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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by Wayne State University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Wayne State University
ClinicalTrials.gov Identifier:
NCT00252655
First received: November 9, 2005
Last updated: April 18, 2007
Last verified: April 2007
History of Changes
  Purpose

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 Intervention Phase
Kidney Transplantation
 Drug: Rapamune and Prograf
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Wayne State University:

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

Secondary Outcome Measures:
  • Incidence of acute rejection.

Estimated Enrollment: 40
Study Start Date: January 2004
Estimated Study Completion Date: June 2009
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00252655

Locations
United States, Michigan
Detroit Medical Center, Harper University Hospital
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
Wayne State University
Investigators
Principal Investigator: Scott A. Gruber, MD, PhD Harper University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00252655     History of Changes
Other Study ID Numbers: 122102M1F
Study First Received: November 9, 2005
Last Updated: April 18, 2007
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Sirolimus
Tacrolimus
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
 Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 22, 2013