Study Evaluating Sirolimus in the Treatment of Kidney Transplant

Wyeth is now a wholly owned subsidiary of Pfizer100 enrolled

Overview

The aim of this study is to test whether withdrawal of calcineurin inhibitors, followed by treatment with sirolimus, may improve renal function in renal transplant recipients with chronic allograft nephropathy.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Kidney Failure Kidney Diseases

Interventions

SirolimusDRUG

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Renal transplantation * Biopsy-confirmed chronic rejection * Treatment with mofetil mycophenolate among cyclosporine or tacrolimus Exclusion Criteria: * Transplant of any organ other than the kidney * Current important infection * Acute rejection within 12 weeks prior to inclusion

Locations (13)

Unnamed facility

A Coruña, Spain

Unnamed facility

Albacete, Spain

Unnamed facility

Barcelona, Spain

Unnamed facility

Cadiz, Spain

Outcomes

Primary Outcomes

Renal function at 12 months; Comparison between slopes of glomerular filtration rate (GFR) of one year before versus one year after start on sirolimus

Secondary Outcomes

Histological parameters at 12 months

Cumulative incidence of biopsy-confirmed acute rejection at 12 months

Effect at 12 months on proteinuria, blood pressure, hyperlipidemia, and proteinuria

Data from ClinicalTrials.gov

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