Use of Sirolimus vs. Tacrolimus For African-American Renal Transplant Recipients
Status unconfirmed · Phase 4
Conditions studied: Kidney Transplantation
In brief
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.
Key facts
- Study ID
- NCT00252655
- Run by
- Wayne State University
- People needed
- 40
- Starts
- 2004-01-01
- Expected to finish
- 2009-06-01
- Last updated by the study team
- 2007-04-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- African-American living- or deceased-donor renal transplant at least 18 years of age with current and historical negative crossmatch who demonstrate urine output > 60 ml/hr and fall in serum creatinine > 20%/day during the first 48 hours posttransplant, without need for dialysis.
You may not qualify if…
- Unwillingness to participate in the study
- Current PRA > 20%
- Noncompliance with the protocol and follow-up visits
- Those who need to be on maintenance steroids due to underlying disease
- Known hypersensitivity to study drugs
- Pregnancy
- Pre-transplant leukopenia, thrombocytopenia, hypercholesterolemia, or hypertriglyceridemia despite optimal medical therapy
- HIV positive recipients.
Where it is running
- Detroit Medical Center, Harper University Hospital — Detroit, Michigan, United States
Full record on ClinicalTrials.gov
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