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

Last updated: October 30, 2024
Sponsor: Astellas Pharma Europe Ltd.
Overall Status: Completed

Phase

3

Condition

Kidney Transplantation

Heart Transplantation

Liver Transplantation

Treatment

FK506E

Clinical Study ID

NCT02118896
F506-CL-0857
2005-005714-20
FG-506-14-02
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study was to offer patients who had participated in one of the phase II PK or phase III studies on FK506E (MR4) the possibility to continue FK506E (MR4) until commercial availability of the drug and to record long term efficacy and safety data.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients who had already participated in the previous phase II pharmacokinetic orphase III studies with FK506E (MR4).

  • Patients capable of understanding the purpose and risks of the study, who had beenfully informed and given written informed consent to participate in the study.

Exclusion

Exclusion Criteria:

  • Pregnant women or nursing mothers.

  • Women unwilling or unable to use adequate contraception during the study.

Study Design

Total Participants: 850
Treatment Group(s): 1
Primary Treatment: FK506E
Phase: 3
Study Start date:
February 24, 2003
Estimated Completion Date:
October 07, 2009

Study Description

The objective of this study was to asses the safety and efficacy of FK506E (MR4) as a long-term treatment in transplant recipients. Only patients who had participated in one of the phase II PK or phase III studies on FK506E (MR4) and had received at least one dose of study medication were enrolled.

Connect with a study center

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales 2050
    Australia

    Site Not Available

  • Princess Alexandra Hospital

    Brisbane, Queensland 4102
    Australia

    Site Not Available

  • Austin Hospital

    Heidelberg, Victoria 3084
    Australia

    Site Not Available

  • Royal Melbourne Hospital

    Melbourne, Victoria 3050
    Australia

    Site Not Available

  • Landeskrankenhaus Innsbruck

    Innsbruck, 6020
    Austria

    Site Not Available

  • AKN Wien

    Wien, 1090
    Austria

    Site Not Available

  • Cliniques Universitaires St. Luc

    Bruxelles, 1200
    Belgium

    Site Not Available

  • Hospital Erasme

    Bruxelles, 1070
    Belgium

    Site Not Available

  • Departement Heelkunde

    Gent, 9000
    Belgium

    Site Not Available

  • Universitair Ziekenhuis Gasthuisberg

    Leuven, 3000
    Belgium

    Site Not Available

  • Domaine Universitaire du Sart Tillman

    Liege, 4000
    Belgium

    Site Not Available

  • Hospital da Clínicas da UNICAMP

    Campinas, 13083-888
    Brazil

    Site Not Available

  • Hospital São Francisco

    Porto Alegre, 90020-090
    Brazil

    Site Not Available

  • Irmandade da Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, 90020-090
    Brazil

    Site Not Available

  • Hospital Geral de Bonsucesso

    Rio de Janeiro, 21041-030
    Brazil

    Site Not Available

  • University of Alberta

    Edmonton, Alberta T6G 2B7
    Canada

    Site Not Available

  • London Health Sciences Centre

    London, Ontario N6A 5A5
    Canada

    Site Not Available

  • University of Ottawa Heart Institute

    Ottawa, Ontario K1Y 4W7
    Canada

    Site Not Available

  • Centre Hospitalier de l'Universite de Montreal (CHUM)

