Open-Label Phase 2 Trial of a Steroid-Free, CNI-Free, Belatacept-Based Immunosuppressive Regimen

• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
• Overall Status: Terminated
• CT.gov ID: NCT01856257
• Collaborator: Clinical Trials in Organ Transplantation (Other)
• Enrollment: 71
• Locations: 3
• Arms: 3
• Duration (Months): 33
• Patients Per Site: 23.7
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

The primary objective is to evaluate a NULOJIX® (belatacept) based regimens as a means of improving long-term graft function without increasing the risks of immunologic graft injury by avoiding both calcineurin inhibitors (CNIs) and corticosteroids.

Condition or Disease	Intervention/Treatment	Phase
Primary Renal Allograft Candidate; Kidney Transplantation	Biological: Anti-thymocyte Globulin (Rabbit); Biological: belatacept; Drug: methylprednisolone; Biological: basiliximab; Drug: mycophenolate mofetil; Drug: tacrolimus	Phase 2

Detailed Description

Taking standard anti-rejection medications for a long time can cause serious side effects, including kidney damage. Transplant recipients have to take anti-rejection medications to prevent their immune system (the body's natural defense system against illness) from rejecting their new kidney. Most patients who receive a kidney transplant must take these anti-rejection medications for the rest of their lives, or for as long as the kidney continues to work.

The purpose of this study is to determine if NULOJIX® (belatacept), will minimize serious long term side effects seen with anti-rejection medications while still protecting the transplanted kidney from damage. The researchers also want to learn more about the safety of this treatment and the long term health of the transplanted kidney.

Study Design

• Study Type: Interventional
• Actual Enrollment: 71 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Steroid and Tacrolimus Avoidance Using NULOJIX® (Belatacept) in Renal Transplantation (CTOT-16)
• Study Start Date: Jul 1, 2013
• Actual Primary Completion Date: Apr 1, 2016
• Actual Study Completion Date: Apr 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Thymoglobulin®+tacrolimus+MMF Induction with Thymoglobulin®, methylprednisolone, and maintenance immunosuppression with tacrolimus and mycophenolate mofetil (MMF)	Biological: Anti-thymocyte Globulin (Rabbit); The target dosage is 6mg/kg total over 3 to 4 days. The recommended route of administration is intravenous infusion using a high-flow vein.; Other Names: Thymoglobulin® ATG (Rabbit) ; Drug: methylprednisolone; Methylprednisolone will be administered at a target dose of 500 mg beginning on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant and day 5 post-transplant 0 mg if therapeutic tacrolimus level achieved for groups 1 and 3.; Other Names: Medrol® ; Drug: mycophenolate mofetil; Mycophenolate Mofetil will be administered at a target dose of 1000 mg orally twice a day. Myfortic® (mycophenolate sodium) may be used as a replacement for MMF. Mycophenolate sodium will be dosed at 720 mg PO BID. Mycophenolate sodium will be adjusted based on clinical complications.; Other Names: MMF CellCept® mycophenolate acid ; Drug: tacrolimus; The site investigator will identify a starting tacrolimus dose at their discretion, in order to achieve the target trough levels, no later than 5 days post-transplantation. The dose will be adjusted to 5-8ng/ml for the active comparator arm (thymoglobulin + tacrolimus + MMF arm) or tapered off in the experimental arm (basiliximab + 20 weeks of tacrolimus + MMF + belatacept).; Other Names: Prograf®
Experimental: Thymoglobulin®+belatacept+MMF Induction with Thymoglobulin®, methylprednisolone, and maintenance with belatacept and mycophenolate mofetil (MMF)	Biological: Anti-thymocyte Globulin (Rabbit); The target dosage is 6mg/kg total over 3 to 4 days. The recommended route of administration is intravenous infusion using a high-flow vein.; Other Names: Thymoglobulin® ATG (Rabbit) ; Biological: belatacept; Participants will receive belatacept at a dose of 10mg/kg up on day 1, 5, 14, 28, 56 and 84. After 84 days, subjects will receive a maintenance dose of 5 mg/kg every 4 weeks until completion of the trial.; Other Names: NULOJIX® ; Drug: methylprednisolone; Methylprednisolone will be administered at a target dose of 500 mg beginning on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant and day 5 post-transplant 0 mg if therapeutic tacrolimus level achieved for groups 1 and 3.; Other Names: Medrol® ; Drug: mycophenolate mofetil; Mycophenolate Mofetil will be administered at a target dose of 1000 mg orally twice a day. Myfortic® (mycophenolate sodium) may be used as a replacement for MMF. Mycophenolate sodium will be dosed at 720 mg PO BID. Mycophenolate sodium will be adjusted based on clinical complications.; Other Names: MMF CellCept® mycophenolate acid
Experimental: Basiliximab+20 weeks of tacrolimus+MMF + belatacept Induction basiliximab and methylprednisolone, administration of NULOJIX® (belatacept) 24 hours post reperfusion (+/-12 hrs); maintenance immunosuppression with 1. )20 week course of Prograf® (tacrolimus) or equivalent 2.) CellCept® (mycophenolate mofetil- MMF), or Myfortic® (mycophenolate sodium), or equivalent. Subjects participating in this arm may have tacrolimus reinstated, at a dose to be determined by the site investigator, if any of the following events occur: 1 - An acute rejection episode 2- Request of the subject or site Investigator.	Biological: belatacept; Participants will receive belatacept at a dose of 10mg/kg up on day 1, 5, 14, 28, 56 and 84. After 84 days, subjects will receive a maintenance dose of 5 mg/kg every 4 weeks until completion of the trial.; Other Names: NULOJIX® ; Drug: methylprednisolone; Methylprednisolone will be administered at a target dose of 500 mg beginning on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant and day 5 post-transplant 0 mg if therapeutic tacrolimus level achieved for groups 1 and 3.; Other Names: Medrol® ; Biological: basiliximab; Basiliximab will be administered in two doses of 20 mg each.; Other Names: Simulect® ; Drug: mycophenolate mofetil; Mycophenolate Mofetil will be administered at a target dose of 1000 mg orally twice a day. Myfortic® (mycophenolate sodium) may be used as a replacement for MMF. Mycophenolate sodium will be dosed at 720 mg PO BID. Mycophenolate sodium will be adjusted based on clinical complications.; Other Names: MMF CellCept® mycophenolate acid ; Drug: tacrolimus; The site investigator will identify a starting tacrolimus dose at their discretion, in order to achieve the target trough levels, no later than 5 days post-transplantation. The dose will be adjusted to 5-8ng/ml for the active comparator arm (thymoglobulin + tacrolimus + MMF arm) or tapered off in the experimental arm (basiliximab + 20 weeks of tacrolimus + MMF + belatacept).; Other Names: Prograf®

Outcome Measures

Primary Outcome Measures

1. Mean Estimated Glomerular Filtration Rate (eGFR) Calculated for Each Treatment Group Using the CKD-EPI Equation at Wk 52 Post-Transplant [Week 52]

   eGFR was calculated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI): A score of ≥90 means kidney function is normal. A score between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Scores between 30 and 59 indicates moderately reduced kidney function. Scores between 15 and 29 indicate severely reduced kidney function. Scores below 15 indicate very severe or end stage kidney failure.

Secondary Outcome Measures

1. Count of Participants With Biopsy Proven Acute Rejection By Wk 52 Post-Transplant [Transplantation through Week 52]

   Biopsy proven acute rejection definition: histologic evidence of a Banff grade of ≥1A per local pathologist.

2. Count of Participants With eGFR < 60 mL/Min/1.73 m^2 Measured by CKD-EPI at Wk 52 Post-Transplant [Week 52]

   eGFR was calculated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI): A score of ≥90 means kidney function is normal. A score between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Scores between 30 and 59 indicates moderately reduced kidney function. Scores between 15 and 29 indicate severely reduced kidney function. Scores below 15 indicate very severe or end stage kidney failure.

