Study Comparing Graft Function in Renal Allograft Recepients Receiving Reduced or Standard Dose CsA With Sirolimus

Wyeth is now a wholly owned subsidiary of Pfizer250 enrolled

Overview

This study evaluated renal graft function (based on calcuated creatinine clearance) 12 months after transplantation in patients receiving either a regimen of reduced dose or standard dose cyclosporine in combination with sirolimus and corticosteroids. The incidence of acute graft rejection at 6 and 12 months following transplantation and patient and graft survival at 12 months were evaluated also.

This study evaluated renal graft function (based on calcuated creatinine clearance) 12 months after kidney transplantation in patients receiving either a regimen of reduced dose or standard dose cyclosporine (CsA) in combination with sirolimus and corticosteroids. The incidence of acute graft rejection at 6 and 12 months following transplantation and patient and graft survival at 12 months after transplantation were evaluated also.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

250

Conditions

Kidney Transplantation

Interventions

Rapamune® (Sirolimus)DRUG

Neoral® (Cyclosporine)DRUG

CorticosteroidsDRUG

Left up to local practice but steroids are typically used perioperatively

Eligibility

Sex: ALLMin age: 18 Months

Medical Language ↔ Plain English

Inclusion Criteria: * Adults more than 18 years of age * End-stage renal disease, with patients receiving a primary or secondary renal allograft from a cadaveric, living-unrelated or living-related mismatched donor * Patients with a secondary transplant must have maintained their primary graft for at least 6 months Exclusion Criteria: * Planned antibody induction therapy * Multiple organ transplants * Patients at a high risk of acute rejection

Outcomes

Primary Outcomes

Calculated creatinine clearance to evaluate renal function at 12 months post transplantation

Time frame: 12 months

Secondary Outcomes

Incidence of acute graft rejection at 6 and 12 months post transplantation and patient and graft survival at 12 months post transplantation

Time frame: 12 months

Data from ClinicalTrials.gov

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