Efficacy of Sirolimus-Based, Steroid Avoidance Immunosuppression African Americans
This trial is active, not recruiting.
|Conditions||end stage renal disease, kidney transplantation|
|Sponsor||University of Michigan|
|Collaborator||Wyeth is now a wholly owned subsidiary of Pfizer|
|Start date||August 2004|
|Trial size||35 participants|
|Trial identifier||NCT00189202, Steroid Avoidance in A.A.|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
To test the efficacy of SRL-based steroid avoidance regimen in high risk de novo renal allograft recipients. Efficacy endpoints for this objective are: Cumulative one-year acute rejection rates, one-year graft survival and one-year patient survival
To determine whether SRL-based steroid avoidance maintenance regimen is associated with decreased rates of metabolic complications. Metabolic endpoints include incidence of posttransplant diabetes mellitus, drug-treated dyslipidemic syndrome, controlled
Male or female participants at least 18 years old.
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 - WBC < 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)
|Official title||Efficacy of Sirolimus-Based, Steroid Avoidance Maintenance Immunosuppression in Black de Novo Kidney Transplant Recipients|
|Principal investigator||Akinlolu Ojo, MD|
|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 control arm will consist of race matched solitary renal transplant recipients who received a CsA-based immunosuppressive regimen. The subjects will be matched for organ source (living donor vs. cadaveric). The experimental treatment arm will have an immunosuppression regimen consisting of Sirolimus, Reduced dose cyclosporine, Thymoglobulin, and ONLY 3 doses of steroids.|
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