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

• ClinicalTrials.gov Identifier: NCT01856257
• Recruitment Status: Terminated
• First Posted: May 17, 2013
• Results First Posted: August 7, 2017
• Last Update Posted: December 17, 2020
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Clinical Trials in Organ Transplantation
• Information provided by (Responsible Party): National Institute of Allergy and Infectious Diseases (NIAID)

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Conditions: Primary Renal Allograft Candidate; Kidney Transplantation
• Interventions: Biological: Anti-thymocyte Globulin (Rabbit); Biological: belatacept; Drug: methylprednisolone; Biological: basiliximab; Drug: mycophenolate mofetil; Drug: tacrolimus
• Enrollment: 71

Participant Flow

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

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
Reason Not Completed
Death	2	0	0	0
Physician Decision	0	0	0	1
Withdrawal by Subject	1	1	0	0
Donor complication	0	0	0	1

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 Number of Baseline Participants		29	29	11	69
Baseline Analysis Population Description		Randomized Participants
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	29 participants	29 participants	11 participants	69 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	29 100.0%	29 100.0%	11 100.0%	69 100.0%
	>=65 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	29 participants	29 participants	11 participants	69 participants
		47.7 (6.76)	44.5 (10.45)	44.6 (9.63)	45.9 (8.93)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	29 participants	29 participants	11 participants	69 participants
	Female	9 31.0%	8 27.6%	4 36.4%	21 30.4%
	Male	20 69.0%	21 72.4%	7 63.6%	48 69.6%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	29 participants	29 participants	11 participants	69 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 87.0%
	Unknown or Not Reported	1 3.4%	2 6.9%	1 9.1%	4 5.8%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	29 participants	29 participants	11 participants	69 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Asian	1 3.4%	3 10.3%	0 0.0%	4 5.8%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 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 31.0%	11 37.9%	4 36.4%	24 34.8%
	More than one race	0 0.0%	0 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; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	29 participants	29 participants	11 participants	69 participants
		29	29	11	69

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
Overall Number of Participants Analyzed	26	27	11
Mean (Standard Deviation); Unit of Measure: 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	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.544
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	3.512
	Confidence Interval	(2-Sided) 95%; -7.999 to 15.024
	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	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.531
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	4.820
	Confidence Interval	(2-Sided) 95%; -10.481 to 20.121
	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
Overall Number of Participants Analyzed	29	29	11
Measure Type: Count of Participants; Unit of Measure: 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
Overall Number of Participants Analyzed	29	29	11
Measure Type: Count of Participants; Unit of Measure: 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
Overall Number of Participants Analyzed	29	29	11
Measure Type: Count of Participants; Unit of Measure: Participants
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 31.0%	6 54.5%
Stage 3B	6 20.7%	2 6.9%	0 0.0%
Stage 4	1 3.4%	1 3.4%	0 0.0%
Stage 5	3 10.3%	3 10.3%	0 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
Overall Number of Participants Analyzed	29	29	11
Measure Type: Count of Participants; Unit of Measure: Participants
	4 13.8%	4 13.8%	0 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
Overall Number of Participants Analyzed	26	27	11
Mean (Standard Deviation); Unit of Measure: 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
Overall Number of Participants Analyzed	28	29	11
Mean (Standard Deviation); Unit of Measure: 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
Overall Number of Participants Analyzed	29	29	11
Measure Type: Count of Participants; Unit of Measure: Participants
	6 20.7%	9 31.0%	0 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
Overall Number of Participants Analyzed	29	29	11
Measure Type: Count of Participants; Unit of Measure: 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
Overall Number of Participants Analyzed	29	29	11
Measure Type: Count of Participants; Unit of Measure: Participants
IA	0 0.0%	3 10.3%	2 18.2%
IB	1 3.4%	1 3.4%	2 18.2%
IIA	0 0.0%	4 13.8%	0 0.0%
IIB	0 0.0%	0 0.0%	0 0.0%
III	0 0.0%	2 6.9%	0 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
Overall Number of Participants Analyzed	29	29	11
Measure Type: Count of Participants; Unit of Measure: Participants
	1 3.4%	1 3.4%	0 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
Overall Number of Participants Analyzed	29	29	11
Measure Type: Number; Unit of Measure: Biopsy
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
Overall Number of Participants Analyzed	29	29	11
Measure Type: Number; Unit of Measure: Biopsy
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
Overall Number of Participants Analyzed	0	0	0

No data displayed because Outcome Measure has zero total analyzed.

