Trial Outcomes & Findings for Optimization of NULOJIX® Usage As A Means of Avoiding CNI and Steroids in Renal Transplantation (NCT NCT01436305)

Last Updated: 2017-09-27

Results Overview

GFR 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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

19 participants

Primary outcome timeframe

Week 52

Results posted on

2017-09-27

Participant Flow

Three sites in the United States enrolled a total of 19 participants in the study.

Participant milestones

Participant milestones
Measure	Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter.	Induction: Alemtuzumab, Maintenance: MMF + Belatacept Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.	Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks. Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped.
Overall Study STARTED	6	6	7
Overall Study COMPLETED	4	2	7
Overall Study NOT COMPLETED	2	4	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter.	Induction: Alemtuzumab, Maintenance: MMF + Belatacept Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.
Overall Study Death	1	0
Overall Study Lost to Follow-up	0	1
Overall Study Withdrawal by Subject	1	3

Baseline Characteristics

Optimization of NULOJIX® Usage As A Means of Avoiding CNI and Steroids in Renal Transplantation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus n=6 Participants Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter.	Induction: Alemtuzumab, Maintenance: MMF + Belatacept n=6 Participants Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.	Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac n=7 Participants Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks. Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped.	Total n=19 Participants Total of all reporting groups
Age, Continuous	46.8 years STANDARD_DEVIATION 13.1 • n=5 Participants	43.3 years STANDARD_DEVIATION 9.5 • n=7 Participants	49.1 years STANDARD_DEVIATION 9.0 • n=5 Participants	46.6 years STANDARD_DEVIATION 10.3 • n=4 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	6 Participants n=4 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants	13 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	16 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants	8 Participants n=4 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	10 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	6 participants n=5 Participants	6 participants n=7 Participants	7 participants n=5 Participants	19 participants n=4 Participants

PRIMARY outcome

Timeframe: Week 52

Population: Intent-to-treat population with measurable data at Week 52

Outcome measures

Outcome measures
Measure	Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus n=4 Participants Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter.	Induction: Alemtuzumab, Maintenance: MMF + Belatacept n=3 Participants Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.	Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac n=7 Participants Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks. Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped.
Mean Glomerular Filtration Rate (GFR) Calculated for Each Treatment Group Using the CKD-EPI Equation at Wk 52	55.9 mL/min/1.73m^2 Standard Deviation 8.9	51.6 mL/min/1.73m^2 Standard Deviation 23.5	58.3 mL/min/1.73m^2 Standard Deviation 12.2

SECONDARY outcome

Timeframe: Transplantation through last study visit (up to week 156)

Population: Intent-to-treat

Biopsy proven acute rejection was defined as histologic evidence of borderline or higher cellular rejection per local pathologist.

Outcome measures

Outcome measures
Measure	Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus n=6 Participants Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter.	Induction: Alemtuzumab, Maintenance: MMF + Belatacept n=6 Participants Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.	Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac n=7 Participants Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks. Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped.
Count of Participants With Biopsy Proven Acute Rejection at Any Time Post-Transplant	3 Participants	2 Participants	5 Participants

SECONDARY outcome

Timeframe: Week 52, Week 104, and Week 156

Population: Intent-to-treat population with available data at Weeks 52, 104 and 156.

GFR 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. This measure specifically looked at participants with scores less than 60.

Outcome measures

Outcome measures
Measure	Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus n=4 Participants Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter.	Induction: Alemtuzumab, Maintenance: MMF + Belatacept n=3 Participants Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.	Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac n=7 Participants Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks. Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped.
Count of Participants With Estimated Glomerular Filtration Rate (GFR) < 60 mL/Min/1.73 m^2 by CKD EPI Week 52	3 Participants	2 Participants	4 Participants
Count of Participants With Estimated Glomerular Filtration Rate (GFR) < 60 mL/Min/1.73 m^2 by CKD EPI Week 104	2 Participants	1 Participants	3 Participants
Count of Participants With Estimated Glomerular Filtration Rate (GFR) < 60 mL/Min/1.73 m^2 by CKD EPI Week 156	2 Participants	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Week 52, Week 104, and Week 156

Population: Intent-to-treat population with available data at Weeks 52, 104 and 156

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

Outcome measures

Outcome measures
Measure	Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus n=4 Participants Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter.	Induction: Alemtuzumab, Maintenance: MMF + Belatacept n=3 Participants Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.	Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac n=7 Participants Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks. Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped.
Count of Participants by Chronic Kidney Disease (CKD) Stage Post-Transplant Week 52 - Stage 1	0 Participants	0 Participants	0 Participants
Count of Participants by Chronic Kidney Disease (CKD) Stage Post-Transplant Week 52 - Stage 2	1 Participants	1 Participants	3 Participants
Count of Participants by Chronic Kidney Disease (CKD) Stage Post-Transplant Week 52 - Stage 3A	3 Participants	1 Participants	3 Participants
Count of Participants by Chronic Kidney Disease (CKD) Stage Post-Transplant Week 52 - Stage 3B	0 Participants	0 Participants	1 Participants
Count of Participants by Chronic Kidney Disease (CKD) Stage Post-Transplant Week 52 - Stage 4	0 Participants	1 Participants	0 Participants
Count of Participants by Chronic Kidney Disease (CKD) Stage Post-Transplant Week 104 - Stage 1	0 Participants	1 Participants	1 Participants
Count of Participants by Chronic Kidney Disease (CKD) Stage Post-Transplant Week 104 - Stage 2	1 Participants	0 Participants	3 Participants
Count of Participants by Chronic Kidney Disease (CKD) Stage Post-Transplant Week 104 - Stage 3A	1 Participants	1 Participants	2 Participants
Count of Participants by Chronic Kidney Disease (CKD) Stage Post-Transplant Week 104 - Stage 3B	1 Participants	0 Participants	1 Participants
Count of Participants by Chronic Kidney Disease (CKD) Stage Post-Transplant Week 104 - Stage 4	0 Participants	0 Participants	0 Participants
Count of Participants by Chronic Kidney Disease (CKD) Stage Post-Transplant Week 156 - Stage 1	0 Participants	0 Participants	0 Participants
Count of Participants by Chronic Kidney Disease (CKD) Stage Post-Transplant Week 156 - Stage 2	1 Participants	1 Participants	5 Participants
Count of Participants by Chronic Kidney Disease (CKD) Stage Post-Transplant Week 156 - Stage 3A	1 Participants	1 Participants	1 Participants
Count of Participants by Chronic Kidney Disease (CKD) Stage Post-Transplant Week 156 - Stage 3B	1 Participants	0 Participants	1 Participants
Count of Participants by Chronic Kidney Disease (CKD) Stage Post-Transplant Week 156 - Stage 4	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 52, Week 104, and Week 156

Population: Intent-to-treat population with available data at Weeks 52, 104 and 156

The stages of Chronic Kidney Disease are defined using the participant's GFR value as indicated below. Stage 1 if GFR value is ≥90; Stage 2 if 60 ≤ GFR \< 90; Stage 3A if 45 ≤ GFR \< 60; Stage 3B if 30 ≤ GFR \< 45; Stage 4 if 15 ≤ GFR \< 30; Stage 5 if GFR \< 15. Stage 1 means kidney function is normal. Stage 2 indicates mildly reduced kidney function, pointing to kidney disease. Stages 3A abd 3B indicate moderately reduced kidney function. Stage 4 indicates severely reduced kidney function. Stage 5 indicates very severe or end stage kidney failure.

