Efficacy of Sirolimus-Based, Steroid Avoidance Immunosuppression African Americans

End Stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00189202
• Other study ID #: Steroid Avoidance in A.A.
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 13, 2005
• Last updated: February 27, 2018
• Start date: August 2004
• Est. completion date: July 1, 2008

Study information

• Verified date: February 2018
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: July 1, 2008
• Est. primary completion date: July 1, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic
• Kidney Transplantation

Intervention

Drug:
• Sirolimus
Thymoglobulin induction, sirolimus and no maintenance corticosteroid

Locations

Country	Name	City	State
United States	University of Michigan Health Center	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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