3. Count of Participants by CKD Stage at Wk 52 [Week 52]

   The stages of Chronic Kidney Disease are defined using the participant's GFR value: Stage 1 if GFR value is ≥90 ( kidney function is normal) Stage 2 if 60 ≤ GFR < 90 (mildly reduced kidney function, pointing to kidney disease) Stage 3A if 45 ≤ GFR < 60* Stage 3B if 30 ≤ GFR < 45* Stage 4 if 15 ≤ GFR < 30 (severely reduced kidney function) Stage 5 if GFR < 15 (severe or end stage kidney failure). Stages 3A and 3B indicate moderately reduced kidney function.*

4. Count of Participants With Defined CKD Stage 4 or 5 at Wk 52 Post-Transplant [Week 52]

   The stages of Chronic Kidney Disease (CKD) are defined using the participant's GFR value: Stage 1 if GFR value is ≥ 90 (kidney function is normal) Stage 2 if 60 ≤ GFR < 90 (mildly reduced kidney function, pointing to kidney disease) Stage 3A if 45 <= GFR < 60* Stage 3B if 30 <= GFR < 45* Stage 4 if 15 ≤ GFR < 30 (severely reduced kidney function) Stage 5 if GFR < 15 (severe or end stage kidney failure). Stages 3A abd 3B indicate moderately reduced kidney function.*

5. Mean Calculated eGFR Using MDRD 4 Variable Model at Wk 52 Post-Transplant [Week 52]

   The estimated Glomerular Filtration Rate (eGFR) was calculated using the Modification of Diet in Renal Disease equation (MDRD): A score of ≥ 90 means kidney function is normal. A score between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Scores between 30 and 59 indicates moderately reduced kidney function. Scores between 15 and 29 indicate severely reduced kidney function. Scores below 15 indicate severe or endstage kidney failure.

6. The Slope of eGFR by CKD-EPI Over Time Based on Serum Creatinine Post-Transplant [Day 28 through Week 52 Post-Transplant]

   The estimated Glomerular Filtration Rate (eGFR) was calculated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI): A score of ≥ 90 means kidney function is normal. A score between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Scores between 30 and 59 indicates moderately reduced kidney function. Scores between 15 and 29 indicate severely reduced kidney function. Scores below 15 indicate very severe or endstage kidney failure. An estimate of the slope, or change over time, in eGFR was produced using standard statistical linear modeling procedures. The estimate was then re-scaled so that it could be interpreted as a change in eGFR per month. Positive numbers indicate increasing kidney function. Larger numbers indicate greater change in kidney function.

7. Count of Participants With Delayed Graft Function at Wk 52 Post-Transplant [Transplantation through Week 52]

   Delayed grafted function is defined as dialysis in the first week on one or more occasions for any indication other than the treatment of acute hyperkalemia in the setting of otherwise acceptable renal function.

8. Count of Participants With Acute Cellular Rejection Grade ≥ IA Defined by Banff 2007 Criteria By Wk 52 Post-Transplant [Transplantation through Week 52]

   Acute cellular rejection occurs when lesions at the site of the graft characteristically are infiltrated with large numbers of lymphocytes and macrophages that cause tissue damage. Acute cellular rejection for this endpoint is defined as a grade equal to or greater than IA by Banff 2007 criteria as determined by local pathology.

9. Count of Participants by Severity of First Acute Cellular Rejection by Wk 52 Post-Transplant [Transplantation through Week 52]

   Acute cellular rejection occurs when lesions at the site of the graft characteristically are infiltrated with large numbers of lymphocytes and macrophages that cause tissue damage. Acute cellular rejection for this endpoint is defined as a grade equal to or greater than IA by Banff 2007 criteria as determined by local pathology. 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. Originally it was 2 endpoints but all participants' highest grade was also their first grade so only reporting their first grade.

10. Count of Participants With Antibody Mediated Rejection by Wk 52 Post-Transplant [Transplantation through Week 52]

    Antibody mediated rejection is defined by diffusely positive staining for C4d, presence of circulating anti-donor antibodies, and morphologic evidence of acute tissue injury and was determined by local pathology.

11. Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies [Transplantation through Week 52]

    Upon having a biopsy performed, persons often receive treatment for rejection based on the results of the biopsy, which may or may not have shown signs of rejection. Details of local biopsy findings are presented here for rejection. Acronyms and abbreviations are defined as follows: ACR= Acute T-Cell Mediated rejection AMR= Acute Antibody-mediated rejection Chr. AMR=Chronic Antibody Mediated Rejection Gd.=Grade IFTA=Interstitial Fibrosis and Tubular Atrophy

12. Type of Treatment for Detected Graft Rejection [Transplantation through Week 52]

    Upon having a biopsy performed, persons often receive treatment for rejection based on the results of the biopsy, which may or may not have shown signs of rejection. Details of treatment are presented here for rejection. Acronyms and abbreviations are defined below. ATG=Thymoglobulin

13. Count of Participants With De Novo Anti-Donor Histocompatibility Antigen (HLA) Antibodies at Wk 52 Post-Transplant [Week 52]

    The presence of antibodies reactive to Histocompatibility Antigen (HLA) molecules expressed on the renal allograft have been associated with both acute and chronic injury to the transplanted kidney. The development of de novo anti donor HLA antibodies may mean a person is more likely to reject the graft. No data available.

14. Count of Participants With Either New Onset Diabetes After Transplant (NODAT) or Impaired Fasting Glucose (IFG) at Week 52 Post-Transplant -Based on Criteria Specified by the ADA and WHO [Transplantation through Week 52]

    New onset diabetes is the development of diabetes post-kidney transplant. It was identified by the clinical sites caring for each participant and reported directly in the clinical database. Impaired fasting glucose (IFG) is a determination made by referencing glucose measurements obtained from a standard chemistry panel. Any fasting glucose measure that is between 110 and 125 mg/dL is classified as IFG. Acronyms: American Diabetes Association (ADA); World Health Organization (WHO).

15. Count of Participants With Treated Diabetes Between Day 14 and Wk 52 Post-Transplant [Day 14 through week 52]

    Treated diabetes is defined as receipt of any oral medication or insulin for the treatment of diabetes for >14 days.

16. Hemoglobin A1c (HbA1c) Measurements Over Time [Baseline (Pre-Transplant) and Days 28 and -84, and Weeks 28, -36, and -52 Post-Transplant]

    Hemoglobin A1c (HbA1c) measures the average blood glucose levels over 8-12 weeks, thus acting as a useful long-term gauge of blood glucose control: A value below 6.0% reflects normal levels, 6.0% to 6.4% reflects prediabetes, and a value of ≥ 6.5% reflects diabetes.

17. Standardized Blood Pressure Measurement at Wk 52 Post-Transplant [Week 52]

    A blood pressure measurement consists of two numbers: the systolic and diastolic pressures. Systolic pressure measures the pressure in blood vessels when the heart beats. Diastolic pressure measures the pressure in blood vessels between beats of the heart. Systolic measures of <120 and diastolic measures of <80 are considered normal. Systolic measures of 120-139 and diastolic measures of 80-89 are considered at risk (or pre-hypertension). Systolic measures of ≥140 and diastolic measures of ≥90 are considered high.

18. Count of Participants With Use of Anti-hypertensive Medication at Wk 52 Post-Transplant [Week 52]

    Anti-hypertensive medications are a class of drugs that are used to treat hypertension. The medications seek to prevent the complications of high blood pressure, such as stroke and myocardial infarction.

19. Fasting Lipid Profile at Baseline (Pre-Transplant) [Baseline]

    A fasting lipid profiles measures total cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride levels. These measurements are used in assessing one's risk of cardiovascular disease. Target ranges for each of these measures are provided: Total cholesterol: 75-169 mg/dL if age ≤20; 100-199 mg/dL if age ≥ 21; high values indicate risk of cardiovascular disease LDL cholesterol: <70 mg/dL for people with documented cardiovascular disease or metabolic syndrome; <100 mg/dL for people considered high risk for cardiovascular disease; <130 mg/dL for people considered low risk for cardiovascular disease; high values indicate risk of cardiovascular disease HDL cholesterol: 40mg/dL and higher; high values indicate reduced risk of cardiovascular disease Non-HDL cholesterol: 30 mg/dL above the target value for LDL cholesterol; high values indicate risk of cardiovascular disease and Triglycerides: <150 mg/dL; high values indicate risk of cardiovascular disease.

