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

August 16, 2007 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

A Phase II, Open-Label, Concentration-Controlled, Randomized, 6-Month Study of 'Standard Dose' Tacrolimus + Sirolimus + Corticosteroids Compared to 'Reduced Dose' Tacrolimus + Sirolimus + Corticosteroids in Renal Allograft Recipients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2000

Primary Completion

December 7, 2022

Study Completion (Actual)

June 1, 2002

Study Registration Dates

First Submitted

July 26, 2007

First Submitted That Met QC Criteria

August 16, 2007

First Posted (Estimate)

August 20, 2007

Study Record Updates

Last Update Posted (Estimate)

August 20, 2007

Last Update Submitted That Met QC Criteria

August 16, 2007

Last Verified

August 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0468E1-100193

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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