Efficacy of Sirolimus-Based, Steroid Avoidance Immunosuppression African Americans

NCT ID: NCT00189202

Last Updated: 2018-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-08-31
• Study Completion Date: 2008-07-01

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.

Conditions

End Stage Renal Disease; Kidney Transplantation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sirolimus, steroid avoidance arm

Thymoglobulin induction, sirolimus and no maintenance corticosteroid.

Group Type: EXPERIMENTAL

Sirolimus

Intervention Type: DRUG

Thymoglobulin induction, sirolimus and no maintenance corticosteroid

Interventions

Sirolimus

Thymoglobulin induction, sirolimus and no maintenance corticosteroid

Intervention Type: DRUG

Other Intervention Names

Rapamune

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Akinlolu Ojo

Emeritus Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Akinlolu Ojo, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan Health Center

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

Steroid Avoidance in A.A.

Identifier Type: -

Identifier Source: org_study_id