Trial Outcomes & Findings for A Phase II Study of Belatacept (BMS-224818) With a Steroid-free Regimen in Subjects Undergoing Kidney Transplantation (NCT NCT00455013)

Last Updated: 2014-06-09

Results Overview

AR is clinicopathological event requiring clinical evidence and biopsy confirmation by central pathologist. One or more conditions were met and a renal biopsy revealed histologic evidence of rejection: unexplained rise of serum creatine (SCr) greater than or equal to 25% from baseline plus one or more of the following: unexplained decreased urine output; fever, graft tenderness; SCr that remained elevated 14 days post-transplantation and clinical suspicion of AR; other reason and participant treated for episode. Day 1=transplantation. Banff 97 working classification of kidney transplant pathology: Type I=tubulointerstitial AR without arteritis (IA: interstitial infiltration with \>25% of parenchyma affected and moderate tubulitis with \>4 mononuclear cells/tubular cross section; IB: \>10 mononuclear cells; Type II vascular AR with (IA) intimal arteritis (IIA=mild - moderate; IIB=severe; Type III=severe rejection with transmural arterial changes, necrosis of smooth muscle cells.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

93 participants

Primary outcome timeframe

Day 1 to Month 6 post-transplantation

Results posted on

2014-06-09

Participant Flow

First 6 months (July 2007 to October 2008) assessed acute rejection of the renal transplant up to that time. All outcome measures were also assessed at 12 months post transplantation. Participants who wished to continue into the long term extension (LTE) signed a new consent form and were evaluated at 24, 36, and 48 Months post transplantation.

Epstein-Barr virus positive recipients of renal allograft from living or deceased donor. Excluded if panel reactive antibodies greater than, equal to (\>=) 50 % or prior graft loss due to acute rejection. 93 participants randomized; 89 transplanted/treated: (1) fever on the day of surgery, (1) problem with allograft, and (2) withdrawal of consent.

Participant milestones

Participant milestones
Measure	Belatacept, Mycophenolate Mofetil (MMF) Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; intravenous infusion (IV) belatacept: 10 milligram per kilogram of weight (mg/kg) Day 1 (day of transplant) and Day 5, then every other week through Month 3 (Weeks 2,4,6,8,10,12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until 12 months; MMF (mycophenolate mofetil) 1g twice daily(BID). Participants were allowed to switch from MMF to sirolimus. Background immunosuppressive medications: methylprednisolone administered as 500, 250, 125, and 60 mg IV on Days 1, 2, 3, 4; thymoglobulin 1.5 mg/kg IV infusion on Days 1 (day of transplant), 2, 3, 4, up to maximum dose of 6 mg/kg.	Belatacept, Sirolimus Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 nanograms per milliliter (ng/mL) for first 6 months, followed by 5 - 10 ng/mL until 12 months. Participants were allowed to switch from sirolimus to MMF. Background immunosuppressive medications: methylprednisolone was administered as 500, 250, 125, and 60 mg IV on Days 1, 2, 3, 4, up to maximum dose of 6 mg/kg.	Tacrolimus, MMF Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF 1g BID. Background immunosuppressive medications: methylprednisolone administered as 500, 250, 125, and 60 mg IV on Days 1, 2, 3, 4; thymoglobulin 1.5 mg/kg IV infusion on Days 1, 2, 3, 4 up to maximum dose of 6 mg/kg.
Short Term Period STARTED	33	26	30
Short Term Period COMPLETED	27	21	28
Short Term Period NOT COMPLETED	6	5	2
Long Term Extension (LTE) STARTED	27	19	27
Long Term Extension (LTE) COMPLETED	25	16	20
Long Term Extension (LTE) NOT COMPLETED	2	3	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Belatacept, Mycophenolate Mofetil (MMF) Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; intravenous infusion (IV) belatacept: 10 milligram per kilogram of weight (mg/kg) Day 1 (day of transplant) and Day 5, then every other week through Month 3 (Weeks 2,4,6,8,10,12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until 12 months; MMF (mycophenolate mofetil) 1g twice daily(BID). Participants were allowed to switch from MMF to sirolimus. Background immunosuppressive medications: methylprednisolone administered as 500, 250, 125, and 60 mg IV on Days 1, 2, 3, 4; thymoglobulin 1.5 mg/kg IV infusion on Days 1 (day of transplant), 2, 3, 4, up to maximum dose of 6 mg/kg.	Belatacept, Sirolimus Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 nanograms per milliliter (ng/mL) for first 6 months, followed by 5 - 10 ng/mL until 12 months. Participants were allowed to switch from sirolimus to MMF. Background immunosuppressive medications: methylprednisolone was administered as 500, 250, 125, and 60 mg IV on Days 1, 2, 3, 4, up to maximum dose of 6 mg/kg.	Tacrolimus, MMF Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF 1g BID. Background immunosuppressive medications: methylprednisolone administered as 500, 250, 125, and 60 mg IV on Days 1, 2, 3, 4; thymoglobulin 1.5 mg/kg IV infusion on Days 1, 2, 3, 4 up to maximum dose of 6 mg/kg.
Short Term Period Adverse Event	2	5	0
Short Term Period Withdrawal by Subject	0	0	1
Short Term Period Lack of Efficacy	4	0	0
Short Term Period Other	0	0	1
Long Term Extension (LTE) Adverse Event	0	1	1
Long Term Extension (LTE) Withdrawal by Subject	1	0	1
Long Term Extension (LTE) Death	1	1	0
Long Term Extension (LTE) No longer met criteria	0	0	1
Long Term Extension (LTE) Subject Request or refused	0	0	3
Long Term Extension (LTE) Poor non-compliance	0	1	0
Long Term Extension (LTE) non-specified	0	0	1

