Efficacy of Sirolimus-Based, Steroid Avoidance Immunosuppression African Americans

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Michigan
• Collaborator: Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Everolimus; Sirolimus

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)