A Study to Evaluate the Safety and Efficacy of FK506E (MR4) in Patients Undergoing Primary Liver Transplantation.
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
1 other identifier
interventional
475
16 countries
51
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Aug 2004
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 19, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedJuly 9, 2014
July 1, 2014
2.3 years
September 13, 2005
July 7, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of and time to biopsy-proven acute rejections
12 months
Secondary Outcomes (1)
Incidence of acute rejections
12 months
Study Arms (2)
1
ACTIVE COMPARATOR2
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Patients receiving a primary, split liver or a whole liver graft from a cadaveric donor with compatible ABO blood type.
You may not qualify if:
- 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..
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (51)
Unknown Facility
Heidelberg, VIC 3084, Australia
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Sydney, 2050, Australia
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Ghent, 9000, Belgium
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Liège, 4000, Belgium
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Bel Horizonte, 30130, Brazil
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Porto Alegre, Brazil
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Rio de Janeiro, 21041, Brazil
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São Paulo, 01431, Brazil
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Edmonton, Alberta, Canada
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Vancouver, British Columbia, Canada
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London, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Prague, Czechia
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Helsinki, Finland
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Clichy, France
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Créteil, France
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Lyon, France
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Montpellier, France
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Rennes, France
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Strasbourg, France
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Toulouse, France
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Villejuif, France
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Berlin, Germany
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Hamburg, Germany
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Heidelberg, Germany
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Regensburg, Germany
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Dublin, Ireland
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Bergamo, Italy
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Bologna, Italy
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Genova, Italy
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Modena, Italy
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Palermo, Italy
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Udine, Italy
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Oslo, Norway
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Warsaw, Poland
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Barakaldo, Spain
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Barcelona, 08035, Spain
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Barcelona, 08036, Spain
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Córdoba, Spain
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Santiago de Compostela, Spain
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Seville, Spain
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Valencia, Spain
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Gothenburg, Sweden
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Stockholm, Sweden
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Bern, Switzerland
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Zurich, Switzerland
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Leeds, United Kingdom
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London, NW3 2QG, United Kingdom
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London, SE5 9 RS, United Kingdom
Unknown Facility
Newcastle upon Tyne, United Kingdom
Related Publications (1)
Ericzon BG, Varo E, Trunecka P, Fischer L, Colledan M, Gridelli B, Valdivieso A, O'Grady J, Dickinson J, Undre N. Pharmacokinetics of prolonged-release tacrolimus versus immediate-release tacrolimus in de novo liver transplantation: A randomized phase III substudy. Clin Transplant. 2017 Jun;31(6). doi: 10.1111/ctr.12958. Epub 2017 Apr 27.
PMID: 28295581DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
J. Langrehr
Charite Campus Virchow Klinikum
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 19, 2005
Study Start
August 1, 2004
Primary Completion
December 1, 2006
Study Completion
December 1, 2006
Last Updated
July 9, 2014
Record last verified: 2014-07