Baseline Characteristics

A Phase II Study of Belatacept (BMS-224818) With a Steroid-free Regimen in Subjects Undergoing Kidney Transplantation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Belatacept, Mycophenolate Mofetil (MMF) n=33 Participants Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.	Belatacept, Sirolimus n=26 Participants Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.	Tacrolimus, MMF n=30 Participants Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.	Total n=89 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Age, Categorical Between 18 and 65 years	33 Participants n=93 Participants	24 Participants n=4 Participants	26 Participants n=27 Participants	83 Participants n=483 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants	6 Participants n=483 Participants
Age, Continuous	49.2 years STANDARD_DEVIATION 11.1 • n=93 Participants	52.7 years STANDARD_DEVIATION 10.8 • n=4 Participants	53.6 years STANDARD_DEVIATION 13.2 • n=27 Participants	51.7 years STANDARD_DEVIATION 11.8 • n=483 Participants
Sex: Female, Male Female	8 Participants n=93 Participants	6 Participants n=4 Participants	8 Participants n=27 Participants	22 Participants n=483 Participants
Sex: Female, Male Male	25 Participants n=93 Participants	20 Participants n=4 Participants	22 Participants n=27 Participants	67 Participants n=483 Participants
Region of Enrollment North America	22 participants n=93 Participants	16 participants n=4 Participants	20 participants n=27 Participants	58 participants n=483 Participants
Region of Enrollment Europe	11 participants n=93 Participants	10 participants n=4 Participants	10 participants n=27 Participants	31 participants n=483 Participants

PRIMARY outcome

Timeframe: Day 1 to Month 6 post-transplantation

Population: Participants with more than one episode of AR were counted once only and the episode with the worst grade was used. For 95% Confidence Interval (CI) within each group, normal approximation was used if N greater than, or equal to (\>=) 5. Otherwise, exact method was used. ITT population defined as all randomized and transplanted participants.

Outcome measures

Outcome measures
Measure	Belatacept, Mycophenolate Mofetil (MMF) n=33 Participants Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.	Belatacept, Sirolimus n=26 Participants Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.	Tacrolimus, MMF n=30 Participants Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
Number of Participants With Acute Rejection (AR) of Transplant up to 6 Months Post Transplantation - Intent to Treat (ITT) Population Total Number of Participants with AR	4 participants Interval 3.4 to 28.2	1 participants Interval 0.1 to 19.6	1 participants Interval 0.1 to 17.2
Number of Participants With Acute Rejection (AR) of Transplant up to 6 Months Post Transplantation - Intent to Treat (ITT) Population Mild Acute IA	0 participants	0 participants	0 participants
Number of Participants With Acute Rejection (AR) of Transplant up to 6 Months Post Transplantation - Intent to Treat (ITT) Population Mild Acute IB	0 participants	0 participants	0 participants
Number of Participants With Acute Rejection (AR) of Transplant up to 6 Months Post Transplantation - Intent to Treat (ITT) Population Moderate Acute IIA	2 participants	0 participants	1 participants
Number of Participants With Acute Rejection (AR) of Transplant up to 6 Months Post Transplantation - Intent to Treat (ITT) Population Moderate Acute IIB	1 participants	1 participants	0 participants

SECONDARY outcome

Timeframe: Day 1 to Month 12 post transplantation

Population: For 95% CI within each group, normal approximation was used if N greater than, equal to 5. Otherwise, exact method was used.

AR defined as a clinicopathological event requiring clinical evidence and biopsy confirmation by central pathologist. One or more conditions were met and a renal biopsy revealed histologic evidence of rejection: unexplained rise of serum creatine (SCr) \>= 25 % from baseline plus one or more of the following: unexplained decreased urine output; fever and graft tenderness; a SCr that remained elevated within 14 days after transplantation and clinical suspicion of AR; reason other than those listed and participant was treated for this episode. Day 1 was day of transplantation. Banff grade used Banff 97 working classification of kidney transplant pathology. ITT population was all randomized and transplanted participants.