Outcome measures

Outcome measures
Measure	Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus n=4 Participants Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter.	Induction: Alemtuzumab, Maintenance: MMF + Belatacept n=3 Participants Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.	Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac n=7 Participants Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks. Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped.
Count of Participants With CKD Stage 4 or 5 Week 52	0 Participants	1 Participants	0 Participants
Count of Participants With CKD Stage 4 or 5 Week 104	0 Participants	0 Participants	0 Participants
Count of Participants With CKD Stage 4 or 5 Week 156	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 52, Week 104, and Week 156

Population: Intent-to-treat population with available data at Weeks 52, 104 and 156

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 very severe or endstage kidney failure.

Outcome measures

Outcome measures
Measure	Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus n=4 Participants Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter.	Induction: Alemtuzumab, Maintenance: MMF + Belatacept n=3 Participants Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.	Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac n=7 Participants Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks. Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped.
Mean Calculated eGFR Using MDRD 4 Variable Model Week 52	52.4 mL/min/1.73m^2 Standard Deviation 8.3	47.8 mL/min/1.73m^2 Standard Deviation 22.3	55.7 mL/min/1.73m^2 Standard Deviation 11.0
Mean Calculated eGFR Using MDRD 4 Variable Model Week 104	54.2 mL/min/1.73m^2 Standard Deviation 13.1	69.3 mL/min/1.73m^2 Standard Deviation 27.3	60.4 mL/min/1.73m^2 Standard Deviation 16.8
Mean Calculated eGFR Using MDRD 4 Variable Model Week 156	49.0 mL/min/1.73m^2 Standard Deviation 16.3	65.5 mL/min/1.73m^2 Standard Deviation 20.2	61.5 mL/min/1.73m^2 Standard Deviation 13.9

SECONDARY outcome

Timeframe: Week 52, Week 104, and Week 156

Population: Intent-to-treat with available data

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 can be interpreted as a change in eGFR per month. Positive numbers indicate increasing kidney function. Larger numbers indicate greater change in kidney function.

Outcome measures

Outcome measures
Measure	Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus n=6 Participants Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter.	Induction: Alemtuzumab, Maintenance: MMF + Belatacept n=4 Participants Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.	Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac n=7 Participants Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks. Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped.
The Slope of eGFR by CKD-EPI Over Time Based on Serum Creatinine Week 52	1.29 Change in eGFR (mL/min/1.73m^2) by month Standard Deviation 1.85	0.62 Change in eGFR (mL/min/1.73m^2) by month Standard Deviation 0.99	1.07 Change in eGFR (mL/min/1.73m^2) by month Standard Deviation 1.16
The Slope of eGFR by CKD-EPI Over Time Based on Serum Creatinine Week 104	1.27 Change in eGFR (mL/min/1.73m^2) by month Standard Deviation 1.86	0.62 Change in eGFR (mL/min/1.73m^2) by month Standard Deviation 1.18	0.68 Change in eGFR (mL/min/1.73m^2) by month Standard Deviation 0.83
The Slope of eGFR by CKD-EPI Over Time Based on Serum Creatinine Week 156	1.33 Change in eGFR (mL/min/1.73m^2) by month Standard Deviation 1.82	0.69 Change in eGFR (mL/min/1.73m^2) by month Standard Deviation 1.14	0.48 Change in eGFR (mL/min/1.73m^2) by month Standard Deviation 0.48

SECONDARY outcome

Timeframe: Any time within the first week post-transplant

Population: Intent-to-treat

Delayed graft 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

Outcome measures

Outcome measures
Measure	Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus n=6 Participants Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter.	Induction: Alemtuzumab, Maintenance: MMF + Belatacept n=6 Participants Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.	Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac n=7 Participants Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks. Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped.
Count of Participants With Delayed Graft Function Post-Transplant	0 Participants	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 52, Week 104, and Week 156

Population: There was an insufficient number of biopsies collected for the summarized data to be reliable.

CAN/IFTA grades reflect the severity of interstitial fibrosis and tubular atrophy present in the tissue obtained during a kidney biopsy. Higher grades indicate greater severity in interstitial fibrosis and tubular atrophy present the kidney biopsy tissue. The aim of this measure was to compare central lab reviewed pre-implantation biopsies to post-transplant biopsies, as pre-specified per protocol; however, the central lab had an inadequate set of biopsies to proceed with evaluation.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Transplantation through last study visit (up to week 156)

Population: Intent-to-treat

CAN/IFTA grades were determined per local pathology interpretations of biopsy tissue. These grades reflect the severity of interstitial fibrosis and tubular atrophy present in the tissue obtained during a kidney biopsy. Higher grades indicate greater severity in interstitial fibrosis and tubular atrophy present the kidney biopsy tissue.

Outcome measures

Outcome measures
Measure	Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus n=6 Participants Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter.	Induction: Alemtuzumab, Maintenance: MMF + Belatacept n=6 Participants Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.	Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac n=7 Participants Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks. Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped.
Count of Participants With CAN/IFTA Grade I, II or III at Any Time Post-transplant	1 Participants	3 Participants	5 Participants

SECONDARY outcome

Timeframe: Transplantation through last study visit (up to week 156)

Population: Intent-to-treat

Outcome measures

Outcome measures
Measure	Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus n=6 Participants Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter.	Induction: Alemtuzumab, Maintenance: MMF + Belatacept n=6 Participants Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.	Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac n=7 Participants Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks. Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped.
Count of Participants With Acute Cellular Rejection Grade Equal to or Greater Than IA, by the Banff 2007 Criteria	0 Participants	2 Participants	4 Participants

SECONDARY outcome

Timeframe: Transplantation through Week 52

Population: Intent-to-treat

Acute cellular rejection is 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 ≥ IA by Banff 2007 criteria. 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, this endpoint was worded as "The severity of first and highest acute cellular rejection within the first 52 weeks." But since the highest grade for each subject coincided with the first ACR episode for each subject, only a summary of severity of the first episode is presented here.

