Study to Ascertain if Prolonged Release Tacrolimus (FK506E - MR4) is Safe and Effective When Used in the Long Term and in Combination With Other Immunosuppressive Drugs in Patients Who Have Received a Transplant
NCT ID: NCT02118896
Last Updated: 2024-11-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
850 participants
INTERVENTIONAL
2003-02-24
2009-10-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1: FK506E (MR4)
Single open arm of FK506E (MR4). Since this was an extension study for many studies, generally the dose given at enrollment was to be continued. The investigator was permitted to adjust the subject's dose and modify the MR4 dose regimen as deemed necessary to minimize Adverse Events (AEs) and maintain effective immunosuppression. MR4 capsules were taken orally, once daily in the morning. MR4 capsules were to be swallowed with fluid (preferably water) on an empty stomach or at least 1 hour before or 2 to 3 hours after a meal. MR4 was supplied as 0.5 mg, 1 mg and 5 mg capsules in amber glass bottles or in blister packs.
FK506E
oral
Interventions
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FK506E
oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients capable of understanding the purpose and risks of the study, who had been fully informed and given written informed consent to participate in the study.
Exclusion Criteria
* Women unwilling or unable to use adequate contraception during the study.
18 Years
ALL
No
Sponsors
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Astellas Pharma Europe Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Central Contact
Role: STUDY_CHAIR
Astellas Pharma Europe Ltd.
Locations
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University Hospital
Cincinnati, Ohio, United States
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Princess Alexandra Hospital
Brisbane, Queensland, Australia
Austin Hospital
Heidelberg, Victoria, Australia
Royal Melbourne Hospital
Melbourne, Victoria, Australia
Landeskrankenhaus Innsbruck
Innsbruck, , Austria
AKN Wien
Vienna, , Austria
Hospital Erasme
Brussels, , Belgium
Cliniques Universitaires St. Luc
Brussels, , Belgium
Departement Heelkunde
Ghent, , Belgium
Universitair Ziekenhuis Gasthuisberg
Leuven, , Belgium
Domaine Universitaire du Sart Tillman
Liège, , Belgium
Hospital da Clínicas da UNICAMP
Campinas, , Brazil
Hospital São Francisco
Porto Alegre, , Brazil
Irmandade da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, , Brazil
Hospital Geral de Bonsucesso
Rio de Janeiro, , Brazil
University of Alberta
Edmonton, Alberta, Canada
London Health Sciences Centre
London, Ontario, Canada
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Institut de Cardiologie de Montréal
Montreal, Quebec, Canada
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec, Canada
Royal Victoria Hospital
Montreal, Quebec, Canada
Vancouver Hospital & Health Sciences Centre
Vancouver, , Canada
IKEM
Prague, , Czechia
Skejby University Hospital
Århus N, , Denmark
Helsinki University Central Hospital
Helsinki, , Finland
Hôpital Bicêtre
Le Kremlin-Bicêtre, Bicetre Cedex, France
Hopital Saint-Eloi
Montpellier, Cedex 05, France
Hopital Laennec
Nantes, Cedex 1, France
Hotel Dieu
Nantes, Cedex 1, France
Service de Nephrologie
Nice, Cedex 1, France
Hôpital Edouard Hérriot
Lyon, Cedex 3, France
Hôpital Lapeyronie
Montpellier, Cedex 5, France
Hôpital Rangueil
Toulouse, Cedex 9, France
Hôpital Calmette
Lille, Cedex, France
Hopital Pontchaillou
Rennes, Cedex, France
Hôpital Beaujon
Clichy, , France
Hôpital Henri Mondor
Créteil, , France
Hôpital Henri Mondor
Créteil, , France
Chu Nord
Grenoble, , France
CHU Saint-Etienne
Saint-Etienne, , France
Hôpital Hautepierre
Strasbourg, , France
Hopital Paul Brousse
