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

Phase 2

Completed

• Conditions: Kidney Transplantation

• Registration Number: NCT00518271
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2000-04
• Study Completion: 2002-06
• Study First Submitted: 2007-07-26
• Status Verified: 2007-08
• Study First Submitted QC: 2007-08-16
• Last Update Submitted: 2007-08-16
• Study First Posted: 2007-08-20
• Last Update Posted: 2007-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.