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Study of Belatacept in Subjects Who Are Undergoing a Renal Transplant
Official Title:
Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial - Extended Criteria Donors (BENEFIT-EXT)Basic Trial Information
| Phase | Type | Age | Sponsor | Protocol IDs | Status |
|---|---|---|---|---|---|
| Phase 3 | Interventional | 18 Years and older | Bristol-Myers Squibb |
IM103-027 NCT00114777 |
Active, but closed to enrollment |
Study Design:
Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety StudyPrincipal Investigator
Flavio Vincenti, M.D.
Professor of Clinical Medicine
Division of Nephrology
Departments of Medicine and Surgery
Trial Summary
The purpose of this trial is to learn if Belatacept is effective and safe as a first line of
immunosuppression treatment in patients undergoing a renal transplant where the donor kidney
is obtained in patients with extended criteria.
Eligibility
Inclusion Criteria:
- Subject is a first-time recipient of a kidney transplant from a deceased donor.
- Specific donor criteria
Exclusion Criteria:
- Donor age <10 years
- Subjects receiving a concurrent solid organ or cell transplant (lung, heart, etc.)
- Subjects with a positive T-cell lymphocytotoxic crossmatch.
- Subjects who are positive for Hepatitis B or C, or HIV
- Active TB
- History of cancer in the last 5 years
- History of substance abuse
- Specific laboratory results are exclusionary
- Mammography suspicious for cancer
- Allergy to iodine
- 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