A Study to Evaluate the Safety and Efficacy of FK506E (MR4) in Patients Undergoing Primary Kidney 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 MMF (Cellcept®) and Steroids in Patients Undergoing Kidney Transplantation

The purpose of this study is to evaluate and to compare the efficacy and safety of a triple modified release tacrolimus FK506E (MR4) / MMF / steroid regimen with a triple standard tacrolimus FK506 / MMF / steroid regimen in patients undergoing kidney 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 triple modified release tacrolimus FK506E (MR4) / MMF / steroid regimen with a triple standard tacrolimus FK506 / MMF / steroid regimen.

Study Type

Interventional

Enrollment (Actual)

699

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

  • Argentina
      • Buenos Aires, Argentina
      • Santa Fe, Argentina
  • Australia
      • Melbourne, Australia
      • Sydney, Australia
      • Westmead, Australia
      • Woudville South, Australia
  • Austria
      • Innsbruck, Austria
  • Belgium
      • Bruxelles, Belgium, 1070
      • Bruxelles, Belgium, 1200
      • Leuven, Belgium
  • Brazil
      • Campinas - SP, Brazil
      • Porto Alegre, Brazil
      • Rio de Janeiro - RJ, Brazil
      • San Paulo - SP, Brazil
  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
    • Ontario
      • London, Ontario, Canada
      • Toronto, Ontario, Canada
    • Quebec
      • Montreal, Quebec, Canada
  • Czech Republic
      • Praha 4, Czech Republic
  • Finland
      • Helsinki, Finland
  • France
      • Creteil, France
      • Grenoble, France
      • Le Kremlin Bicetre Cedex, France
      • Lille Cedex, France
      • Montpellier Cedex 05, France
      • Nantes Cedex 01, France
      • Nice Cedex 1, France
      • Saint-Etienne, France
      • Toulouse Cedex 9, France
      • Vandoeuvre les Nancy Cedex, France
  • Germany
      • Berlin, Germany
      • Bochum, Germany
      • Erlangen, Germany
      • Essen, Germany
      • Frankfurt, Germany
      • Halle, Germany
      • Hann, Germany
      • Koln, Germany
      • Munchen, Germany
      • Regensburg, Germany
  • Greece
      • Athens, Greece
      • Thessaloniki, Greece
  • Hungary
      • Budapest, Hungary
  • Ireland
      • Dublin, Ireland
  • Italy
      • Bari, Italy
      • Milano, Italy
      • Padova, Italy
      • Palermo, Italy
      • Pisa, Italy
      • Siena, Italy
      • Treviso, Italy
  • Mexico
      • Cuernavaca Morelos, Mexico
      • Mexico D.F., Mexico
  • Netherlands
      • Maastricht, Netherlands
      • Utrecht, Netherlands
  • Norway
      • Oslo, Norway
  • Poland
      • Bydgoszcz, Poland
      • Szczecin, Poland
  • South Africa
      • Cape Town, South Africa, 7925
      • Cape Town, South Africa, 8001
      • Durban, South Africa
      • Pretoria, South Africa
  • Spain
      • Badalona Barcelona, Spain
      • Barcelona, Spain
      • Barcelona, Spain, 08035
      • Barcelona, Spain, 08025
      • Cordoba, Spain
      • La Coruna, Spain
      • Madrid, Spain, 28034
      • Malaga, Spain
      • Santander, Spain
      • Sevilla, Spain
  • Sweden
      • Goteborg, Sweden
      • Uppsala, Sweden
  • Switzerland
      • Zurich, Switzerland
  • United Kingdom
      • Belfast, United Kingdom
      • Birmingham, United Kingdom
      • Coventry, United Kingdom
      • Glasgow, United Kingdom
      • Manchester, 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 to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients receiving a kidney transplant from a cadaveric donor or a living non HLA identical donor between 5 and 65 years of age with compatible ABO blood type.
  • Patients with end stage kidney disease who are suitable candidates for primary renal transplantation or re-transplantation (unless the graft was lost because of immunological reasons within 12 months).

Exclusion Criteria:

  • Patients receiving or having previously received an organ transplant other than a kidney.
  • Patients with a high immunological risk, defined as a panel reactive antibodies (PRA) grade >50% in the previous 6 months and/or with a previous graft survival of less than 12 months due to immunological reasons.
  • Cold ischaemia time of the donor kidney >30 hours.

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: Double

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
Time to and incidence of biopsy-proven acute rejections
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall rate 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: B Krämer, Klinikum der Universität Regensburg

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-12-03

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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