20. Fasting Lipid Profile at Wk 28 Post-Transplant [Week 28]

    A fasting lipid profiles measures total cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride levels. These measurements are used in assessing one's risk of cardiovascular disease. Target ranges for each of these measures are provided: Total cholesterol: 75-169 mg/dL if age ≤20; 100-199 mg/dL if age ≥ 21; high values indicate risk of cardiovascular disease LDL cholesterol: <70 mg/dL for people with documented cardiovascular disease or metabolic syndrome; <100 mg/dL for people considered high risk for cardiovascular disease; <130 mg/dL for people considered low risk for cardiovascular disease; high values indicate risk of cardiovascular disease HDL cholesterol: 40mg/dL and higher; high values indicate reduced risk of cardiovascular disease Non-HDL cholesterol: 30 mg/dL above the target value for LDL cholesterol; high values indicate risk of cardiovascular disease and Triglycerides: <150 mg/dL; high values indicate risk of cardiovascular disease.

21. Fasting Lipid Profile at Wk 52 Post-Transplant [Week 52]

    A fasting lipid profiles measures total cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride levels. These measurements are used in assessing one's risk of cardiovascular disease. Target ranges for each of these measures are provided: Total cholesterol: 75-169 mg/dL if age ≤ 20; 100-199 mg/dL if age ≥ 21; high values indicate risk of cardiovascular disease LDL cholesterol: <70 mg/dL for people with documented cardiovascular disease or metabolic syndrome; <100 mg/dL for people considered high risk for cardiovascular disease; <130 mg/dL for people considered low risk for cardiovascular disease; high values indicate risk of cardiovascular disease HDL cholesterol: 40mg/dL and higher; high values indicate reduced risk of cardiovascular disease Non-HDL cholesterol: 30 mg/dL above the target value for LDL cholesterol; high values indicate risk of cardiovascular disease and Triglycerides: <150 mg/dL; high values indicate risk of cardiovascular disease.

22. Count of Participants With Use of Lipid Lowering Medications at Baseline and Wk 28 and Wk 52 Post-Transplant [Baseline (Pre-Transplant), Week 28, and Week 52]

    Lipid lowering medications are used in the treatment of high levels of fats (lipids), such as cholesterol in blood.

23. Total Daily Prescribed Pill Count [Day 28, Day 84, Week 28, Week 36, and Week 52]

    This is a measure of the total number of pills a participant was prescribed on a given day

24. Count of Participant Deaths or Graft Loss by Wk 52 Post-Transplant [Transplantation through Week 52]

    This measure counts deaths and graft loss occurring at any point post transplantation. Graft loss is defined as 90 days of dialysis dependency.

25. Count of Participants With Graft Rejection by Wk 52 Post-Transplant [Transplantation through Week 52]

    The number of participants who were treated by their local physician for any type of rejection including, but not limited to cellular rejection and antibody- mediated rejection of the transplanted kidney regardless of the presence of a biopsy.

26. Count of Participants Experiencing ≥ 1 Adverse Event (AEs) or Serious Adverse Events (SAEs) by Wk 52 [Enrollment through Week 52]

    Adverse events were collected systematically from enrollment through Wk 52, the last study visit. Provided are numbers of participants with ≥ 1 adverse event (serious or non-serious adverse events) by treatment arm.

27. Count of Participants With Infections Requiring Hospitalization or Systemic Therapy by Wk 52 Post-Transplant [Transplantation through Week 52]

    Infections of certain types (i.e., excluding those identified in the protocol as occurring commonly in this study population) were required to be reported as a serious adverse event if they required either inpatient hospitalization or prolongation of a current hospitalization.

28. Count of Participants With BK Polyoma Virus (BKV) and Cytomegalovirus (CMV) Viremia (Local Center Monitoring) as Adverse Events by Wk 52 Post-Transplant [Transplantation through Week 52]

    Viral infections following renal transplantation is significant source of recipient morbidity and mortality, and a significant cause of allograft dysfunction and loss. Specific viruses were monitored during the study, using participant blood samples. Displayed are counts of participants who experienced BKV and CMV viremia as adverse events by treatment arm.

29. Count of Participants With Epstein-Barr Virus (EBV) Infection as Reported on the Case Report Form as Adverse Events [Transplantation through Week 52]

    Viral infections following renal transplantation, including but not limited to EBV infection, is a significant source of recipient morbidity and mortality, and a significant cause of allograft dysfunction and loss.

30. Count of Participants With Fever > 39 Degrees Celsius and Blood Pressure < 90 mmHg Within 24 Hours of Onset of Transplant Procedure [Within 24 Hours of transplant procedure]

    Temperature of >39 degrees Celsius (e.g., 102.2 degrees Fahrenheit) would be an indication of fever most often in response to an infection or illness. Systolic blood pressure <90mm Hg would be an indication of low blood pressure.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Male or Female, 18-65 years of age at the time of enrollment;

• Ability to understand and provide written informed consent;

• Candidate for primary renal allograft from either living or deceased donor;

• No known contraindications to study therapy using NULOJIX® (belatacept);

• Female participants of childbearing potential must have a negative pregnancy test upon study entry;

• Participants with reproductive potential must agree to use an appropriate method(s) of birth control as outlined in the CellCept® , Myfortic® or generic package labeling during participation in the study and for 4 months following completion of the study;

• No donor specific antibodies prior to transplant that are considered to be of clinical significance by the site investigator;

• Negative crossmatch or Panel Reactive Antibodies (PRA) of 0% on historic and current sera, as determined by each participating study center;

• A documented negative tuberculosis (TB) test within the 6 months prior to transplant. If documentation is not present at the time of transplantation, and the subject does not have any risk factors for TB, a TB-specific interferon gamma release assay (IGRA) may be performed.

Exclusion Criteria:

• Need for multi-organ transplant;

• Recipient of previous organ transplant;

• Epstein-Barr Virus (EBV) seronegative (or unknown) recipients;

• Active infection including hepatitis B, hepatitis C, or human Immunodeficiency Virus (HIV);

• Individuals who have required treatment with prednisone or other immunosuppressive drugs within 1 year prior to transplant;

• Individuals undergoing transplant using organs from extended criteria donor (ECD) or donation after cardiac death (DCD) donors;

• Histocompatibility antigen (HLA) identical living donors;

• Individuals at significant risk of early recurrence of the primary renal disease including focal segmental glomerulosclerosis (FSGS) and membranoproliferative glomerulonephritis (MPGN) type 2 or any other disease that in the opinion of the investigator is at increased likelihood of recurrence and which may result in rapid decline in renal function;

• Known history of thrombotic events or risk factors, including any of the following:

• Factor V Leiden, elevated homocysteine, positive lupus anticoagulant, elevated anticardiolipin antibody, heparin-induced thrombocytopenia,

• A family history of a heritable thrombotic condition,

• Recurrent deep vein thrombosis (DVT) or pulmonary emboli (PE),

• Unexplained stillborn infant or recurrent spontaneous abortion or other congenital or acquired thrombotic disorder.

At the discretion of the investigator, a history of thrombosis of a dialysis access graft, fistula, or indwelling catheter/device may not be considered an exclusion criterion.

• Any condition that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements;

• Use of investigational drugs within 4 weeks of enrollment;

• Known hypersensitivity to mycophenolate mofetil (MMF)or any of the drug's components;

• Administration of live attenuated vaccine(s) within 8 weeks of enrollment;

• Blood type A2 and A2B donors into blood type B recipients.

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, San Francisco	San Francisco	California	United States	94143
3	Emory University	Atlanta	Georgia	United States	30322

Sponsors and Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID)
• Clinical Trials in Organ Transplantation

Investigators

• Principal Investigator: Kenneth Newell, MD, PhD, Emory University
• Study Chair: Roslyn B. Mannon, M.D., University of Alabama at Birmingham

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• 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: NCT01856257
• Other Study ID Numbers: DAIT CTOT-16
• First Posted: May 17, 2013
• Last Update Posted: Dec 17, 2020
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID): Kidney Transplantation; Transplantation; NULOJIX; belatacept; chronic immunosuppression
• Additional relevant MeSH terms: Mycophenolic Acid; Methylprednisolone; Abatacept; Tacrolimus; Thymoglobulin; Antilymphocyte Serum; Basiliximab

Study Results

Participant Flow

Recruitment Details	Three sites in the United States recruited and enrolled 71 participants into this trial.

