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

NCT00252655 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2007-04-19

No results posted yet for this study

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.

Conditions

  • Kidney Transplantation

Interventions

DRUG

Rapamune and Prograf

Sponsors & Collaborators

  • Wayne State University

    lead OTHER

Principal Investigators

  • Scott A. Gruber, MD, PhD · Harper University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-01-31
Completion
2009-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00252655 on ClinicalTrials.gov