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Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression (BENEFIT)
Official Title:
Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial (BENEFIT)Basic Trial Information
| Phase | Type | Age | Sponsor | Protocol IDs | Status |
|---|---|---|---|---|---|
| Phase 3 | Interventional | 18 Years and older | Bristol-Myers Squibb |
IM103-008 NCT00256750 NCT00432497 |
Active, but closed to enrollment |
Study Design:
Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy StudyPrincipal Investigator
Flavio Vincenti, M.D.
Professor of Clinical Medicine
Division of Nephrology
Departments of Medicine and Surgery
Trial 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.
Eligibility
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)
Important
Final eligibility is determined by the health professionals conducting the trial and the protocol approved by the Committee on Human Resources (CHR) at the University of California, San Francisco (UCSF). The Patient Consent Form for this trial is available upon request. For more information about this trial, please see the full posting at ClinicalTrials.gov.
For More Information
For questions about this trial or eligibility, contact:
Esterlina Gurion, RN
415-353-8380
Esterlina.Gurion@ucsfmedctr.org