015
• Last Update Posted: Aug 16, 2022
• Last Verified: Jul 1, 2022

• Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID): Kidney Transplantation; infliximab; Tissue Donors; Remicade; Induction Therapy; Deceased Donor Kidney Transplant Recipients
• Additional relevant MeSH terms: Acetaminophen; Diphenhydramine; Promethazine; Loratadine; Mycophenolic Acid; Prednisone; Methylprednisolone; Methylprednisolone Hemisuccinate; Infliximab; Tacrolimus; Thymoglobulin; Antilymphocyte Serum

Study Results

Participant Flow

Recruitment Details	Fifteen sites consented 290 participants for evaluation of eligibility criteria. 242 participants were determined to be eligible and enrolled into this trial.
Pre-assignment Detail	290 potential participants signed an informed consent before undergoing any study procedures. After the informed consent was signed and the participant was determined to meet entry criteria, the participant was enrolled in the study. A total of 242 were determined eligible to start the study.

Arm/Group Title	Experimental	Control	Enrolled, Discontinued Pre-Transplant	Screen Failure
Arm/Group Description	The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	Participants who were eligible and enrolled but withdrew from the study prior to receiving a transplant.	Participants who were consented but did not meet inclusion/exclusion criteria.
Period Title: Overall Study
STARTED	113	112	17	48
COMPLETED	93	91	0	0
NOT COMPLETED	20	21	17	48

Baseline Characteristics

Arm/Group Title	Experimental	Control	Total
Arm/Group Description	The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	Total of all reporting groups
Overall Participants	113	112	225
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	93 82.3%	96 85.7%	189 84%
>=65 years	20 17.7%	16 14.3%	36 16%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53.2 (10.70)	53.6 (10.69)	53.4 (10.67)
Sex: Female, Male (Count of Participants)
Female	42 37.2%	48 42.9%	90 40%
Male	71 62.8%	64 57.1%	135 60%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	17 15%	12 10.7%	29 12.9%
Not Hispanic or Latino	96 85%	99 88.4%	195 86.7%
Unknown or Not Reported	0 0%	1 0.9%	1 0.4%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 0.9%	1 0.9%	2 0.9%
Asian	7 6.2%	6 5.4%	13 5.8%
Native Hawaiian or Other Pacific Islander	2 1.8%	2 1.8%	4 1.8%
Black or African American	40 35.4%	46 41.1%	86 38.2%
White	51 45.1%	48 42.9%	99 44%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	12 10.6%	9 8%	21 9.3%
Region of Enrollment (participants) [Number]
Canada	2 1.8%	2 1.8%	4 1.8%
United States	111 98.2%	110 98.2%	221 98.2%
Reason for Transplant (Count of Participants)
Diabetes	28 24.8%	32 28.6%	60 26.7%
Glomerular disease	21 18.6%	18 16.1%	39 17.3%
Hypertension	24 21.2%	23 20.5%	47 20.9%
Polycystic kidney disease	15 13.3%	10 8.9%	25 11.1%
Other	25 22.1%	29 25.9%	54 24%
Donor Cause of Death (Count of Participants)
CVA	34 30.1%	22 19.6%	56 24.9%
Non-CVA	79 69.9%	90 80.4%	169 75.1%

Outcome Measures

1. Primary Outcome

Title	The Difference Between the Mean eGFR (Modified MDRD) in the Experimental vs. Control Groups.
Description	Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Modification of Diet in Renal Disease (MDRD) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. eGFR values from months 1, 3, 6, 12, 18, and 24 were used to generate an estimate of the month 24 eGFR for each treatment group.
Time Frame	24-Month post-transplantation

Outcome Measure Data

Analysis Population Description

Intent-to-treat population included all transplanted and randomized participants who received the infliximab/placebo infusion, subset to participants with available eGFR data.

Arm/Group Title	Experimental	Control
Arm/Group Description	The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Measure Participants	111	109
Mean (95% Confidence Interval) [mL/min/1.73m2]	52.45	57.35

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental, Control
	Comments	Mean eGFR of the two treatment groups was compared. The p-value, estimated month 24 eGFR within each treatment group, estimate of the treatment group difference, and estimated 95% confidence intervals result from a repeated measures mixed model using available eGFR data from months 1, 3, 6, 12, 18, and 24 to compare the experimental group to the control group. Random effects for the intercept and eGFR collection day were utilized in the model.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.099
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-4.90
	Confidence Interval	(2-Sided) 95%; -10.73 to 0.93
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Percent of Participants With Biopsy Proven Acute Cellular Rejection (BPAR)
Description	Acute cellular rejection was defined based on central lab pathology interpretation using the Banff 2007 criteria. Participants with a Banff grade of greater than or equal to IA with or without clinical symptoms within 6 months of transplant were determined to have met the endpoint. Severity is graded as IA, IB, IIA, IIB, or III, with IA being the mildest form of cellular rejection and III being the most severe form of cellular rejection.Criteria include: IA-significant interstitial infiltration and foci of moderate tubulitis; IB-significant interstitial infiltration and foci of severe tubulitis; IIA-mild to moderate intimal arteritis; IIB-severe intimal arteritis; III-transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation.
Time Frame	6 month post-transplantation

Outcome Measure Data

Analysis Population Description

Intent-to-treat population included all transplanted and randomized participants who received the infliximab/placebo infusion, subset to participants with available central pathology read data.

Arm/Group Title	Experimental	Control
Arm/Group Description	The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Measure Participants	71	66
Number (95% Confidence Interval) [percentage of participants]	4.2 3.7%	3.0 2.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	>0.999
	Comments
	Method	Fisher Exact
	Comments

3. Secondary Outcome

Title	Percent of Participants With Biopsy Proven Acute Cellular Rejection (BPAR).
Description	Acute cellular rejection was defined based on central lab pathology interpretation using the Banff 2007 criteria. Participants with a Banff grade of greater than or equal to IA with or without clinical symptoms within 24 months of transplant were determined to have met the endpoint. Severity is graded as IA, IB, IIA, IIB, or III, with IA being the mildest form of cellular rejection and III being the most severe form of cellular rejection. Criteria include: IA-significant interstitial infiltration and foci of moderate tubulitis; IB-significant interstitial infiltration and foci of severe tubulitis; IIA-mild to moderate intimal arteritis; IIB-severe intimal arteritis; III-transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation.
Time Frame	24 months post-transplantation

Outcome Measure Data

Analysis Population Description

Intent-to-treat population included all transplanted and randomized participants who received the infliximab/placebo infusion, subset to participants with available central pathology read data.

Arm/Group Title	Experimental	Control
Arm/Group Description	The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Measure Participants	78	71
Number (95% Confidence Interval) [percentage of participants]	5.1 4.5%	4.2 3.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	>0.999
	Comments
	Method	Fisher Exact
	Comments

4. Secondary Outcome

Title	BANFF Grades of First Acute Cellular Rejections (ACR).
Description	Acute cellular rejection was defined based on central lab pathology interpretation using the Banff 2007 criteria. Participants with a Banff grade of greater than or equal to IA with or without clinical symptoms within 6 months of transplant were determined to have met the endpoint. Severity is graded as IA, IB, IIA, IIB, or III, with IA being the mildest form of cellular rejection and III being the most severe form of cellular rejection.Criteria include: IA-significant interstitial infiltration and foci of moderate tubulitis; IB-significant interstitial infiltration and foci of severe tubulitis; IIA-mild to moderate intimal arteritis; IIB-severe intimal arteritis; III-transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation.
Time Frame	6 month post-transplantation

Outcome Measure Data

Analysis Population Description

Intent-to-treat population included all transplanted and randomized participants who received the infliximab/placebo infusion, subset to participants who had ACR within the first 6 months.

Arm/Group Title	Experimental	Control
Arm/Group Description	The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Measure Participants	3	2
IA	1 0.9%	1 0.9%
IB	1 0.9%	0 0%
IIA	1 0.9%	1 0.9%
IIB	0 0%	0 0%
III	0 0%	0 0%

5. Secondary Outcome

Title	Percent of Participants With Biopsy Proven Acute Cellular Rejection (BPAR) or Borderline Rejection.
Description	Acute cellular rejection was defined based on central lab pathology interpretation using the Banff 2007 criteria. Participants with a Banff grade of borderline or greater than or equal to IA with or without clinical symptoms within 6 months of transplant were determined to have met the endpoint. Severity is graded as Borderline, IA, IB, IIA, IIB, or III, with borderline representing possible cellular rejection, IA being the mildest form of cellular rejection, and III being the most severe form of cellular rejection.Criteria include: Borderline-no intimal arteritis is present but foci of mild tubulitis; IA-significant interstitial infiltration and foci of moderate tubulitis; IB-significant interstitial infiltration and foci of severe tubulitis; IIA-mild to moderate intimal arteritis; IIB-severe intimal arteritis; III-transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation.
Time Frame	6 months post-transplantation

Outcome Measure Data

Analysis Population Description

Intent-to-treat population included all transplanted and randomized participants who received the infliximab/placebo infusion, subset to participants with available central pathology read data.