Outcome measures

Outcome measures
Measure	Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus n=6 Participants Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter.	Induction: Alemtuzumab, Maintenance: MMF + Belatacept n=6 Participants Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.	Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac n=7 Participants Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks. Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped.
Count of Participants by Severity of First Acute Cellular Rejection by Wk 52 Grade IA	0 Participants	1 Participants	1 Participants
Count of Participants by Severity of First Acute Cellular Rejection by Wk 52 Grade IB	0 Participants	0 Participants	0 Participants
Count of Participants by Severity of First Acute Cellular Rejection by Wk 52 Grade IIA	0 Participants	0 Participants	2 Participants
Count of Participants by Severity of First Acute Cellular Rejection by Wk 52 Grade IIB	0 Participants	1 Participants	1 Participants
Count of Participants by Severity of First Acute Cellular Rejection by Wk 52 Grade III	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Transplantation through last study visit (up to week 156)

Population: Intent-to-treat

Antibody mediated rejection (AMR) is defined as diffusely positive staining for C4d, presence of circulating anti-donor antibodies and morphologic evidence of acute tissue injury.

Outcome measures

Outcome measures
Measure	Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus n=6 Participants Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter.	Induction: Alemtuzumab, Maintenance: MMF + Belatacept n=6 Participants Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.	Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac n=7 Participants Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks. Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped.
Count of Participants With Antibody Mediated Rejection	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Transplantation through last study visit (up to week 156)

Population: Intent-to-treat

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 biopsy findings and corresponding treatment are presented here for each instance of treatment for rejection. Acronyms and abbreviations are defined below. ACR=Acute Cellular Rejection ATG=Anti-thymocyte globulin therapy Chr. AMR=Chronic Antibody Mediated Rejection Gd.=Grade IFTA=Interstitial Fibrosis and Tubular Atrophy IVIG=Intravenous Immunoglobulin therapy. Only 'for cause' biopsies were performed post-transplant; thus, it is possible for a participant to be included in the analysis population and not have a biopsy for this outcome measure.

Outcome measures

Outcome measures
Measure	Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus n=5 Biopsies Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter.	Induction: Alemtuzumab, Maintenance: MMF + Belatacept n=10 Biopsies Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.	Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac n=10 Biopsies Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks. Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped.
Type of Treatment of Rejection Borderline rejection; IVIG and plasmapheresis	1 Biopsy	0 Biopsy	0 Biopsy
Type of Treatment of Rejection ACR Gd. IA + Chr. AMR + IFTA Gd. I; Pulse Steroids	0 Biopsy	1 Biopsy	0 Biopsy
Type of Treatment of Rejection ACR Gd. IA + IFTA Gd. II; Pulse Steroids	0 Biopsy	1 Biopsy	0 Biopsy
Type of Treatment of Rejection ACR Gd. IIB; ATG and Pulse Steroids	0 Biopsy	1 Biopsy	0 Biopsy
Type of Treatment of Rejection Borderline + IFTA Gd. I; with Pulse Steroids	0 Biopsy	0 Biopsy	1 Biopsy
Type of Treatment of Rejection ACR Gd. IA + IFTA Gd. I; Pulse Steroids	0 Biopsy	0 Biopsy	1 Biopsy
Type of Treatment of Rejection ACR Gd. IIA; Pulse Steroids	0 Biopsy	0 Biopsy	1 Biopsy
Type of Treatment of Rejection ACR Gd. IIA + IFTA Gd. I; ATG and Pulse Steroids	0 Biopsy	0 Biopsy	2 Biopsy
Type of Treatment of Rejection ACR Gd. IIB + IFTA Gd. I; ATG and Pulse Steroids	0 Biopsy	0 Biopsy	1 Biopsy

SECONDARY outcome

Timeframe: Week 52

Population: Intent-to-treat

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.

Outcome measures

Outcome measures
Measure	Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus n=6 Participants Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter.	Induction: Alemtuzumab, Maintenance: MMF + Belatacept n=6 Participants Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.	Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac n=7 Participants Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks. Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped.
Count of Participants With de Novo Anti-donor HLA Antibodies at Wk 52	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 52

Population: Intent-to-treat

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).

Outcome measures

Outcome measures
Measure	Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus n=6 Participants Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter.	Induction: Alemtuzumab, Maintenance: MMF + Belatacept n=6 Participants Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.	Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac n=7 Participants Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks. Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped.
Count of Participants With Either New Onset Diabetes After Transplant (NODAT) or Impaired Fasting Glucose (IFG) at Wk 52 Based on Criteria Specified by the ADA and WHO New onset diabetes during first 52 weeks	0 Participants	0 Participants	0 Participants
Count of Participants With Either New Onset Diabetes After Transplant (NODAT) or Impaired Fasting Glucose (IFG) at Wk 52 Based on Criteria Specified by the ADA and WHO Impaired fasting glucose at week 52	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 14 to Week 52

Population: Intent-to-treat with available data

Treated diabetes is defined as the receipt of oral medication or insulin for \>14 days between 14 days and 52 weeks post-transplant

Outcome measures

Outcome measures
Measure	Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus n=4 Participants Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter.	Induction: Alemtuzumab, Maintenance: MMF + Belatacept n=3 Participants Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.	Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac n=7 Participants Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks. Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped.
Count of Participants With Treated Diabetes Between Day 14 and Wk 52	1 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Day 28, Day 84, Week 24, Week 36, Week 52, Week 72, Week 104, Week 156

Population: Intent-to-treat with available data

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.

Outcome measures

Outcome measures
Measure	Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus n=6 Participants Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter.	Induction: Alemtuzumab, Maintenance: MMF + Belatacept n=4 Participants Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.	Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac n=7 Participants Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks. Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped.
HbA1c Measured at Days 28 & 84, and Weeks 24, 36, 52, 72, 104 and 156 Day 28	5.3 percent Standard Deviation 1.1	5.1 percent Standard Deviation 0.5	5.8 percent Standard Deviation 0.2
HbA1c Measured at Days 28 & 84, and Weeks 24, 36, 52, 72, 104 and 156 Day 84	5.7 percent Standard Deviation 1.4	5.0 percent Standard Deviation 0.6	5.9 percent Standard Deviation 0.8
HbA1c Measured at Days 28 & 84, and Weeks 24, 36, 52, 72, 104 and 156 Week 24	6.9 percent Standard Deviation 1.8	5.1 percent Standard Deviation 0.3	6.5 percent Standard Deviation 1.0
HbA1c Measured at Days 28 & 84, and Weeks 24, 36, 52, 72, 104 and 156 Week 36	6.7 percent Standard Deviation 1.5	5.3 percent Standard Deviation 0.4	7.2 percent Standard Deviation 2.6
HbA1c Measured at Days 28 & 84, and Weeks 24, 36, 52, 72, 104 and 156 Week 52	7.0 percent Standard Deviation 2.9	4.8 percent Standard Deviation 0.7	7.6 percent
HbA1c Measured at Days 28 & 84, and Weeks 24, 36, 52, 72, 104 and 156 Week 72	—	—	8.1 percent
HbA1c Measured at Days 28 & 84, and Weeks 24, 36, 52, 72, 104 and 156 Week 104	5.7 percent Standard Deviation 0.4	5.2 percent Standard Deviation 0.1	6.6 percent Standard Deviation 1.8
HbA1c Measured at Days 28 & 84, and Weeks 24, 36, 52, 72, 104 and 156 Week 156	5.6 percent Standard Deviation 0.1	5.2 percent Standard Deviation 0.1	7.8 percent Standard Deviation 2.5

