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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00189826
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : July 9, 2014
Information provided by:
Astellas Pharma Inc

Brief Summary:
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 or disease Intervention/treatment Phase
Liver Transplantation Drug: tacrolimus Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 475 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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
Study Start Date : August 2004
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus

Arm Intervention/treatment
Active Comparator: 1 Drug: tacrolimus
Other Name: FK506E, MR4

Experimental: 2 Drug: tacrolimus
Other Name: FK506E, MR4

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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..

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00189826

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Sponsors and Collaborators
Astellas Pharma Inc
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Principal Investigator: J. Langrehr Charite Campus Virchow Klinikum
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Disclosure Office Europe, Astellas Pharma Europe BV Identifier: NCT00189826    
Other Study ID Numbers: FG-506E-11-03
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: July 9, 2014
Last Verified: July 2014
Keywords provided by Astellas Pharma Inc:
Liver transplantation
Additional relevant MeSH terms:
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Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action