Arm/Group Title	Experimental	Control
Arm/Group Description	The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Measure Participants	71	66
Number (95% Confidence Interval) [percentage of participants]	8.5 7.5%	6.1 5.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.746
	Comments
	Method	Fisher Exact
	Comments

6. Secondary Outcome

Title	Percent of Participants With Biopsy Proven Acute Cellular Rejection (BPAR) or Borderline Rejection
Description	Acute cellular rejection was defined based on central lab pathology interpretation using the Banff 2007 criteria. Participants with a Banff grade of borderline or greater than or equal to IA with or without clinical symptoms within 24 months of transplant were determined to have met the endpoint. Severity is graded as Borderline, IA, IB, IIA, IIB, or III, with borderline representing possible cellular rejection, IA being the mildest form of cellular rejection, and III being the most severe form of cellular rejection. Criteria include: Borderline-no intimal arteritis is present but foci of mild tubulitis; IA-significant interstitial infiltration and foci of moderate tubulitis; IB-significant interstitial infiltration and foci of severe tubulitis; IIA-mild to moderate intimal arteritis; IIB-severe intimal arteritis; III-transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation.
Time Frame	24 months post-transplantation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Experimental	Control
Arm/Group Description	The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Measure Participants	78	71
Number (95% Confidence Interval) [percentage of participants]	12.8 11.3%	7 6.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.242
	Comments
	Method	Chi-squared
	Comments

7. Secondary Outcome

Title	Percent of Participants With Biopsy Proven Acute Antibody Mediated Rejection (AMR)
Description	Antibody mediated rejection (AMR) was defined based on central lab pathology interpretation using the Banff 2013 criteria. Participants with a Banff finding of AMR within 6 months of transplant were determined to have met the endpoint. AMR is classified as acute/active, chronic/active, or C4d staining positive.Criteria include: acute/active-histologic evidence of acute tissue injury, evidence of current/recent antibody interaction with vascular endothelium, and serologic evidence of donor-specific antibodies (DSAs); chronic/active-morphologic evidence of chronic tissue injury, evidence of current/recent antibody interaction with vascular endothelium, and serologic evidence of DSAs; C4d staining positive-linear C4d staining in peritubular capillaries, glomerulitis=0, peritubular capillary=0, chronic glomerulopathy=0, no acute cell-mediated rejection or borderline changes.
Time Frame	6 months post-transplantation

Outcome Measure Data

Analysis Population Description

Intent-to-treat population included all transplanted and randomized participants who received the infliximab/placebo infusion, subset to participants with available central pathology read data.

Arm/Group Title	Experimental	Control
Arm/Group Description	The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Measure Participants	71	66
Count of Participants [Participants]	0.0 0%	0.0 0%

8. Secondary Outcome

Title	Percent of Participants With Biopsy Proven Acute Antibody Mediated Rejection (AMR).
Description	Antibody mediated rejection (AMR) was defined based on central lab pathology interpretation using the Banff 2013 criteria. Participants with a Banff finding of AMR within 24 months of transplant were determined to have met the endpoint. AMR is classified as acute/active, chronic/active, or C4d staining positive. Criteria include: acute/active-histologic evidence of acute tissue injury, evidence of current/recent antibody interaction with vascular endothelium, and serologic evidence of donor-specific antibodies (DSAs); chronic/active-morphologic evidence of chronic tissue injury, evidence of current/recent antibody interaction with vascular endothelium, and serologic evidence of DSAs; C4d staining positive-linear C4d staining in peritubular capillaries, glomerulitis=0, peritubular capillary=0, chronic glomerulopathy=0, no acute cell-mediated rejection or borderline changes.
Time Frame	24 months post-transplantation

Outcome Measure Data

Analysis Population Description

Intent-to-treat population included all transplanted and randomized participants who received the infliximab/placebo infusion, subset to participants with available central pathology read data.

Arm/Group Title	Experimental	Control
Arm/Group Description	The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Measure Participants	78	71
Number (95% Confidence Interval) [percentage of participant]	1.3	0.0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	>0.999
	Comments
	Method	Fisher Exact
	Comments

9. Secondary Outcome

Title	Percent of Participants With Biopsy Proven Acute Antibody Mediated Rejection AMR or Suspicious for AMR
Description	Antibody mediated rejection (AMR) was defined based on central lab pathology interpretation using the Banff 2013 criteria. Participants with a Banff finding of AMR or suspicious for AMR within 6 months of transplant were determined to have met the endpoint. AMR is classified as acute/active, chronic/active, C4d staining positive, or suspicious. Criteria include: acute/active-histologic evidence of acute tissue injury, evidence of current/recent antibody interaction with vascular endothelium, and serologic evidence of donor-specific antibodies (DSAs); chronic/active-morphologic evidence of chronic tissue injury, evidence of current/recent antibody interaction with vascular endothelium, and serologic evidence of DSAs; C4d staining positive-linear C4d staining in peritubular capillaries, glomerulitis=0, peritubular capillary=0, chronic glomerulopathy=0, no acute cell-mediated rejection or borderline changes; suspicious-when 2 of 3 factors for acute/active are present.
Time Frame	6 months post-transplantation

Outcome Measure Data

Analysis Population Description

Intent-to-treat population included all transplanted and randomized participants who received the infliximab/placebo infusion, subset to participants with available central pathology read data.

Arm/Group Title	Experimental	Control
Arm/Group Description	The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Measure Participants	71	66
Number (95% Confidence Interval) [percentage of participants]	2.8 2.5%	0.0 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.497
	Comments
	Method	Fisher Exact
	Comments

10. Secondary Outcome

Title	Percent of Participants With Biopsy Proven Acute Antibody Mediated Rejection AMR or Suspicious for AMR.
Description	Antibody mediated rejection (AMR) was defined based on central lab pathology interpretation using the Banff 2013 criteria. Participants with a Banff finding of AMR or suspicious for AMR within 24 months of transplant were determined to have met the endpoint. AMR is classified as acute/active, chronic/active, C4d staining positive, or suspicious. Criteria include: acute/active-histologic evidence of acute tissue injury, evidence of current/recent antibody interaction with vascular endothelium, and serologic evidence of donor-specific antibodies (DSAs); chronic/active-morphologic evidence of chronic tissue injury, evidence of current/recent antibody interaction with vascular endothelium, and serologic evidence of DSAs; C4d staining positive-linear C4d staining in peritubular capillaries, glomerulitis=0, peritubular capillary=0, chronic glomerulopathy=0, no acute cell-mediated rejection or borderline changes; suspicious-when 2 of 3 factors for acute/active are present
Time Frame	24 months post-transplantation

Outcome Measure Data

Analysis Population Description

Intent-to-treat population included all transplanted and randomized participants who received the infliximab/placebo infusion, subset to participants with available central pathology read data.

Arm/Group Title	Experimental	Control
Arm/Group Description	The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Measure Participants	78	71
Number (95% Confidence Interval) [percentage of participants]	3.8 3.4%	1.4 1.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.622
	Comments
	Method	Fisher Exact
	Comments

11. Secondary Outcome

Title	BANFF Grades of First AMR.
Description	Antibody mediated rejection (AMR) was defined based on central lab pathology interpretation using the Banff 2013 criteria. Participants with a Banff finding of AMR within 6 months of transplant were determined to have met the endpoint. AMR is classified as acute/active, chronic/active, or C4d staining positive. Criteria include: acute/active-histologic evidence of acute tissue injury, evidence of current/recent antibody interaction with vascular endothelium, and serologic evidence of donor-specific antibodies (DSAs); chronic/active-morphologic evidence of chronic tissue injury, evidence of current/recent antibody interaction with vascular endothelium, and serologic evidence of DSAs; C4d staining positive-linear C4d staining in peritubular capillaries, glomerulitis=0, peritubular capillary=0, chronic glomerulopathy=0, no acute cell-mediated rejection or borderline changes.
Time Frame	6 months post-transplantation

Outcome Measure Data

Analysis Population Description

Intent-to-treat population included all transplanted and randomized participants who received the infliximab/placebo infusion, subset to participants with available central pathology read data.

Arm/Group Title	Experimental	Control
Arm/Group Description	The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Measure Participants	71	66
Count of Participants [Participants]	0 0%	0 0%

12. Secondary Outcome

Title	Percent of Participants With BANFF Chronicity Scores > or Equal 2 on the 24 Month Biopsy.
Description	The Banff 2013 classification involves scoring numerous characteristics of renal biopsy specimens. The ci (interstitial fibrosis) and ct (tubular atrophy) scores are two such characteristics. The scores can take values of 0, 1, 2, or 3 for each characteristic (ci and ct), indicating increasing severity of disease as the scores increase. Participants are considered to have met this endpoint if their ci + ct score on the 24 month biopsy summed to be > or equal to 2.
Time Frame	24 months post-transplantation

Outcome Measure Data

Analysis Population Description

Intent-to-treat population included all transplanted and randomized participants who received the infliximab/placebo infusion, subset to participants with available 24 month central pathology read data.

Arm/Group Title	Experimental	Control
Arm/Group Description	The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Measure Participants	26	22
Number (95% Confidence Interval) [percentage of participants]	73.1 64.7%	36.4 32.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.011
	Comments
	Method	Chi-squared
	Comments

13. Secondary Outcome

Title	Change in BANFF Chronicity Scores Between Implantation and the 24 Month Biopsy.
Description	The Banff 2013 classification involves scoring numerous characteristics of renal biopsy specimens. The ci (interstitial fibrosis) and ct (tubular atrophy) scores are two such characteristics. The scores can take values of 0, 1, 2, or 3 for each characteristic (ci and ct), indicating increasing severity of disease as the scores increase. For this endpoint, the sum of ci+ct scores from the implantation biopsy was subtracted from the sum of the ci+ct scores from the month 24 biopsy and the difference between the two time points was classified as 0, 1, 2, or 3+. Higher values of this difference indicate more severe disease.
Time Frame	24 months post-transplantation

Outcome Measure Data

Analysis Population Description

Intent-to-treat population included all transplanted and randomized participants who received the infliximab/placebo infusion, subset to participants with available ci and ct scores from central pathology on both the implantation and 24 month biopsy.