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
Overall Number of Participants Analyzed		29	29	11
Measure Type: Count of Participants; Unit of Measure: Participants
New onset diabetes during first 52 weeks	Number Analyzed	29 participants	29 participants	11 participants
		1 3.4%	1 3.4%	0 0.0%
Impaired fasting glucose at week 52	Number Analyzed	14 participants	15 participants	8 participants
		2 14.3%	0 0.0%	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
Overall Number of Participants Analyzed	26	28	11
Measure Type: Count of Participants; Unit of Measure: Participants
	3 11.5%	2 7.1%	0 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
Overall Number of Participants Analyzed		26	28	11
Mean (Standard Deviation); Unit of Measure: percentage
Baseline	Number Analyzed	26 participants	28 participants	10 participants
		5.7 (1.3)	5.7 (1.1)	5.9 (0.8)
Day 28	Number Analyzed	25 participants	27 participants	11 participants
		5.4 (0.8)	5.6 (1.0)	5.4 (1.1)
Day 84	Number Analyzed	24 participants	24 participants	11 participants
		5.6 (1.1)	5.5 (1.1)	5.4 (0.8)
Week 28	Number Analyzed	20 participants	17 participants	11 participants
		6.2 (1.9)	6.0 (1.4)	5.6 (0.8)
Week 36	Number Analyzed	15 participants	15 participants	11 participants
		6.7 (2.6)	5.9 (1.2)	5.5 (0.8)
Week 52	Number Analyzed	10 participants	9 participants	9 participants
		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
Overall Number of Participants Analyzed	26	18	3
Mean (Standard Deviation); Unit of Measure: mmHg
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
Overall Number of Participants Analyzed	26	28	11
Measure Type: Count of Participants; Unit of Measure: Participants
	18 69.2%	23 82.1%	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
Overall Number of Participants Analyzed		22	26	7
Mean (Standard Deviation); Unit of Measure: mg/dL
Total cholesterol	Number Analyzed	22 participants	26 participants	7 participants
		167.1 (37.5)	159.4 (45.0)	167.6 (84.8)
Non-HDL	Number Analyzed	22 participants	26 participants	7 participants
		122.0 (35.1)	116.1 (45.7)	123.4 (85.3)
LDL	Number Analyzed	21 participants	25 participants	6 participants
		91.1 (28.0)	83.1 (38.5)	65.2 (15.3)
HDL	Number Analyzed	22 participants	26 participants	7 participants
		45.1 (11.8)	43.3 (13.0)	44.1 (19.9)
Triglyceride	Number Analyzed	22 participants	26 participants	7 participants
		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
Overall Number of Participants Analyzed		15	15	10
Mean (Standard Deviation); Unit of Measure: mg/dL
Total cholesterol	Number Analyzed	15 participants	15 participants	10 participants
		169.6 (38.6)	179.5 (44.4)	167.3 (39.5)
Non-HDL	Number Analyzed	14 participants	15 participants	10 participants
		119.6 (35.9)	133.5 (46.7)	115.0 (38.0)
LDL	Number Analyzed	14 participants	14 participants	10 participants
		95.6 (31.4)	109.8 (43.0)	82.7 (18.2)
HDL	Number Analyzed	14 participants	15 participants	10 participants
		51.0 (14.5)	46.0 (18.6)	52.3 (27.5)
Triglyceride	Number Analyzed	14 participants	15 participants	10 participants
		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
Overall Number of Participants Analyzed	8	9	8
Mean (Standard Deviation); Unit of Measure: mg/dL
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
Overall Number of Participants Analyzed		29	29	11
Measure Type: Count of Participants; Unit of Measure: Participants
Baseline	Number Analyzed	29 participants	29 participants	11 participants
		13 44.8%	7 24.1%	3 27.3%
Week 28	Number Analyzed	27 participants	29 participants	11 participants
		8 29.6%	9 31.0%	4 36.4%
Week 52	Number Analyzed	26 participants	28 participants	11 participants
		9 34.6%	9 32.1%	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
Overall Number of Participants Analyzed		28	28	11
Mean (Standard Deviation); Unit of Measure: pills per day
Day 28	Number Analyzed	28 participants	28 participants	11 participants
		25.8 (9.9)	18.9 (7.5)	23.5 (8.9)
Day 84	Number Analyzed	25 participants	26 participants	11 participants
		22.2 (6.3)	17.2 (6.3)	21.0 (7.0)
Week 28	Number Analyzed	19 participants	17 participants	11 participants
		19.7 (7.2)	15.5 (6.0)	16.6 (8.1)
Week 36	Number Analyzed	13 participants	14 participants	11 participants
		19.1 (8.0)	15.4 (4.8)	13.9 (5.9)
Week 52	Number Analyzed	7 participants	9 participants	9 participants
		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
Overall Number of Participants Analyzed	29	29	11
Measure Type: Count of Participants; Unit of Measure: Participants
	2 6.9%	0 0.0%	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
Overall Number of Participants Analyzed	29	29	11
Measure Type: Count of Participants; Unit of Measure: 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
Overall Number of Participants Analyzed	29	29	11
Measure Type: Count of Participants; Unit of Measure: Participants
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
Overall Number of Participants Analyzed	29	29	11
Measure Type: Count of Participants; Unit of Measure: 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
Overall Number of Participants Analyzed	29	29	11
Measure Type: Count of Participants; Unit of Measure: Participants
BKV	0 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
Overall Number of Participants Analyzed	29	29	11
Measure Type: Count of Participants; Unit of Measure: Participants
	0 0.0%	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
Overall Number of Participants Analyzed	29	29	11
Measure Type: Count of Participants; Unit of Measure: Participants
Fever >39 Celsius	0 0.0%	0 0.0%	0 0.0%
Systolic BP < 90 mmHg	0 0.0%	0 0.0%	0 0.0%