    Montreal, Quebec H2X 3J4
    Canada

    Site Not Available

  • Royal Victoria Hospital

    Montreal, Quebec H3A 1A1
    Canada

    Site Not Available

  • Institut de Cardiologie de Montréal

    Montréal, Quebec H1T 1C8
    Canada

    Site Not Available

  • Vancouver Hospital & Health Sciences Centre

    Vancouver, V5Z 1L7
    Canada

    Site Not Available

  • IKEM

    Praha 4, 14021
    Czechia

    Site Not Available

  • Skejby University Hospital

    Århus N, 8200
    Denmark

    Site Not Available

  • Helsinki University Central Hospital

    Helsinki, 00130
    Finland

    Site Not Available

  • Hôpital Bicêtre

    Le Kremlin-Bicêtre, Bicetre Cedex 94275
    France

    Site Not Available

  • Hôpital Calmette

    Lille, Cedex 59037
    France

    Site Not Available

  • Hopital Pontchaillou

    Rennes, Cedex 35033
    France

    Site Not Available

  • Hopital Saint-Eloi

    Montpellier, Cedex 05 34295
    France

    Site Not Available

  • Hopital Laennec

    Nantes, Cedex 1 44093
    France

    Site Not Available

  • Hotel Dieu

    Nantes, Cedex 1 44093
    France

    Site Not Available

  • Service de Nephrologie

    Nice, Cedex 1 06002
    France

    Site Not Available

  • Hôpital Edouard Hérriot

    Lyon, Cedex 3 69437
    France

    Site Not Available

  • Hôpital Lapeyronie

    Montpellier, Cedex 5 34295
    France

    Site Not Available

  • Hôpital Rangueil

    Toulouse, Cedex 9 31059
    France

    Site Not Available

  • Hôpital Beaujon

    Clichy, 92118
    France

    Site Not Available

  • Hôpital Henri Mondor

    Creteil, 94010
    France

    Site Not Available

  • Hôpital Henri Mondor

    Créteil, 94000
    France

    Site Not Available

  • Chu Nord

    Grenoble, 38043
    France

    Site Not Available

  • CHU Saint-Etienne

    St Etienne, 42055
    France

    Site Not Available

  • Hôpital Hautepierre

    Strasbourg, 67098
    France

    Site Not Available

  • Hopital Paul Brousse

    Villejuif, 94804
    France

    Site Not Available

  • Herz- und Diabeteszentrum NRW

    Bad Oeynhausen, 32545
    Germany

    Site Not Available

  • Charite Campus Virchow Klinikum

    Berlin, 13353
    Germany

    Site Not Available

  • Universitätsklinik Charité

    Berlin, 10117
    Germany

    Site Not Available

  • Knappschaftskrankenhaus Bochum-Langendreer

    Bochum, 44892
    Germany

    Site Not Available

  • Medizinische Klink IV

    Erlangen, 91504
    Germany

    Site Not Available

  • Universitätklinikum Essen

    Essen, 45122
    Germany

    Site Not Available

  • Funktionsbereich Nephrologie

    Frankfurt/Main, 60590
    Germany

    Site Not Available

  • Univ. Klinik und Poliklinik fuer Urologie

    Halle, 06120
    Germany

    Site Not Available

  • Universitäts-Krankenhaus Eppendorf

    Hamburg, 20246
    Germany

    Site Not Available

  • Medizinische Hochschule Hannover

    Hannover, 30625
    Germany

    Site Not Available

  • Leiter Viszerale Organtransplantation

    Heidelberg, 69120
    Germany

    Site Not Available

  • DR MED Wolfgang Arns

    Koeln, 51109
    Germany

    Site Not Available

  • Klinikum Rechts der Isar

    Munchen, 81675
    Germany

    Site Not Available

  • Klinik und Poliklinik fuer Chirurgie

    Regensburg, 93042
    Germany

    Site Not Available

  • Klinikum der Universität Regensburg

    Regensburg, 93053
    Germany

    Site Not Available

  • Semmelweis University of Medicine

    Budapest, 1082
    Hungary

    Site Not Available

  • Beaumont Private Clinic

    Dublin, 9
    Ireland

    Site Not Available

  • National Liver Transplantation Unit

    Dublin, 4
    Ireland

    Site Not Available

  • Ospedali Riuniti di Bergamo

    Bergamo, 24122
    Italy

    Site Not Available

  • Unita Operativa Trapianto di Fegato e Multiorgano

    Bologna, 40138
    Italy

    Site Not Available