Arm/Group Title	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept	Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept	Enrolled, Not Randomized
Arm/Group Description	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.	Induction: Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3. The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84	Subjects who signed informed consent and were thus enrolled, but were not randomized to study treatment.
Period Title: Overall Study
STARTED	29	29	11	2
COMPLETED	26	28	11	0
NOT COMPLETED	3	1	0	2

Baseline Characteristics

Arm/Group Title	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept	Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept	Total
Arm/Group Description	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.	Induction: Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3. The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84	Total of all reporting groups
Overall Participants	29	29	11	69
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	29 100%	29 100%	11 100%	69 100%
>=65 years	0 0%	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	47.7 (6.76)	44.5 (10.45)	44.6 (9.63)	45.9 (8.93)
Sex: Female, Male (Count of Participants)
Female	9 31%	8 27.6%	4 36.4%	21 30.4%
Male	20 69%	21 72.4%	7 63.6%	48 69.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 6.9%	2 6.9%	1 9.1%	5 7.2%
Not Hispanic or Latino	26 89.7%	25 86.2%	9 81.8%	60 87%
Unknown or Not Reported	1 3.4%	2 6.9%	1 9.1%	4 5.8%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	1 3.4%	3 10.3%	0 0%	4 5.8%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	16 55.2%	13 44.8%	5 45.5%	34 49.3%
White	9 31%	11 37.9%	4 36.4%	24 34.8%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	3 10.3%	2 6.9%	2 18.2%	7 10.1%
Region of Enrollment (participants) [Number]
United States	29 100%	29 100%	11 100%	69 100%

Outcome Measures

1. Primary Outcome

Title	Mean Estimated Glomerular Filtration Rate (eGFR) Calculated for Each Treatment Group Using the CKD-EPI Equation at Wk 52 Post-Transplant
Description	eGFR was calculated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI): A score of ≥90 means kidney function is normal. A score between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Scores between 30 and 59 indicates moderately reduced kidney function. Scores between 15 and 29 indicate severely reduced kidney function. Scores below 15 indicate very severe or end stage kidney failure.
Time Frame	Week 52

Outcome Measure Data

Analysis Population Description

Intent-to-treat population with available data at week 52

Arm/Group Title	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept	Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept
Arm/Group Description	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.	Induction: Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3. The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84
Measure Participants	26	27	11
Mean (Standard Deviation) [mL/min/1.73m^2]	59.2 (19.9)	61.5 (23.3)	63.0 (17.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac, Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.544
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	3.512
	Confidence Interval	(2-Sided) 95%; -7.999 to 15.024
	Parameter Dispersion	Type: Value:
	Estimation Comments	The p-value, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available eGFR data from weeks 4, 12, 28, 36, and 52 to compare Group 2 to Group 1.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac, Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.531
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	4.820
	Confidence Interval	(2-Sided) 95%; -10.481 to 20.121
	Parameter Dispersion	Type: Value:
	Estimation Comments	P-value estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available eGFR data from weeks 4, 12, 28, 36, and 52 to compare Group 3 to Group 1.

2. Secondary Outcome

Title	Count of Participants With Biopsy Proven Acute Rejection By Wk 52 Post-Transplant
Description	Biopsy proven acute rejection definition: histologic evidence of a Banff grade of ≥1A per local pathologist.
Time Frame	Transplantation through Week 52

Outcome Measure Data

Analysis Population Description

Intent-to-treat population

Arm/Group Title	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept	Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept
Arm/Group Description	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.	Induction: Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3. The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84
Measure Participants	29	29	11
Count of Participants [Participants]	1 3.4%	10 34.5%	4 36.4%

3. Secondary Outcome

Title	Count of Participants With eGFR < 60 mL/Min/1.73 m^2 Measured by CKD-EPI at Wk 52 Post-Transplant
Description	eGFR was calculated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI): A score of ≥90 means kidney function is normal. A score between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Scores between 30 and 59 indicates moderately reduced kidney function. Scores between 15 and 29 indicate severely reduced kidney function. Scores below 15 indicate very severe or end stage kidney failure.
Time Frame	Week 52

Outcome Measure Data

Analysis Population Description

Intent-to-treat population

Arm/Group Title	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept	Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept
Arm/Group Description	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.	Induction: Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3. The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84
Measure Participants	29	29	11
Count of Participants [Participants]	21 72.4%	15 51.7%	6 54.5%

4. Secondary Outcome

Title	Count of Participants by CKD Stage at Wk 52
Description	The stages of Chronic Kidney Disease are defined using the participant's GFR value: Stage 1 if GFR value is ≥90 ( kidney function is normal) Stage 2 if 60 ≤ GFR < 90 (mildly reduced kidney function, pointing to kidney disease) Stage 3A if 45 ≤ GFR < 60* Stage 3B if 30 ≤ GFR < 45* Stage 4 if 15 ≤ GFR < 30 (severely reduced kidney function) Stage 5 if GFR < 15 (severe or end stage kidney failure). Stages 3A and 3B indicate moderately reduced kidney function.*
Time Frame	Week 52

Outcome Measure Data

Analysis Population Description

Intent-to-treat population

Arm/Group Title	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept	Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept
Arm/Group Description	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.	Induction: Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3. The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84
Measure Participants	29	29	11
Stage 1	3 10.3%	3 10.3%	1 9.1%
Stage 2	5 17.2%	11 37.9%	4 36.4%
Stage 3A	11 37.9%	9 31%	6 54.5%
Stage 3B	6 20.7%	2 6.9%	0 0%
Stage 4	1 3.4%	1 3.4%	0 0%
Stage 5	3 10.3%	3 10.3%	0 0%

5. Secondary Outcome

Title	Count of Participants With Defined CKD Stage 4 or 5 at Wk 52 Post-Transplant
Description	The stages of Chronic Kidney Disease (CKD) are defined using the participant's GFR value: Stage 1 if GFR value is ≥ 90 (kidney function is normal) Stage 2 if 60 ≤ GFR < 90 (mildly reduced kidney function, pointing to kidney disease) Stage 3A if 45 <= GFR < 60* Stage 3B if 30 <= GFR < 45* Stage 4 if 15 ≤ GFR < 30 (severely reduced kidney function) Stage 5 if GFR < 15 (severe or end stage kidney failure). Stages 3A abd 3B indicate moderately reduced kidney function.*
Time Frame	Week 52

Outcome Measure Data

Analysis Population Description

Intent-to-treat population

Arm/Group Title	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept	Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept
Arm/Group Description	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.	Induction: Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3. The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84
Measure Participants	29	29	11
Count of Participants [Participants]	4 13.8%	4 13.8%	0 0%

6. Secondary Outcome

Title	Mean Calculated eGFR Using MDRD 4 Variable Model at Wk 52 Post-Transplant
Description	The estimated Glomerular Filtration Rate (eGFR) was calculated using the Modification of Diet in Renal Disease equation (MDRD): A score of ≥ 90 means kidney function is normal. A score between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Scores between 30 and 59 indicates moderately reduced kidney function. Scores between 15 and 29 indicate severely reduced kidney function. Scores below 15 indicate severe or endstage kidney failure.
Time Frame	Week 52

Outcome Measure Data

Analysis Population Description

Intent-to-treat population with available data

Arm/Group Title	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept	Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept
Arm/Group Description	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.	Induction: Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3. The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84
Measure Participants	26	27	11
Mean (Standard Deviation) [mL/min/1.73m^2]	56.1 (18.5)	57.0 (20.7)	58.2 (14.4)

7. Secondary Outcome

Title	The Slope of eGFR by CKD-EPI Over Time Based on Serum Creatinine Post-Transplant
Description	The estimated Glomerular Filtration Rate (eGFR) was calculated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI): A score of ≥ 90 means kidney function is normal. A score between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Scores between 30 and 59 indicates moderately reduced kidney function. Scores between 15 and 29 indicate severely reduced kidney function. Scores below 15 indicate very severe or endstage kidney failure. An estimate of the slope, or change over time, in eGFR was produced using standard statistical linear modeling procedures. The estimate was then re-scaled so that it could be interpreted as a change in eGFR per month. Positive numbers indicate increasing kidney function. Larger numbers indicate greater change in kidney function.
Time Frame	Day 28 through Week 52 Post-Transplant

Outcome Measure Data

Analysis Population Description

Intent-to-treat population with available data

Arm/Group Title	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept	Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept
Arm/Group Description	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.	Induction: Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3. The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84
Measure Participants	28	29	11
Mean (Standard Deviation) [eGFR change over time (by month)]	0.3 (4.1)	1.3 (2.6)	0.8 (1.4)