Outcome measures

Outcome measures
Measure	Belatacept, Mycophenolate Mofetil (MMF) n=33 Participants Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.	Belatacept, Sirolimus n=26 Participants Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.	Tacrolimus, MMF n=30 Participants Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
Number of Participants With Acute Rejection of Transplant up to Month 12 Post Transplantation - Intent to Treat Population Total number of participants with AR	5 participants Interval 2.9 to 27.4	1 participants Interval 0.1 to 19.6	1 participants Interval 0.1 to 17.2
Number of Participants With Acute Rejection of Transplant up to Month 12 Post Transplantation - Intent to Treat Population Mild Acute IA	0 participants	0 participants	0 participants
Number of Participants With Acute Rejection of Transplant up to Month 12 Post Transplantation - Intent to Treat Population Mild Acute IB	0 participants	0 participants	0 participants
Number of Participants With Acute Rejection of Transplant up to Month 12 Post Transplantation - Intent to Treat Population Moderate Acute IIA	3 participants	0 participants	1 participants
Number of Participants With Acute Rejection of Transplant up to Month 12 Post Transplantation - Intent to Treat Population Moderate Acute IIB	2 participants	1 participants	0 participants

SECONDARY outcome

Timeframe: Day 1 to Month 6 and Month 12 post transplantation

Population: Participants surviving with a functioning graft were 30, 24, 30 in belatacept/MMF, belatacept/sirolimus, tacrolimus/MMF arms, respectively. Participant who died had functioning graft at time of death.

Graft loss was defined as either functional loss or physical loss. Functional loss was defined as either: sustained level of SCr greater than or equal to (\>=) 6.0 mg/dL (530 micromoles/Liter; micromol/L) for \>= 4 weeks as determined by the local laboratory; regularly scheduled dialysis treatments over a period of 56 days; impairment of renal function to such a degree that the participant undergoes re-transplant. Day 1 was day of transplantation. ITT population defined as all participants randomized and transplanted.

Outcome measures

Outcome measures
Measure	Belatacept, Mycophenolate Mofetil (MMF) n=33 Participants Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.	Belatacept, Sirolimus n=26 Participants Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.	Tacrolimus, MMF n=30 Participants Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
Number of Participants With Graft Loss or Death up to Month 6 and Month 12 Post Transplantation - Intent to Treat Population Graft loss up to Month 6 post transplantation	1 participants	1 participants	0 participants
Number of Participants With Graft Loss or Death up to Month 6 and Month 12 Post Transplantation - Intent to Treat Population Graft loss up to Month 12 post transplantation	2 participants	2 participants	0 participants
Number of Participants With Graft Loss or Death up to Month 6 and Month 12 Post Transplantation - Intent to Treat Population Death up to Month 6 post transplantation	1 participants	0 participants	0 participants
Number of Participants With Graft Loss or Death up to Month 6 and Month 12 Post Transplantation - Intent to Treat Population Death up to Month 12 post transplantation	1 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Day 1 up to Month 6

Population: Intent to treat population included all randomized and transplanted participants.

Participants with graft loss or death prior to Month 6 were considered having an event of AR, therefore, the incidence of AR was reported as a composite of AR, death, and graft loss.

Outcome measures

Outcome measures
Measure	Belatacept, Mycophenolate Mofetil (MMF) n=33 Participants Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.	Belatacept, Sirolimus n=26 Participants Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.	Tacrolimus, MMF n=30 Participants Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
Number of Participants With Composite of Death, Graft Loss and Acute Rejection up to Month 6 - Intent to Treat Population	6 participants	2 participants	1 participants

SECONDARY outcome

Timeframe: Day 1 up to Month 12

Subjects with graft loss or death prior to Month 12 were considered having an event of AR, therefore, the incidence of AR was reported as a composite of AR, death, and graft loss.

Outcome measures

Outcome measures
Measure	Belatacept, Mycophenolate Mofetil (MMF) n=33 Participants Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.	Belatacept, Sirolimus n=26 Participants Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.	Tacrolimus, MMF n=30 Participants Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
Number of Participants With Composite of Death, Graft Loss and Acute Rejection up to Month 12 - Intent to Treat Population	7 participants	3 participants	1 participants

SECONDARY outcome

Timeframe: From Day 1 up to and including Day 8 post transplantation

Delayed graft function (DGF) is defined as participant requiring dialysis within the first week (Day 1-8) post transplantation. Participants losing their graft less than 48 hours post transplant and receiving chronic dialysis were not considered as having DGF. Day 1 was day of transplantation. Intent to treat population defined as all participants randomized and transplanted

Outcome measures

Outcome measures
Measure	Belatacept, Mycophenolate Mofetil (MMF) n=33 Participants Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.	Belatacept, Sirolimus n=26 Participants Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.	Tacrolimus, MMF n=30 Participants Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
Number of Participants With Delayed Graft Function - Intent to Treat Population	6 participants	4 participants	2 participants

SECONDARY outcome

Timeframe: Baseline to Month 12

Baseline defined as day before transplantation. A participant who did not have diabetes prior to randomization and received an antidiabetic medication for a duration of at least 30 days or a participant who meets the following criteria and did not have diabetes prior to randomization: Symptoms of diabetes plus casual plasma glucose (PG) concentration ≥ 200 mg/dL (11.1 mmol/L); or fasting plasma glucose ≥ 126 mg/dL (7.0 mmol/L); or 2-hour PG ≥ 200 mg/dL (11.1 mmol/L) during an oral glucose tolerance test and a confirmatory laboratory test based on measurements of venous PG must have been done on another day in the absence of unequivocal hyperglycemia accompanied by acute metabolic decompensation. Intent to treat population included all participants randomized and transplanted.

