DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



This Study is 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

Information source: Astellas Pharma Inc
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Kidney Transplantation; Liver Transplantation; Heart Transplantation

Intervention: FK506E (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Astellas Pharma Europe Ltd.

Official(s) and/or principal investigator(s):
Central Contact, Study Chair, Affiliation: Astellas Pharma Europe Ltd.

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.

Clinical Details

Official title: A Long-term Follow up Study to Evaluate the Safety and Efficacy in Transplant Recipients Treated With Modified Release Tacrolimus, FK506E (MR4), Based Immunosuppression Regimen

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Patient survival

Graft survival

Secondary outcome:

Incidence of first biopsy-proven acute rejection episodes

Time to first biopsy-proven acute rejection episodes

Incidence of adverse events

Detailed description: Only patients who have participated in one of the phase II PK or phase III studies on FK506E (MR4) and have received at least one dose of study medication will be enrolled.

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients who had already participated in the previous phase II pharmacokinetic or

phase III studies with FK506E (MR4).

- Patients capable of understanding the purpose and risks of the study, who have been

fully informed and given written informed consent to participate in the study. Exclusion Criteria:

- Pregnant women or nursing mothers.

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

Locations and Contacts

Landeskrankenhaus Innsbruck, Innsbruck 6020, Austria

AKN Wien, Wien 1090, Austria

Cliniques Universitaires St. Luc, Bruxelles 1200, Belgium

Hospital Erasme, Bruxelles 1070, Belgium

Departement Heelkunde, Gent 9000, Belgium

Universitair Ziekenhuis Gasthuisberg, Leuven 3000, Belgium

Domaine Universitaire du Sart Tillman, Liege 4000, Belgium

Hospital da Clínicas da UNICAMP, Campinas 13083-888, Brazil

Hospital São Francisco, Porto Alegre 90020-090, Brazil

Irmandade da Santa Casa de Misericordia de Porto Alegre, Porto Alegre 90020-090, Brazil