Arm/Group Title	Experimental	Control
Arm/Group Description	The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Measure Participants	26	18
0	4 3.5%	6 5.4%
1	6 5.3%	6 5.4%
2	9 8%	2 1.8%
3+	7 6.2%	4 3.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.135
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments

14. Secondary Outcome

Title	Percent of Participants With Locally Treated Rejection, Defined as Treatment Administered for Rejection Based on Clinical Signs or Biopsy Findings.
Description	Biopsies were read by the local pathologist at the hospital where the participant was a patient. These local reads informed clinical care for the participant, which may or may not include prescribing/administering medication to the participant to help with clinical concerns or findings noted on a biopsy. Participants were considered to have met this endpoint if they have a report of receiving treatment for clinical or biopsy-proven rejection during the first 6 months post-transplant.
Time Frame	6 months post-transplantation

Outcome Measure Data

Analysis Population Description

Intent-to-treat population included all transplanted and randomized participants who received the infliximab/placebo infusion, subset to participants with available local pathology read data during the first 6 months of post-transplant follow-up.

Arm/Group Title	Experimental	Control
Arm/Group Description	The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Measure Participants	95	83
Number (95% Confidence Interval) [percentage of participants]	12.6 11.2%	20.5 18.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.157
	Comments
	Method	Chi-squared
	Comments

15. Secondary Outcome

Title	Percent of Participants With Locally Treated Rejection, Defined as Treatment Administered for Rejection Based on Clinical Signs or Biopsy Findings.
Description	Biopsies were read by the local pathologist at the hospital where the participant was a patient. These local reads informed clinical care for the participant, which may or may not include prescribing/administering medication to the participant to help with clinical concerns or findings noted on a biopsy. Participants were considered to have met this endpoint if they have a report of receiving treatment for clinical or biopsy-proven rejection during the 24 month post-transplant follow-up.
Time Frame	24 months post-transplantation

Outcome Measure Data

Analysis Population Description

Intent-to-treat population included all transplanted and randomized participants who received the infliximab/placebo infusion, subset to participants with available local pathology read data during the 24 month post-transplant follow-up.

Arm/Group Title	Experimental	Control
Arm/Group Description	The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Measure Participants	99	89
Number (95% Confidence Interval) [percentage of participants]	16.2 14.3%	27 24.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.071
	Comments
	Method	Chi-squared
	Comments

16. Secondary Outcome

Title	Change in eGFR Between 3 Months and 24 Months as Measured by MDRD
Description	Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Modification of Diet in Renal Disease (MDRD) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. The change in eGFR between months 3 and 24 was calculated as the month 24 eGFR minus the month 3 eGFR for each participant. A window of +/- 14 days was used for month 3 and +/- 1 month was used for month 24.
Time Frame	3 months and 24 months post-transplantation

Outcome Measure Data

Analysis Population Description

Intent-to-treat population included all transplanted and randomized participants who received the infliximab/placebo infusion, subset to participants with available eGFR data within window at months 3 and 24.

Arm/Group Title	Experimental	Control
Arm/Group Description	The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Measure Participants	38	41
Mean (Standard Deviation) [mL/min/1.73m2]	2.8 (15.06)	4.8 (13.26)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.543
	Comments
	Method	t-test, 2 sided
	Comments

17. Secondary Outcome

Title	Change in eGFR Between 3 Months and 24 Months as Measured by CKD-EPI
Description	Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. The change in eGFR between months 3 and 24 was calculated as the month 24 eGFR minus the month 3 eGFR for each participant. A window of +/- 14 days was used for month 3 and +/- 1 month was used for month 24.
Time Frame	3 months and 24 months post-transplantation

Outcome Measure Data

Analysis Population Description

Intent-to-treat population included all transplanted and randomized participants who received the infliximab/placebo infusion, subset to participants with available eGFR data within window at months 3 and 24.

Arm/Group Title	Experimental	Control
Arm/Group Description	The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Measure Participants	38	41
Mean (Standard Deviation) [mL/min/1.73m2]	2.7 (16.38)	4.4 (13.91)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.617
	Comments
	Method	t-test, 2 sided
	Comments

18. Secondary Outcome

Title	Change in eGFR Between Post-transplant Nadir and 24 Months as Measured by MDRD
Description	Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Modification of Diet in Renal Disease (MDRD) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. Post-transplant nadir was defined as the lowest value of eGFR from the first 6 months post-transplant. The change in eGFR between nadir and month 24 was calculated as the month 24 eGFR minus the nadir eGFR for each participant. A window of +/- 21 days was used for month 6 and +/- 1 month was used for month 24.
Time Frame	6 months and 24 months post-transplantation

Outcome Measure Data

Analysis Population Description

Intent-to-treat population included all transplanted and randomized participants who received the infliximab/placebo infusion, subset to participants with available eGFR data within window at months 6 and 24.

Arm/Group Title	Experimental	Control
Arm/Group Description	The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Measure Participants	42	42
Mean (Standard Deviation) [mL/min/1.73m2]	8.1 (14.06)	11.6 (14.69)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.275
	Comments
	Method	t-test, 2 sided
	Comments

19. Secondary Outcome

Title	Change in eGFR Between Post-transplant Nadir and 24 Months as Measured by CKD-EPI
Description	Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. Post-transplant nadir was defined as the lowest value of eGFR from the first 6 months post-transplant. The change in eGFR between nadir and month 24 was calculated as the month 24 eGFR minus the nadir eGFR for each participant. A window of +/- 21 days was used for month 6 and +/- 1 month was used for month 24.
Time Frame	6 months and 24 months post-transplantation

Outcome Measure Data

Analysis Population Description

Intent-to-treat population included all transplanted and randomized participants who received the infliximab/placebo infusion, subset to participants with available eGFR data within window at months 6 and 24.

Arm/Group Title	Experimental	Control
Arm/Group Description	The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Measure Participants	42	42
Mean (Standard Deviation) [mL/min/1.73m2]	8.5 (15.21)	12.0 (15.36)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.300
	Comments
	Method	t-test, 2 sided
	Comments

20. Secondary Outcome

Title	Change in eGFR Between 6 Months and 24 Months as Measured by MDRD
Description	Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Modification of Diet in Renal Disease (MDRD) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. The change in eGFR between months 6 and 24 was calculated as the month 24 eGFR minus the month 6 eGFR for each participant. A window of +/- 21 days was used for month 6 and +/- 1 month was used for month 24.
Time Frame	6 months and 24 months post-transplantation

Outcome Measure Data

Analysis Population Description

Intent-to-treat population included all transplanted and randomized participants who received the infliximab/placebo infusion, subset to participants with available eGFR data within window at months 6 and 24.

Arm/Group Title	Experimental	Control
Arm/Group Description	The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Measure Participants	39	36
Mean (Standard Deviation) [mL/min/1.73m2]	1.0 (11.73)	5.2 (13.05)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.152
	Comments
	Method	t-test, 2 sided
	Comments

21. Secondary Outcome

Title	Change in eGFR Between 6 Months and 24 Months as Measured by CKD-EPI
Description	Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. The change in eGFR between months 6 and 24 was calculated as the month 24 eGFR minus the month 6 eGFR for each participant. A window of +/- 21 days was used for month 6 and +/- 1 month was used for month 24.
Time Frame	6 months and 24 months post-transplantation

Outcome Measure Data

Analysis Population Description

Intent-to-treat population included all transplanted and randomized participants who received the infliximab/placebo infusion, subset to participants with available eGFR data within window at months 6 and 24.

Arm/Group Title	Experimental	Control
Arm/Group Description	The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Measure Participants	39	36
Mean (Standard Deviation) [mL/min/1.73m2]	0.8 (12.67)	4.8 (13.42)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.181
	Comments
	Method	t-test, 2 sided
	Comments

22. Secondary Outcome

Title	eGFR Values as Measured by MDRD
Description	Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Modification of Diet in Renal Disease (MDRD) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. eGFR values from day 7 and months 1, 3, 6, 12, 18, and 24 were used to generate an estimate of the eGFR at each time point of interest for each treatment group.
Time Frame	Day 7 post-transplantation

Outcome Measure Data

Analysis Population Description

Intent-to-treat population included all transplanted and randomized participants who received the infliximab/placebo infusion, subset to participants with available eGFR data.

Arm/Group Title	Experimental	Control
Arm/Group Description	The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Measure Participants	112	110
Mean (95% Confidence Interval) [mL/min/1.73m2]	38.93	39.96

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental, Control
	Comments	Day 7. Mean eGFR of the two treatment groups was compared. The p-value, estimated day 7 eGFR within each treatment group, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available eGFR data from day 7 and months 1, 3, 6, 12, 18, and 24 to compare the experimental group to the control group at day 7. Random effects for the intercept and eGFR collection day were utilized in the model.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.639
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.03
	Confidence Interval	(2-Sided) 95%; -5.37 to 3.30
	Parameter Dispersion	Type: Value:
	Estimation Comments

23. Secondary Outcome

Title	eGFR Values as Measured by MDRD
Description	Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Modification of Diet in Renal Disease (MDRD) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. eGFR values from day 7 and months 1, 3, 6, 12, 18, and 24 were used to generate an estimate of the eGFR at each time point of interest for each treatment group.
Time Frame	Days 30, 60, and 180 post-transplantation

Outcome Measure Data

Analysis Population Description

Intent-to-treat population included all transplanted and randomized participants who received the infliximab/placebo infusion, subset to participants with available eGFR data.