Outcome measures

Outcome measures
Measure	Belatacept, Mycophenolate Mofetil (MMF) n=33 Participants Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.	Belatacept, Sirolimus n=26 Participants Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.	Tacrolimus, MMF n=30 Participants Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
Number of Participants With New Onset Diabetes Mellitus From Baseline to Month 12 Post Transplantation - Intent to Treat Population	0 participants	2 participants	1 participants

SECONDARY outcome

Timeframe: Baseline and Month 12

Population: ITT population, 33, 26, 30 for each arm, respectively, was used for each time point (baseline and Month 12). At baseline, 2 participants in each arm were not using at least one medication. 8, 6, and 10 participants in each arm respectively, were not using at least one medication at Month 12.

Baseline was defined as day prior to transplantation. Number of anti-hypertension medications taken were categorized from 1 to 6 and greater than (\>)6. Intent to treat population included all participants randomized and transplanted.

Outcome measures

Outcome measures
Measure	Belatacept, Mycophenolate Mofetil (MMF) n=33 Participants Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.	Belatacept, Sirolimus n=26 Participants Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.	Tacrolimus, MMF n=30 Participants Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
Number of Participants Who Used Anti-hypertension Medications at Baseline and at 12 Months Post Transplantation - Intent to Treat Population Total using at least 1 medication at baseline	31 participants	24 participants	28 participants
Number of Participants Who Used Anti-hypertension Medications at Baseline and at 12 Months Post Transplantation - Intent to Treat Population Total using at least 1 medication at Month 12	25 participants	20 participants	20 participants
Number of Participants Who Used Anti-hypertension Medications at Baseline and at 12 Months Post Transplantation - Intent to Treat Population Participants using 1 medication at baseline	10 participants	9 participants	5 participants
Number of Participants Who Used Anti-hypertension Medications at Baseline and at 12 Months Post Transplantation - Intent to Treat Population Participants using 1 medication at Month 12	11 participants	5 participants	4 participants
Number of Participants Who Used Anti-hypertension Medications at Baseline and at 12 Months Post Transplantation - Intent to Treat Population Participants using 2 medications at baseline	5 participants	5 participants	8 participants
Number of Participants Who Used Anti-hypertension Medications at Baseline and at 12 Months Post Transplantation - Intent to Treat Population Participants using 2 medications at Month 12	6 participants	8 participants	13 participants
Number of Participants Who Used Anti-hypertension Medications at Baseline and at 12 Months Post Transplantation - Intent to Treat Population Participants using 3 medications at baseline	8 participants	5 participants	8 participants
Number of Participants Who Used Anti-hypertension Medications at Baseline and at 12 Months Post Transplantation - Intent to Treat Population Participants using 3 medications at Month 12	6 participants	5 participants	0 participants
Number of Participants Who Used Anti-hypertension Medications at Baseline and at 12 Months Post Transplantation - Intent to Treat Population Participants using 4 medications at baseline	3 participants	2 participants	3 participants
Number of Participants Who Used Anti-hypertension Medications at Baseline and at 12 Months Post Transplantation - Intent to Treat Population Participants using 4 medications at Month 12	1 participants	2 participants	3 participants
Number of Participants Who Used Anti-hypertension Medications at Baseline and at 12 Months Post Transplantation - Intent to Treat Population Participants using 5 medications at baseline	3 participants	1 participants	2 participants
Number of Participants Who Used Anti-hypertension Medications at Baseline and at 12 Months Post Transplantation - Intent to Treat Population Participants using 5 medications at Month 12	0 participants	0 participants	0 participants
Number of Participants Who Used Anti-hypertension Medications at Baseline and at 12 Months Post Transplantation - Intent to Treat Population Participants using 6 medications at baseline	2 participants	2 participants	1 participants
Number of Participants Who Used Anti-hypertension Medications at Baseline and at 12 Months Post Transplantation - Intent to Treat Population Participants using 6 medications at Month 12	1 participants	0 participants	0 participants
Number of Participants Who Used Anti-hypertension Medications at Baseline and at 12 Months Post Transplantation - Intent to Treat Population Participants using >6 medications at baseline	0 participants	0 participants	1 participants
Number of Participants Who Used Anti-hypertension Medications at Baseline and at 12 Months Post Transplantation - Intent to Treat Population Participants using >6 medications at Month 12	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Baseline and 12 months post transplantation

Population: Number analyzed at baseline presented above. Number analyzed at Month 12: 28, 22, 29 in belatacept/MMF, belatacept/sirolimus, and tacrolimus/MMF treatment arms,respectively. Measurements obtained immediately after drug infusion were excluded from analysis.

Systolic, diastolic and mean arterial blood pressures were measured in millimeters of mercury (mm Hg). Baseline was defined as value obtained before transplantation. Intent to treat population included all participants randomized and transplanted.

