Study Comparing the Safety and Efficacy of BMS-224818 to Cyclosporine, in Patients Receiving a Kidney Transplant, When Used in Combination With CellCept, Simulect, and Corticosteroids.
Official Title:
Phase II/III, Open-Label, Randomized, Controlled, Multiple-Dose Study of Efficacy and Safety of BMS-224818 as Part of a Quadruple Drug Regimen in First Renal Transplant Recipients
Basic Trial Information
|
Phase |
Type |
Age |
Sponsor |
Protocol IDs |
Status |
|
Phase 2 |
Interventional |
18 Years and older |
Bristol-Myers Squibb |
IM103-100 NCT00035555
|
Active, but closed to enrollment
|
Study Design:
Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Principal 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 see if BMS-224818 treatment will be as efficacious as
cyclosporine at preventing acute rejection, and a superior safety / tolerability profile
(better kidney function, better blood pressure, less lipid problems, less diabetes mellitus,
etc.)
Eligibility
Inclusion criteria
- Kidney transplant recipient
Exclusion criteria
- HLA-identical living-related donor/recipient pairs
- active viral or bacterial infection
- multiple organ transplant recipients
- certain underlying causes of kidney failure
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.