Arm/Group Title	Experimental	Control
Arm/Group Description	The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Measure Participants	111	109
Day 30	46.64	48.20
Day 90	47.14	48.99
Day 180	47.89	50.16

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental, Control
	Comments	Day 30. Mean eGFR of the two treatment groups was compared. The p-value, estimated day 30 eGFR within each treatment group, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available eGFR data from months 1, 3, 6, 12, 18, and 24 to compare the experimental group to the control group at day 30. Random effects for the intercept and eGFR collection day were utilized in the model.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.510
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.56
	Confidence Interval	(2-Sided) 95%; -6.22 to 3.10
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Experimental, Control
	Comments	Day 90. Mean eGFR of the two treatment groups was compared. The p-value, estimated day 90 eGFR within each treatment group, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available eGFR data from months 1, 3, 6, 12, 18, and 24 to compare the experimental group to the control group at day 90. Random effects for the intercept and eGFR collection day were utilized in the model.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.430
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.85
	Confidence Interval	(2-Sided) 95%; -6.45 to 2.76
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Experimental, Control
	Comments	Day 180. Mean eGFR of the two treatment groups was compared. The p-value, estimated day 180 eGFR within each treatment group, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available eGFR data from months 1, 3, 6, 12, 18, and 24 to compare the experimental group to the control group at day 180. Random effects for the intercept and eGFR collection day were utilized in the model.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.328
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-2.28
	Confidence Interval	(2-Sided) 95%; -6.86 to 2.31
	Parameter Dispersion	Type: Value:
	Estimation Comments

24. Secondary Outcome

Title	eGFR Values as Measured by CKD-EPI
Description	Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. eGFR values from day 7 and months 1, 3, 6, 12, 18, and 24 were used to generate an estimate of the eGFR at each time point of interest for each treatment group.
Time Frame	Day 7 post-transplantation

Outcome Measure Data

Analysis Population Description

Intent-to-treat population included all transplanted and randomized participants who received the infliximab/placebo infusion, subset to participants with available eGFR data.

Arm/Group Title	Experimental	Control
Arm/Group Description	The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Measure Participants	112	110
Mean (95% Confidence Interval) [mL/min/1.73m2]	41.01	41.85

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental, Control
	Comments	Day 7. Mean eGFR of the two treatment groups was compared. The p-value, estimated day 7 eGFR within each treatment group, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available eGFR data from day 7 and months 1, 3, 6, 12, 18, and 24 to compare the experimental group to the control group at day 7. Random effects for the intercept and eGFR collection day were utilized in the model.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.725
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.85
	Confidence Interval	(2-Sided) 95%; -5.58 to 3.89
	Parameter Dispersion	Type: Value:
	Estimation Comments

25. Secondary Outcome

Title	eGFR Values as Measured by CKD-EPI
Description	Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. eGFR values from day 7 and months 1, 3, 6, 12, 18, and 24 were used to generate an estimate of the eGFR at each time point of interest for each treatment group.
Time Frame	Days 30, 90, and 180 post-transplantation

Outcome Measure Data

Analysis Population Description

Intent-to-treat population included all transplanted and randomized participants who received the infliximab/placebo infusion, subset to participants with available eGFR data.

Arm/Group Title	Experimental	Control
Arm/Group Description	The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Measure Participants	111	109
Day 30	49.29	50.63
Day 90	49.80	51.44
Day 180	50.56	52.65

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental, Control
	Comments	Day 30. Mean eGFR of the two treatment groups was compared. The p-value, estimated day 30 eGFR within each treatment group, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available eGFR data from months 1, 3, 6, 12, 18, and 24 to compare the experimental group to the control group at day 30. Random effects for the intercept and eGFR collection day were utilized in the model.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.601
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.35
	Confidence Interval	(2-Sided) 95%; -6.41 to 3.72
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Experimental, Control
	Comments	Day 90. Mean eGFR of the two treatment groups was compared. The p-value, estimated day 90 eGFR within each treatment group, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available eGFR data from months 1, 3, 6, 12, 18, and 24 to compare the experimental group to the control group at day 90. Random effects for the intercept and eGFR collection day were utilized in the model.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.519
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.64
	Confidence Interval	(2-Sided) 95%; -6.66 to 3.37
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Experimental, Control
	Comments	Day 180. Mean eGFR of the two treatment groups was compared. The p-value, estimated day 180 eGFR within each treatment group, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available eGFR data from months 1, 3, 6, 12, 18, and 24 to compare the experimental group to the control group at day 180. Random effects for the intercept and eGFR collection day were utilized in the model.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.411
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-2.09
	Confidence Interval	(2-Sided) 95%; -7.08 to 2.91
	Parameter Dispersion	Type: Value:
	Estimation Comments

26. Secondary Outcome

Title	Percent of Participants With Death or Graft Failure.
Description	Participants who died or experienced graft failure were considered to have met this endpoint. Graft failure was defined as the need for post-transplant dialysis for more than 56 days.
Time Frame	24 months post-transplantation

Outcome Measure Data

Analysis Population Description

Intent-to-treat population included all transplanted and randomized participants who received the infliximab/placebo infusion.

Arm/Group Title	Experimental	Control
Arm/Group Description	The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Measure Participants	113	112
Number (95% Confidence Interval) [percentage of participants]	5.3 4.7%	7.1 6.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.569
	Comments
	Method	Chi-squared
	Comments

27. Secondary Outcome

Title	Percent of Participants With Only Graft Failure.
Description	Participants who experienced graft failure were considered to have met this endpoint. Graft failure was defined as the need for post-transplant dialysis for more than 56 days.
Time Frame	24 months post-transplantation

Outcome Measure Data

Analysis Population Description

Intent-to-treat population included all transplanted and randomized participants who received the infliximab/placebo infusion.

Arm/Group Title	Experimental	Control
Arm/Group Description	The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Measure Participants	113	112
Number (95% Confidence Interval) [percentage of participants]	2.7 2.4%	2.7 2.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	>0.999
	Comments
	Method	Fisher Exact
	Comments

28. Secondary Outcome

Title	Percent of Participants That Required at Least One Dialysis Treatment.
Description	Dialysis within the first week post-transplant is used in the setting of delayed graft function (DGF). Participants are considered to have had DGF if they had at least one dialysis treatment in the first week post-transplant.
Time Frame	1 week post-transplantation

Outcome Measure Data

Analysis Population Description

Intent-to-treat population included all transplanted and randomized participants who received the infliximab/placebo infusion.

Arm/Group Title	Experimental	Control
Arm/Group Description	The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Measure Participants	113	112
Number (95% Confidence Interval) [percentage of participants]	31.0 27.4%	35.7 31.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.451
	Comments
	Method	Chi-squared
	Comments

29. Secondary Outcome

Title	Number of Dialysis Sessions.
Description	The number of dialysis sessions a person had during their first 8 weeks post-transplant was used for this endpoint.
Time Frame	8 weeks post-transplantation

Outcome Measure Data

Analysis Population Description

Intent-to-treat population included all transplanted and randomized participants who received the infliximab/placebo infusion, subset to participants with available data during the first 8 weeks.

Arm/Group Title	Experimental	Control
Arm/Group Description	The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Measure Participants	111	109
Mean (Standard Deviation) [Dialysis sessions]	0.14 (1.0)	0.26 (2.32)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.614
	Comments
	Method	t-test, 2 sided
	Comments

30. Secondary Outcome

Title	Duration of Delayed Graft Function (DGF), Defined as Time From Transplantation to the Last Required Dialysis Treatment.
Description	Participants are considered to have had DGF if they had at least one dialysis treatment in the first week post-transplant. For this endpoint, duration was calculated as the date of last post-transplant dialysis treatment minus the date of the first post-transplant dialysis treatment.
Time Frame	First post-transplant dialysis treatment to last post-transplant dialysis treatment

Outcome Measure Data

Analysis Population Description

Intent-to-treat population included all transplanted and randomized participants who received the infliximab/placebo infusion.

Arm/Group Title	Experimental	Control
Arm/Group Description	The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Measure Participants	33	39
Mean (Standard Deviation) [Days]	13.27 (13.89)	15.74 (38.37)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.710
	Comments
	Method	t-test, 2 sided
	Comments

31. Secondary Outcome

Title	Percent of Participants With Primary Non-Function (PNF), Defined as Dialysis-dependency for More Than 3 Months.
Description	Post-transplant dialysis is sometimes required in the setting of kidney transplant. If such dialysis continues for more than 3 months, the participant is considered to have PNF and, as such, meets this endpoint definition.
Time Frame	Transplantation through at least month 3 up to month 24

Outcome Measure Data

Analysis Population Description

Intent-to-treat population included all transplanted and randomized participants who received the infliximab/placebo infusion, subset to participants with available data for dialysis used.

Arm/Group Title	Experimental	Control
Arm/Group Description	The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Measure Participants	109	107
Number (95% Confidence Interval) [Percent of Participants]	2.8 2.5%	0.9 0.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.622
	Comments
	Method	Fisher Exact
	Comments

32. Secondary Outcome

Title	Change From Baseline (Immediately After Surgery) in Serum Creatinine.
Description	Serum creatinine (mg/dL) is used to measure kidney function. A normal result is 0.7 to 1.3 mg/dL for men and 0.6 to 1.1 mg/dL for women. Higher results indicate poorer kidney function, as creatinine is removed from the body by the kidneys. eGFR values from 24, 48, and 72 hours post-transplant (i.e., days 1, 2, and 3) were used to generate an estimate of the serum creatinine at each time point of interest for each treatment group.
Time Frame	24, 48 and 72 hours post-transplantation

Outcome Measure Data

Analysis Population Description

Intent-to-treat population included all transplanted and randomized participants who received the infliximab/placebo infusion, subset to participants with available serum creatinine data during the first 72 hours post-transplant.

