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

Sponsored by:	Wayne State University
Information provided by:	Wayne State University
ClinicalTrials.gov Identifier:	NCT00252655

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 IV

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Tacrolimus Sirolimus Tacrolimus anhydrous

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

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

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

Study placed in the following topic categories:

Sirolimus
Tacrolimus

ClinicalTrials.gov processed this record on January 14, 2009