SECONDARY outcome

Timeframe: Week 52

Population: Intent-to-treat with available data at Week 52

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

Outcome measures

Outcome measures
Measure	Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus n=4 Participants Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter.	Induction: Alemtuzumab, Maintenance: MMF + Belatacept n=3 Participants Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.	Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac n=7 Participants Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks. Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped.
Standardized Blood Pressure Measurement at Wk 52 Systolic Blood Pressure at Week 52	147.5 mmHg Standard Deviation 18.7	146.7 mmHg Standard Deviation 5.1	139.9 mmHg Standard Deviation 18.1
Standardized Blood Pressure Measurement at Wk 52 Diastolic Blood Pressure at Week 52	80.8 mmHg Standard Deviation 12.8	92.7 mmHg Standard Deviation 9.8	79.3 mmHg Standard Deviation 8.5

SECONDARY outcome

Timeframe: Week 52

Population: Intent-to-treat with available data at Week 52

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

Outcome measures

Outcome measures
Measure	Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus n=4 Participants Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter.	Induction: Alemtuzumab, Maintenance: MMF + Belatacept n=3 Participants Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.	Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac n=7 Participants Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks. Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped.
Count of Participants With Use of Anti-hypertensive Medications at Wk 52	3 Participants	3 Participants	7 Participants

SECONDARY outcome

Timeframe: Baseline, Week 24, Week 52, Week 104, Week 156

Population: Intent-to-treat

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 detailed below. 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 Triglycerides: \<150 mg/dL; high values indicate risk of cardiovascular disease

Outcome measures

Outcome measures
Measure	Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus n=6 Participants Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter.	Induction: Alemtuzumab, Maintenance: MMF + Belatacept n=6 Participants Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.	Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac n=7 Participants Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks. Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped.
Fasting Lipid Profile (Total Cholesterol, Non-HDL Cholesterol, LDL, HDL, and Triglyceride) at Baseline and Wks 24, 52, 104 and 156 Tot. Chol. Baseline	141.2 mg/dL Standard Deviation 28.8	160.2 mg/dL Standard Deviation 37.8	165.6 mg/dL Standard Deviation 37.4
Fasting Lipid Profile (Total Cholesterol, Non-HDL Cholesterol, LDL, HDL, and Triglyceride) at Baseline and Wks 24, 52, 104 and 156 Tot. Chol. W24	171.6 mg/dL Standard Deviation 44.0	159.0 mg/dL Standard Deviation 11.1	185.6 mg/dL Standard Deviation 40.1
Fasting Lipid Profile (Total Cholesterol, Non-HDL Cholesterol, LDL, HDL, and Triglyceride) at Baseline and Wks 24, 52, 104 and 156 Tot. Chol. W52	156.0 mg/dL Standard Deviation 30.7	187.0 mg/dL	157.5 mg/dL Standard Deviation 53.0
Fasting Lipid Profile (Total Cholesterol, Non-HDL Cholesterol, LDL, HDL, and Triglyceride) at Baseline and Wks 24, 52, 104 and 156 Tot. Chol. W104	170.5 mg/dL Standard Deviation 2.1	142.5 mg/dL Standard Deviation 3.5	189.0 mg/dL Standard Deviation 49.9
Fasting Lipid Profile (Total Cholesterol, Non-HDL Cholesterol, LDL, HDL, and Triglyceride) at Baseline and Wks 24, 52, 104 and 156 Tot. Chol. W156	183.5 mg/dL Standard Deviation 3.5	133.5 mg/dL Standard Deviation 7.8	181.7 mg/dL Standard Deviation 60.6
Fasting Lipid Profile (Total Cholesterol, Non-HDL Cholesterol, LDL, HDL, and Triglyceride) at Baseline and Wks 24, 52, 104 and 156 Non-HDL Baseline	108.2 mg/dL Standard Deviation 22.0	118.8 mg/dL Standard Deviation 19.0	122.3 mg/dL Standard Deviation 44.9
Fasting Lipid Profile (Total Cholesterol, Non-HDL Cholesterol, LDL, HDL, and Triglyceride) at Baseline and Wks 24, 52, 104 and 156 Non-HDL W24	128.0 mg/dL Standard Deviation 38.0	129.3 mg/dL Standard Deviation 10.0	129.0 mg/dL Standard Deviation 35.3
Fasting Lipid Profile (Total Cholesterol, Non-HDL Cholesterol, LDL, HDL, and Triglyceride) at Baseline and Wks 24, 52, 104 and 156 Non-HDL W52	117.5 mg/dL Standard Deviation 23.4	151.0 mg/dL	61.0 mg/dL
Fasting Lipid Profile (Total Cholesterol, Non-HDL Cholesterol, LDL, HDL, and Triglyceride) at Baseline and Wks 24, 52, 104 and 156 Non-HDL W104	129.5 mg/dL Standard Deviation 0.7	110.5 mg/dL Standard Deviation 3.5	135.6 mg/dL Standard Deviation 42.4
Fasting Lipid Profile (Total Cholesterol, Non-HDL Cholesterol, LDL, HDL, and Triglyceride) at Baseline and Wks 24, 52, 104 and 156 Non-HDL W156	138.5 mg/dL Standard Deviation 2.1	102.5 mg/dL Standard Deviation 2.1	136.0 mg/dL Standard Deviation 58.0
Fasting Lipid Profile (Total Cholesterol, Non-HDL Cholesterol, LDL, HDL, and Triglyceride) at Baseline and Wks 24, 52, 104 and 156 LDL Baseline	76.7 mg/dL Standard Deviation 22.0	86.6 mg/dL Standard Deviation 29.8	83.4 mg/dL Standard Deviation 41.4
Fasting Lipid Profile (Total Cholesterol, Non-HDL Cholesterol, LDL, HDL, and Triglyceride) at Baseline and Wks 24, 52, 104 and 156 LDL W24	76.7 mg/dL Standard Deviation 22.0	86.6 mg/dL Standard Deviation 29.8	83.4 mg/dL Standard Deviation 41.4
Fasting Lipid Profile (Total Cholesterol, Non-HDL Cholesterol, LDL, HDL, and Triglyceride) at Baseline and Wks 24, 52, 104 and 156 LDL W52	69.5 mg/dL Standard Deviation 38.0	114.0 mg/dL	49.0 mg/dL
Fasting Lipid Profile (Total Cholesterol, Non-HDL Cholesterol, LDL, HDL, and Triglyceride) at Baseline and Wks 24, 52, 104 and 156 LDL W104	100.5 mg/dL Standard Deviation 0.7	58.0 mg/dL Standard Deviation 18.4	101.4 mg/dL Standard Deviation 42.3
Fasting Lipid Profile (Total Cholesterol, Non-HDL Cholesterol, LDL, HDL, and Triglyceride) at Baseline and Wks 24, 52, 104 and 156 LDL W156	116.0 mg/dL Standard Deviation 2.8	55.5 mg/dL Standard Deviation 19.1	106.0 mg/dL Standard Deviation 46.3
Fasting Lipid Profile (Total Cholesterol, Non-HDL Cholesterol, LDL, HDL, and Triglyceride) at Baseline and Wks 24, 52, 104 and 156 HDL Baseline	33.0 mg/dL Standard Deviation 10.4	41.3 mg/dL Standard Deviation 22.8	43.3 mg/dL Standard Deviation 10.7
Fasting Lipid Profile (Total Cholesterol, Non-HDL Cholesterol, LDL, HDL, and Triglyceride) at Baseline and Wks 24, 52, 104 and 156 HDL W24	43.6 mg/dL Standard Deviation 8.2	29.7 mg/dL Standard Deviation 2.1	56.6 mg/dL Standard Deviation 19.6
Fasting Lipid Profile (Total Cholesterol, Non-HDL Cholesterol, LDL, HDL, and Triglyceride) at Baseline and Wks 24, 52, 104 and 156 HDL W52	38.5 mg/dL Standard Deviation 12.3	36.0 mg/dL	59.0 mg/dL
Fasting Lipid Profile (Total Cholesterol, Non-HDL Cholesterol, LDL, HDL, and Triglyceride) at Baseline and Wks 24, 52, 104 and 156 HDL W104	41.0 mg/dL Standard Deviation 2.8	32.0 mg/dL Standard Deviation 7.1	53.4 mg/dL Standard Deviation 16.6
Fasting Lipid Profile (Total Cholesterol, Non-HDL Cholesterol, LDL, HDL, and Triglyceride) at Baseline and Wks 24, 52, 104 and 156 HDL W156	45.0 mg/dL Standard Deviation 1.4	31.0 mg/dL Standard Deviation 5.7	45.7 mg/dL Standard Deviation 14.6
Fasting Lipid Profile (Total Cholesterol, Non-HDL Cholesterol, LDL, HDL, and Triglyceride) at Baseline and Wks 24, 52, 104 and 156 Triglyc. Baseline	158.7 mg/dL Standard Deviation 92.4	307.8 mg/dL Standard Deviation 350.1	206.9 mg/dL Standard Deviation 148.5
Fasting Lipid Profile (Total Cholesterol, Non-HDL Cholesterol, LDL, HDL, and Triglyceride) at Baseline and Wks 24, 52, 104 and 156 Triglyc. W24	161.0 mg/dL Standard Deviation 53.9	249.7 mg/dL Standard Deviation 172.4	115.9 mg/dL Standard Deviation 68.1
Fasting Lipid Profile (Total Cholesterol, Non-HDL Cholesterol, LDL, HDL, and Triglyceride) at Baseline and Wks 24, 52, 104 and 156 Triglyc. W52	319.3 mg/dL Standard Deviation 294.0	187.0 mg/dL	58.0 mg/dL
Fasting Lipid Profile (Total Cholesterol, Non-HDL Cholesterol, LDL, HDL, and Triglyceride) at Baseline and Wks 24, 52, 104 and 156 Triglyc. W104	146.0 mg/dL Standard Deviation 1.4	220.0 mg/dL Standard Deviation 168.3	172.8 mg/dL Standard Deviation 130.0
Fasting Lipid Profile (Total Cholesterol, Non-HDL Cholesterol, LDL, HDL, and Triglyceride) at Baseline and Wks 24, 52, 104 and 156 Triglyc. W156	115.0 mg/dL Standard Deviation 4.2	228.0 mg/dL Standard Deviation 93.3	156.5 mg/dL Standard Deviation 75.6