Arm/Group Title	Experimental	Control
Arm/Group Description	The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Measure Participants	113	111
24 Hours	7.35	6.85
48 Hours	6.24	5.87
72 Hours	5.77	5.21

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental, Control
	Comments	24 Hours/Day 1. Mean serum creatinine of the two treatment groups was compared. The p-value, estimated 24 hour creatinine level within each treatment group, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available serum creatinine data from 24, 48, and 72 hours to compare the experimental group to the control group at 24 hours/day 1. A random effect for the intercept was utilized in the model.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.256
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.49
	Confidence Interval	(2-Sided) 95%; -0.36 to 1.35
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Experimental, Control
	Comments	48 Hours/Day 2. Mean serum creatinine of the two treatment groups was compared. The p-value, estimated 48 hour creatinine level within each treatment group, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available serum creatinine data from 24, 48, and 72 hours to compare the experimental group to the control group at 48 hours/day 2. A random effect for the intercept was utilized in the model.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.391
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.37
	Confidence Interval	(2-Sided) 95%; -0.48 to 1.23
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Experimental, Control
	Comments	72 Hours/Day 3. Mean serum creatinine of the two treatment groups was compared. The p-value, estimated 72 hour creatinine level within each treatment group, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available serum creatinine data from 24, 48, and 72 hours to compare the experimental group to the control group at 72 hours/day 3. A random effect for the intercept was utilized in the model.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.199
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.56
	Confidence Interval	(2-Sided) 95%; -0.30 to 1.42
	Parameter Dispersion	Type: Value:
	Estimation Comments

33. Secondary Outcome

Title	Days From Transplantation Until Event (ACR, AMR, or Hospitalization for Infection and/or Malignancy)
Description	Participants are considered to have met this endpoint if they experienced biopsy-proven T-cell mediated rejection (ACR) or antibody mediated rejection (AMR) based on central pathology reading or were hospitalized for infection and/or malignancy. For participants who met one or more of these three components, the earliest event date of the three components was used as the time of meeting the endpoint. Participants who did not meet any of the three components were censored at their last date of follow-up. Event (or censor) day was calculated as event (or censor) date minus transplant date.
Time Frame	24 months post-transplantation

Outcome Measure Data

Analysis Population Description

Intent-to-treat population included all transplanted and randomized participants who received the infliximab/placebo infusion, subset to participants with available central pathology data and hospitalization data.

Arm/Group Title	Experimental	Control
Arm/Group Description	The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Measure Participants	96	92
Median (95% Confidence Interval) [Days to event]	642	613

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.812
	Comments
	Method	Log Rank
	Comments

34. Secondary Outcome

Title	The Percent of Participants With a Serum Creatinine of More Than 3 mg/dL.
Description	Serum creatinine (mg/dL) is used to measure kidney function. A normal result is 0.7 to 1.3 mg/dL for men and 0.6 to 1.1 mg/dL for women. Higher results indicate poorer kidney function, as creatinine is removed from the body by the kidneys. This endpoint is ascertaining slow graft function in the immediate days post-transplant. A participant was considered to have met this endpoint if their day 5 serum creatinine was greater than 3 mg/dL.
Time Frame	Day 5 post-transplantation

Outcome Measure Data

Analysis Population Description

Intent-to-treat population included all transplanted and randomized participants who received the infliximab/placebo infusion, subset to participants who did not experience delayed graft function and with available serum creatinine data at day 5 post-transplant.

Arm/Group Title	Experimental	Control
Arm/Group Description	The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Measure Participants	78	70
Number (95% Confidence Interval) [percentage of participants]	47.4 41.9%	42.9 38.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.576
	Comments
	Method	Chi-squared
	Comments

35. Secondary Outcome

Title	Creatinine Reduction Ratio (CRR), Defined as the First Creatinine on Day 2 Divided by he First Creatinine After Surgery
Description	Serum creatinine (mg/dL) is used to measure kidney function. A normal result is 0.7 to 1.3 mg/dL for men and 0.6 to 1.1 mg/dL for women. Higher results indicate poorer kidney function, as creatinine is removed from the body by the kidneys. CRR was calculated as the day 1 post-transplant creatinine value minus the day 2 creatinine value divided by the day 1 creatinine value and multiplied by 100, resulting in a percentage. Higher numbers indicate a greater reduction in serum creatinine and, thus, potentially better kidney function.
Time Frame	Day 2 post-transplantation

Outcome Measure Data

Analysis Population Description

Intent-to-treat population included all transplanted and randomized participants who received the infliximab/placebo infusion, subset to participants who did not experience delayed graft function and with available serum creatinine data on days 1 and 2 post-transplant.

Arm/Group Title	Experimental	Control
Arm/Group Description	The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Measure Participants	77	70
Mean (Standard Deviation) [Percentage]	24.28 (22.60)	20.97 (16.64)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.311
	Comments
	Method	t-test, 2 sided
	Comments

36. Secondary Outcome

Title	Creatinine Reduction Ratio (CRR), Defined as the First Creatinine on Day 5 Divided by the First Creatinine After Surgery.
Description	Serum creatinine (mg/dL) is used to measure kidney function. A normal result is 0.7 to 1.3 mg/dL for men and 0.6 to 1.1 mg/dL for women. Higher results indicate poorer kidney function, as creatinine is removed from the body by the kidneys. CRR was calculated as the day 1 post-transplant creatinine value minus the day 5 creatinine value divided by the day 1 creatinine value and multiplied by 100, resulting in a percentage. Higher numbers indicate a greater reduction in serum creatinine and, thus, potentially better kidney function.
Time Frame	Day 5 post-transplantation

Outcome Measure Data

Analysis Population Description

Intent-to-treat population included all transplanted and randomized participants who received the infliximab/placebo infusion, subset to participants who did not experience delayed graft function and with available serum creatinine data on days 1 and 5 post-transplant.

Arm/Group Title	Experimental	Control
Arm/Group Description	The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Measure Participants	78	69
Mean (Standard Deviation) [Percentage]	47.06 (28.86)	43.37 (25.79)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.418
	Comments
	Method	t-test, 2 sided
	Comments

37. Secondary Outcome

Title	The Percent of Participants Whose Day 5 Serum CRR Was Less Than 70%.
Description	Serum creatinine (mg/dL) is used to measure kidney function. A normal result is 0.7 to 1.3 mg/dL for men and 0.6 to 1.1 mg/dL for women. Higher results indicate poorer kidney function, as creatinine is removed from the body by the kidneys. CRR was calculated as the day 1 post-transplant creatinine value minus the day 5 creatinine value divided by the day 1 creatinine value and multiplied by 100, resulting in a percentage. Higher numbers indicate a greater reduction in serum creatinine and, thus, potentially better kidney function. A participant was considered to have met this endpoint if their day 5 serum CRR was less than 70%.
Time Frame	Day 5 post-transplantation

Outcome Measure Data

Analysis Population Description

Intent-to-treat population included all transplanted and randomized participants who received the infliximab/placebo infusion, subset to participants who did not experience delayed graft function and with available serum creatinine data on days 1 and 5 post-transplant.

Arm/Group Title	Experimental	Control
Arm/Group Description	The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Measure Participants	78	69
Number (95% Confidence Interval) [percentage of participants]	74.4 65.8%	88.4 78.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.030
	Comments
	Method	Chi-squared
	Comments

38. Secondary Outcome

Title	The Percent of Participants Whose Day 2 Serum CRR Was Less Than 30%.
Description	Serum creatinine (mg/dL) is used to measure kidney function. A normal result is 0.7 to 1.3 mg/dL for men and 0.6 to 1.1 mg/dL for women. Higher results indicate poorer kidney function, as creatinine is removed from the body by the kidneys. CRR was calculated as the day 1 post-transplant creatinine value minus the day 2 creatinine value divided by the day 1 creatinine value and multiplied by 100, resulting in a percentage. Higher numbers indicate a greater reduction in serum creatinine and, thus, potentially better kidney function. A participant was considered to have met this endpoint if their day 2 serum CRR was less than 30%.
Time Frame	Day 2 post-transplantation

Outcome Measure Data

Analysis Population Description

Intent-to-treat population included all transplanted and randomized participants who received the infliximab/placebo infusion, subset to participants who did not experience delayed graft function and with available serum creatinine data on days 1 and 2 post-transplant.

Arm/Group Title	Experimental	Control
Arm/Group Description	The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Measure Participants	77	70
Number (95% Confidence Interval) [percentage of participants]	57.1 50.5%	68.6 61.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.153
	Comments
	Method	Chi-squared
	Comments

39. Secondary Outcome

Title	The Percent of Participants Who Need Dialysis After Week 1.
Description	Participants who needed dialysis after the first week post-transplant were considered to have met this endpoint.
Time Frame	1 week to 24 months post-transplantation

Outcome Measure Data

Analysis Population Description

Intent-to-treat population included all transplanted and randomized participants who received the infliximab/placebo infusion, subset to participants who did not experience delayed graft function and with available data after week 1.

Arm/Group Title	Experimental	Control
Arm/Group Description	The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Measure Participants	78	71
Number (95% Confidence Interval) [percentage of participants]	9.0 8%	2.8 2.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.171
	Comments
	Method	Fisher Exact
	Comments

40. Secondary Outcome

Title	Percent of Participants With de Novo DSA.
Description	Donor specific antibody (DSA) can be formed post-transplant as part of the recipient's alloimmune response to the transplanted organ. DSA was determined by a central laboratory. Participants with newly developed DSA (i.e., de novo) following transplant were considered to have met this endpoint.
Time Frame	24 months post-transplantation

Outcome Measure Data

Analysis Population Description

Intent-to-treat population included all transplanted and randomized participants who received the infliximab/placebo infusion, subset to participants who had available DSA data.

Arm/Group Title	Experimental	Control
Arm/Group Description	The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Measure Participants	112	110
Number (95% Confidence Interval) [percentage of participants]	8.0 7.1%	3.6 3.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.163
	Comments
	Method	Chi-squared
	Comments

41. Secondary Outcome

Title	Percent of Participants With Any Infection Requiring Hospitalization or Resulting in Death.
Description	Participants were considered to have met this endpoint if they had an infection that required hospitalization or resulted in death.
Time Frame	24 months post-transplantation

Outcome Measure Data

Analysis Population Description

Safety population included all participants who received at least a portion of the infliximab/placebo infusion. This population includes one participant in the Experimental group who received some of the infliximab infusion prior to the transplant procedure being aborted.

