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OpenTrials
Completed

NCT Number: NCT00189202

Efficacy of Sirolimus-Based, Steroid Avoidance Immunosuppression African Americans

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.

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Key information

Conditions

End Stage Renal Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Kidney Transplantation Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of Michigan Health Center

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

sirolimus

Drug

Thymoglobulin induction, sirolimus and no maintenance corticosteroid

Other names: Rapamune

Primary outcomes

  1. 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

  2. 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

  3. 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 outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Wyeth is now a wholly owned subsidiary of Pfizer

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Sep 16, 2005
Registry last updated
Mar 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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