Efficacy of Sirolimus-Based, Steroid Avoidance Immunosuppression African Americans

University of Michigan

Status and phase: Completed; Phase 3; Phase 2

Conditions: Kidney Transplantation; End Stage Renal Disease

Treatments: Drug: Sirolimus

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00189202

Steroid Avoidance in A.A.

Details and patient eligibility

About

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.

Full 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.

Enrollment: 49 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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49 participants in 1 patient group

Sirolimus, steroid avoidance arm

Experimental group

Description:

Thymoglobulin induction, sirolimus and no maintenance corticosteroid.

Treatment:

Drug: Sirolimus