8. Secondary Outcome

Title	Count of Participants With Delayed Graft Function at Wk 52 Post-Transplant
Description	Delayed grafted function is defined as dialysis in the first week on one or more occasions for any indication other than the treatment of acute hyperkalemia in the setting of otherwise acceptable renal function.
Time Frame	Transplantation through Week 52

Outcome Measure Data

Analysis Population Description

Intent-to-treat population

Arm/Group Title	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept	Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept
Arm/Group Description	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.	Induction: Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3. The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84
Measure Participants	29	29	11
Count of Participants [Participants]	6 20.7%	9 31%	0 0%

9. Secondary Outcome

Title	Count of Participants With Acute Cellular Rejection Grade ≥ IA Defined by Banff 2007 Criteria By Wk 52 Post-Transplant
Description	Acute cellular rejection occurs when lesions at the site of the graft characteristically are infiltrated with large numbers of lymphocytes and macrophages that cause tissue damage. Acute cellular rejection for this endpoint is defined as a grade equal to or greater than IA by Banff 2007 criteria as determined by local pathology.
Time Frame	Transplantation through Week 52

Outcome Measure Data

Analysis Population Description

Intent-to-treat population

Arm/Group Title	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept	Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept
Arm/Group Description	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.	Induction: Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3. The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84
Measure Participants	29	29	11
Count of Participants [Participants]	1 3.4%	10 34.5%	4 36.4%

10. Secondary Outcome

Title	Count of Participants by Severity of First Acute Cellular Rejection by Wk 52 Post-Transplant
Description	Acute cellular rejection occurs when lesions at the site of the graft characteristically are infiltrated with large numbers of lymphocytes and macrophages that cause tissue damage. Acute cellular rejection for this endpoint is defined as a grade equal to or greater than IA by Banff 2007 criteria as determined by local pathology. 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. Originally it was 2 endpoints but all participants' highest grade was also their first grade so only reporting their first grade.
Time Frame	Transplantation through Week 52

Outcome Measure Data

Analysis Population Description

Intent-to-treat population

Arm/Group Title	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept	Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept
Arm/Group Description	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.	Induction: Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3. The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84
Measure Participants	29	29	11
IA	0 0%	3 10.3%	2 18.2%
IB	1 3.4%	1 3.4%	2 18.2%
IIA	0 0%	4 13.8%	0 0%
IIB	0 0%	0 0%	0 0%
III	0 0%	2 6.9%	0 0%

11. Secondary Outcome

Title	Count of Participants With Antibody Mediated Rejection by Wk 52 Post-Transplant
Description	Antibody mediated rejection is defined by diffusely positive staining for C4d, presence of circulating anti-donor antibodies, and morphologic evidence of acute tissue injury and was determined by local pathology.
Time Frame	Transplantation through Week 52

Outcome Measure Data

Analysis Population Description

Intent-to-treat population

Arm/Group Title	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept	Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept
Arm/Group Description	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.	Induction: Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3. The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84
Measure Participants	29	29	11
Count of Participants [Participants]	1 3.4%	1 3.4%	0 0%

12. Secondary Outcome

Title	Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies
Description	Upon having a biopsy performed, persons often receive treatment for rejection based on the results of the biopsy, which may or may not have shown signs of rejection. Details of local biopsy findings are presented here for rejection. Acronyms and abbreviations are defined as follows: ACR= Acute T-Cell Mediated rejection AMR= Acute Antibody-mediated rejection Chr. AMR=Chronic Antibody Mediated Rejection Gd.=Grade IFTA=Interstitial Fibrosis and Tubular Atrophy
Time Frame	Transplantation through Week 52

Outcome Measure Data

Analysis Population Description

Intent-to-treat population

Arm/Group Title	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept	Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept
Arm/Group Description	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.	Induction: Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3. The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84
Measure Participants	29	29	11
Borderline	3	5	0
Borderline, AMR-Gd. I (ATN-Like)	1	0	0
Borderline, AMR-Gd.I (ATN-Like), Chr.AMR, IFTA-Gd1	1	0	0
Borderline, AMR-Gd. I (ATN-Like), IFTA-Gd. I	0	1	0
Borderline, Chr.AMR, IFTA-Gd. I	1	0	0
Borderline, IFTA-Gd. I	1	2	1
Borderline, IFTA- Gd. II	2	1	0
ACR-Gd. IA	0	4	2
ACR-Gd. IA, IFTA-Gd. I	0	1	0
ACR-Gd. IA, IFTA-Gd. II	1	0	0
ACR-Gd. IB	1	0	0
ACR-Gd. IB, IFTA-Gd. I	0	1	1
ACR-Gd. IB, IFTA-Gd. II	0	0	1
ACR-Gd. IB, IFTA-Gd. III	0	1	0
ACR-Gd. IIA	0	2	0
ACR-Gd. IIA, IFTA-Gd. I	0	2	0
ACR-Gd. III	0	2	0
AMR-Gd. II (Capillary/Glomerular)	1	0	0
IFTA-Gd. I	4	5	1
IFTA-Gd. II	1	2	0

13. Secondary Outcome

Title	Type of Treatment for Detected Graft Rejection
Description	Upon having a biopsy performed, persons often receive treatment for rejection based on the results of the biopsy, which may or may not have shown signs of rejection. Details of treatment are presented here for rejection. Acronyms and abbreviations are defined below. ATG=Thymoglobulin
Time Frame	Transplantation through Week 52

Outcome Measure Data

Analysis Population Description

Intent-to-treat population

Arm/Group Title	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept	Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept
Arm/Group Description	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.	Induction: Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3. The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84
Measure Participants	29	29	11
ATG	0	1	0
ATG, Pulse Steroids	0	5	2
ATG, Pulse Steroids, Prograf	0	1	0
Antibiotic	1	0	0
Plasmapheresis	1	0	0
Plasmapheresis, Oral Steroids	1	0	0
Pulse Steroids	6	9	3
Pulse Steroids, Leflunomide	0	1	0
Pulse Steroids, Plasmapheresis, Eculizumab	1	0	0
Prednisone	0	2	0

14. Secondary Outcome

Title	Count of Participants With De Novo Anti-Donor Histocompatibility Antigen (HLA) Antibodies at Wk 52 Post-Transplant
Description	The presence of antibodies reactive to Histocompatibility Antigen (HLA) molecules expressed on the renal allograft have been associated with both acute and chronic injury to the transplanted kidney. The development of de novo anti donor HLA antibodies may mean a person is more likely to reject the graft. No data available.
Time Frame	Week 52

Outcome Measure Data

Analysis Population Description

No analysis due to no available data. Data were not reported from the central laboratory and, therefore, unable to be summarized.

Arm/Group Title	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept	Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept
Arm/Group Description	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.	Induction: Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3. The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84
Measure Participants	0	0	0

15. Secondary Outcome

Title	Count of Participants With Either New Onset Diabetes After Transplant (NODAT) or Impaired Fasting Glucose (IFG) at Week 52 Post-Transplant -Based on Criteria Specified by the ADA and WHO
Description	New onset diabetes is the development of diabetes post-kidney transplant. It was identified by the clinical sites caring for each participant and reported directly in the clinical database. Impaired fasting glucose (IFG) is a determination made by referencing glucose measurements obtained from a standard chemistry panel. Any fasting glucose measure that is between 110 and 125 mg/dL is classified as IFG. Acronyms: American Diabetes Association (ADA); World Health Organization (WHO).
Time Frame	Transplantation through Week 52

Outcome Measure Data

Analysis Population Description

Intent-to-treat population with available data

Arm/Group Title	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept	Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept
Arm/Group Description	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.	Induction: Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3. The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84
Measure Participants	29	29	11
New onset diabetes during first 52 weeks	1 3.4%	1 3.4%	0 0%
Impaired fasting glucose at week 52	2 6.9%	0 0%	0 0%

16. Secondary Outcome

Title	Count of Participants With Treated Diabetes Between Day 14 and Wk 52 Post-Transplant
Description	Treated diabetes is defined as receipt of any oral medication or insulin for the treatment of diabetes for >14 days.
Time Frame	Day 14 through week 52

