Efficacy of Sirolimus-Based, Steroid Avoidance Immunosuppression African Americans
Recruitment status was Active, not recruiting
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:
- Whether a sirolimus based steroid avoidance regimen in African Americans may decrease the risks of drug-related toxicities,
- Decreased rates of metabolic complications such as post-transplant diabetes,
- The effect of Sirolimus plus a reduced dose cyclosporine on renal allograft function.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Efficacy of Sirolimus-Based, Steroid Avoidance Maintenance Immunosuppression in Black de Novo Kidney Transplant Recipients|
- 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
|Study Start Date:||August 2004|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00189202
|United States, Michigan|
|University of Michigan Health Center|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Akinlolu Ojo, MD||University of Michigan|