Study Evaluating of Calcineurin Inhibitor and Sirolimus (Rapamune) Treatment in Liver Transplant Recipients

April 20, 2010 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

A Randomized, Open-Label, Comparative Evaluation of Conversion From Calcineurin Inhibitor Treatment to Sirolimus Treatment Versus Continued Calcineurin Inhibitor Treatment in Liver Allograft Recipients Undergoing Maintenance Therapy

The purpose of this study is to evaluate the sirolimus conversion regimen as compared with the calcineurin inhibitor continuation regimen with regards to renal function in stable liver transplant subjects.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

607

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Gent, Belgium, 9000
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
    • Ontario
      • London, Ontario, Canada, N6A 5A5
      • Toronto, Ontario, Canada, M5G 2C4
  • Czech Republic
      • Prague, Czech Republic, 14021
  • France
      • Clichy, France, 92118
      • Lyon, France, 69437
      • Nice, France, 06200
      • Paris, France, 75679
      • Rennes, France, 35033
      • Villejuif, France, 94800
  • Germany
      • Berlin, Germany, 13353
      • Hamburg, Germany, 20251
      • München, Germany, 81377
  • Italy
      • Bologna, Italy
      • Milano, Italy, 20122
      • Padova, Italy, 35128
  • Netherlands
      • Leiden, Netherlands, 2300
  • Portugal
      • Coimbra, Portugal, 3049
      • Lisboa, Portugal, 1069-166
  • Spain
      • Barcelona, Spain, 08036
      • Barcelona, Spain, 08035
      • Barcelona, Spain, 08907
      • Madrid, Spain, 28034
      • Pamplona, Spain, 31008
      • Santiago de Compostela, Spain, 15706
      • Valencia, Spain, 46009
  • Switzerland
      • Bern, Switzerland, CH-3010
      • Zürich, Switzerland, CH-8091
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
      • Edinburgh, United Kingdom, EH16 4SA
      • Leeds, United Kingdom, LS9 7TF
  • United States
    • California
      • San Francisco, California, United States, 94143-0780
    • Florida
      • Tampa, Florida, United States, 33606
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
    • Michigan
      • Detroit, Michigan, United States, 48202
    • Minnesota
      • Rochester, Minnesota, United States, 55905
    • Nebraska
      • Omaha, Nebraska, United States, 68198-3285
    • New York
      • New York, New York, United States, 10029
      • Rochester, New York, United States, 14642-8410
    • Ohio
      • Cleveland, Ohio, United States, 44195
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104

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 13 years (age greater than 18 years as required by some local regulations).
  • Receiving immunosuppressive therapy with calcineurin inhibitors (CI) +/- corticosteroids +/- antimetabolite.
  • 6 to 144 months after orthotopic liver transplantation.
  • Cockcroft-Gault GFR values ≥40 mL/min and ≤90mL/min at screening

Exclusion Criteria:

  • History of nonhepatic transplantation
  • Evidence of systemic infection (sepsis, bacteremia, pneumonia etc).
  • Known or suspected malignancy < 5 years before random assignment.

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
Drug: Sirolimus (Rapamune)
Active Comparator: B
Drug: Cyclosporine or Tacrolimus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline Adjusted Mean in Glomerular Filtration Rate (GFR)
Time Frame: Baseline and 12 months
GFR is an index of kidney function. GFR was calculated using Cockcroft-Gault method. A normal GFR is >90 mL/min, higher values indicate better function. Change=adjusted mean of 12 months minus baseline. Mean adjusted for baseline GFR, with antimetabolite therapy status and hepatitis C status as fixed effects.
Baseline and 12 months
Patient and Graft Survival
Time Frame: 12 months
Endpoint was a composite assessment of patient and graft survival. Patients categorized as graft survival or graft loss. Graft loss defined as pure graft loss (requiring retransplant) or death (with a functioning graft), if the event occurred in the first 12 months after randomization. Patients with missing graft data were counted as graft losses.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients With a Biopsy Confirmed Acute Rejection
Time Frame: 12 months
Overall event rate is determined as yes or no.
12 months
Mean Serum Creatinine
Time Frame: 12 months
Observed mean values for serum creatinine.
12 months

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

Investigators

  • Principal Investigator: Trial Manager, For Czech Republic, WPPGCLI@wyeth.com
  • Principal Investigator: Trial Manager, For Switzerland, med@wyeth.com
  • Principal Investigator: Trial Manager, For Italy, decresg@wyeth.com

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

December 1, 2002

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

June 30, 2004

First Submitted That Met QC Criteria

July 1, 2004

First Posted (Estimate)

July 2, 2004

Study Record Updates

Last Update Posted (Estimate)

April 28, 2010

Last Update Submitted That Met QC Criteria

April 20, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0468H1-313

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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