A Study Comparing the Withdrawal of Steroids or Tacrolimus in Kidney Transplant Recipients

Phase 4CompletedNCT00195429

Wyeth is now a wholly owned subsidiary of Pfizer47 enrolled

Overview

This study evaluates two different immunosuppression drug regimens in patients with a recent kidney transplant. Patients initially received a regimen of Sirolimus, Tacrolimus and Prednisone and then randomized to discontinue either Tacrolimus or Prednisone.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Kidney Failure Graft vs Host Disease

Interventions

TacrolimusDRUG

SirolimusDRUG

prednisoneDRUG

Eligibility

Sex: ALLMin age: 13 Years

Medical Language ↔ Plain English

Inclusion Criteria: * End-stage renal disease, with patients scheduled to receive a kidney transplant. * Women who are of childbearing potential who are not pregnant and agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months following discontinuation of study drugs. Any woman becoming pregnant during the treatment period must discontinue the use of study drugs; * Signed informed consent. Exclusion Criteria: * Evidence of active systemic or localized major infection at the time of initial study drug administration; * Multiple organ transplants; * Any pathology or medical condition that can interfere with this protocol study proposal. Other exclusion applies.

Locations (1)

Unnamed facility

São Paulo, Brazil

Outcomes

Primary Outcomes

Number of Patients With Biopsy Confirmed Acute Rejection at 12 Months Follow up.

Diagnosis of acute rejection was made via kidney biopsy using the Banff criteria (a standardized model for interpretation of renal allograft biopsies).

Time frame: 12 months

Secondary Outcomes

Creatinine Clearance Rate

Creatinine clearance is a measure of kidney function. Creatinine clearance rate (CCr) is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Creatinine clearance can be measured directly or estimated using established formulas. For this study, CCr was calculated using the Nakivell formula. Normal values for healthy, young males are in the range of 100-135 ml/min and for females, 90-125 ml/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.

Time frame: 12 months

Data from ClinicalTrials.gov

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