A Study to Evaluate the Safety and Efficacy of FK506E (MR4) in Patients Undergoing Primary Liver Transplantation.

July 7, 2014 updated by: Astellas Pharma Inc

A Multicentre, Randomised, Double Blind, Two Arm Parallel Group Study to Evaluate and Compare the Efficacy and Safety of Modified Release Tacrolimus FK506E (MR4) Versus Tacrolimus FK506 in Combination With Steroids in Patients Undergoing Primary Liver Transplantation

To evaluate and to compare efficacy and safety of a dual regimen with oral modified release tacrolimus FK506E (MR4) / steroids versus a dual regimen with oral tacrolimus FK506 / steroids in patients undergoing primary liver transplantation. It shall be demonstrated that FK506E (MR4) is non-inferior to FK506 with regards to the primary endpoint.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A multicentre, 1:1 randomised, double blind, double dummy, two arm parallel group phase III study comparing a dual modified release FK506E (MR4) / steroid regimen with a standard tacrolimus FK506 / steroid regimen.

Study Type

Interventional

Enrollment (Actual)

475

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

  • Australia
      • Heidelberg, Australia, VIC 3084
      • Sydney, Australia, 2050
  • Belgium
      • Gent, Belgium, 9000
      • Liege, Belgium, 4000
  • Brazil
      • Bel Horizonte, Brazil, 30130
      • Porto Alegre, Brazil
      • Rio de Janeiro, Brazil, 21041
      • Sao Paulo, Brazil, 01431
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
    • Ontario
      • London, Ontario, Canada
      • Toronto, Ontario, Canada
    • Quebec
      • Montreal, Quebec, Canada
  • Czech Republic
      • Praha 4, Czech Republic
  • Finland
      • Helsinki, Finland
  • France
      • Clichy, France
      • Creteil, France
      • Lyon Cedex 03, France
      • Montpellier Cedex 05, France
      • Rennes Cedex, France
      • Strasbourg, France
      • Toulouse Cedex 9, France
      • Villejuif, France
  • Germany
      • Berlin, Germany
      • Hamburg, Germany
      • Heidelberg, Germany
      • Regensburg, Germany
  • Ireland
      • Dublin 4, Ireland
  • Italy
      • Bergamo, Italy
      • Bologna, Italy
      • Genova, Italy
      • Modena, Italy
      • Palermo, Italy
      • Udine, Italy
  • Norway
      • Oslo, Norway
  • Poland
      • Warsaw, Poland
  • Spain
      • Barakaldo, Spain
      • Barcelona, Spain, 08036
      • Barcelona, Spain, 08035
      • Cordoba, Spain
      • Santiago de Compostela, Spain
      • Sevilla, Spain
      • Valencia, Spain
  • Sweden
      • Goteborg, Sweden
      • Stockholm, Sweden
  • Switzerland
      • Bern, Switzerland
      • Zurich, Switzerland
  • United Kingdom
      • Leeds, United Kingdom
      • London, United Kingdom, NW3 2QG
      • London, United Kingdom, SE5 9 RS
      • Newcastle upon Tyne, United Kingdom

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:

  • Patients receiving a primary, split liver or a whole liver graft from a cadaveric donor with compatible ABO blood type.

Exclusion Criteria:

  • Patients receiving a multi-organ transplant or having previously received an organ transplant (including liver re-transplantation).
  • Patients with severe diarrhoea, vomiting, active peptic ulcer or gastrointestinal disorder that may affect the absorption of tacrolimus.
  • Patients with serum creatinine > 200 µmol/l..

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2
Drug: tacrolimus
immunosuppression
Other Names:
  • FK506E, MR4
Active Comparator: 1
Drug: tacrolimus
immunosuppression
Other Names:
  • FK506E, MR4

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of and time to biopsy-proven acute rejections
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of acute rejections
Time Frame: 12 months
12 months

Collaborators and Investigators

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

Sponsor

Astellas Pharma Inc

Investigators

  • Principal Investigator: J. Langrehr, Charité Campus Virchow Klinikum

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

Helpful Links

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

August 1, 2004

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 19, 2005

Study Record Updates

Last Update Posted (Estimate)

July 9, 2014

Last Update Submitted That Met QC Criteria

July 7, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FG-506E-11-03

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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