Study Comparing Conversion From Calcineurin Inhibitors to Rapamune Versus Standard Therapy in Established Renal Allograft Recipients

Wyeth is now a wholly owned subsidiary of Pfizer190 enrolled

Overview

The purpose of the study is to determine the effect of conversion from calcineurin inhibitor based therapy to Rapamune based therapy in patients with mild to moderate renal insufficiency.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

190

Conditions

Graft Rejection Kidney Failure Kidney Transplantation

Interventions

Cyclosporin or tacrolimusDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age over 18 * Treatment with a calcineurin inhibitor * Patients with mild to moderate renal insufficiency Exclusion Criteria: * Patients with acute rejection * Patients who received a transplant more than 10 years ago

Outcomes

Primary Outcomes

Difference between treatment groups in renal function at 12 months.

Secondary Outcomes

Incidence of acute rejection, patient and graft survival at 12 months, labs and physical examinations, quality of life etc.

Data from ClinicalTrials.gov

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