Use of Sirolimus vs. Tacrolimus For African-American Renal Transplant Recipients

• Status: Unknown status
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wayne State University
• Treatments: Sirolimus; Tacrolimus

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.