Outcome Measure Data

Analysis Population Description

Intent-to-treat population with available data

Arm/Group Title	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept	Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept
Arm/Group Description	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.	Induction: Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3. The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84
Measure Participants	26	28	11
Count of Participants [Participants]	3 10.3%	2 6.9%	0 0%

17. Secondary Outcome

Title	Hemoglobin A1c (HbA1c) Measurements Over Time
Description	Hemoglobin A1c (HbA1c) measures the average blood glucose levels over 8-12 weeks, thus acting as a useful long-term gauge of blood glucose control: A value below 6.0% reflects normal levels, 6.0% to 6.4% reflects prediabetes, and a value of ≥ 6.5% reflects diabetes.
Time Frame	Baseline (Pre-Transplant) and Days 28 and -84, and Weeks 28, -36, and -52 Post-Transplant

Outcome Measure Data

Analysis Population Description

Intent-to-treat population with available data

Arm/Group Title	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept	Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept
Arm/Group Description	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.	Induction: Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3. The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84
Measure Participants	26	28	11
Baseline	5.7 (1.3)	5.7 (1.1)	5.9 (0.8)
Day 28	5.4 (0.8)	5.6 (1.0)	5.4 (1.1)
Day 84	5.6 (1.1)	5.5 (1.1)	5.4 (0.8)
Week 28	6.2 (1.9)	6.0 (1.4)	5.6 (0.8)
Week 36	6.7 (2.6)	5.9 (1.2)	5.5 (0.8)
Week 52	7.8 (3.3)	6.7 (1.6)	5.8 (1.3)

18. Secondary Outcome

Title	Standardized Blood Pressure Measurement at Wk 52 Post-Transplant
Description	A blood pressure measurement consists of two numbers: the systolic and diastolic pressures. Systolic pressure measures the pressure in blood vessels when the heart beats. Diastolic pressure measures the pressure in blood vessels between beats of the heart. Systolic measures of <120 and diastolic measures of <80 are considered normal. Systolic measures of 120-139 and diastolic measures of 80-89 are considered at risk (or pre-hypertension). Systolic measures of ≥140 and diastolic measures of ≥90 are considered high.
Time Frame	Week 52

Outcome Measure Data

Analysis Population Description

Intent-to-treat population with available data

Arm/Group Title	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept	Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept
Arm/Group Description	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.	Induction: Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3. The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84
Measure Participants	26	18	3
Systolic BP at W52	135.0 (18.9)	133.7 (14.7)	132.0 (8.7)
Diastolic BP at W52	77.7 (10.9)	79.1 (10.2)	75.7 (13.1)

19. Secondary Outcome

Title	Count of Participants With Use of Anti-hypertensive Medication at Wk 52 Post-Transplant
Description	Anti-hypertensive medications are a class of drugs that are used to treat hypertension. The medications seek to prevent the complications of high blood pressure, such as stroke and myocardial infarction.
Time Frame	Week 52

Outcome Measure Data

Analysis Population Description

Intent-to-treat population with available data

Arm/Group Title	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept	Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept
Arm/Group Description	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.	Induction: Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3. The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84
Measure Participants	26	28	11
Count of Participants [Participants]	18 62.1%	23 79.3%	8 72.7%

20. Secondary Outcome

Title	Fasting Lipid Profile at Baseline (Pre-Transplant)
Description	A fasting lipid profiles measures total cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride levels. These measurements are used in assessing one's risk of cardiovascular disease. Target ranges for each of these measures are provided: Total cholesterol: 75-169 mg/dL if age ≤20; 100-199 mg/dL if age ≥ 21; high values indicate risk of cardiovascular disease LDL cholesterol: <70 mg/dL for people with documented cardiovascular disease or metabolic syndrome; <100 mg/dL for people considered high risk for cardiovascular disease; <130 mg/dL for people considered low risk for cardiovascular disease; high values indicate risk of cardiovascular disease HDL cholesterol: 40mg/dL and higher; high values indicate reduced risk of cardiovascular disease Non-HDL cholesterol: 30 mg/dL above the target value for LDL cholesterol; high values indicate risk of cardiovascular disease and Triglycerides: <150 mg/dL; high values indicate risk of cardiovascular disease.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Intent-to-treat population with available data

Arm/Group Title	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept	Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept
Arm/Group Description	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.	Induction: Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3. The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84
Measure Participants	22	26	7
Total cholesterol	167.1 (37.5)	159.4 (45.0)	167.6 (84.8)
Non-HDL	122.0 (35.1)	116.1 (45.7)	123.4 (85.3)
LDL	91.1 (28.0)	83.1 (38.5)	65.2 (15.3)
HDL	45.1 (11.8)	43.3 (13.0)	44.1 (19.9)
Triglyceride	156.8 (103.6)	194.4 (171.1)	227.1 (248.1)

21. Secondary Outcome

Title	Fasting Lipid Profile at Wk 28 Post-Transplant
Description	A fasting lipid profiles measures total cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride levels. These measurements are used in assessing one's risk of cardiovascular disease. Target ranges for each of these measures are provided: Total cholesterol: 75-169 mg/dL if age ≤20; 100-199 mg/dL if age ≥ 21; high values indicate risk of cardiovascular disease LDL cholesterol: <70 mg/dL for people with documented cardiovascular disease or metabolic syndrome; <100 mg/dL for people considered high risk for cardiovascular disease; <130 mg/dL for people considered low risk for cardiovascular disease; high values indicate risk of cardiovascular disease HDL cholesterol: 40mg/dL and higher; high values indicate reduced risk of cardiovascular disease Non-HDL cholesterol: 30 mg/dL above the target value for LDL cholesterol; high values indicate risk of cardiovascular disease and Triglycerides: <150 mg/dL; high values indicate risk of cardiovascular disease.
Time Frame	Week 28

Outcome Measure Data

Analysis Population Description

Intent-to-treat population with available data

Arm/Group Title	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept	Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept
Arm/Group Description	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.	Induction: Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3. The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84
Measure Participants	15	15	10
Total cholesterol	169.6 (38.6)	179.5 (44.4)	167.3 (39.5)
Non-HDL	119.6 (35.9)	133.5 (46.7)	115.0 (38.0)
LDL	95.6 (31.4)	109.8 (43.0)	82.7 (18.2)
HDL	51.0 (14.5)	46.0 (18.6)	52.3 (27.5)
Triglyceride	126.4 (51.0)	153.3 (93.0)	166.6 (128.9)

22. Secondary Outcome

Title	Fasting Lipid Profile at Wk 52 Post-Transplant
Description	A fasting lipid profiles measures total cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride levels. These measurements are used in assessing one's risk of cardiovascular disease. Target ranges for each of these measures are provided: Total cholesterol: 75-169 mg/dL if age ≤ 20; 100-199 mg/dL if age ≥ 21; high values indicate risk of cardiovascular disease LDL cholesterol: <70 mg/dL for people with documented cardiovascular disease or metabolic syndrome; <100 mg/dL for people considered high risk for cardiovascular disease; <130 mg/dL for people considered low risk for cardiovascular disease; high values indicate risk of cardiovascular disease HDL cholesterol: 40mg/dL and higher; high values indicate reduced risk of cardiovascular disease Non-HDL cholesterol: 30 mg/dL above the target value for LDL cholesterol; high values indicate risk of cardiovascular disease and Triglycerides: <150 mg/dL; high values indicate risk of cardiovascular disease.
Time Frame	Week 52

Outcome Measure Data

Analysis Population Description

Intent-to-treat population with available data

Arm/Group Title	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept	Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept
Arm/Group Description	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.	Induction: Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3. The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84
Measure Participants	8	9	8
Total cholesterol	177.1 (25.6)	163.7 (38.8)	174.8 (54.7)
Non-HDL	128.6 (30.6)	121.2 (32.0)	130.8 (45.6)
LDL	102.9 (17.7)	86.3 (50.6)	94.6 (46.4)
HDL	48.5 (11.3)	42.4 (15.6)	44.0 (14.9)
Triglyceride	125.8 (93.0)	170.0 (118.6)	182.8 (84.2)

23. Secondary Outcome

Title	Count of Participants With Use of Lipid Lowering Medications at Baseline and Wk 28 and Wk 52 Post-Transplant
Description	Lipid lowering medications are used in the treatment of high levels of fats (lipids), such as cholesterol in blood.
Time Frame	Baseline (Pre-Transplant), Week 28, and Week 52

