Study Comparing Sirolimus/Prograf vs Sirolimus/CsA in High-Risk Renal Transplant Recipients

Wyeth is now a wholly owned subsidiary of Pfizer460 enrolled

Overview

The purpose of this study is to assess whether in high-risk kidney transplant patients (patients whose previous kidney transplant failed, have a high PRA lab test result or are of African-American descent) that a combination of Rapamune with Prograf and steroids will prevent acute rejection as well as Rapamune and cyclosporine and steroids.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

460

Conditions

Renal Allograft Recipients

Interventions

RapamuneDRUG

Eligibility

Sex: ALLMin age: 13 Years

Medical Language ↔ Plain English

Inclusion criteria: * Patients of African-American descent or patient with a history of multiple transplants and/or patients with a high panel reactive antibody lab test with a renal transplant from a cadaveric donor, a living unrelated donor or a living-related mismatched donor. * Age \>= 13 years, weight \>= 40 kg * Women must have a negative pregnancy test at study entry Exclusion criteria * Multiple organ transplants or double kidney transplants (pediatric en-bloc or double adult) * Active systemic infection, or localized major infection or known HIV * Patients with residual kidney function \>20 mL/min

Outcomes

Primary Outcomes

First biopsy-confirmed acute rejection, patient death or graft loss in the first 12 months following transplantation. First occurence of kidney graft loss or patient death in the first 12 months following transplantation.

Data from ClinicalTrials.gov

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