SECONDARY outcome

Timeframe: Baseline, Week 24, Week 52, Week 104, Week 156

Population: Intent-to-treat

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

Outcome measures

Outcome measures
Measure	Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus n=6 Participants Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter.	Induction: Alemtuzumab, Maintenance: MMF + Belatacept n=6 Participants Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.	Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac n=7 Participants Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks. Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped.
Count of Participants With Use of Lipid Lowering Medications at Baseline and Wks 24, 52, 104 and 156 Baseline	5 Participants	1 Participants	2 Participants
Count of Participants With Use of Lipid Lowering Medications at Baseline and Wks 24, 52, 104 and 156 Week 24	4 Participants	1 Participants	2 Participants
Count of Participants With Use of Lipid Lowering Medications at Baseline and Wks 24, 52, 104 and 156 Week 52	3 Participants	1 Participants	2 Participants
Count of Participants With Use of Lipid Lowering Medications at Baseline and Wks 24, 52, 104 and 156 Week 104	3 Participants	1 Participants	3 Participants
Count of Participants With Use of Lipid Lowering Medications at Baseline and Wks 24, 52, 104 and 156 Week 156	3 Participants	1 Participants	3 Participants

SECONDARY outcome

Timeframe: Day 28, Day 84, Week 24, Week 36, Week 52, Week 72, Week 104, Week 156

Population: Intent-to-treat with available data

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

Outcome measures

Outcome measures
Measure	Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus n=6 Participants Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter.	Induction: Alemtuzumab, Maintenance: MMF + Belatacept n=4 Participants Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.	Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac n=7 Participants Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks. Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped.
Total Daily Prescribed Pill Number at Days 28 and 84, and Wks 24, 36, 52, 72, 104 and 156 Day 28	28.8 Number of pills Standard Deviation 12.3	15.8 Number of pills Standard Deviation 6.3	27.3 Number of pills Standard Deviation 7.6
Total Daily Prescribed Pill Number at Days 28 and 84, and Wks 24, 36, 52, 72, 104 and 156 Day 84	22.2 Number of pills Standard Deviation 6.6	13.5 Number of pills Standard Deviation 4.4	21.3 Number of pills Standard Deviation 7.5
Total Daily Prescribed Pill Number at Days 28 and 84, and Wks 24, 36, 52, 72, 104 and 156 Week 24	14.8 Number of pills Standard Deviation 3.8	8.3 Number of pills Standard Deviation 4.0	16.6 Number of pills Standard Deviation 5.7
Total Daily Prescribed Pill Number at Days 28 and 84, and Wks 24, 36, 52, 72, 104 and 156 Week 36	13.0 Number of pills Standard Deviation 2.0	14.0 Number of pills Standard Deviation 1.0	17.0 Number of pills Standard Deviation 5.1
Total Daily Prescribed Pill Number at Days 28 and 84, and Wks 24, 36, 52, 72, 104 and 156 Week 52	14.6 Number of pills Standard Deviation 5.0	14.3 Number of pills Standard Deviation 1.5	17.8 Number of pills Standard Deviation 3.5
Total Daily Prescribed Pill Number at Days 28 and 84, and Wks 24, 36, 52, 72, 104 and 156 Week 72	—	—	16.0 Number of pills Standard Deviation 4.4
Total Daily Prescribed Pill Number at Days 28 and 84, and Wks 24, 36, 52, 72, 104 and 156 Week 104	15.3 Number of pills Standard Deviation 5.7	15.5 Number of pills Standard Deviation 2.1	14.8 Number of pills Standard Deviation 5.3
Total Daily Prescribed Pill Number at Days 28 and 84, and Wks 24, 36, 52, 72, 104 and 156 Week 156	14.0 Number of pills Standard Deviation 6.2	15.0 Number of pills Standard Deviation 1.4	12.7 Number of pills Standard Deviation 6.2