Outcome measures

Outcome measures
Measure	Belatacept, Mycophenolate Mofetil (MMF) n=33 Participants Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.	Belatacept, Sirolimus n=26 Participants Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.	Tacrolimus, MMF n=30 Participants Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
Mean Systolic, Diastolic and Arterial Blood Pressure at Baseline and Month 12 - Intent to Treat Population Systolic blood pressure at baseline	133.1 mm Hg Standard Deviation 26.43	126.9 mm Hg Standard Deviation 18.72	141.8 mm Hg Standard Deviation 23.79
Mean Systolic, Diastolic and Arterial Blood Pressure at Baseline and Month 12 - Intent to Treat Population Systolic blood pressure at Month 12	129.3 mm Hg Standard Deviation 19.24	131.0 mm Hg Standard Deviation 19.88	138.2 mm Hg Standard Deviation 19.50
Mean Systolic, Diastolic and Arterial Blood Pressure at Baseline and Month 12 - Intent to Treat Population Diastolic blood pressure at baseline	78.6 mm Hg Standard Deviation 12.50	72.3 mm Hg Standard Deviation 11.27	75.3 mm Hg Standard Deviation 15.08
Mean Systolic, Diastolic and Arterial Blood Pressure at Baseline and Month 12 - Intent to Treat Population Diastolic blood pressure at Month 12	73.3 mm Hg Standard Deviation 11.96	75.1 mm Hg Standard Deviation 10.71	77.6 mm Hg Standard Deviation 10.51
Mean Systolic, Diastolic and Arterial Blood Pressure at Baseline and Month 12 - Intent to Treat Population Mean Arterial pressure at baseline	96.8 mm Hg Standard Deviation 15.60	90.5 mm Hg Standard Deviation 12.84	97.5 mm Hg Standard Deviation 15.87
Mean Systolic, Diastolic and Arterial Blood Pressure at Baseline and Month 12 - Intent to Treat Population Mean Arterial pressure at Month 12	91.9 mm Hg Standard Deviation 12.80	93.7 mm Hg Standard Deviation 11.64	97.8 mm Hg Standard Deviation 10.90

SECONDARY outcome

Timeframe: Month 12

Population: Analysis based on all participants who were followed up at least 364 days.

Participants using \> = 1 antihyperlipidemic medication at Month 12.

Outcome measures

Outcome measures
Measure	Belatacept, Mycophenolate Mofetil (MMF) n=31 Participants Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.	Belatacept, Sirolimus n=26 Participants Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.	Tacrolimus, MMF n=26 Participants Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
Number of Participants Using Antihyperlipidemic Medications at Month 12 - Intent to Treat Population	11 participants	10 participants	9 participants

SECONDARY outcome

Timeframe: Baseline to Month 12

Population: 33, 26, 30 participants were included in the ITT population. Number of participants analyzed for HDL-C = 26, 22, 26; non-HDL-C = 26, 22, 26; LDL-C = 20, 14, 21; TC = 26, 22, 26; triglycerides = 20, 14, 21, in belatacept/MMF, belatacept/sirolimus, and tacrolimus/MMF arms, respectively.

Baseline (BL) was value obtained day prior to transplantation. Lipid values measured in milligrams/deciliter (mg/dL) included: high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), non-HDL cholesterol (non-HDL-C), total cholesterol (TC), triglycerides. Intent to treat population included all participants randomized and transplanted.

Outcome measures

Outcome measures
Measure	Belatacept, Mycophenolate Mofetil (MMF) n=33 Participants Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.	Belatacept, Sirolimus n=26 Participants Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.	Tacrolimus, MMF n=30 Participants Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
Mean Change From Baseline (BL) to Month 12 Post Transplantation in Lipid Values - Intent to Treat Population HDL-C change from BL to Month 12	1.5 mg/dL Standard Deviation 12.70	-3.7 mg/dL Standard Deviation 12.94	-0.5 mg/dL Standard Deviation 12.24
Mean Change From Baseline (BL) to Month 12 Post Transplantation in Lipid Values - Intent to Treat Population Non-HDL-C change from BL to Month 12	16.0 mg/dL Standard Deviation 45.25	16.1 mg/dL Standard Deviation 45.15	20.5 mg/dL Standard Deviation 42.56
Mean Change From Baseline (BL) to Month 12 Post Transplantation in Lipid Values - Intent to Treat Population LDL-C change from BL to Month 12	23.9 mg/dL Standard Deviation 38.18	25.0 mg/dL Standard Deviation 37.17	34.0 mg/dL Standard Deviation 30.18
Mean Change From Baseline (BL) to Month 12 Post Transplantation in Lipid Values - Intent to Treat Population Total cholesterol change from BL to Month 12	17.5 mg/dL Standard Deviation 40.69	12.5 mg/dL Standard Deviation 49.03	20.0 mg/dL Standard Deviation 45.80
Mean Change From Baseline (BL) to Month 12 Post Transplantation in Lipid Values - Intent to Treat Population Triglycerides change from BL to Month 12	-11.4 mg/dL Standard Deviation 63.31	-1.1 mg/dL Standard Deviation 88.88	-14.2 mg/dL Standard Deviation 94.83

SECONDARY outcome

Timeframe: Months 3, 6 and 12 post transplantation

Population: Month 12 n presented above. Calculated GFR, values \>180 mL/min/1.73 m2 (beyond upper limit of biologic plausibility)were truncated at 180 mL/min/1.73 m\^2. Based on median (SD) GFR of 83 (50).

