Use of Sirolimus vs. Tacrolimus For African-American Renal Transplant Recipients

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. Identifier: NCT00252655
Recruitment Status : Unknown
Verified April 2007 by Wayne State University.
Recruitment status was:  Active, not recruiting
First Posted : November 11, 2005
Last Update Posted : April 19, 2007
Information provided by:
Wayne State University

Brief Summary:

The purpose of this study is to evaluate the efficacy of Sirolimus (Rapamune) in improving the function of the transplant kidney, without any increase in the risk of acute rejection or adverse side effects, compared with Tacrolimus (Prograf).

We hypothesize that Sirolimus, as one component of a long-term steroid-free immunosuppressive regimen, will be effective in maintaining a low incidence of acute rejection and a short- and long-term graft survival comparable to Tacrolimus with better graft function in the high-risk African-American renal transplant population with immediate graft function.

Condition or disease Intervention/treatment Phase
Kidney Transplantation Drug: Rapamune and Prograf Phase 4

Detailed Description:
It has been repeatedly demonstrated that African-American renal allograft recipients have worse graft outcomes when compared with Caucasians. This has been attributed to various immunologic and non-immunologic factors, including a greater rate of acute rejection, resistance to standard doses of calcineurin inhibitors (CNIs) and corticosteroids, different pharmacokinetic and pharmacodynamic profiles, and noncompliance. It has therefore been suggested that quadruple immunosuppression, including antilymphocyte antibodies for induction, should be used in this high-risk population to improve graft survival. CNIs are currently the mainstay of immunosuppressive regimens. Tacrolimus has been shown to be significantly more effective than Cyclosporine A in preventing acute rejection. As a result, Tacrolimus has become the CNI of choice in preventing acute rejection, and has produced similar graft survival rates at one year, with higher creatinine clearances. However, there is no report examining the efficacy of Sirolimus in improving renal function and its side effect profile when compared with Tacrolimus in renal allograft recipients, particularly in African-Americans with immediate graft function in a steroid-free environment.

Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of Sirolimus Vs. Tacrolimus As The Primary Agent In Immunosuppressive Regimen For African-American Renal Allograft Recipients With Immediate Graft Function: A Pilot Study
Study Start Date : January 2004
Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Renal function at 1, 3, 6, and 12 months post transplant.

Secondary Outcome Measures :
  1. Incidence of acute rejection.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • African-American living- or deceased-donor renal transplant at least 18 years of age with current and historical negative crossmatch who demonstrate urine output > 60 ml/hr and fall in serum creatinine > 20%/day during the first 48 hours posttransplant, without need for dialysis.

Exclusion Criteria:

  • Unwillingness to participate in the study
  • Current PRA > 20%
  • Noncompliance with the protocol and follow-up visits
  • Those who need to be on maintenance steroids due to underlying disease
  • Known hypersensitivity to study drugs
  • Pregnancy
  • Pre-transplant leukopenia, thrombocytopenia, hypercholesterolemia, or hypertriglyceridemia despite optimal medical therapy
  • HIV positive recipients.

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 identifier (NCT number): NCT00252655

United States, Michigan
Detroit Medical Center, Harper University Hospital
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
Wayne State University
Principal Investigator: Scott A. Gruber, MD, PhD Harper University Hospital Identifier: NCT00252655     History of Changes
Other Study ID Numbers: 122102M1F
First Posted: November 11, 2005    Key Record Dates
Last Update Posted: April 19, 2007
Last Verified: April 2007

Additional relevant MeSH terms:
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents