Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression (BENEFIT)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Chronic Kidney Failure; Kidney Transplantation

Treatments: Drug: Belatacept LI (less intensive); Drug: Belatacept MI (more intensive); Drug: Cyclosporine (CsA)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00256750

IM103-008

Details and patient eligibility

About

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.

Enrollment: 738 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

738 participants in 3 patient groups

Cyclosporine (CsA)

Active Comparator group

Treatment:

Drug: Cyclosporine (CsA)

Belatacept LI (less intensive)

Experimental group

Treatment:

Drug: Belatacept LI (less intensive)

Belatacept MI (more intensive)

Experimental group

Treatment:

Drug: Belatacept MI (more intensive)