Expired Study
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Ann Arbor, Michigan 48109


Purpose:

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.


Study summary:

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.


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)


Study is Available At:


Original ID:

Steroid Avoidance in A.A.


NCT ID:

NCT00189202


Secondary ID:


Study Acronym:


Brief Title:

Efficacy of Sirolimus-Based, Steroid Avoidance Immunosuppression African Americans


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 2/Phase 3


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Michigan


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

49


Enrollment Type:

Actual


Overall Contact Information

Official Name:Akinlolu Ojo, MD
Principal Investigator
University of Michigan

Study Dates

Start Date:August 2004
Completion Date:July 1, 2008
Completion Type:Actual
Primary Completion Date:July 1, 2008
Primary Completion Type:Actual
Verification Date:February 2018
Last Changed Date:February 27, 2018
First Received Date:September 13, 2005
First Results Date:February 20, 2017

Study Outcomes

Outcome Type:Primary Outcome
Measure:Cumulative One-year Acute Rejection Rates
Time Frame:12 months
Safety Issues:False
Description: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
Outcome Type:Primary Outcome
Measure:One-year Graft Survival
Time Frame:12 months
Safety Issues:False
Description: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
Outcome Type:Primary Outcome
Measure:One-year Patient Survival
Time Frame:12 months
Safety Issues:False
Description: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
Outcome Type:Secondary Outcome
Measure:Incidence of Post Transplant Diabetes
Time Frame:12 months
Safety Issues:False
Description:To determine whether SRL-based steroid avoidance maintenance regimen is associated with decreased rates of metabolic complications. Endpoint is incidence of posttransplant diabetes mellitus
Outcome Type:Secondary Outcome
Measure:Drug-treated Dyslipidemic Syndrome
Time Frame:12 months
Safety Issues:False
Description:To determine whether SRL-based steroid avoidance maintenance regimen is associated with decreased rates of metabolic complications. Endpoint is drug-treated dyslipidemic syndrome
Outcome Type:Secondary Outcome
Measure:Blood Pressure Control
Time Frame:12 months
Safety Issues:False
Description: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

Study Interventions

Intervention Type:Drug
Name:Sirolimus
Description:Thymoglobulin induction, sirolimus and no maintenance corticosteroid
Arm Name:Sirolimus, steroid avoidance arm
Other Name:Rapamune

Study Arms

Study Arm Type:Experimental
Arm Name:Sirolimus, steroid avoidance arm
Description:Thymoglobulin induction, sirolimus and no maintenance corticosteroid.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Michigan
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Wyeth is now a wholly owned subsidiary of Pfizer

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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