SECONDARY outcome

Timeframe: Transplantation through last study visit (up to week 156)

Population: Intent-to-treat

This measure counts deaths and graft loss occurring at any point post transplantation. Graft loss is defined as need for dialysis for greater than 30 days duration, allograft nephrectomy, or retransplantation.

Outcome measures

Outcome measures
Measure	Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus n=6 Participants Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter.	Induction: Alemtuzumab, Maintenance: MMF + Belatacept n=6 Participants Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.	Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac n=7 Participants Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks. Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped.
Number of Events of Death or Graft Loss	2 Events	3 Events	0 Events

SECONDARY outcome

Timeframe: Transplantation through last study visit (up to week 156)

Population: Intent-to-treat

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.

Outcome measures

Outcome measures
Measure	Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus n=6 Participants Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter.	Induction: Alemtuzumab, Maintenance: MMF + Belatacept n=6 Participants Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.	Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac n=7 Participants Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks. Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped.
Count of Participants With Rejection	1 Participants	3 Participants	5 Participants

SECONDARY outcome

Timeframe: Enrollment through last study visit (up to week 156)

Population: Intent-to-treat

Adverse events were collected systematically from enrollment through last study visit. Displayed below are counts of all adverse events per treatment group (including both serious and non-serious adverse events). Separately counts of all adverse events determined to be serious are displayed per treatment group. More detail about adverse events for this trial is displayed in the 'Adverse Event' section.

Outcome measures

Outcome measures
Measure	Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus n=6 Participants Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter.	Induction: Alemtuzumab, Maintenance: MMF + Belatacept n=6 Participants Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.	Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac n=7 Participants Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks. Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped.
Number of All Adverse Events (AEs) and Serious Adverse Events (SAEs) All Adverse Events	21 Events	25 Events	40 Events
Number of All Adverse Events (AEs) and Serious Adverse Events (SAEs) Serious Adverse Events	6 Events	11 Events	7 Events

SECONDARY outcome

Timeframe: Transplantation through last study visit (up to week 156)

Population: Intent-to-treat

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 of prolongation of a current hospitalization.

Outcome measures

Outcome measures
Measure	Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus n=6 Participants Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter.	Induction: Alemtuzumab, Maintenance: MMF + Belatacept n=6 Participants Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.	Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac n=7 Participants Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks. Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped.
Count of Participants With Infections Requiring Hospitalization or Systemic Therapy Reported as Serious Adverse Events	2 Participants	2 Participants	1 Participants

SECONDARY outcome

Timeframe: Transplantation through last study visit (up to week 156)

Population: Intent-to-treat

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 this study using participant blood samples. Acronyms: BK Polyoma Virus (BKV); Cytomegalovirus (CMV).

Outcome measures

Outcome measures
Measure	Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus n=6 Participants Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter.	Induction: Alemtuzumab, Maintenance: MMF + Belatacept n=6 Participants Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.	Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac n=7 Participants Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks. Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped.
Count of Participants With BKV and CMV Viremia (Local Center Monitoring) Reported as Adverse Events BKV	0 Participants	0 Participants	2 Participants
Count of Participants With BKV and CMV Viremia (Local Center Monitoring) Reported as Adverse Events CMV	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Transplantation through last study visit (up to week 156)

Population: Intent-to-treat

Viral infections following renal transplantation is a significant source of recipient morbidity and mortality, and a significant cause of allograft dysfunction and loss. Specific viruses were monitored during this study using participant blood samples. Acronym: Epstein-Barr virus (EBV)

Outcome measures

Outcome measures
Measure	Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus n=6 Participants Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter.	Induction: Alemtuzumab, Maintenance: MMF + Belatacept n=6 Participants Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.	Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac n=7 Participants Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks. Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped.
Count of Participants With EBV Infection as Reported on the Case Report Form as Adverse Events	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 24 hours after transplantation

Population: Intent-to-treat

Temperature of \>39 degrees Celsius 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.

Outcome measures

Outcome measures
Measure	Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus n=6 Participants Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter.	Induction: Alemtuzumab, Maintenance: MMF + Belatacept n=6 Participants Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.	Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac n=7 Participants Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks. Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped.
Count of Participants With Fever > 39 Degrees Celsius and Blood Pressure < 90mm Hg Within 24 Hours of Onset of Transplant Procedure Fever >39 degrees	0 Participants	0 Participants	0 Participants
Count of Participants With Fever > 39 Degrees Celsius and Blood Pressure < 90mm Hg Within 24 Hours of Onset of Transplant Procedure Systolic BP <90	0 Participants	1 Participants	0 Participants

Adverse Events

Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus

Serious events: 3 serious events

Other events: 6 other events

Deaths: 1 deaths

Induction: Alemtuzumab, Maintenance: MMF + Belatacept

Serious events: 5 serious events

Other events: 4 other events

Deaths: 0 deaths

Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac

Serious events: 5 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Director, Clinical Research Operations Program