Adverse Events

Time Frame	Enrollment through end of study (up to Week 52)
Adverse Event Reporting Description	[Not Specified]
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 (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	2/29 (6.90%)		0/29 (0.00%)		0/11 (0.00%)		0/2 (0.00%)
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 (65.52%)		21/29 (72.41%)		6/11 (54.55%)		0/2 (0.00%)
Blood and lymphatic system disorders
Anaemia † 1	0/29 (0.00%)	0	1/29 (3.45%)	1	0/11 (0.00%)	0	0/2 (0.00%)	0
Haemolytic uraemic syndrome † 1	1/29 (3.45%)	1	0/29 (0.00%)	0	0/11 (0.00%)	0	0/2 (0.00%)	0
Cardiac disorders
Atrial fibrillation † 1	1/29 (3.45%)	1	0/29 (0.00%)	0	0/11 (0.00%)	0	0/2 (0.00%)	0
Gastrointestinal disorders
Abdominal pain lower † 1	1/29 (3.45%)	1	0/29 (0.00%)	0	0/11 (0.00%)	0	0/2 (0.00%)	0
Diarrhoea † 1	0/29 (0.00%)	0	1/29 (3.45%)	1	0/11 (0.00%)	0	0/2 (0.00%)	0
Duodenal ulcer haemorrhage † 1	1/29 (3.45%)	1	0/29 (0.00%)	0	0/11 (0.00%)	0	0/2 (0.00%)	0
Ileus † 1	0/29 (0.00%)	0	1/29 (3.45%)	1	0/11 (0.00%)	0	0/2 (0.00%)	0
Intra-abdominal haemorrhage † 1	1/29 (3.45%)	1	0/29 (0.00%)	0	0/11 (0.00%)	0	0/2 (0.00%)	0
Nausea † 1	2/29 (6.90%)	2	1/29 (3.45%)	2	1/11 (9.09%)	1	0/2 (0.00%)	0
Pancreatitis † 1	0/29 (0.00%)	0	1/29 (3.45%)	1	0/11 (0.00%)	0	0/2 (0.00%)	0
Retroperitoneal haematoma † 1	0/29 (0.00%)	0	1/29 (3.45%)	1	0/11 (0.00%)	0	0/2 (0.00%)	0
Vomiting † 1	2/29 (6.90%)	2	1/29 (3.45%)	2	1/11 (9.09%)	1	0/2 (0.00%)	0
General disorders
Chest pain † 1	1/29 (3.45%)	1	0/29 (0.00%)	0	0/11 (0.00%)	0	0/2 (0.00%)	0
Pyrexia † 1	1/29 (3.45%)	1	0/29 (0.00%)	0	0/11 (0.00%)	0	0/2 (0.00%)	0
Hepatobiliary disorders
Bile duct stone † 1	1/29 (3.45%)	1	0/29 (0.00%)	0	0/11 (0.00%)	0	0/2 (0.00%)	0
Immune system disorders
Kidney transplant rejection † 1	0/29 (0.00%)	0	0/29 (0.00%)	0	1/11 (9.09%)	1	0/2 (0.00%)	0
Transplant rejection † 1	2/29 (6.90%)	2	8/29 (27.59%)	10	2/11 (18.18%)	2	0/2 (0.00%)	0
Infections and infestations
Bacteraemia † 1	0/29 (0.00%)	0	1/29 (3.45%)	1	0/11 (0.00%)	0	0/2 (0.00%)	0
Clostridium difficile colitis † 1	1/29 (3.45%)	1	0/29 (0.00%)	0	0/11 (0.00%)	0	0/2 (0.00%)	0
Cytomegalovirus infection † 1	0/29 (0.00%)	0	0/29 (0.00%)	0	1/11 (9.09%)	1	0/2 (0.00%)	0
Cytomegalovirus viraemia † 1	0/29 (0.00%)	0	4/29 (13.79%)	4	0/11 (0.00%)	0	0/2 (0.00%)	0
Gastroenteritis † 1	1/29 (3.45%)	1	0/29 (0.00%)	0	0/11 (0.00%)	0	0/2 (0.00%)	0
Gastroenteritis viral † 1	1/29 (3.45%)	1	0/29 (0.00%)	0	0/11 (0.00%)	0	0/2 (0.00%)	0
Peritonitis bacterial † 1	1/29 (3.45%)	1	0/29 (0.00%)	0	0/11 (0.00%)	0	0/2 (0.00%)	0