  • DISCAT - Centro Trapianti

    Genova, 16132
    Italy

    Site Not Available

  • Azienda Ospedaliera Ospedale Maggiore di Milano

    Milano, 20122
    Italy

    Site Not Available

  • Azienda Ospedaliera Policlinico di Modena

    Modena, 41100
    Italy

    Site Not Available

  • Azienda Ospedaliera di Padova

    Padova, 35128
    Italy

    Site Not Available

  • ISMETT

    Palermo, 90134
    Italy

    Site Not Available

  • Policlinico Universitario Agostino Gemelli

    Roma, 00168
    Italy

    Site Not Available

  • Unita Operativa Complessa di Chirurgia dei Trapianti

    Siena, 53100
    Italy

    Site Not Available

  • Clinica Chirurgica Universitaria

    Udine, 33100
    Italy

    Site Not Available

  • Instituto Mexicano de Transplantes Cuernava

    Morelos, 62448
    Mexico

    Site Not Available

  • Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán"

    Tlalpan, 14000
    Mexico

    Site Not Available

  • Akademisch Ziekenhuis Maastricht

    Maastricht, 6229
    Netherlands

    Site Not Available

  • New Zealand Liver Transplant Unit

    Auckland,
    New Zealand

    Site Not Available

  • Samodzielny Publiczny Szpital Kliniczny

    Bydgoszcz, 85-094
    Poland

    Site Not Available

  • Samodzielny Publiczny Szpital Kliniczny

    Szczecin, 70-111
    Poland

    Site Not Available

  • Christiaan Barnard Memorial Hospital

    Cape Town, 8001
    South Africa

    Site Not Available

  • Groote Schuur Hospital

    Cape Town, 7925
    South Africa

    Site Not Available

  • St Augustine's Hospital

    Durban, 4001
    South Africa

    Site Not Available

  • Jacaranda Hospital

    Pretoria, 0181
    South Africa

    Site Not Available

  • University of Stellenbosch, Tygerberg Hospital

    Tygerberg, 7505
    South Africa

    Site Not Available

  • Hospital de Cruces

    Barakaldo, Vizcaya 48903
    Spain

    Site Not Available

  • Hospital Clinic i Provincial

    Barcelona, 08036
    Spain

    Site Not Available

  • Hospital Vall d'Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Servicio de Nefrologia

    Barcelona, 08035
    Spain

    Site Not Available

  • Unidad de Trasplante Hepatico

    Barcelona, 08036
    Spain

    Site Not Available

  • Consultas de Trasplante Renal

    Madrid, 28041
    Spain

    Site Not Available

  • Hospital General Universitario Gregorio Maranón

    Madrid, 28007
    Spain

    Site Not Available

  • Hospital Ramon y Cajal

    Madrid, 28034
    Spain

    Site Not Available

  • Hospital Central de Asturias

    Oviedo, 33006
    Spain

    Site Not Available

  • Clinica de Navarra

    Pamplona, 31008
    Spain

    Site Not Available

  • Hospital Clinico Universitario de Santiago

    Santiago de Compostela, 15706
    Spain

    Site Not Available

  • SU/Sahlgrenska University Hospital

    Gothenburg, 41345
    Sweden

    Site Not Available

  • Karolinska University Hospital Huddinge

    Stockholm, 14186
    Sweden

    Site Not Available

  • Universitätsspital Zürich

    Zurich, 8091
    Switzerland

    Site Not Available

  • Walsgrove Hospital

    Coventry, CV2 2DX
    United Kingdom

    Site Not Available

  • Queen Elizabeth Hospital

    Edgbaston, B15 2TH
    United Kingdom

    Site Not Available

  • Western Infirmary

    Glasgow, G11 6NT
    United Kingdom

    Site Not Available

  • Kings College Hospital

    London, SE5 9RS
    United Kingdom

    Site Not Available

  • Department of Renal Medicine

    Manchester, M13 9WL
    United Kingdom

    Site Not Available

  • Wythenshaw Hospital

    Manchester, M23 9LT
    United Kingdom

    Site Not Available

  • The Freeman Hospital

    Newcastle upon Tyne, NE7 7DN
    United Kingdom

    Site Not Available

  • University Hospital

    Cincinnati, Ohio 45267-0542
    United States

    Site Not Available

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