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

Phase 4

Completed

• Conditions: Graft vs Host Disease; Kidney Failure
• Interventions: Drug: Tacrolimus; Drug: Sirolimus; Drug: prednisone

• Registration Number: NCT00195429
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-16
• Study First Posted: 2005-09-19
• Study Completion: 2007-10
• Results First Submitted: 2008-12-19
• Results First Submitted QC: 2009-04-06
• Results First Posted: 2009-06-02
• Status Verified: 2010-04
• Last Update Submitted: 2023-12-07
• Last Update Posted: 2023-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sirolimus + Tacrolimus	Sirolimus	-
Sirolimus + Prednisone	Sirolimus	-
Sirolimus + Prednisone	prednisone	-
Sirolimus + Tacrolimus	Tacrolimus	-

Primary Outcome Measures

Name	Time	Method
Number of Patients With Biopsy Confirmed Acute Rejection at 12 Months Follow up.	12 months	Diagnosis of acute rejection was made via kidney biopsy using the Banff criteria (a standardized model for interpretation of renal allograft biopsies).

Secondary Outcome Measures

Name	Time	Method
Creatinine Clearance Rate	12 months	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.