Villejuif, , France
Herz- und Diabeteszentrum NRW
Bad Oeynhausen, , Germany
Universitätsklinik Charité
Berlin, , Germany
Charite Campus Virchow Klinikum
Berlin, , Germany
Knappschaftskrankenhaus Bochum-Langendreer
Bochum, , Germany
DR MED Wolfgang Arns
Cologne, , Germany
Medizinische Klink IV
Erlangen, , Germany
Universitätklinikum Essen
Essen, , Germany
Funktionsbereich Nephrologie
Frankfurt am Main, , Germany
Univ. Klinik und Poliklinik fuer Urologie
Halle, , Germany
Universitäts-Krankenhaus Eppendorf
Hamburg, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Leiter Viszerale Organtransplantation
Heidelberg, , Germany
Klinikum Rechts der Isar
München, , Germany
Klinik und Poliklinik fuer Chirurgie
Regensburg, , Germany
Klinikum der Universität Regensburg
Regensburg, , Germany
Semmelweis University of Medicine
Budapest, , Hungary
National Liver Transplantation Unit
Dublin, , Ireland
Beaumont Private Clinic
Dublin, , Ireland
Ospedali Riuniti di Bergamo
Bergamo, , Italy
Unita Operativa Trapianto di Fegato e Multiorgano
Bologna, , Italy
DISCAT - Centro Trapianti
Genova, , Italy
Azienda Ospedaliera Ospedale Maggiore di Milano
Milan, , Italy
Azienda Ospedaliera Policlinico di Modena
Modena, , Italy
Azienda Ospedaliera di Padova
Padua, , Italy
ISMETT
Palermo, , Italy
Policlinico Universitario Agostino Gemelli
Roma, , Italy
Unita Operativa Complessa di Chirurgia dei Trapianti
Siena, , Italy
Clinica Chirurgica Universitaria
Udine, , Italy
Instituto Mexicano de Transplantes Cuernava
Morelos, , Mexico
Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán"
Tlalpan, , Mexico
Akademisch Ziekenhuis Maastricht
Maastricht, , Netherlands
New Zealand Liver Transplant Unit
Auckland, , New Zealand
Samodzielny Publiczny Szpital Kliniczny
Bydgoszcz, , Poland
Samodzielny Publiczny Szpital Kliniczny
Szczecin, , Poland
Groote Schuur Hospital
Cape Town, , South Africa
Christiaan Barnard Memorial Hospital
Cape Town, , South Africa
St Augustine's Hospital
Durban, , South Africa
Jacaranda Hospital
Pretoria, , South Africa
University of Stellenbosch, Tygerberg Hospital
Tygerberg, , South Africa
Hospital de Cruces
Barakaldo, Vizcaya, Spain
Servicio de Nefrologia
Barcelona, , Spain
Hospital Vall d'Hebron
Barcelona, , Spain
Servicio de Nefrologia
Barcelona, , Spain
Hospital Clinic i Provincial
Barcelona, , Spain
Unidad de Trasplante Hepatico
Barcelona, , Spain
Servicio de Nefrologia
Barcelona, , Spain
Hospital General Universitario Gregorio Maranón
Madrid, , Spain
Hospital Ramon y Cajal
Madrid, , Spain
Consultas de Trasplante Renal
Madrid, , Spain
Hospital Central de Asturias
Oviedo, , Spain
Clinica de Navarra
Pamplona, , Spain
Hospital Clinico Universitario de Santiago
Santiago de Compostela, , Spain
SU/Sahlgrenska University Hospital
Gothenburg, , Sweden
Karolinska University Hospital Huddinge
Stockholm, , Sweden
Universitätsspital Zürich
Zurich, , Switzerland
Walsgrove Hospital
Coventry, , United Kingdom
Queen Elizabeth Hospital
Edgbaston, , United Kingdom
Western Infirmary
Glasgow, , United Kingdom
Kings College Hospital
London, , United Kingdom
Department of Renal Medicine
Manchester, , United Kingdom
Wythenshaw Hospital
Manchester, , United Kingdom
The Freeman Hospital
Newcastle upon Tyne, , United Kingdom
Countries
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Related Links
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Link to Results on the Astellas Clinical Study Results website
Other Identifiers
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2005-005714-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
FG-506-14-02
Identifier Type: OTHER
Identifier Source: secondary_id
F506-CL-0857
Identifier Type: -
Identifier Source: org_study_id
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