Hospital Geral de Bonsucesso, Rio de Janeiro 21041-030, Brazil

Vancouver Hospital & Health Sciences Centre, Vancouver V5Z 1L7, Canada

IKEM, Praha 4 14021, Czech Republic

Skejby University Hospital, Århus N 8200, Denmark

Helsinki University Central Hospital, Helsinki 00130, Finland

Hôpital Beaujon, Clichy 92118, France

Hôpital Henri Mondor, Creteil 94010, France

Hôpital Henri Mondor, Créteil 94000, France

Chu Nord, Grenoble 38043, France

CHU Saint-Etienne, St Etienne 42055, France

Hôpital Hautepierre, Strasbourg 67098, France

Hopital Paul Brousse, Villejuif 94804, France

Herz- und Diabeteszentrum NRW, Bad Oeynhausen 32545, Germany

Charite Campus Virchow Klinikum, Berlin 13353, Germany

Universitätsklinik Charité, Berlin 10117, Germany

Knappschaftskrankenhaus Bochum-Langendreer, Bochum 44892, Germany

Medizinische Klink IV, Erlangen 91504, Germany

Universitätklinikum Essen, Essen 45122, Germany

Funktionsbereich Nephrologie, Frankfurt/Main 60590, Germany

Univ. Klinik und Poliklinik fuer Urologie, Halle 06120, Germany

Universitäts-Krankenhaus Eppendorf, Hamburg 20246, Germany

Medizinische Hochschule Hannover, Hannover 30625, Germany

Leiter Viszerale Organtransplantation, Heidelberg 69120, Germany

DR MED Wolfgang Arns, Koeln 51109, Germany

Klinikum Rechts der Isar, Munchen 81675, Germany

Klinik und Poliklinik fuer Chirurgie, Regensburg 93042, Germany

Klinikum der Universität Regensburg, Regensburg 93053, Germany

Semmelweis University of Medicine, Budapest 1082, Hungary

Beaumont Private Clinic, Dublin 9, Ireland

National Liver Transplantation Unit, Dublin 4, Ireland

Ospedali Riuniti di Bergamo, Bergamo 24122, Italy

Unita Operativa Trapianto di Fegato e Multiorgano, Bologna 40138, Italy

DISCAT - Centro Trapianti, Genova 16132, Italy

Azienda Ospedaliera Ospedale Maggiore di Milano, Milano 20122, Italy

Azienda Ospedaliera Policlinico di Modena, Modena 41100, Italy

Azienda Ospedaliera di Padova, Padova 35128, Italy

ISMETT, Palermo 90134, Italy

Policlinico Universitario Agostino Gemelli, Roma 00168, Italy

Unita Operativa Complessa di Chirurgia dei Trapianti, Siena 53100, Italy

Clinica Chirurgica Universitaria, Udine 33100, Italy

Instituto Mexicano de Transplantes Cuernava, Morelos 62448, Mexico

Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán", Tlalpan 14000, Mexico

Akademisch Ziekenhuis Maastricht, Maastricht 6229, Netherlands

New Zealand Liver Transplant Unit, Auckland, New Zealand

Samodzielny Publiczny Szpital Kliniczny, Bydgoszcz 85-094, Poland

Samodzielny Publiczny Szpital Kliniczny, Szczecin 70-111, Poland

Christiaan Barnard Memorial Hospital, Cape Town 8001, South Africa

Groote Schuur Hospital, Cape Town 7925, South Africa

St Augustine's Hospital, Durban 4001, South Africa

Jacaranda Hospital, Pretoria 0181, South Africa

University of Stellenbosch, Tygerberg Hospital, Tygerberg 7505, South Africa

Hospital Clinic i Provincial, Barcelona 08036, Spain

Hospital Vall d'Hebron, Barcelona 08035, Spain

Servicio de Nefrologia, Barcelona 08916, Spain

Servicio de Nefrologia, Barcelona 08035, Spain

Servicio de Nefrologia, Barcelona 08025, Spain

Unidad de Trasplante Hepatico, Barcelona 08036, Spain

Consultas de Trasplante Renal, Madrid 28041, Spain

Hospital General Universitario Gregorio Maranón, Madrid 28007, Spain

Hospital Ramon y Cajal, Madrid 28034, Spain

Hospital Central de Asturias, Oviedo 33006, Spain

Clinica de Navarra, Pamplona 31008, Spain

Hospital Clinico Universitario de Santiago, Santiago de Compostela 15706, Spain

SU/Sahlgrenska University Hospital, Gothenburg 41345, Sweden

Karolinska University Hospital Huddinge, Stockholm 14186, Sweden

Universitätsspital Zürich, Zurich 8091, Switzerland

Walsgrove Hospital, Coventry CV2 2DX, United Kingdom

Queen Elizabeth Hospital, Edgbaston B15 2TH, United Kingdom

Western Infirmary, Glasgow G11 6NT, United Kingdom

Kings College Hospital, London SE5 9RS, United Kingdom

Department of Renal Medicine, Manchester M13 9WL, United Kingdom

Wythenshaw Hospital, Manchester M23 9LT, United Kingdom

The Freeman Hospital, Newcastle upon Tyne NE7 7DN, United Kingdom

University of Alberta, Edmonton, Alberta T6G 2B7, Canada

Hôpital Bicêtre, Le Kremlin-Bicêtre, Bicetre Cedex 94275, France

Hôpital Calmette, Lille, Cedex 59037, France

Hopital Pontchaillou, Rennes, Cedex 35033, France

Hopital Saint-Eloi, Montpellier, Cedex 05 34295, France

Hopital Laennec, Nantes, Cedex 1 44093, France

Hotel Dieu, Nantes, Cedex 1 44093, France

Service de Nephrologie, Nice, Cedex 1 06002, France

Hôpital Edouard Hérriot, Lyon, Cedex 3 69437, France

Hôpital Lapeyronie, Montpellier, Cedex 5 34295, France

Hôpital Rangueil, Toulouse, Cedex 9 31059, France

Royal Prince Alfred Hospital, Camperdown, New South Wales 2050, Australia

University Hospital, Cincinnati, Ohio 45267-0542, United States

London Health Sciences Centre, London, Ontario N6A 5A5, Canada

University of Ottawa Heart Institute, Ottawa, Ontario K1Y 4W7, Canada

Centre Hospitalier de l'Universite de Montreal (CHUM), Montreal, Quebec H2X 3J4, Canada

Royal Victoria Hospital, Montreal, Quebec H3A 1A1, Canada

Institut de Cardiologie de Montréal, Montréal, Quebec H1T 1C8, Canada

Princess Alexandra Hospital, Brisbane, Queensland 4102, Australia

Austin Hospital, Heidelberg, Victoria 3084, Australia

Royal Melbourne Hospital, Melbourne, Victoria 3050, Australia

Hospital de Cruces, Barakaldo, Vizcaya 48903, Spain

Additional Information

Link to Results on JAPIC - enter 140509 in the JapicCTI-RNo. field

Starting date: January 2003
Last updated: July 14, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017