Use of Sirolimus vs. Tacrolimus For African-American Renal Transplant Recipients
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|ClinicalTrials.gov Identifier: NCT00252655|
Recruitment Status : Unknown
Verified April 2007 by Wayne State University.
Recruitment status was: Active, not recruiting
First Posted : November 11, 2005
Last Update Posted : April 19, 2007
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.
|Condition or disease||Intervention/treatment||Phase|
|Kidney Transplantation||Drug: Rapamune and Prograf||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||January 2004|
|Estimated Study Completion Date :||June 2009|
- Renal function at 1, 3, 6, and 12 months post transplant.
- Incidence of acute rejection.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|