Arm/Group Title	Experimental	Control
Arm/Group Description	The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Measure Participants	114	112
Number (95% Confidence Interval) [percentage of participants]	43.0 38.1%	39.3 35.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.572
	Comments
	Method	Chi-squared
	Comments

42. Secondary Outcome

Title	Percent of Participants With Mycobacterial or Fungal Infections
Description	Participants were considered to have met this endpoint if they had at least one mycobacterial of fungal infection.
Time Frame	24 months post-transplantation

Outcome Measure Data

Analysis Population Description

Safety population included all participants who received at least a portion of the infliximab/placebo infusion. This population includes one participant in the Experimental group who received some of the infliximab infusion prior to the transplant procedure being aborted.

Arm/Group Title	Experimental	Control
Arm/Group Description	The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Measure Participants	114	112
Number (95% Confidence Interval) [percentage of participants]	6.1 5.4%	6.3 5.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.973
	Comments
	Method	Chi-squared
	Comments

43. Secondary Outcome

Title	Percent of Participants With CMV Viremia That Require a Change in Immunosuppression or Anti-viral Treatment as Per Standard of Care at the Site
Description	Participants were considered to have met this endpoint if they had a reported case of CMV viremia that required a change in their existing immunosuppression or the use of anti-viral therapy.
Time Frame	24 months post-transplantation

Outcome Measure Data

Analysis Population Description

Safety population included all participants who received at least a portion of the infliximab/placebo infusion. This population includes one participant in the Experimental group who received some of the infliximab infusion prior to the transplant procedure being aborted.

Arm/Group Title	Experimental	Control
Arm/Group Description	The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Measure Participants	114	112
Number (95% Confidence Interval) [percentage of participants]	18.4 16.3%	11.6 10.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.152
	Comments
	Method	Chi-squared
	Comments

44. Secondary Outcome

Title	Percent of Participants With BK Viremia That Require a Change in Immunosuppression or Anti-viral Treatment as Per Standard of Care at the Site.
Description	Participants were considered to have met this endpoint if they had a reported case of BK viremia that required a change in their existing immunosuppression or the use of anti-viral therapy.
Time Frame	24 months post-transplantation

Outcome Measure Data

Analysis Population Description

Safety population included all participants who received at least a portion of the infliximab/placebo infusion. This population includes one participant in the Experimental group who received some of the infliximab infusion prior to the transplant procedure being aborted.

Arm/Group Title	Experimental	Control
Arm/Group Description	The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Measure Participants	114	112
Number (95% Confidence Interval) [Percent of participants]	28.9 25.6%	13.4 12%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.004
	Comments
	Method	Chi-squared
	Comments

45. Secondary Outcome

Title	Percent of Participants With Malignancy.
Description	Participants were considered to have met this endpoint if they had a reported case of malignancy.
Time Frame	24 months post-transplantation

Outcome Measure Data

Analysis Population Description

Safety population included all participants who received at least a portion of the infliximab/placebo infusion. This population includes one participant in the Experimental group who received some of the infliximab infusion prior to the transplant procedure being aborted.

Arm/Group Title	Experimental	Control
Arm/Group Description	The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Measure Participants	114	112
Number (95% Confidence Interval) [Percent of Participants]	1.8 1.6%	0.9 0.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	>0.999
	Comments
	Method	Fisher Exact
	Comments

46. Secondary Outcome

Title	Percent of Participants With Impaired Wound Healing Manifested by Wound Dehiscence, Wound Infection, or Hernia at the Site of the Transplant Incision
Description	Participants were considered to have met this endpoint if they had a reported case of impaired wound healing at the site of the transplant incision manifested by one wound dehiscence, wound infection, or hernia.
Time Frame	24 months post-transplantation

Outcome Measure Data

Analysis Population Description

Safety population included all participants who received at least a portion of the infliximab/placebo infusion. This population includes one participant in the Experimental group who received some of the infliximab infusion prior to the transplant procedure being aborted.

Arm/Group Title	Experimental	Control
Arm/Group Description	The experimental group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade®) followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone	The control group underwent a transplant procedure and received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone
Measure Participants	114	112
Number (95% Confidence Interval) [Percent of participants]	7.9 7%	11.6 10.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.347
	Comments
	Method	Chi-squared
	Comments

