Status:
COMPLETED
Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression (BENEFIT)
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Kidney Transplantation
Chronic Kidney Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ...
Eligibility Criteria
Inclusion
- The subject is a recipient of a living donor or deceased donor kidney transplant.
- Male or Female, 18 or older
Exclusion
- 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)
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
738 Patients enrolled
Trial Details
Trial ID
NCT00256750
Start Date
March 1 2005
End Date
April 1 2015
Last Update
August 19 2016
Active Locations (105)
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1
University Of Alabama At Birmingham
Birmingham, Alabama, United States, 35294
2
Loma Linda University Medical Center-Transplantation Institu
Loma Linda, California, United States, 92354
3
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
4
California Institute Of Renal Research
San Diego, California, United States, 92123