Blood urea nitrogen (BUN) in mg/dL; Albumin (Alb) in g/dL;Serum creatinine (SCr) in mg/dL; Age in years. Glomerular filtration rate (GFR) was calculated based upon serum creatinine (SCr) using the Modification of Diet in Renal Disease (MDRD) formula as suggested by Levey et al: MDRD GFR = 170 x \[SCr/0.95\]\^(-0.999) x \[Age\]\^(-0.176) x \[0.762 if participant was female\] x \[1.180 if participant was black\] x \[BUN\]\^(-0.170) x \[Alb\]\^(+0.318). Intent to Treat (ITT) population is defined as all participants randomized and transplanted.

Outcome measures

Outcome measures
Measure	Belatacept, Mycophenolate Mofetil (MMF) n=29 Participants Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.	Belatacept, Sirolimus n=24 Participants Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.	Tacrolimus, MMF n=29 Participants Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
Mean (Standard Deviation) in Calculated Glomerular Filtration Rate (GFR) mL/Min/1.73m^2 at Month 3, Month 6 and Month 12 Post Transplantation - Intent to Treat Population Month 3 post transplantation(n=29,24,27)	57.8 mL/min/1.73m^2 Standard Deviation 15.41	60.5 mL/min/1.73m^2 Standard Deviation 26.69	51.2 mL/min/1.73m^2 Standard Deviation 14.78
Mean (Standard Deviation) in Calculated Glomerular Filtration Rate (GFR) mL/Min/1.73m^2 at Month 3, Month 6 and Month 12 Post Transplantation - Intent to Treat Population Month 6 post transplantation(n=29,24,25)	57.5 mL/min/1.73m^2 Standard Deviation 14.75	58.7 mL/min/1.73m^2 Standard Deviation 28.36	51.7 mL/min/1.73m^2 Standard Deviation 17.80
Mean (Standard Deviation) in Calculated Glomerular Filtration Rate (GFR) mL/Min/1.73m^2 at Month 3, Month 6 and Month 12 Post Transplantation - Intent to Treat Population Month 12 post transplantation(n=27, 23, 29)	63.6 mL/min/1.73m^2 Standard Deviation 27.27	61.8 mL/min/1.73m^2 Standard Deviation 30.66	54.0 mL/min/1.73m^2 Standard Deviation 14.95

SECONDARY outcome

Timeframe: Day 1 through Month 12

Population: For 95% CI within each group, normal approximation was used if N greater than, equal to (\>=)5. Otherwise, exact method was used. Numbers of participants analyzed at Month 6 in each arm were 33, 26, 30 and numbers of participants analyzed at Month 12 were 32, 26, 30, in belatacept/MMF, belatacept/sirolimus, and tacrolimus/MMF arms, respectively.

Participants were said to be corticosteroid-free at Month 6 if they were not receiving corticosteroids for greater than (\>) 7 consecutive days during Days 141 through Days 196, and at Month 12 if not receiving corticosteroids for \> 7 days during Days 337 through 392. Intent to treat population included all randomized and transplanted participants.

Outcome measures

Outcome measures
Measure	Belatacept, Mycophenolate Mofetil (MMF) n=33 Participants Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.	Belatacept, Sirolimus n=26 Participants Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.	Tacrolimus, MMF n=30 Participants Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
Number of Corticosteroid-free Participants at 6 and 12 Months Post Transplantation - Intent to Treat Population At 6 Months post transplantation	27 participants Interval 68.7 to 95.0	23 participants Interval 76.2 to 100.0	28 participants Interval 84.4 to 100.0
Number of Corticosteroid-free Participants at 6 and 12 Months Post Transplantation - Intent to Treat Population At 12 Months post transplantation	24 participants Interval 60.0 to 90.0	20 participants Interval 60.7 to 93.1	28 participants Interval 84.4 to 100.0

SECONDARY outcome

Timeframe: Day 1 to Month 12 post transplantation

Population: Analysis on both CNI-free and CS-free participants based on all followed up at least 151 days for Month 6 or 347 days for Month 12. One participant in the tacrolimus arm was counted as CNI-free since he discontinued tacrolimus on Day 2 of transplant and no data were available regarding immunosuppressive therapy after discontinuation.

Participants were said to be CNI-free at Month 6 or 12 if they were not receiving a CNI during Day 141 to Day 196, or Day 337 to Day 392. Participants in the tacrolimus arm were not relevant to this analysis because tacrolimus is a calcinurin inhibitor. Participants were corticosteroid-free (CS-free) at Month 6 if they were not receiving corticosteroids for \> 7 consecutive days during Days 141 through Days 196, and at Month 12 if not receiving corticosteroids for \> 7 days during Days 337 through 392. Day 1 was day of transplantation. Intent to treat population included all randomized and transplanted participants.

