Efficacy of Sirolimus-Based, Steroid Avoidance Immunosuppression African Americans

Completed · Phase 2/Phase 3

Conditions studied: End Stage Renal Disease, Kidney Transplantation

In brief

African Americans receiving a kidney transplant are considered at high risk for early rejection of their transplanted kidney and require more immunosuppression to maintain their kidney transplant function. This increase in immunosuppression puts this group at risk for drug-related toxicities and complications such as post-transplant diabetes. This study will evaluate: 1. Whether a sirolimus based steroid avoidance regimen in African Americans may decrease the risks of drug-related toxicities, 2. Decreased rates of metabolic complications such as post-transplant diabetes, 3. The effect of Sirolimus plus a reduced dose cyclosporine on renal allograft function.

Key facts

Study ID

NCT00189202

Run by

University of Michigan

People needed

49

Starts

2004-08-01

Expected to finish

2008-07-01

Last updated by the study team

2018-03-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• African American recipient race
• Solitary cadaveric or living donor renal transplantation
• Age ≥18years at the time of transplantation
• Negative pregnancy serum test in females with childbearing potential

You may not qualify if…

• Age < 18 years at the time of transplantation
• Multi-organ transplant recipient
• Currently taking steroids
• White Blood Cell Count < 3,000
• Platelet count < 100,000
• Triglycerides >400mg/dL
• Cholesterol > 350 mg/dL
• Unwillingness to comply with study procedures
• Allergic reaction to sirolimus Allergy to polyclonal antilymphocyte drugs (Thymoglobulin)

Where it is running

• University of Michigan Health Center — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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