Study Comparing Conversion to Sirolimus vs. Continued Use of Calcineurin Inhibitors in Kidney Transplant Recipients

April 22, 2010 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

A Randomized, Open-label, Comparative Evaluation of Conversion From Calcineurin Inhibitors to Sirolimus Versus Continued Use of Calcineurin Inhibitors in Renal Allograft Recipients

The purpose of this study is to determine the effect of conversion from calcineurin inhibitor to sirolimus based therapy on renal function.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

830

Phase

  • Phase 3

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

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age greater than or equal to 13 years.
  • Receiving CsA or tacrolimus from the time of transplantation or within 2 weeks thereafter
  • Patients with a functioning allograft and a Nankivell GFR greater than or equal to 20 mL/min, within 2 weeks before randomization

Exclusion Criteria:

  • Biopsy-confirmed acute rejection within 12 weeks before randomization, that was determined to require antirejection treatment
  • Patients in whom kidney-pancreas or other multiple organ transplants have been performed

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)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
Conversion from calcineurin inhibitor immunosuppression to Sirolimus-based immunosuppression
Drug: tacrolimus
Drug: Cyclosporine A
Drug: Sirolimus
Sirolimus, Cyclosporine A & Tacrolimus are concentration controlled
Active Comparator: B
Continued calcineurin inhibitor therapy
Drug: tacrolimus
Drug: Cyclosporine A
Drug: Sirolimus
Sirolimus, Cyclosporine A & Tacrolimus are concentration controlled

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nankivell Glomerular Filtration Rate (GFR)
Time Frame: 52 weeks
Nankivell GFR: patients with baseline GFR of 20.0 to 40.0 mL/min and patients with baseline GFR of greater than 40.0 mL/min. GFR is an index of kidney function. A higher value means better kidney function.
52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
First Occurrence of Biopsy-confirmed Acute Rejection, Graft Loss, or Death.
Time Frame: 52 and 104 weeks
Number of patients who experienced for the first time either biopsy-confirmed acute rejection, graft loss, or death by weeks 52 and 104. Assessed by individual endpoint and as composite endpoint (all combined).
52 and 104 weeks

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2002

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

June 5, 2002

First Submitted That Met QC Criteria

June 6, 2002

First Posted (Estimate)

June 7, 2002

Study Record Updates

Last Update Posted (Estimate)

May 14, 2010

Last Update Submitted That Met QC Criteria

April 22, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0468H1-316

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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