DAIT/NIAID

Phone: 301-594-7669

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus n=6 participants at risk Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter.	Induction: Alemtuzumab, Maintenance: MMF + Belatacept n=6 participants at risk Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.	Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac n=7 participants at risk Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks. Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped.
Blood and lymphatic system disorders Leukopenia	0.00% 0/6 • Enrollment through study completion, up to 3 years	16.7% 1/6 • Number of events 1 • Enrollment through study completion, up to 3 years	0.00% 0/7 • Enrollment through study completion, up to 3 years
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/6 • Enrollment through study completion, up to 3 years	16.7% 1/6 • Number of events 1 • Enrollment through study completion, up to 3 years	0.00% 0/7 • Enrollment through study completion, up to 3 years
General disorders Pyrexia	0.00% 0/6 • Enrollment through study completion, up to 3 years	16.7% 1/6 • Number of events 1 • Enrollment through study completion, up to 3 years	0.00% 0/7 • Enrollment through study completion, up to 3 years
General disorders Suprapubic pain	0.00% 0/6 • Enrollment through study completion, up to 3 years	16.7% 1/6 • Number of events 1 • Enrollment through study completion, up to 3 years	0.00% 0/7 • Enrollment through study completion, up to 3 years
Hepatobiliary disorders Cholelithiasis	16.7% 1/6 • Number of events 1 • Enrollment through study completion, up to 3 years	0.00% 0/6 • Enrollment through study completion, up to 3 years	0.00% 0/7 • Enrollment through study completion, up to 3 years
Immune system disorders Transplant rejection	0.00% 0/6 • Enrollment through study completion, up to 3 years	16.7% 1/6 • Number of events 1 • Enrollment through study completion, up to 3 years	42.9% 3/7 • Number of events 3 • Enrollment through study completion, up to 3 years
Infections and infestations Arteriovenous graft site infection	0.00% 0/6 • Enrollment through study completion, up to 3 years	0.00% 0/6 • Enrollment through study completion, up to 3 years	14.3% 1/7 • Number of events 1 • Enrollment through study completion, up to 3 years
Infections and infestations Cytomegalovirus infection	16.7% 1/6 • Number of events 1 • Enrollment through study completion, up to 3 years	0.00% 0/6 • Enrollment through study completion, up to 3 years	0.00% 0/7 • Enrollment through study completion, up to 3 years
Infections and infestations Endocarditis staphylococcal	16.7% 1/6 • Number of events 2 • Enrollment through study completion, up to 3 years	0.00% 0/6 • Enrollment through study completion, up to 3 years	0.00% 0/7 • Enrollment through study completion, up to 3 years
Infections and infestations Infected skin ulcer	0.00% 0/6 • Enrollment through study completion, up to 3 years	16.7% 1/6 • Number of events 1 • Enrollment through study completion, up to 3 years	0.00% 0/7 • Enrollment through study completion, up to 3 years
Infections and infestations Urinary tract infection	16.7% 1/6 • Number of events 1 • Enrollment through study completion, up to 3 years	16.7% 1/6 • Number of events 1 • Enrollment through study completion, up to 3 years	0.00% 0/7 • Enrollment through study completion, up to 3 years
Investigations Blood creatinine increased	0.00% 0/6 • Enrollment through study completion, up to 3 years	0.00% 0/6 • Enrollment through study completion, up to 3 years	14.3% 1/7 • Number of events 1 • Enrollment through study completion, up to 3 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	16.7% 1/6 • Number of events 1 • Enrollment through study completion, up to 3 years	0.00% 0/6 • Enrollment through study completion, up to 3 years	0.00% 0/7 • Enrollment through study completion, up to 3 years
Renal and urinary disorders Renal failure acute	0.00% 0/6 • Enrollment through study completion, up to 3 years	0.00% 0/6 • Enrollment through study completion, up to 3 years	28.6% 2/7 • Number of events 2 • Enrollment through study completion, up to 3 years
Renal and urinary disorders Renal vein thrombosis	0.00% 0/6 • Enrollment through study completion, up to 3 years	16.7% 1/6 • Number of events 1 • Enrollment through study completion, up to 3 years	0.00% 0/7 • Enrollment through study completion, up to 3 years
Vascular disorders Arterial thrombosis	0.00% 0/6 • Enrollment through study completion, up to 3 years	16.7% 1/6 • Number of events 1 • Enrollment through study completion, up to 3 years	0.00% 0/7 • Enrollment through study completion, up to 3 years
Vascular disorders Peripheral artery dissection	0.00% 0/6 • Enrollment through study completion, up to 3 years	16.7% 1/6 • Number of events 1 • Enrollment through study completion, up to 3 years	0.00% 0/7 • Enrollment through study completion, up to 3 years
Vascular disorders Venous thrombosis	0.00% 0/6 • Enrollment through study completion, up to 3 years	16.7% 1/6 • Number of events 1 • Enrollment through study completion, up to 3 years	0.00% 0/7 • Enrollment through study completion, up to 3 years

