Status:
COMPLETED
Efficacy of Sirolimus-Based, Steroid Avoidance Immunosuppression African Americans
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
End Stage Renal Disease
Kidney Transplantation
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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 func...
Detailed Description
This is an open labeled prospective trial with race matched historical controls. The treatment group (experimental arm) will be African American de novo solitary renal transplant recipients. The contr...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00189202
Start Date
August 1 2004
End Date
July 1 2008
Last Update
March 27 2018
Active Locations (1)
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1
University of Michigan Health Center
Ann Arbor, Michigan, United States, 48109