Pneumonia cytomegaloviral † 1	1/29 (3.45%)	1	0/29 (0.00%)	0	0/11 (0.00%)	0	0/2 (0.00%)	0
Polyomavirus-associated nephropathy † 1	0/29 (0.00%)	0	2/29 (6.90%)	2	0/11 (0.00%)	0	0/2 (0.00%)	0
Pyelonephritis † 1	1/29 (3.45%)	1	0/29 (0.00%)	0	0/11 (0.00%)	0	0/2 (0.00%)	0
Septic shock † 1	1/29 (3.45%)	1	0/29 (0.00%)	0	0/11 (0.00%)	0	0/2 (0.00%)	0
Urinary tract infection † 1	5/29 (17.24%)	5	4/29 (13.79%)	5	1/11 (9.09%)	1	0/2 (0.00%)	0
Zygomycosis † 1	0/29 (0.00%)	0	1/29 (3.45%)	1	0/11 (0.00%)	0	0/2 (0.00%)	0
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis † 1	0/29 (0.00%)	0	1/29 (3.45%)	1	0/11 (0.00%)	0	0/2 (0.00%)	0
Complications of transplanted kidney † 1	2/29 (6.90%)	2	4/29 (13.79%)	4	0/11 (0.00%)	0	0/2 (0.00%)	0
Gun shot wound † 1	0/29 (0.00%)	0	1/29 (3.45%)	1	0/11 (0.00%)	0	0/2 (0.00%)	0
Infusion related reaction † 1	0/29 (0.00%)	0	1/29 (3.45%)	1	0/11 (0.00%)	0	0/2 (0.00%)	0
Perinephric collection † 1	1/29 (3.45%)	1	0/29 (0.00%)	0	0/11 (0.00%)	0	0/2 (0.00%)	0
Metabolism and nutrition disorders
Diabetes mellitus inadequate control † 1	0/29 (0.00%)	0	1/29 (3.45%)	1	0/11 (0.00%)	0	0/2 (0.00%)	0
Fluid overload † 1	0/29 (0.00%)	0	1/29 (3.45%)	1	0/11 (0.00%)	0	0/2 (0.00%)	0
Hyperkalaemia † 1	1/29 (3.45%)	1	0/29 (0.00%)	0	0/11 (0.00%)	0	0/2 (0.00%)	0
Renal and urinary disorders
Glomerulonephritis minimal lesion † 1	1/29 (3.45%)	1	0/29 (0.00%)	0	0/11 (0.00%)	0	0/2 (0.00%)	0
Haematuria † 1	0/29 (0.00%)	0	1/29 (3.45%)	1	0/11 (0.00%)	0	0/2 (0.00%)	0
Hydronephrosis † 1	1/29 (3.45%)	1	0/29 (0.00%)	0	0/11 (0.00%)	0	0/2 (0.00%)	0
Renal artery dissection † 1	0/29 (0.00%)	0	1/29 (3.45%)	1	0/11 (0.00%)	0	0/2 (0.00%)	0
Renal failure acute † 1	4/29 (13.79%)	4	0/29 (0.00%)	0	0/11 (0.00%)	0	0/2 (0.00%)	0
Renal tubular necrosis † 1	1/29 (3.45%)	1	0/29 (0.00%)	0	0/11 (0.00%)	0	0/2 (0.00%)	0
Reproductive system and breast disorders
Oedema genital † 1	1/29 (3.45%)	1	0/29 (0.00%)	0	0/11 (0.00%)	0	0/2 (0.00%)	0
Vascular disorders
Deep vein thrombosis † 1	0/29 (0.00%)	0	1/29 (3.45%)	1	0/11 (0.00%)	0	0/2 (0.00%)	0
Hypertensive crisis † 1	1/29 (3.45%)	1	0/29 (0.00%)	0	0/11 (0.00%)	0	0/2 (0.00%)	0
Orthostatic hypotension † 1	0/29 (0.00%)	0	1/29 (3.45%)	1	0/11 (0.00%)	0	0/2 (0.00%)	0
1 Term from vocabulary, MedDRA 13.1; † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	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 (51.72%)		24/29 (82.76%)		7/11 (63.64%)		0/2 (0.00%)
Blood and lymphatic system disorders
Anaemia † 1	7/29 (24.14%)	8	5/29 (17.24%)	5	3/11 (27.27%)	3	0/2 (0.00%)	0
