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Efficacy of Sirolimus-Based, Steroid Avoidance Immunosuppression African Americans

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by University of Michigan.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT00189202
First received: September 13, 2005
Last updated: October 9, 2008
Last verified: October 2008
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 University of Michigan:

Primary Outcome Measures:
  • To test the efficacy of SRL-based steroid avoidance regimen in high risk de novo renal allograft recipients. Efficacy endpoints for this objective are: Cumulative one-year acute rejection rates, one-year graft survival and one-year patient survival

Secondary Outcome Measures:
  • To determine whether SRL-based steroid avoidance maintenance regimen is associated with decreased rates of metabolic complications. Metabolic endpoints include incidence of posttransplant diabetes mellitus, drug-treated dyslipidemic syndrome, controlled

Estimated Enrollment: 35
Study Start Date: August 2004
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 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  • WBC < 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00189202     History of Changes
Other Study ID Numbers: Steroid Avoidance in A.A.
Study First Received: September 13, 2005
Last Updated: October 9, 2008
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 25, 2014