This trial is active, not recruiting.

Conditions kidney transplantation, chronic kidney failure
Treatments csa, belatacept li, belatacept mi
Phase phase 3
Sponsor Bristol-Myers Squibb
Start date March 2005
End date June 2008
Trial size 660 participants
Trial identifier NCT00256750, IM103-008, NCT00432497


The purpose of this study is to learn if Belatacept can provide protection from organ rejection following kidney transplantation while avoiding some of the toxic effects of standard immunosuppressive medications such as kidney damage. Effects on kidney function and patient survival as well as drug safety will also be studied.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
(Active Comparator)
tablet, oral, 1st month target: 150-300 ng/mL, after 1st month target: 100-250 ng/mL, daily, 36 months months (ST), 100-250 ng/mL, daily, 24 months (LT)
belatacept li
solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
belatacept mi
solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)

Primary Outcomes

The composite of subject and graft survival
time frame: by 12 months
The composite of measured GFR <60ml/min/1.73 m2
time frame: at Month 12
A decrease in measured GFR >= 10mL/min/1.73m2
time frame: from Month 3 to Month 12
The incidence of acute rejection
time frame: by 12 months

Secondary Outcomes

Measured GFR
time frame: at 12 months
Biopsy-proven chronic allograft nephropathy
time frame: at 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - The subject is a recipient of a living donor or deceased donor kidney transplant. - Male or Female, 18 or older Exclusion Criteria: - First time recipient, PRA >- 50% or for retransplantation PRA >- 30%. - If retransplantation, previous graft loss cannot be due to acute rejection. - Positive cross match. - Subject receiving extended criteria donor (ECD) organ - For Long-term extension study-Subjects who have completed three years of study treatment (through Week 156)

Additional Information

Official title Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial (BENEFIT)
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.