Eosinophilia † 1	2/29 (6.90%)	2	0/29 (0.00%)	0	0/11 (0.00%)	0	0/2 (0.00%)	0
Leukocytosis † 1	3/29 (10.34%)	3	2/29 (6.90%)	2	1/11 (9.09%)	1	0/2 (0.00%)	0
Leukopenia † 1	4/29 (13.79%)	4	3/29 (10.34%)	3	1/11 (9.09%)	1	0/2 (0.00%)	0
Cardiac disorders
Tachycardia † 1	2/29 (6.90%)	2	1/29 (3.45%)	1	0/11 (0.00%)	0	0/2 (0.00%)	0
General disorders
Chest pain † 1	2/29 (6.90%)	2	0/29 (0.00%)	0	0/11 (0.00%)	0	0/2 (0.00%)	0
Immune system disorders
Transplant rejection † 1	1/29 (3.45%)	2	4/29 (13.79%)	6	1/11 (9.09%)	2	0/2 (0.00%)	0
Infections and infestations
Urinary tract infection † 1	1/29 (3.45%)	3	8/29 (27.59%)	9	0/11 (0.00%)	0	0/2 (0.00%)	0
Injury, poisoning and procedural complications
Complications of transplanted kidney † 1	3/29 (10.34%)	3	8/29 (27.59%)	8	0/11 (0.00%)	0	0/2 (0.00%)	0
Investigations
Alanine aminotransferase increased † 1	0/29 (0.00%)	0	2/29 (6.90%)	2	0/11 (0.00%)	0	0/2 (0.00%)	0
White blood cell count decreased † 1	4/29 (13.79%)	4	3/29 (10.34%)	4	1/11 (9.09%)	1	0/2 (0.00%)	0
Metabolism and nutrition disorders
Fluid overload † 1	2/29 (6.90%)	2	0/29 (0.00%)	0	0/11 (0.00%)	0	0/2 (0.00%)	0
Hyperkalaemia † 1	5/29 (17.24%)	7	4/29 (13.79%)	5	1/11 (9.09%)	1	0/2 (0.00%)	0
Hypoglycaemia † 1	0/29 (0.00%)	0	2/29 (6.90%)	2	0/11 (0.00%)	0	0/2 (0.00%)	0
Hypophosphataemia † 1	1/29 (3.45%)	1	3/29 (10.34%)	3	1/11 (9.09%)	1	0/2 (0.00%)	0
Vascular disorders
Hypertension † 1	1/29 (3.45%)	1	2/29 (6.90%)	2	0/11 (0.00%)	0	0/2 (0.00%)	0
1 Term from vocabulary, MedDRA 13.1; † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

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

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

Results Point of Contact

• Name/Title: Director, Clinical Research Operations Program
• Organization: DAIT/NIAID
• Phone: 301-594-7669
• EMail: DAITClinicalTrialsGov@niaid.nih.gov

Publications of Results:

Mannon RB, Armstrong B, Stock PG, Mehta AK, Farris AB, Watson N, Morrison Y, Sarwal M, Sigdel T, Bridges N, Robien M, Newell KA, Larsen CP. Avoidance of CNI and steroids using belatacept-Results of the Clinical Trials in Organ Transplantation 16 trial. Am J Transplant. 2020 Dec;20(12):3599-3608. doi: 10.1111/ajt.16152. Epub 2020 Jul 13.

• Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
• ClinicalTrials.gov Identifier: NCT01856257
• Other Study ID Numbers: DAIT CTOT-16
• First Submitted: May 14, 2013
• First Posted: May 17, 2013
• Results First Submitted: June 23, 2017
• Results First Posted: August 7, 2017
• Last Update Posted: December 17, 2020