Status:
UNKNOWN
Use of Sirolimus vs. Tacrolimus For African-American Renal Transplant Recipients
Lead Sponsor:
Wayne State University
Conditions:
Kidney Transplantation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 ef...
Detailed Description
It has been repeatedly demonstrated that African-American renal allograft recipients have worse graft outcomes when compared with Caucasians. This has been attributed to various immunologic and non-im...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
End Date :
June 1 2009
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00252655
Start Date
January 1 2004
End Date
June 1 2009
Last Update
April 19 2007
Active Locations (1)
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1
Detroit Medical Center, Harper University Hospital
Detroit, Michigan, United States, 48201