Adverse Events

Time Frame	From initiation of the investigational treatment through end of study, up to 60 months post-transplant
Adverse Event Reporting Description	Events grade 2 or higher were collected before protocol v4.0. Starting with protocol v4.0, non-serious AE grade 3 or higher were collected. All adverse events meeting serious criteria regardless of severity grade were collected. AE/SAE information was recorded by sites on electronic case report form. SAEs included death, life-threatening events, hospitalization (or prolongation), inability to conduct normal life functions, birth defect, or condition requiring intervention to prevent these items.
Arm/Group Title	Experimental		Control
Arm/Group Description	The experimental group received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) co-administered with anti-TNFa (infliximab/Remicade") followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone. This group includes one subject who was randomized to the infliximab/Remicade" arm and received a partial infusion of infliximab/Remicade" prior to the transplant procedure being aborted.		The control group received rabbit anti-thymocyte globulin (rATG, Thymoglobulin) plus placebo (sterile normal saline) induction followed by maintenance therapy with tacrolimus, either Mycophenolate Mofetil/MMF or Mycophenolate Acid/MPA (or their generic equivalents) and prednisone,
All Cause Mortality
	Experimental		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/114 (2.6%)		5/112 (4.5%)
Serious Adverse Events
	Experimental		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	87/114 (76.3%)		82/112 (73.2%)
Blood and lymphatic system disorders
Anaemia	5/114 (4.4%)	5	4/112 (3.6%)	4
Cytopenia	0/114 (0%)	0	1/112 (0.9%)	1
Febrile neutropenia	1/114 (0.9%)	1	0/112 (0%)	0
Leukocytosis	1/114 (0.9%)	1	0/112 (0%)	0
Leukopenia	2/114 (1.8%)	2	1/112 (0.9%)	1
Thrombocytopenia	1/114 (0.9%)	1	1/112 (0.9%)	1
Cardiac disorders
Acute myocardial infarction	0/114 (0%)	0	6/112 (5.4%)	6
Atrial fibrillation	1/114 (0.9%)	1	2/112 (1.8%)	2
Cardiac arrest	3/114 (2.6%)	3	1/112 (0.9%)	1
Cardiac failure	0/114 (0%)	0	1/112 (0.9%)	1
Cardiac failure congestive	4/114 (3.5%)	6	0/112 (0%)	0
Cardiovascular disorder	1/114 (0.9%)	1	0/112 (0%)	0
Diastolic dysfunction	1/114 (0.9%)	1	0/112 (0%)	0
Ear and labyrinth disorders
Vertigo	1/114 (0.9%)	1	0/112 (0%)	0
Endocrine disorders
Hyperparathyroidism tertiary	0/114 (0%)	0	2/112 (1.8%)	2
Eye disorders
Vitreous haemorrhage	1/114 (0.9%)	1	0/112 (0%)	0
Gastrointestinal disorders
Abdominal pain	0/114 (0%)	0	2/112 (1.8%)	2
Abdominal pain lower	0/114 (0%)	0	1/112 (0.9%)	1
Abdominal pain upper	2/114 (1.8%)	2	1/112 (0.9%)	1
Ascites	2/114 (1.8%)	2	0/112 (0%)	0
Diarrhoea	6/114 (5.3%)	7	3/112 (2.7%)	3
Enterocutaneous fistula	0/114 (0%)	0	1/112 (0.9%)	1
Food poisoning	0/114 (0%)	0	1/112 (0.9%)	1
Gastritis	0/114 (0%)	0	1/112 (0.9%)	1
Gastrointestinal haemorrhage	2/114 (1.8%)	2	1/112 (0.9%)	1
Gastrooesophageal reflux disease	0/114 (0%)	0	1/112 (0.9%)	1
Haematochezia	1/114 (0.9%)	1	0/112 (0%)	0
Ileus	0/114 (0%)	0	2/112 (1.8%)	3
Impaired gastric emptying	1/114 (0.9%)	1	0/112 (0%)	0
Localised intraabdominal fluid collection	0/114 (0%)	0	1/112 (0.9%)	1
Mouth ulceration	1/114 (0.9%)	1	0/112 (0%)	0
Nausea	2/114 (1.8%)	2	0/112 (0%)	0
Neutropenic colitis	1/114 (0.9%)	1	0/112 (0%)	0
Odynophagia	1/114 (0.9%)	1	0/112 (0%)	0
Oesophagitis	0/114 (0%)	0	1/112 (0.9%)	1
Pancreatitis	2/114 (1.8%)	2	0/112 (0%)	0
Retroperitoneal haematoma	0/114 (0%)	0	1/112 (0.9%)	1
Small intestinal obstruction	4/114 (3.5%)	4	1/112 (0.9%)	1
Vomiting	2/114 (1.8%)	2	0/112 (0%)	0
General disorders
Asthenia	1/114 (0.9%)	1	0/112 (0%)	0
Chest pain	1/114 (0.9%)	1	1/112 (0.9%)	1
Death	0/114 (0%)	0	1/112 (0.9%)	1
Fatigue	0/114 (0%)	0	1/112 (0.9%)	1
Generalised oedema	1/114 (0.9%)	1	0/112 (0%)	0
Hernia	0/114 (0%)	0	1/112 (0.9%)	1
Non-cardiac chest pain	0/114 (0%)	0	1/112 (0.9%)	1
Pyrexia	2/114 (1.8%)	2	0/112 (0%)	0
Hepatobiliary disorders
Biliary dilatation	1/114 (0.9%)	1	0/112 (0%)	0
Cholecystitis chronic	1/114 (0.9%)	1	0/112 (0%)	0
Hepatic failure	0/114 (0%)	0	1/112 (0.9%)	1
Immune system disorders
Transplant rejection	4/114 (3.5%)	4	9/112 (8%)	9
Infections and infestations
Abscess	1/114 (0.9%)	1	0/112 (0%)	0
Abscess limb	1/114 (0.9%)	1	0/112 (0%)	0
Arthritis infective	1/114 (0.9%)	1	0/112 (0%)	0
BK virus infection	3/114 (2.6%)	3	0/112 (0%)	0
Bacteraemia	3/114 (2.6%)	3	5/112 (4.5%)	5
Bacterial diarrhoea	0/114 (0%)	0	1/112 (0.9%)	1
Bacterial infection	0/114 (0%)	0	1/112 (0.9%)	1
Bacteriuria	1/114 (0.9%)	1	0/112 (0%)	0
Bronchopulmonary aspergillosis	2/114 (1.8%)	2	0/112 (0%)	0
Campylobacter gastroenteritis	1/114 (0.9%)	1	0/112 (0%)	0
Cellulitis	3/114 (2.6%)	3	2/112 (1.8%)	2
Clostridium difficile infection	3/114 (2.6%)	3	1/112 (0.9%)	1
Corona virus infection	4/114 (3.5%)	4	5/112 (4.5%)	5
Cytomegalovirus colitis	1/114 (0.9%)	1	2/112 (1.8%)	2
Cytomegalovirus enteritis	1/114 (0.9%)	1	0/112 (0%)	0
Cytomegalovirus hepatitis	1/114 (0.9%)	1	0/112 (0%)	0
Cytomegalovirus infection	1/114 (0.9%)	1	2/112 (1.8%)	2
Cytomegalovirus viraemia	5/114 (4.4%)	5	1/112 (0.9%)	1
Diabetic foot infection	0/114 (0%)	0	1/112 (0.9%)	1
Diverticulitis	1/114 (0.9%)	1	0/112 (0%)	0
Escherichia urinary tract infection	1/114 (0.9%)	1	0/112 (0%)	0
Gangrene	2/114 (1.8%)	2	0/112 (0%)	0
Gastroenteritis	4/114 (3.5%)	4	2/112 (1.8%)	2
Gastroenteritis norovirus	0/114 (0%)	0	1/112 (0.9%)	1
Herpes zoster	1/114 (0.9%)	1	0/112 (0%)	0
Infected seroma	1/114 (0.9%)	1	0/112 (0%)	0
Influenza	2/114 (1.8%)	2	4/112 (3.6%)	4
Klebsiella bacteraemia	1/114 (0.9%)	1	0/112 (0%)	0
Meningitis cryptococcal	0/114 (0%)	0	1/112 (0.9%)	1
Mycobacterium avium complex infection	1/114 (0.9%)	1	0/112 (0%)	0
Orchitis	0/114 (0%)	0	1/112 (0.9%)	1
Osteomyelitis	1/114 (0.9%)	1	1/112 (0.9%)	1
Osteomyelitis acute	1/114 (0.9%)	1	0/112 (0%)	0
Parvovirus infection	1/114 (0.9%)	1	0/112 (0%)	0
Perineal abscess	0/114 (0%)	0	1/112 (0.9%)	1
Perinephric abscess	1/114 (0.9%)	1	0/112 (0%)	0
Peritonitis	1/114 (0.9%)	1	0/112 (0%)	0
Peritonitis bacterial	1/114 (0.9%)	1	0/112 (0%)	0
Pneumonia	4/114 (3.5%)	4	7/112 (6.3%)	9
Pneumonia fungal	1/114 (0.9%)	1	0/112 (0%)	0
Pneumonia mycoplasmal	1/114 (0.9%)	1	0/112 (0%)	0
Polyomavirus-associated nephropathy	1/114 (0.9%)	1	2/112 (1.8%)	2
Pyelonephritis	3/114 (2.6%)	3	7/112 (6.3%)	8
Pyelonephritis acute	1/114 (0.9%)	1	1/112 (0.9%)	1
Renal abscess	0/114 (0%)	0	1/112 (0.9%)	1
Respiratory tract infection	0/114 (0%)	0	1/112 (0.9%)	1
Rhinovirus infection	1/114 (0.9%)	1	0/112 (0%)	0
Sepsis	1/114 (0.9%)	1	3/112 (2.7%)	3
Septic shock	0/114 (0%)	0	1/112 (0.9%)	1
Staphylococcal bacteraemia	1/114 (0.9%)	1	0/112 (0%)	0
Streptococcal sepsis	0/114 (0%)	0	1/112 (0.9%)	1
Tick-borne fever	1/114 (0.9%)	1	0/112 (0%)	0
Tinea pedis	0/114 (0%)	0	1/112 (0.9%)	1
Upper respiratory tract infection	0/114 (0%)	0	1/112 (0.9%)	1
Ureteritis	0/114 (0%)	0	1/112 (0.9%)	1
Urinary tract infection	8/114 (7%)	10	10/112 (8.9%)	13
Urinary tract infection pseudomonal	0/114 (0%)	0	1/112 (0.9%)	1
Urosepsis	8/114 (7%)	9	3/112 (2.7%)	3
Viral infection	0/114 (0%)	0	1/112 (0.9%)	1
Wound infection	2/114 (1.8%)	2	1/112 (0.9%)	1
Wound infection pseudomonas	1/114 (0.9%)	1	0/112 (0%)	0
Wound infection staphylococcal	0/114 (0%)	0	1/112 (0.9%)	1
Injury, poisoning and procedural complications
Arteriovenous fistula site haemorrhage	0/114 (0%)	0	1/112 (0.9%)	1
Complications of transplant surgery	1/114 (0.9%)	1	2/112 (1.8%)	2
Complications of transplanted kidney	1/114 (0.9%)	1	0/112 (0%)	0
Delayed graft function	8/114 (7%)	8	12/112 (10.7%)	12
Fall	1/114 (0.9%)	1	0/112 (0%)	0
Femoral neck fracture	1/114 (0.9%)	1	0/112 (0%)	0
Graft loss	1/114 (0.9%)	1	0/112 (0%)	0
Incision site haematoma	1/114 (0.9%)	1	1/112 (0.9%)	1
Incisional hernia	1/114 (0.9%)	1	0/112 (0%)	0
Limb injury	0/114 (0%)	0	1/112 (0.9%)	1
Overdose	0/114 (0%)	0	1/112 (0.9%)	1
