Efficacy of Sirolimus-Based, Steroid Avoidance Immunosuppression African Americans

Phase 2

Completed

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 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.

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 control arm will consist of race matched solitary renal transplant recipients who received a Cyclosporine (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.

Recruitment & Eligibility

Inclusion Criteria

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)

Arm && Interventions

Group	Intervention	Description
Sirolimus, steroid avoidance arm	Sirolimus	Thymoglobulin induction, sirolimus and no maintenance corticosteroid.

Primary Outcome Measures

Name	Time	Method
One-year Graft Survival	12 months	To test the efficacy of SRL-based steroid avoidance regimen in high risk de novo renal allograft recipients. Efficacy endpoints for this objective is: one-year graft survival
Cumulative One-year Acute Rejection Rates	12 months	To test the efficacy of Sirolimus (SRL)-based steroid avoidance regimen in high risk de novo renal allograft recipients. Efficacy endpoints for this objective is: cumulative one-year acute rejection rates of the transplant
One-year Patient Survival	12 months	To test the efficacy of SRL-based steroid avoidance regimen in high risk de novo renal allograft recipients. Efficacy endpoints for this objective is: one-year patient survival

Secondary Outcome Measures

Name	Time	Method
Incidence of Post Transplant Diabetes	12 months	To determine whether SRL-based steroid avoidance maintenance regimen is associated with decreased rates of metabolic complications. Endpoint is incidence of posttransplant diabetes mellitus
Blood Pressure Control	12 months	To determine whether SRL-based steroid avoidance maintenance regimen is associated with decreased rates of metabolic complications. Endpoint is number of people who had their blood pressure in the target control range with or without medication
Drug-treated Dyslipidemic Syndrome	12 months	To determine whether SRL-based steroid avoidance maintenance regimen is associated with decreased rates of metabolic complications. Endpoint is drug-treated dyslipidemic syndrome