Outcome Measure Data

Analysis Population Description

Intent-to-treat population with available data

Arm/Group Title	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept	Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept
Arm/Group Description	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.	Induction: Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3. The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84
Measure Participants	29	29	11
Baseline	13 44.8%	7 24.1%	3 27.3%
Week 28	8 27.6%	9 31%	4 36.4%
Week 52	9 31%	9 31%	5 45.5%

24. Secondary Outcome

Title	Total Daily Prescribed Pill Count
Description	This is a measure of the total number of pills a participant was prescribed on a given day
Time Frame	Day 28, Day 84, Week 28, Week 36, and Week 52

Outcome Measure Data

Analysis Population Description

Intent-to-treat population with available data

Arm/Group Title	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept	Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept
Arm/Group Description	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.	Induction: Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3. The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84
Measure Participants	28	28	11
Day 28	25.8 (9.9)	18.9 (7.5)	23.5 (8.9)
Day 84	22.2 (6.3)	17.2 (6.3)	21.0 (7.0)
Week 28	19.7 (7.2)	15.5 (6.0)	16.6 (8.1)
Week 36	19.1 (8.0)	15.4 (4.8)	13.9 (5.9)
Week 52	24.4 (11.8)	15.7 (5.4)	13.7 (5.1)

25. Secondary Outcome

Title	Count of Participant Deaths or Graft Loss by Wk 52 Post-Transplant
Description	This measure counts deaths and graft loss occurring at any point post transplantation. Graft loss is defined as 90 days of dialysis dependency.
Time Frame	Transplantation through Week 52

Outcome Measure Data

Analysis Population Description

Intent-to-treat population

Arm/Group Title	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept	Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept
Arm/Group Description	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.	Induction: Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3. The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84
Measure Participants	29	29	11
Count of Participants [Participants]	2 6.9%	0 0%	0 0%

26. Secondary Outcome

Title	Count of Participants With Graft Rejection by Wk 52 Post-Transplant
Description	The number of participants who were treated by their local physician for any type of rejection including, but not limited to cellular rejection and antibody- mediated rejection of the transplanted kidney regardless of the presence of a biopsy.
Time Frame	Transplantation through Week 52

Outcome Measure Data

Analysis Population Description

Intent-to-treat population

Arm/Group Title	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept	Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept
Arm/Group Description	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.	Induction: Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3. The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84
Measure Participants	29	29	11
Count of Participants [Participants]	7 24.1%	14 48.3%	4 36.4%

27. Secondary Outcome

Title	Count of Participants Experiencing ≥ 1 Adverse Event (AEs) or Serious Adverse Events (SAEs) by Wk 52
Description	Adverse events were collected systematically from enrollment through Wk 52, the last study visit. Provided are numbers of participants with ≥ 1 adverse event (serious or non-serious adverse events) by treatment arm.
Time Frame	Enrollment through Week 52

Outcome Measure Data

Analysis Population Description

Intent-to-treat population

Arm/Group Title	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept	Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept
Arm/Group Description	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.	Induction: Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3. The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84
Measure Participants	29	29	11
Adverse Events	21 72.4%	28 96.6%	9 81.8%
Serious Adverse Events	19 65.5%	21 72.4%	6 54.5%

28. Secondary Outcome

Title	Count of Participants With Infections Requiring Hospitalization or Systemic Therapy by Wk 52 Post-Transplant
Description	Infections of certain types (i.e., excluding those identified in the protocol as occurring commonly in this study population) were required to be reported as a serious adverse event if they required either inpatient hospitalization or prolongation of a current hospitalization.
Time Frame	Transplantation through Week 52

Outcome Measure Data

Analysis Population Description

Intent-to-treat population

Arm/Group Title	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept	Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept
Arm/Group Description	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.	Induction: Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3. The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84
Measure Participants	29	29	11
Count of Participants [Participants]	1 3.4%	8 27.6%	2 18.2%

29. Secondary Outcome

Title	Count of Participants With BK Polyoma Virus (BKV) and Cytomegalovirus (CMV) Viremia (Local Center Monitoring) as Adverse Events by Wk 52 Post-Transplant
Description	Viral infections following renal transplantation is significant source of recipient morbidity and mortality, and a significant cause of allograft dysfunction and loss. Specific viruses were monitored during the study, using participant blood samples. Displayed are counts of participants who experienced BKV and CMV viremia as adverse events by treatment arm.
Time Frame	Transplantation through Week 52

Outcome Measure Data

Analysis Population Description

Intent-to-treat population

Arm/Group Title	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept	Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept
Arm/Group Description	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.	Induction: Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3. The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84
Measure Participants	29	29	11
BKV	0 0%	4 13.8%	1 9.1%
CMV	1 3.4%	6 20.7%	1 9.1%

30. Secondary Outcome

Title	Count of Participants With Epstein-Barr Virus (EBV) Infection as Reported on the Case Report Form as Adverse Events
Description	Viral infections following renal transplantation, including but not limited to EBV infection, is a significant source of recipient morbidity and mortality, and a significant cause of allograft dysfunction and loss.
Time Frame	Transplantation through Week 52

Outcome Measure Data

Analysis Population Description

Intent-to-treat population

Arm/Group Title	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept	Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept
Arm/Group Description	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.	Induction: Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3. The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84
Measure Participants	29	29	11
Count of Participants [Participants]	0 0%	0 0%	0 0%

31. Secondary Outcome

Title	Count of Participants With Fever > 39 Degrees Celsius and Blood Pressure < 90 mmHg Within 24 Hours of Onset of Transplant Procedure
Description	Temperature of >39 degrees Celsius (e.g., 102.2 degrees Fahrenheit) would be an indication of fever most often in response to an infection or illness. Systolic blood pressure <90mm Hg would be an indication of low blood pressure.
Time Frame	Within 24 Hours of transplant procedure

Outcome Measure Data

Analysis Population Description

Intent-to-treat population

Arm/Group Title	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept	Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept
Arm/Group Description	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.	Induction: Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3. The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84
Measure Participants	29	29	11
Fever >39 Celsius	0 0%	0 0%	0 0%
Systolic BP < 90 mmHg	0 0%	0 0%	0 0%

