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A Study of BMS-224818 (Belatacept) in Patients Who Have Undergone a Kidney Transplant and Are Currently on Stable Cyclosporine or Tacrolimus Regimen With or Without Corticosteroids
Official Title:
Belatacept Conversion Trial in Renal TransplantationBasic Trial Information
| Phase | Type | Age | Sponsor | Protocol IDs | Status |
|---|---|---|---|---|---|
| Phase 2/Phase 3 | Interventional | 18 Years and older | Bristol-Myers Squibb |
IM103-010 LEA29Y NCT00402168 |
Active, but closed to enrollment |
Study Design:
Treatment, Randomized, Open Label, 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 conversion to belatacept from cyclosporine or
tacrolimus will preserve kidney function in people who have had a kidney transplant. The
safety and tolerability of this treatment will also be studied
Eligibility
Inclusion Criteria:
- Men and women age 18 and older
- 6-36 months after kidney transplant receiving cyclosporine or tacrolimus
- calculated GFR ≥35 and ≤75mL/min/1.73 m²
- subjects must have completed 1 year in the IM103-010ST and remained on study
treatment (Long Term Extension)
Exclusion Criteria:
- Significant infection
- acute rejection within 3 months
- prior graft loss due to rejection
- pregnancy
- positive crossmatch
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