Measure	Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus n=6 participants at risk Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter.	Induction: Alemtuzumab, Maintenance: MMF + Belatacept n=6 participants at risk Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.	Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac n=7 participants at risk Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks. Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/6 • Enrollment through study completion, up to 3 years	0.00% 0/6 • Enrollment through study completion, up to 3 years	14.3% 1/7 • Number of events 1 • Enrollment through study completion, up to 3 years
Blood and lymphatic system disorders Leukopenia	16.7% 1/6 • Number of events 1 • Enrollment through study completion, up to 3 years	16.7% 1/6 • Number of events 1 • Enrollment through study completion, up to 3 years	14.3% 1/7 • Number of events 5 • Enrollment through study completion, up to 3 years
Cardiac disorders Tachycardia	0.00% 0/6 • Enrollment through study completion, up to 3 years	16.7% 1/6 • Number of events 1 • Enrollment through study completion, up to 3 years	0.00% 0/7 • Enrollment through study completion, up to 3 years
Eye disorders Asthenopia	0.00% 0/6 • Enrollment through study completion, up to 3 years	0.00% 0/6 • Enrollment through study completion, up to 3 years	14.3% 1/7 • Number of events 1 • Enrollment through study completion, up to 3 years
Gastrointestinal disorders Diarrhoea	0.00% 0/6 • Enrollment through study completion, up to 3 years	0.00% 0/6 • Enrollment through study completion, up to 3 years	14.3% 1/7 • Number of events 1 • Enrollment through study completion, up to 3 years
Gastrointestinal disorders Nausea	0.00% 0/6 • Enrollment through study completion, up to 3 years	0.00% 0/6 • Enrollment through study completion, up to 3 years	14.3% 1/7 • Number of events 1 • Enrollment through study completion, up to 3 years
Immune system disorders Transplant rejection	0.00% 0/6 • Enrollment through study completion, up to 3 years	16.7% 1/6 • Number of events 1 • Enrollment through study completion, up to 3 years	0.00% 0/7 • Enrollment through study completion, up to 3 years
Immune system disorders Type IV hypersensitivity reaction	0.00% 0/6 • Enrollment through study completion, up to 3 years	16.7% 1/6 • Number of events 1 • Enrollment through study completion, up to 3 years	28.6% 2/7 • Number of events 2 • Enrollment through study completion, up to 3 years
Infections and infestations Acarodermatitis	0.00% 0/6 • Enrollment through study completion, up to 3 years	0.00% 0/6 • Enrollment through study completion, up to 3 years	14.3% 1/7 • Number of events 1 • Enrollment through study completion, up to 3 years
Infections and infestations Gastroenteritis	16.7% 1/6 • Number of events 1 • Enrollment through study completion, up to 3 years	0.00% 0/6 • Enrollment through study completion, up to 3 years	0.00% 0/7 • Enrollment through study completion, up to 3 years
Infections and infestations Urinary tract infection	0.00% 0/6 • Enrollment through study completion, up to 3 years	0.00% 0/6 • Enrollment through study completion, up to 3 years	14.3% 1/7 • Number of events 4 • Enrollment through study completion, up to 3 years
Infections and infestations Urinary tract infection bacterial	0.00% 0/6 • Enrollment through study completion, up to 3 years	16.7% 1/6 • Number of events 1 • Enrollment through study completion, up to 3 years	0.00% 0/7 • Enrollment through study completion, up to 3 years
Injury, poisoning and procedural complications Complications of transplanted kidney	16.7% 1/6 • Number of events 1 • Enrollment through study completion, up to 3 years	0.00% 0/6 • Enrollment through study completion, up to 3 years	0.00% 0/7 • Enrollment through study completion, up to 3 years
Injury, poisoning and procedural complications Perirenal haematoma	16.7% 1/6 • Number of events 1 • Enrollment through study completion, up to 3 years	0.00% 0/6 • Enrollment through study completion, up to 3 years	0.00% 0/7 • Enrollment through study completion, up to 3 years
Investigations Blood creatinine increased	33.3% 2/6 • Number of events 2 • Enrollment through study completion, up to 3 years	0.00% 0/6 • Enrollment through study completion, up to 3 years	28.6% 2/7 • Number of events 5 • Enrollment through study completion, up to 3 years
Investigations Blood urea increased	16.7% 1/6 • Number of events 1 • Enrollment through study completion, up to 3 years	0.00% 0/6 • Enrollment through study completion, up to 3 years	0.00% 0/7 • Enrollment through study completion, up to 3 years
Investigations Haematocrit increased	0.00% 0/6 • Enrollment through study completion, up to 3 years	16.7% 1/6 • Number of events 1 • Enrollment through study completion, up to 3 years	0.00% 0/7 • Enrollment through study completion, up to 3 years
Investigations Haemoglobin increased	0.00% 0/6 • Enrollment through study completion, up to 3 years	16.7% 1/6 • Number of events 1 • Enrollment through study completion, up to 3 years	0.00% 0/7 • Enrollment through study completion, up to 3 years
Investigations Liver function test abnormal	0.00% 0/6 • Enrollment through study completion, up to 3 years	0.00% 0/6 • Enrollment through study completion, up to 3 years	14.3% 1/7 • Number of events 1 • Enrollment through study completion, up to 3 years
Investigations Polyomavirus test positive	0.00% 0/6 • Enrollment through study completion, up to 3 years	0.00% 0/6 • Enrollment through study completion, up to 3 years	28.6% 2/7 • Number of events 2 • Enrollment through study completion, up to 3 years
Investigations White blood cell count decreased	16.7% 1/6 • Number of events 1 • Enrollment through study completion, up to 3 years	16.7% 1/6 • Number of events 2 • Enrollment through study completion, up to 3 years	0.00% 0/7 • Enrollment through study completion, up to 3 years
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/6 • Enrollment through study completion, up to 3 years	0.00% 0/6 • Enrollment through study completion, up to 3 years	14.3% 1/7 • Number of events 2 • Enrollment through study completion, up to 3 years
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/6 • Enrollment through study completion, up to 3 years	16.7% 1/6 • Number of events 1 • Enrollment through study completion, up to 3 years	14.3% 1/7 • Number of events 1 • Enrollment through study completion, up to 3 years
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/6 • Enrollment through study completion, up to 3 years	0.00% 0/6 • Enrollment through study completion, up to 3 years	14.3% 1/7 • Number of events 1 • Enrollment through study completion, up to 3 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.00% 0/6 • Enrollment through study completion, up to 3 years	0.00% 0/6 • Enrollment through study completion, up to 3 years	14.3% 1/7 • Number of events 1 • Enrollment through study completion, up to 3 years
Nervous system disorders Migraine	0.00% 0/6 • Enrollment through study completion, up to 3 years	16.7% 1/6 • Number of events 1 • Enrollment through study completion, up to 3 years	0.00% 0/7 • Enrollment through study completion, up to 3 years
Nervous system disorders Syncope	16.7% 1/6 • Number of events 1 • Enrollment through study completion, up to 3 years	0.00% 0/6 • Enrollment through study completion, up to 3 years	0.00% 0/7 • Enrollment through study completion, up to 3 years
Nervous system disorders Tremor	33.3% 2/6 • Number of events 2 • Enrollment through study completion, up to 3 years	16.7% 1/6 • Number of events 1 • Enrollment through study completion, up to 3 years	0.00% 0/7 • Enrollment through study completion, up to 3 years
Renal and urinary disorders Proteinuria	16.7% 1/6 • Number of events 2 • Enrollment through study completion, up to 3 years	0.00% 0/6 • Enrollment through study completion, up to 3 years	0.00% 0/7 • Enrollment through study completion, up to 3 years
Renal and urinary disorders Renal artery thrombosis	16.7% 1/6 • Number of events 1 • Enrollment through study completion, up to 3 years	0.00% 0/6 • Enrollment through study completion, up to 3 years	0.00% 0/7 • Enrollment through study completion, up to 3 years
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/6 • Enrollment through study completion, up to 3 years	0.00% 0/6 • Enrollment through study completion, up to 3 years	14.3% 1/7 • Number of events 1 • Enrollment through study completion, up to 3 years
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/6 • Enrollment through study completion, up to 3 years	0.00% 0/6 • Enrollment through study completion, up to 3 years	14.3% 1/7 • Number of events 1 • Enrollment through study completion, up to 3 years
Skin and subcutaneous tissue disorders Rash	0.00% 0/6 • Enrollment through study completion, up to 3 years	0.00% 0/6 • Enrollment through study completion, up to 3 years	14.3% 1/7 • Number of events 1 • Enrollment through study completion, up to 3 years
Skin and subcutaneous tissue disorders Urticaria	16.7% 1/6 • Number of events 1 • Enrollment through study completion, up to 3 years	0.00% 0/6 • Enrollment through study completion, up to 3 years	0.00% 0/7 • Enrollment through study completion, up to 3 years
Vascular disorders Haematoma	0.00% 0/6 • Enrollment through study completion, up to 3 years	0.00% 0/6 • Enrollment through study completion, up to 3 years	14.3% 1/7 • Number of events 1 • Enrollment through study completion, up to 3 years
Vascular disorders Hypotension	0.00% 0/6 • Enrollment through study completion, up to 3 years	33.3% 2/6 • Number of events 2 • Enrollment through study completion, up to 3 years	0.00% 0/7 • Enrollment through study completion, up to 3 years