Use of Sirolimus vs. Tacrolimus For African-American Renal Transplant Recipients
Recruitment status was: Active, not recruiting
The purpose of this study is to evaluate the efficacy of Sirolimus (Rapamune) in improving the function of the transplant kidney, without any increase in the risk of acute rejection or adverse side effects, compared with Tacrolimus (Prograf).
We hypothesize that Sirolimus, as one component of a long-term steroid-free immunosuppressive regimen, will be effective in maintaining a low incidence of acute rejection and a short- and long-term graft survival comparable to Tacrolimus with better graft function in the high-risk African-American renal transplant population with immediate graft function.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Use of Sirolimus Vs. Tacrolimus As The Primary Agent In Immunosuppressive Regimen For African-American Renal Allograft Recipients With Immediate Graft Function: A Pilot Study|
- Renal function at 1, 3, 6, and 12 months post transplant.
- Incidence of acute rejection.
|Study Start Date:||January 2004|
|Estimated Study Completion Date:||June 2009|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00252655
|United States, Michigan|
|Detroit Medical Center, Harper University Hospital|
|Detroit, Michigan, United States, 48201|
|Principal Investigator:||Scott A. Gruber, MD, PhD||Harper University Hospital|