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

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Abatacept; Cyclosporine; Cyclosporins

Criteria

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)