Adverse Events

Time Frame	Enrollment through end of study (up to Week 52)
Arm/Group Title	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac		Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept		Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept		Enrolled, Not Randomized
Arm/Group Description	Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.		Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.		Induction: Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3. The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84		Subjects who signed informed consent and were thus enrolled, but were not randomized to study treatment.
All Cause Mortality
	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac		Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept		Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept		Enrolled, Not Randomized
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/29 (6.9%)		0/29 (0%)		0/11 (0%)		0/2 (0%)
Serious Adverse Events
	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac		Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept		Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept		Enrolled, Not Randomized
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	19/29 (65.5%)		21/29 (72.4%)		6/11 (54.5%)		0/2 (0%)
Blood and lymphatic system disorders
Anaemia	0/29 (0%)	0	1/29 (3.4%)	1	0/11 (0%)	0	0/2 (0%)	0
Haemolytic uraemic syndrome	1/29 (3.4%)	1	0/29 (0%)	0	0/11 (0%)	0	0/2 (0%)	0
Cardiac disorders
Atrial fibrillation	1/29 (3.4%)	1	0/29 (0%)	0	0/11 (0%)	0	0/2 (0%)	0
Gastrointestinal disorders
Abdominal pain lower	1/29 (3.4%)	1	0/29 (0%)	0	0/11 (0%)	0	0/2 (0%)	0
Diarrhoea	0/29 (0%)	0	1/29 (3.4%)	1	0/11 (0%)	0	0/2 (0%)	0
Duodenal ulcer haemorrhage	1/29 (3.4%)	1	0/29 (0%)	0	0/11 (0%)	0	0/2 (0%)	0
Ileus	0/29 (0%)	0	1/29 (3.4%)	1	0/11 (0%)	0	0/2 (0%)	0
Intra-abdominal haemorrhage	1/29 (3.4%)	1	0/29 (0%)	0	0/11 (0%)	0	0/2 (0%)	0
Nausea	2/29 (6.9%)	2	1/29 (3.4%)	2	1/11 (9.1%)	1	0/2 (0%)	0
Pancreatitis	0/29 (0%)	0	1/29 (3.4%)	1	0/11 (0%)	0	0/2 (0%)	0
Retroperitoneal haematoma	0/29 (0%)	0	1/29 (3.4%)	1	0/11 (0%)	0	0/2 (0%)	0
Vomiting	2/29 (6.9%)	2	1/29 (3.4%)	2	1/11 (9.1%)	1	0/2 (0%)	0
General disorders
Chest pain	1/29 (3.4%)	1	0/29 (0%)	0	0/11 (0%)	0	0/2 (0%)	0
Pyrexia	1/29 (3.4%)	1	0/29 (0%)	0	0/11 (0%)	0	0/2 (0%)	0
Hepatobiliary disorders
Bile duct stone	1/29 (3.4%)	1	0/29 (0%)	0	0/11 (0%)	0	0/2 (0%)	0
Immune system disorders
Kidney transplant rejection	0/29 (0%)	0	0/29 (0%)	0	1/11 (9.1%)	1	0/2 (0%)	0
Transplant rejection	2/29 (6.9%)	2	8/29 (27.6%)	10	2/11 (18.2%)	2	0/2 (0%)	0
Infections and infestations
Bacteraemia	0/29 (0%)	0	1/29 (3.4%)	1	0/11 (0%)	0	0/2 (0%)	0
Clostridium difficile colitis	1/29 (3.4%)	1	0/29 (0%)	0	0/11 (0%)	0	0/2 (0%)	0
Cytomegalovirus infection	0/29 (0%)	0	0/29 (0%)	0	1/11 (9.1%)	1	0/2 (0%)	0
Cytomegalovirus viraemia	0/29 (0%)	0	4/29 (13.8%)	4	0/11 (0%)	0	0/2 (0%)	0
Gastroenteritis	1/29 (3.4%)	1	0/29 (0%)	0	0/11 (0%)	0	0/2 (0%)	0
Gastroenteritis viral	1/29 (3.4%)	1	0/29 (0%)	0	0/11 (0%)	0	0/2 (0%)	0
Peritonitis bacterial	1/29 (3.4%)	1	0/29 (0%)	0	0/11 (0%)	0	0/2 (0%)	0
Pneumonia cytomegaloviral	1/29 (3.4%)	1	0/29 (0%)	0	0/11 (0%)	0	0/2 (0%)	0
Polyomavirus-associated nephropathy	0/29 (0%)	0	2/29 (6.9%)	2	0/11 (0%)	0	0/2 (0%)	0
Pyelonephritis	1/29 (3.4%)	1	0/29 (0%)	0	0/11 (0%)	0	0/2 (0%)	0
Septic shock	1/29 (3.4%)	1	0/29 (0%)	0	0/11 (0%)	0	0/2 (0%)	0
Urinary tract infection	5/29 (17.2%)	5	4/29 (13.8%)	5	1/11 (9.1%)	1	0/2 (0%)	0
Zygomycosis	0/29 (0%)	0	1/29 (3.4%)	1	0/11 (0%)	0	0/2 (0%)	0
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis	0/29 (0%)	0	1/29 (3.4%)	1	0/11 (0%)	0	0/2 (0%)	0
Complications of transplanted kidney	2/29 (6.9%)	2	4/29 (13.8%)	4	0/11 (0%)	0	0/2 (0%)	0
Gun shot wound	0/29 (0%)	0	1/29 (3.4%)	1	0/11 (0%)	0	0/2 (0%)	0
Infusion related reaction	0/29 (0%)	0	1/29 (3.4%)	1	0/11 (0%)	0	0/2 (0%)	0
Perinephric collection	1/29 (3.4%)	1	0/29 (0%)	0	0/11 (0%)	0	0/2 (0%)	0
Metabolism and nutrition disorders
Diabetes mellitus inadequate control	0/29 (0%)	0	1/29 (3.4%)	1	0/11 (0%)	0	0/2 (0%)	0
Fluid overload	0/29 (0%)	0	1/29 (3.4%)	1	0/11 (0%)	0	0/2 (0%)	0
Hyperkalaemia	1/29 (3.4%)	1	0/29 (0%)	0	0/11 (0%)	0	0/2 (0%)	0
Renal and urinary disorders
Glomerulonephritis minimal lesion	1/29 (3.4%)	1	0/29 (0%)	0	0/11 (0%)	0	0/2 (0%)	0
Haematuria	0/29 (0%)	0	1/29 (3.4%)	1	0/11 (0%)	0	0/2 (0%)	0
Hydronephrosis	1/29 (3.4%)	1	0/29 (0%)	0	0/11 (0%)	0	0/2 (0%)	0
Renal artery dissection	0/29 (0%)	0	1/29 (3.4%)	1	0/11 (0%)	0	0/2 (0%)	0
Renal failure acute	4/29 (13.8%)	4	0/29 (0%)	0	0/11 (0%)	0	0/2 (0%)	0
Renal tubular necrosis	1/29 (3.4%)	1	0/29 (0%)	0	0/11 (0%)	0	0/2 (0%)	0
Reproductive system and breast disorders
Oedema genital	1/29 (3.4%)	1	0/29 (0%)	0	0/11 (0%)	0	0/2 (0%)	0
Vascular disorders
Deep vein thrombosis	0/29 (0%)	0	1/29 (3.4%)	1	0/11 (0%)	0	0/2 (0%)	0
Hypertensive crisis	1/29 (3.4%)	1	0/29 (0%)	0	0/11 (0%)	0	0/2 (0%)	0
Orthostatic hypotension	0/29 (0%)	0	1/29 (3.4%)	1	0/11 (0%)	0	0/2 (0%)	0
Other (Not Including Serious) Adverse Events
	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac		Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept		Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept		Enrolled, Not Randomized
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	15/29 (51.7%)		24/29 (82.8%)		7/11 (63.6%)		0/2 (0%)
Blood and lymphatic system disorders
Anaemia	7/29 (24.1%)	8	5/29 (17.2%)	5	3/11 (27.3%)	3	0/2 (0%)	0
Eosinophilia	2/29 (6.9%)	2	0/29 (0%)	0	0/11 (0%)	0	0/2 (0%)	0
Leukocytosis	3/29 (10.3%)	3	2/29 (6.9%)	2	1/11 (9.1%)	1	0/2 (0%)	0
Leukopenia	4/29 (13.8%)	4	3/29 (10.3%)	3	1/11 (9.1%)	1	0/2 (0%)	0
Cardiac disorders
Tachycardia	2/29 (6.9%)	2	1/29 (3.4%)	1	0/11 (0%)	0	0/2 (0%)	0
General disorders
Chest pain	2/29 (6.9%)	2	0/29 (0%)	0	0/11 (0%)	0	0/2 (0%)	0
Immune system disorders
Transplant rejection	1/29 (3.4%)	2	4/29 (13.8%)	6	1/11 (9.1%)	2	0/2 (0%)	0
Infections and infestations
Urinary tract infection	1/29 (3.4%)	3	8/29 (27.6%)	9	0/11 (0%)	0	0/2 (0%)	0
Injury, poisoning and procedural complications
Complications of transplanted kidney	3/29 (10.3%)	3	8/29 (27.6%)	8	0/11 (0%)	0	0/2 (0%)	0
Investigations
Alanine aminotransferase increased	0/29 (0%)	0	2/29 (6.9%)	2	0/11 (0%)	0	0/2 (0%)	0
White blood cell count decreased	4/29 (13.8%)	4	3/29 (10.3%)	4	1/11 (9.1%)	1	0/2 (0%)	0
Metabolism and nutrition disorders
Fluid overload	2/29 (6.9%)	2	0/29 (0%)	0	0/11 (0%)	0	0/2 (0%)	0
Hyperkalaemia	5/29 (17.2%)	7	4/29 (13.8%)	5	1/11 (9.1%)	1	0/2 (0%)	0
Hypoglycaemia	0/29 (0%)	0	2/29 (6.9%)	2	0/11 (0%)	0	0/2 (0%)	0
Hypophosphataemia	1/29 (3.4%)	1	3/29 (10.3%)	3	1/11 (9.1%)	1	0/2 (0%)	0
Vascular disorders
Hypertension	1/29 (3.4%)	1	2/29 (6.9%)	2	0/11 (0%)	0	0/2 (0%)	0

Limitations/Caveats

[Not Specified]

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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.