A Study to Evaluate the Safety and Efficacy of FK506E (MR4) in Patients Undergoing Primary Liver Transplantation.
NCT ID: NCT00189826
Last Updated: 2014-07-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
475 participants
INTERVENTIONAL
2004-08-31
2006-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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1
tacrolimus
immunosuppression
2
tacrolimus
immunosuppression
Interventions
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tacrolimus
immunosuppression
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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..
18 Years
ALL
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Responsible Party
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Astellas Pharma Europe BV
Principal Investigators
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J. Langrehr
Role: PRINCIPAL_INVESTIGATOR
Charite Campus Virchow Klinikum
Locations
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Heidelberg, , Australia
Sydney, , Australia
Ghent, , Belgium
Liège, , Belgium
Bel Horizonte, , Brazil
Porto Alegre, , Brazil
Rio de Janeiro, , Brazil
São Paulo, , Brazil
Edmonton, Alberta, Canada
Vancouver, British Columbia, Canada
London, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Prague, , Czechia
Helsinki, , Finland
Clichy, , France
Créteil, , France
Lyon, , France
Montpellier, , France
Rennes, , France
Strasbourg, , France
Toulouse, , France
Villejuif, , France
Berlin, , Germany
Hamburg, , Germany
Heidelberg, , Germany
Regensburg, , Germany
Dublin, , Ireland
Bergamo, , Italy
Bologna, , Italy
Genova, , Italy
Modena, , Italy
Palermo, , Italy
Udine, , Italy
Oslo, , Norway
Warsaw, , Poland
Barakaldo, , Spain
Barcelona, , Spain
Barcelona, , Spain
Córdoba, , Spain
Santiago de Compostela, , Spain
Seville, , Spain
Valencia, , Spain
Gothenburg, , Sweden
Stockholm, , Sweden
Bern, , Switzerland
Zurich, , Switzerland
Leeds, , United Kingdom
London, , United Kingdom
London, , United Kingdom
Newcastle upon Tyne, , United Kingdom
Countries
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References
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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.
Other Identifiers
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FG-506E-11-03
Identifier Type: -
Identifier Source: org_study_id
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