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

This study has been completed.
Information provided by:
Astellas Pharma Inc Identifier:
First received: September 13, 2005
Last updated: July 7, 2014
Last verified: July 2014
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.

Condition Intervention Phase
Liver Transplantation Drug: tacrolimus Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Incidence of and time to biopsy-proven acute rejections [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Incidence of acute rejections [ Time Frame: 12 months ]

Enrollment: 475
Study Start Date: August 2004
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: tacrolimus
Other Name: FK506E, MR4
Experimental: 2 Drug: tacrolimus
Other Name: FK506E, MR4

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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..
  Contacts and Locations
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Please refer to this study by its identifier: NCT00189826

  Show 51 Study Locations
Sponsors and Collaborators
Astellas Pharma Inc
Principal Investigator: J. Langrehr Charite Campus Virchow Klinikum
  More Information

Additional Information:
Responsible Party: Disclosure Office Europe, Astellas Pharma Europe BV Identifier: NCT00189826     History of Changes
Other Study ID Numbers: FG-506E-11-03
Study First Received: September 13, 2005
Last Updated: July 7, 2014

Keywords provided by Astellas Pharma Inc:
Liver transplantation

Additional relevant MeSH terms:
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on June 23, 2017