Study Evaluating Two Different Sirolimus-based Immunosuppressive Regimens in Elderly Kidney Transplant Recipients

Wyeth is now a wholly owned subsidiary of Pfizer66 enrolled

Overview

The purpose of this study is to test two different sirolimus-based immunosuppressive regimens for elderly kidney transplant recipients.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Kidney Failure Graft Rejection Aged

Interventions

SirolimusDRUG

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * End stage renal disease * Kidney transplantation * Both donor and recipient older than 60 years Exclusion Criteria: * Prior or concurrent transplant of any organ other than the kidney * Current clinically significant infections

Outcomes

Primary Outcomes

Renal function at 3 and 12 months; measured by Cockroft-Gault formula or serum creatinine

Secondary Outcomes

Incidence of acute rejections at 3 and 12 months

Patient and graft survival at 3 and 12 months

Incidence and duration of episodes of acute tubular necrosis

Time to recover renal function (creatinine< 2 mg/dl)

Data from ClinicalTrials.gov

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