Efficacy of Sirolimus-Based, Steroid Avoidance Immunosuppression African Americans

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efficacy of Sirolimus-Based, Steroid Avoidance Maintenance Immunosuppression in Black de Novo Kidney Transplant Recipients

Conditions
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End Stage Renal Disease, Kidney Transplantation

Intervention / Treatment
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* Drug: Sirolimus


Participation Criteria
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Eligibility Criteria
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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 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sirolimus, steroid avoidance arm<br>Thymoglobulin induction, sirolimus and no maintenance corticosteroid. | Drug: Sirolimus<br>* Thymoglobulin induction, sirolimus and no maintenance corticosteroid<br>* Other names: Rapamune;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative One-year Acute Rejection Rates | 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 | 12 months | 
| One-year Graft Survival | 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 | 12 months | 
| One-year Patient Survival | 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 | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Post Transplant Diabetes | To determine whether SRL-based steroid avoidance maintenance regimen is associated with decreased rates of metabolic complications. Endpoint is incidence of posttransplant diabetes mellitus | 12 months | 
| Drug-treated Dyslipidemic Syndrome | To determine whether SRL-based steroid avoidance maintenance regimen is associated with decreased rates of metabolic complications. Endpoint is drug-treated dyslipidemic syndrome | 12 months | 
| Blood Pressure Control | 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 | 12 months |