This trial is active, not recruiting.

Conditions end stage renal disease, kidney transplantation
Treatment sirolimus
Phase phase 4
Target mTOR
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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

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
time frame:

Secondary Outcomes

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
time frame:

Eligibility Criteria

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)

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2008.
Information provided to ClinicalTrials.gov by University of Michigan.