Outcome measures

Outcome measures
Measure	Belatacept, Mycophenolate Mofetil (MMF) n=33 Participants Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.	Belatacept, Sirolimus n=26 Participants Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.	Tacrolimus, MMF n=30 Participants Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
Number of Participants Who Were Corticosteroid-free at Months 6 and 12 and Number of Participants Who Were Both Calcineurin Inhibitor-free (CNI-free)and Corticosteroid-free at Months 6 and 12 Post Transplantation - Intent to Treat Population CS-free Month 6 (N=33, 26, 30)	27 participants	23 participants	28 participants
Number of Participants Who Were Corticosteroid-free at Months 6 and 12 and Number of Participants Who Were Both Calcineurin Inhibitor-free (CNI-free)and Corticosteroid-free at Months 6 and 12 Post Transplantation - Intent to Treat Population CS-free Month 12 (N=32, 26, 30)	24 participants	20 participants	28 participants
Number of Participants Who Were Corticosteroid-free at Months 6 and 12 and Number of Participants Who Were Both Calcineurin Inhibitor-free (CNI-free)and Corticosteroid-free at Months 6 and 12 Post Transplantation - Intent to Treat Population CNI-free + CS-free Month 6 (N=32, 26, 30)	25 participants	19 participants	1 participants
Number of Participants Who Were Corticosteroid-free at Months 6 and 12 and Number of Participants Who Were Both Calcineurin Inhibitor-free (CNI-free)and Corticosteroid-free at Months 6 and 12 Post Transplantation - Intent to Treat Population CNI -free + CS-free Month 12 (N=32,26,30)	24 participants	18 participants	1 participants

SECONDARY outcome

Timeframe: End of Month 12 to end of Month 48 Post Transplantation

Population: All participants who completed the short term (ST) period, were eligible and accepted to enter the LTE by signing a new informed consent form.

Outcome measures

Outcome measures
Measure	Belatacept, Mycophenolate Mofetil (MMF) n=27 Participants Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.	Belatacept, Sirolimus n=19 Participants Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.	Tacrolimus, MMF n=27 Participants Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
Number of Participants With Acute Rejection of Transplant up to End of Month 48 Post Transplantation - Intent to Treat Population in Long Term Extension	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: End of Month 12 to end of Long Term Extension (Year 4)

Population: N=participants randomized and transplanted and in LTE.

Outcome measures

Outcome measures
Measure	Belatacept, Mycophenolate Mofetil (MMF) n=27 Participants Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.	Belatacept, Sirolimus n=19 Participants Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.	Tacrolimus, MMF n=27 Participants Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
Number of Participants With Graft Loss or Death at Months 24, 36, 48 Post Transplantation - Intent to Treat Population in Long Term Extension Graft Loss or Death at Month 24 (N=27,19,27)	0 participants	1 participants	0 participants
Number of Participants With Graft Loss or Death at Months 24, 36, 48 Post Transplantation - Intent to Treat Population in Long Term Extension Graft Loss or Death at Month 36 (N=27,19,27)	1 participants	2 participants	0 participants
Number of Participants With Graft Loss or Death at Months 24, 36, 48 Post Transplantation - Intent to Treat Population in Long Term Extension Graft Loss or Death at Month 48 (N=27,19,27)	1 participants	2 participants	0 participants

SECONDARY outcome

Timeframe: Months 24, 36 and 48 post transplantation

Population: N=All participants who were randomized, transplanted, in the LTE and had data available at the specific time point.

GFR was calculated based upon serum creatinine (SCr) using the Modification of Diet in Renal Disease (MDRD) formula as suggested by Levey et al: MDRD GFR = 170 x \[SCr/0.95\]\^(-0.999) x \[Age\]\^(-0.176) x \[0.762 if participant was female\] x \[1.180 if participant was black\] x \[BUN\]\^(-0.170) x \[Alb\]\^(+0.318). Age in years, Alb = Albumin in g/dL; SCr = in mg/dL; BUN =Blood urea nitrogen in mg/dL. Intent to Treat population is defined as all participants randomized and transplanted.

Outcome measures

Outcome measures
Measure	Belatacept, Mycophenolate Mofetil (MMF) n=27 Participants Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.	Belatacept, Sirolimus n=18 Participants Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.	Tacrolimus, MMF n=27 Participants Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
Mean (Standard Deviation) in Calculated Glomerular Filtration Rate (GFR) mL/Min/1.73m^2 at Months 24, 36 and 48 Post Transplantation - Intent to Treat Population in Long Term Extension Month 24 (N=27, 18, 27)	60.6 mL/Min/1.73m^2 Standard Deviation 15.12	66.0 mL/Min/1.73m^2 Standard Deviation 23.75	52.2 mL/Min/1.73m^2 Standard Deviation 12.14
Mean (Standard Deviation) in Calculated Glomerular Filtration Rate (GFR) mL/Min/1.73m^2 at Months 24, 36 and 48 Post Transplantation - Intent to Treat Population in Long Term Extension Month 36 (N=25, 16, 22)	62.8 mL/Min/1.73m^2 Standard Deviation 14.05	69.9 mL/Min/1.73m^2 Standard Deviation 22.43	55.5 mL/Min/1.73m^2 Standard Deviation 15.38
Mean (Standard Deviation) in Calculated Glomerular Filtration Rate (GFR) mL/Min/1.73m^2 at Months 24, 36 and 48 Post Transplantation - Intent to Treat Population in Long Term Extension Month 48 (N=18, 14, 15)	59.6 mL/Min/1.73m^2 Standard Deviation 15.30	72.2 mL/Min/1.73m^2 Standard Deviation 25.21	55.7 mL/Min/1.73m^2 Standard Deviation 13.47

SECONDARY outcome

Timeframe: End of Month 12 to end of Long Term Extension (Year 4)

Population: N= All participants who completed the ST period, were eligible and accepted to enter the LTE by signing a new informed consent form, and had data available at the specific time point were analyzed.

