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Transplant Surgery »  Research »  Clinical Trials »  IM13100

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.

For More Information

For questions about this trial or eligibility, contact:

JoAnn Zlatunich, RN
(415) 353-8380
JoAnn.Zlatunich@ucsfmedctr.org  

Information about this trial was obtained from the NIH Clinical Trials website, http://clinicaltrials.gov on 10/22/2009. UCSF specific information including the PI (Principal Investigator), trial enrollment status, and UCSF Study ID, supplement the ClinicalTrials.gov study posting.
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