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

PHASE3CompletedINTERVENTIONAL
Enrollment

850

Participants

Timeline

Start Date

February 24, 2003

Primary Completion Date

October 7, 2009

Study Completion Date

October 7, 2009

Conditions
Heart TransplantationLiver TransplantationKidney Transplantation
Interventions
DRUG

FK506E

oral

Trial Locations (105)

4

National Liver Transplantation Unit, Dublin

9

Beaumont Private Clinic, Dublin

1070

Hospital Erasme, Brussels

1082

Semmelweis University of Medicine, Budapest

1090

AKN Wien, Vienna

1200

Cliniques Universitaires St. Luc, Brussels

2050

Royal Prince Alfred Hospital, Camperdown

3000

Universitair Ziekenhuis Gasthuisberg, Leuven

3050

Royal Melbourne Hospital, Melbourne

3084

Austin Hospital, Heidelberg

4000

Domaine Universitaire du Sart Tillman, Liège

4001

St Augustine's Hospital, Durban

4102

Princess Alexandra Hospital, Brisbane

6020

Landeskrankenhaus Innsbruck, Innsbruck

6229

Akademisch Ziekenhuis Maastricht, Maastricht

7505

University of Stellenbosch, Tygerberg Hospital, Tygerberg

7925

Groote Schuur Hospital, Cape Town

8001

Christiaan Barnard Memorial Hospital, Cape Town

8091

Universitätsspital Zürich, Zurich

8200

Skejby University Hospital, Århus N

9000

Departement Heelkunde, Ghent

10117

Universitätsklinik Charité, Berlin

13353

Charite Campus Virchow Klinikum, Berlin

14000

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

14021

IKEM, Prague

14186

Karolinska University Hospital Huddinge, Stockholm

15706

Hospital Clinico Universitario de Santiago, Santiago de Compostela

16132

DISCAT - Centro Trapianti, Genova

20122

Azienda Ospedaliera Ospedale Maggiore di Milano, Milan

20246

Universitäts-Krankenhaus Eppendorf, Hamburg

24122

Ospedali Riuniti di Bergamo, Bergamo

28007

Hospital General Universitario Gregorio Maranón, Madrid

28034

Hospital Ramon y Cajal, Madrid

28041

Consultas de Trasplante Renal, Madrid

30625

Medizinische Hochschule Hannover, Hanover

31008

Clinica de Navarra, Pamplona

31059

Hôpital Rangueil, Toulouse

32545

Herz- und Diabeteszentrum NRW, Bad Oeynhausen

33006

Hospital Central de Asturias, Oviedo

33100

Clinica Chirurgica Universitaria, Udine

34295

Hopital Saint-Eloi, Montpellier

Hôpital Lapeyronie, Montpellier

35033

Hopital Pontchaillou, Rennes

35128

Azienda Ospedaliera di Padova, Padua

38043

Chu Nord, Grenoble

40138

Unita Operativa Trapianto di Fegato e Multiorgano, Bologna

41100

Azienda Ospedaliera Policlinico di Modena, Modena

41345

SU/Sahlgrenska University Hospital, Gothenburg

42055

CHU Saint-Etienne, Saint-Etienne

44093

Hopital Laennec, Nantes

Hotel Dieu, Nantes

44892

Knappschaftskrankenhaus Bochum-Langendreer, Bochum

45122

Universitätklinikum Essen, Essen

48903

Hospital de Cruces, Barakaldo

51109

DR MED Wolfgang Arns, Cologne

53100

Unita Operativa Complessa di Chirurgia dei Trapianti, Siena

59037

Hôpital Calmette, Lille

60590

Funktionsbereich Nephrologie, Frankfurt am Main

62448

Instituto Mexicano de Transplantes Cuernava, Morelos

67098

Hôpital Hautepierre, Strasbourg

69120

Leiter Viszerale Organtransplantation, Heidelberg

69437

Hôpital Edouard Hérriot, Lyon

81675

Klinikum Rechts der Isar, München

90134

ISMETT, Palermo

91504

Medizinische Klink IV, Erlangen

92118

Hôpital Beaujon, Clichy

93042

Klinik und Poliklinik fuer Chirurgie, Regensburg

93053

Klinikum der Universität Regensburg, Regensburg

94000

Hôpital Henri Mondor, Créteil

94010

Hôpital Henri Mondor, Créteil

94275

Hôpital Bicêtre, Le Kremlin-Bicêtre

94804

Hopital Paul Brousse, Villejuif

45267-0542

University Hospital, Cincinnati

13083-888

Hospital da Clínicas da UNICAMP, Campinas

90020-090

Hospital São Francisco, Porto Alegre

Irmandade da Santa Casa de Misericordia de Porto Alegre, Porto Alegre

21041-030

Hospital Geral de Bonsucesso, Rio de Janeiro

T6G 2B7

University of Alberta, Edmonton

N6A 5A5

London Health Sciences Centre, London

K1Y 4W7

University of Ottawa Heart Institute, Ottawa

H1T 1C8

Institut de Cardiologie de Montréal, Montreal

H2X 3J4

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

H3A 1A1

Royal Victoria Hospital, Montreal

V5Z 1L7

Vancouver Hospital & Health Sciences Centre, Vancouver

00130

Helsinki University Central Hospital, Helsinki

06002

Service de Nephrologie, Nice

06120

Univ. Klinik und Poliklinik fuer Urologie, Halle

00168

Policlinico Universitario Agostino Gemelli, Roma

Unknown

New Zealand Liver Transplant Unit, Auckland

85-094

Samodzielny Publiczny Szpital Kliniczny, Bydgoszcz

70-111

Samodzielny Publiczny Szpital Kliniczny, Szczecin

0181

Jacaranda Hospital, Pretoria

08025

Servicio de Nefrologia, Barcelona

08035

Hospital Vall d'Hebron, Barcelona

Servicio de Nefrologia, Barcelona

08036

Hospital Clinic i Provincial, Barcelona

Unidad de Trasplante Hepatico, Barcelona

08916

Servicio de Nefrologia, Barcelona

CV2 2DX

Walsgrove Hospital, Coventry

B15 2TH

Queen Elizabeth Hospital, Edgbaston

G11 6NT

Western Infirmary, Glasgow

SE5 9RS

Kings College Hospital, London

M13 9WL

Department of Renal Medicine, Manchester

M23 9LT

Wythenshaw Hospital, Manchester

NE7 7DN

The Freeman Hospital, Newcastle upon Tyne

All Listed Sponsors
lead

Astellas Pharma Europe Ltd.

INDUSTRY

NCT02118896 - 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 | Biotech Hunter | Biotech Hunter