In the LTE, a participant was considered corticosteroid-free if they were not receiving corticosteroids for \>7 consecutive days during Day 701 and Day 756, Day 1065 and Day 1120, as well as Day 1429 and Day 1484, respectively.

Outcome measures

Outcome measures
Measure	Belatacept, Mycophenolate Mofetil (MMF) n=27 Participants Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.	Belatacept, Sirolimus n=18 Participants Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.	Tacrolimus, MMF n=27 Participants Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
Number of Corticosteroid-free Participants at Months 24, 36, 48 Post Transplantation - Intent to Treat Population in Long Term Extension Month 48 (N=19, 14, 16)	16 participants	12 participants	16 participants
Number of Corticosteroid-free Participants at Months 24, 36, 48 Post Transplantation - Intent to Treat Population in Long Term Extension Month 24 (N=27, 18, 27)	22 participants	15 participants	25 participants
Number of Corticosteroid-free Participants at Months 24, 36, 48 Post Transplantation - Intent to Treat Population in Long Term Extension Month 36 (N=26, 16, 23)	22 participants	14 participants	20 participants

SECONDARY outcome

Timeframe: Months 24, 36, 48

Participants were considered corticosteroid-free at Months 24, 36, and 48 if they were not receiving corticosteroids for \>7 consecutive days during Day 701 and Day 756, Day 1065 and Day 1120, as well as Day 1429 and Day 1484, respectively. Participants were considered CNI-free at Months 24, 36, and 48 if they were not receiving CNI during Day 701 and Day 756, Day 1065 and Day 1120, as well as Day 1429 and Day 1484, respectively. Participants in the tacrolimus arm were not relevant to this analysis because tacrolimus is a calcinurin inhibitor.

Outcome measures

Outcome measures
Measure	Belatacept, Mycophenolate Mofetil (MMF) n=27 Participants Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.	Belatacept, Sirolimus n=18 Participants Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.	Tacrolimus, MMF n=27 Participants Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
Number of Participants Who Were Both Calcineurin Inhibitor-free (CNI-free)and Corticosteroid-free at Months 24, 36, 48 Post Transplantation - Intent to Treat Population in Long Term Extension Month 24 (N=27, 18, 27)	22 participants	15 participants	0 participants
Number of Participants Who Were Both Calcineurin Inhibitor-free (CNI-free)and Corticosteroid-free at Months 24, 36, 48 Post Transplantation - Intent to Treat Population in Long Term Extension Month 36 (N=26, 16, 23)	22 participants	14 participants	0 participants
Number of Participants Who Were Both Calcineurin Inhibitor-free (CNI-free)and Corticosteroid-free at Months 24, 36, 48 Post Transplantation - Intent to Treat Population in Long Term Extension Month 48 (N=19, 14, 16)	16 participants	12 participants	0 participants

SECONDARY outcome

Timeframe: End of Month 12 to end of Study (Month 48)

Population: N= All participants who completed the ST period, were eligible and accepted to enter the LTE by signing a new informed consent form

Long Term extension was the period from the end of Month 12 to the end of Month 48 post transplantation and the completion of the study 31 July 2012. At any time in the study, participants who were unable to tolerate MMF in the Bela-MMF and Tac-MMF groups could discontinue (DC) MMF and switch to sirolimus and remain in the study and those in the Bela-Siro group who were unable to tolerate sirolimus could DC sirolimus and switch to MMF and remain in the study. Study completion=data base (DB) lock.

Outcome measures

Outcome measures
Measure	Belatacept, Mycophenolate Mofetil (MMF) n=27 Participants Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.	Belatacept, Sirolimus n=19 Participants Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.	Tacrolimus, MMF n=27 Participants Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
Number of Participants Who Switched Between MMF and Sirolimus During Long Term Extension up to Study Completion By Month 24 Switched between MMF and Sirolimus	0 participants Interval 0.0 to 0.0	1 participants Interval 0.1 to 26.0	0 participants Interval 0.0 to 0.0
Number of Participants Who Switched Between MMF and Sirolimus During Long Term Extension up to Study Completion By Month 36 Switched between MMF and Sirolimus	0 participants Interval 0.0 to 0.0	2 participants Interval 1.3 to 33.1	0 participants Interval 0.0 to 0.0
Number of Participants Who Switched Between MMF and Sirolimus During Long Term Extension up to Study Completion By Month 48 Switched between MMF and Sirolimus	0 participants Interval 0.0 to 0.0	3 participants Interval 3.4 to 39.6	0 participants Interval 0.0 to 0.0
Number of Participants Who Switched Between MMF and Sirolimus During Long Term Extension up to Study Completion Up to DB Lock Switched between MMF and Sirolimus	0 participants Interval 0.0 to 0.0	3 participants Interval 3.4 to 39.6	0 participants Interval 0.0 to 0.0

Adverse Events

Belatacept - MMF

Serious events: 25 serious events

Other events: 33 other events

Deaths: 0 deaths

Belatacept - SIRO

Serious events: 19 serious events

Other events: 26 other events

Deaths: 0 deaths

Tacrolimus - MMF

Serious events: 22 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Publication restrictions are in place

Restriction type: OTHER