Study Comparing Standard Dose and Reduced Dose Tacrolimus + Sirolimus + Corticosteroids in Renal Allograft Recipients

Wyeth is now a wholly owned subsidiary of Pfizer120 enrolled

Overview

This study evaluated renal graft function based on calculated creatinine clearance at 6 months after transplantation in patients receiving a regimen of 'reduced' or 'standard' dose tacrolimus plus sirolimus and corticosteroids. Blood serum creatinine, the incidence of biopsy-confirmed acute graft rejection, and patient and graft survival were also evaluated at 6 months post transplantation.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Kidney Transplantation

Interventions

Rapamune® (Sirolimus)DRUG

TacrolimusDRUG

CorticosteroidsDRUG

Perioperative

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria * At least 18 years of age * End-stage renal disease in patients receiving a primary or secondary renal allograft from a cadaveric donor * Patients with secondary kidney transplant must have maintained their primary graft for at least 6 months Exclusion criteria * Planned antibody induction * Multiple organ transplants * Patients at high risk of acute rejection

Outcomes

Primary Outcomes

Graft function as measured by calculated creatinine clearance at month 6 post-transplantation.

Secondary Outcomes

Blood serum creatinine, incidence of biopsy-confirmed acute graft rejection, and patient and graft survival at 6 months; presumptive acute rejection; incidence of infection; histologically-confirmed lymphoproliferative disease or malignancy.

Data from ClinicalTrials.gov

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