Perinephric collection	0/114 (0%)	0	2/112 (1.8%)	2
Post procedural haematoma	4/114 (3.5%)	4	2/112 (1.8%)	2
Post procedural haematuria	1/114 (0.9%)	1	0/112 (0%)	0
Post procedural haemorrhage	1/114 (0.9%)	1	0/112 (0%)	0
Post procedural persistent drain fluid	0/114 (0%)	0	1/112 (0.9%)	1
Post procedural urine leak	0/114 (0%)	0	1/112 (0.9%)	1
Renal transplant torsion	1/114 (0.9%)	1	0/112 (0%)	0
Road traffic accident	0/114 (0%)	0	1/112 (0.9%)	1
Seroma	0/114 (0%)	0	1/112 (0.9%)	1
Subdural haematoma	1/114 (0.9%)	1	0/112 (0%)	0
Tibia fracture	1/114 (0.9%)	1	0/112 (0%)	0
Toxicity to various agents	1/114 (0.9%)	1	2/112 (1.8%)	2
Transplant dysfunction	0/114 (0%)	0	1/112 (0.9%)	1
Wound dehiscence	0/114 (0%)	0	2/112 (1.8%)	2
Investigations
Donor specific antibody present	0/114 (0%)	0	1/112 (0.9%)	1
Lymphocyte count decreased	4/114 (3.5%)	4	4/112 (3.6%)	4
White blood cell count decreased	1/114 (0.9%)	1	0/112 (0%)	0
Metabolism and nutrition disorders
Dehydration	2/114 (1.8%)	2	1/112 (0.9%)	1
Diabetic ketoacidosis	1/114 (0.9%)	1	2/112 (1.8%)	3
Fluid overload	1/114 (0.9%)	1	1/112 (0.9%)	2
Hypercalcaemia	0/114 (0%)	0	1/112 (0.9%)	1
Hyperglycaemia	3/114 (2.6%)	3	4/112 (3.6%)	5
Hyperkalaemia	3/114 (2.6%)	3	7/112 (6.3%)	7
Hyperosmolar hyperglycaemic state	1/114 (0.9%)	1	1/112 (0.9%)	1
Hypervolaemia	0/114 (0%)	0	3/112 (2.7%)	3
Hypocalcaemia	1/114 (0.9%)	1	0/112 (0%)	0
Hypomagnesaemia	0/114 (0%)	0	1/112 (0.9%)	1
Hypovolaemia	1/114 (0.9%)	1	0/112 (0%)	0
Musculoskeletal and connective tissue disorders
Groin pain	0/114 (0%)	0	1/112 (0.9%)	1
Muscle spasms	1/114 (0.9%)	1	0/112 (0%)	0
Neck pain	0/114 (0%)	0	1/112 (0.9%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia	0/114 (0%)	0	1/112 (0.9%)	1
Ovarian neoplasm	1/114 (0.9%)	1	0/112 (0%)	0
Prostate cancer	1/114 (0.9%)	1	0/112 (0%)	0
Nervous system disorders
Cerebrovascular accident	0/114 (0%)	0	3/112 (2.7%)	3
Dizziness	1/114 (0.9%)	1	0/112 (0%)	0
Encephalopathy	0/114 (0%)	0	1/112 (0.9%)	1
Multiple sclerosis	0/114 (0%)	0	1/112 (0.9%)	1
Status epilepticus	0/114 (0%)	0	1/112 (0.9%)	1
Psychiatric disorders
Anxiety	0/114 (0%)	0	1/112 (0.9%)	1
Hypomania	0/114 (0%)	0	1/112 (0.9%)	1
Major depression	0/114 (0%)	0	1/112 (0.9%)	1
Mental status changes	3/114 (2.6%)	3	2/112 (1.8%)	2
Renal and urinary disorders
Acute kidney injury	4/114 (3.5%)	5	7/112 (6.3%)	8
Focal segmental glomerulosclerosis	3/114 (2.6%)	3	1/112 (0.9%)	1
Haematuria	1/114 (0.9%)	1	1/112 (0.9%)	1
Hydronephrosis	4/114 (3.5%)	4	3/112 (2.7%)	3
Nephrolithiasis	1/114 (0.9%)	1	2/112 (1.8%)	2
Nephropathy	0/114 (0%)	0	1/112 (0.9%)	1
Obstructive uropathy	0/114 (0%)	0	1/112 (0.9%)	1
Proteinuria	2/114 (1.8%)	2	0/112 (0%)	0
Renal tubular necrosis	1/114 (0.9%)	1	0/112 (0%)	0
Ureteric obstruction	0/114 (0%)	0	1/112 (0.9%)	1
Ureteric stenosis	1/114 (0.9%)	1	1/112 (0.9%)	1
Urinary retention	1/114 (0.9%)	1	0/112 (0%)	0
Reproductive system and breast disorders
Testicular torsion	0/114 (0%)	0	1/112 (0.9%)	1
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure	1/114 (0.9%)	1	0/112 (0%)	0
Asthma	0/114 (0%)	0	1/112 (0.9%)	1
Atelectasis	0/114 (0%)	0	1/112 (0.9%)	1
Dyspnoea	2/114 (1.8%)	2	0/112 (0%)	0
Hypoxia	0/114 (0%)	0	1/112 (0.9%)	1
Pleural effusion	0/114 (0%)	0	1/112 (0.9%)	1
Pneumonia aspiration	0/114 (0%)	0	2/112 (1.8%)	2
Pulmonary embolism	2/114 (1.8%)	2	1/112 (0.9%)	1
Pulmonary mass	0/114 (0%)	0	1/112 (0.9%)	1
Pulmonary oedema	0/114 (0%)	0	1/112 (0.9%)	1
Respiratory failure	0/114 (0%)	0	1/112 (0.9%)	1
Respiratory tract oedema	1/114 (0.9%)	1	0/112 (0%)	0
Skin and subcutaneous tissue disorders
Diabetic foot	1/114 (0.9%)	1	0/112 (0%)	0
Surgical and medical procedures
Parathyroidectomy	0/114 (0%)	0	1/112 (0.9%)	1
Post procedural drainage	0/114 (0%)	0	1/112 (0.9%)	1
Stent placement	1/114 (0.9%)	1	0/112 (0%)	0
Wound drainage	0/114 (0%)	0	1/112 (0.9%)	1
Vascular disorders
Arteriosclerosis	1/114 (0.9%)	1	0/112 (0%)	0
Arteriovenous fistula	1/114 (0.9%)	1	0/112 (0%)	0
Deep vein thrombosis	3/114 (2.6%)	3	3/112 (2.7%)	3
Haematoma	1/114 (0.9%)	1	0/112 (0%)	0
Hypertension	1/114 (0.9%)	1	1/112 (0.9%)	1
Hypertensive crisis	0/114 (0%)	0	1/112 (0.9%)	1
Hypotension	3/114 (2.6%)	3	1/112 (0.9%)	1
Lymphocele	1/114 (0.9%)	1	2/112 (1.8%)	2
Subclavian vein thrombosis	0/114 (0%)	0	1/112 (0.9%)	1
Other (Not Including Serious) Adverse Events
	Experimental		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	44/114 (38.6%)		41/112 (36.6%)
Blood and lymphatic system disorders
Anaemia	5/114 (4.4%)	5	8/112 (7.1%)	8
Febrile neutropenia	1/114 (0.9%)	1	0/112 (0%)	0
Leukopenia	4/114 (3.5%)	4	6/112 (5.4%)	6
Lymphopenia	2/114 (1.8%)	2	1/112 (0.9%)	1
Neutropenia	1/114 (0.9%)	1	0/112 (0%)	0
Cardiac disorders
Cardiac failure	1/114 (0.9%)	1	0/112 (0%)	0
Ventricular tachycardia	0/114 (0%)	0	1/112 (0.9%)	1
Gastrointestinal disorders
Dysphagia	1/114 (0.9%)	1	0/112 (0%)	0
Gastrooesophageal reflux disease	1/114 (0.9%)	1	0/112 (0%)	0
Odynophagia	1/114 (0.9%)	1	0/112 (0%)	0
Oesophageal stenosis	0/114 (0%)	0	1/112 (0.9%)	1
General disorders
Asthenia	0/114 (0%)	0	1/112 (0.9%)	1
Chest pain	1/114 (0.9%)	1	0/112 (0%)	0
Oedema peripheral	1/114 (0.9%)	1	0/112 (0%)	0
Immune system disorders
Transplant rejection	1/114 (0.9%)	1	2/112 (1.8%)	2
Infections and infestations
BK virus infection	2/114 (1.8%)	2	1/112 (0.9%)	1
Clostridium difficile colitis	1/114 (0.9%)	1	0/112 (0%)	0
Conjunctivitis	1/114 (0.9%)	1	0/112 (0%)	0
Cytomegalovirus viraemia	2/114 (1.8%)	2	0/112 (0%)	0
Gastroenteritis norovirus	0/114 (0%)	0	1/112 (0.9%)	1
Injection site infection	0/114 (0%)	0	1/112 (0.9%)	1
Polyomavirus-associated nephropathy	1/114 (0.9%)	1	1/112 (0.9%)	1
Urinary tract infection	2/114 (1.8%)	2	1/112 (0.9%)	1
Injury, poisoning and procedural complications
Arteriovenous fistula site complication	1/114 (0.9%)	1	0/112 (0%)	0
Delayed graft function	8/114 (7%)	8	6/112 (5.4%)	6
Incisional hernia	0/114 (0%)	0	1/112 (0.9%)	1
Post procedural urine leak	0/114 (0%)	0	1/112 (0.9%)	1
Procedural haemorrhage	1/114 (0.9%)	1	0/112 (0%)	0
Toxicity to various agents	1/114 (0.9%)	1	0/112 (0%)	0
Wound dehiscence	0/114 (0%)	0	1/112 (0.9%)	1
Investigations
Blood pressure decreased	0/114 (0%)	0	1/112 (0.9%)	1
Blood pressure increased	0/114 (0%)	0	1/112 (0.9%)	1
Blood urea increased	0/114 (0%)	0	1/112 (0.9%)	1
Carbon dioxide decreased	0/114 (0%)	0	1/112 (0.9%)	1
Cardiac murmur	1/114 (0.9%)	1	0/112 (0%)	0
Lymphocyte count decreased	4/114 (3.5%)	5	9/112 (8%)	10
Troponin increased	1/114 (0.9%)	1	0/112 (0%)	0
Urine output decreased	0/114 (0%)	0	1/112 (0.9%)	1
White blood cell count decreased	1/114 (0.9%)	1	0/112 (0%)	0
Metabolism and nutrition disorders
Diabetes mellitus	1/114 (0.9%)	1	2/112 (1.8%)	2
Hyperglycaemia	0/114 (0%)	0	2/112 (1.8%)	2
Hyperkalaemia	12/114 (10.5%)	12	8/112 (7.1%)	8
Hypertriglyceridaemia	0/114 (0%)	0	1/112 (0.9%)	1
Hypoalbuminaemia	0/114 (0%)	0	1/112 (0.9%)	1
Hypokalaemia	0/114 (0%)	0	2/112 (1.8%)	2
Hypomagnesaemia	0/114 (0%)	0	1/112 (0.9%)	1
Hypophosphataemia	3/114 (2.6%)	3	1/112 (0.9%)	1
Hypovolaemia	1/114 (0.9%)	1	0/112 (0%)	0
Metabolic acidosis	1/114 (0.9%)	1	0/112 (0%)	0
Nervous system disorders
Neuropathy peripheral	0/114 (0%)	0	1/112 (0.9%)	1
Psychiatric disorders
Major depression	1/114 (0.9%)	1	0/112 (0%)	0
Renal and urinary disorders
Acute kidney injury	1/114 (0.9%)	1	1/112 (0.9%)	1
Glomerulonephritis	0/114 (0%)	0	1/112 (0.9%)	1
Kidney fibrosis	0/114 (0%)	0	1/112 (0.9%)	1
Proteinuria	0/114 (0%)	0	1/112 (0.9%)	1
Renal artery thrombosis	0/114 (0%)	0	1/112 (0.9%)	1
Renal mass	1/114 (0.9%)	1	1/112 (0.9%)	1
Renal tubular atrophy	0/114 (0%)	0	1/112 (0.9%)	1
Renal tubular necrosis	0/114 (0%)	0	1/112 (0.9%)	1
Renal vasculitis	0/114 (0%)	0	1/112 (0.9%)	1
Surgical and medical procedures
Ureteral stent removal	1/114 (0.9%)	1	0/112 (0%)	0
Vascular disorders
Hypertension	4/114 (3.5%)	5	2/112 (1.8%)	2
Hypotension	2/114 (1.8%)	2	2/112 (1.8%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.