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Efficacy of Sirolimus-Based, Steroid Avoidance Immunosuppression African Americans

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00189202
First Posted: September 16, 2005
Last Update Posted: April 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Akinlolu Ojo, University of Michigan
  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.

Condition Intervention Phase
End Stage Renal Disease Kidney Transplantation Drug: Sirolimus Phase 2 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Sirolimus-Based, Steroid Avoidance Maintenance Immunosuppression in Black de Novo Kidney Transplant Recipients

Resource links provided by NLM:


Further study details as provided by Akinlolu Ojo, University of Michigan:

Primary Outcome Measures:
  • Cumulative One-year Acute Rejection Rates [ Time Frame: 12 months ]
    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

  • One-year Graft Survival [ Time Frame: 12 months ]
    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

  • One-year Patient Survival [ Time Frame: 12 months ]
    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


Secondary Outcome Measures:
  • Incidence of Post Transplant Diabetes [ Time Frame: 12 months ]
    To determine whether SRL-based steroid avoidance maintenance regimen is associated with decreased rates of metabolic complications. Endpoint is incidence of posttransplant diabetes mellitus

  • Drug-treated Dyslipidemic Syndrome [ Time Frame: 12 months ]
    To determine whether SRL-based steroid avoidance maintenance regimen is associated with decreased rates of metabolic complications. Endpoint is drug-treated dyslipidemic syndrome

  • Blood Pressure Control [ Time Frame: 12 months ]
    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


Enrollment: 49
Study Start Date: August 2004
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sirolimus, steroid avoidance arm
Thymoglobulin induction, sirolimus and no maintenance corticosteroid.
Drug: Sirolimus
Thymoglobulin induction, sirolimus and no maintenance corticosteroid
Other Name: Rapamune

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.
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00189202


Locations
United States, Michigan
University of Michigan Health Center
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Principal Investigator: Akinlolu Ojo, MD University of Michigan
  More Information

Responsible Party: Akinlolu Ojo, Emeritus Professor of Medicine, University of Michigan
ClinicalTrials.gov Identifier: NCT00189202     History of Changes
Other Study ID Numbers: Steroid Avoidance in A.A.
First Submitted: September 13, 2005
First Posted: September 16, 2005
Results First Submitted: February 20, 2017
Results First Posted: April 5, 2017
Last Update Posted: April 5, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Sirolimus
Everolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs