Study Details

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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

This trial is complete
The study has ended normally, and participants are no longer being examined or treated (that is, the last participant's last visit has occurred).

Clinicaltrials.gov ID

The unique identification code given to each clinical study upon registration at ClinicalTrials.gov.
NCT02118896

Astellas Study ID

The unique identification code given by the study sponsor.

F506-CL-0857

EudraCT ID

The unique identification code given to each clinical study upon registration at EudraCT (European Union Drug Regulating Authorities Clinical Trials Database).

2005-005714-20

Follow Trial

Condition

Heart Transplants, Liver Transplants, Kidney Transplants

Phase

These clinical trials are done to confirm that an experimental treatment helps participants who have a specific condition. These clinical trials often compare the experimental treatment to another treatment or, if appropriate, a placebo.

Phase 3

Age

18 years - N/A

Sex

Female & Male

Product

N/A

Type

A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

Interventional

Trial Dates

Feb 2003 - Oct 2009

Masking

None (Open Label)

Enrollment number

850

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 summary

Study documents

Study Documents, including study results, are available after a study is completed or terminated, according to Astellas Transparency policy.

Get More Information

Would you like more information about clinical trial sites that are recruiting participants for 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? Contact us by filling our your information to the right and we’ll respond to you.

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Locations

Skejby University Hospital

Århus N, Denmark, 8200

London Health Sciences Centre

London, Canada, N6A 5A5

Departement Heelkunde

Gent, Belgium, 9000

Hôpital Henri Mondor

Créteil, France, 94000

Herz- und Diabeteszentrum NRW

Bad Oeynhausen, Germany, 32545

Karolinska University Hospital Huddinge

Stockholm, Sweden, 14186

Walsgrove Hospital

Coventry, United Kingdom, CV2 2DX

Hopital Pontchaillou

Rennes, France, 35033

Hospital Geral de Bonsucesso

Rio de Janeiro, Brazil, 21041-030

The Freeman Hospital

Newcastle upon Tyne, United Kingdom, NE7 7DN

Hospital Erasme

Bruxelles, Belgium, 1070

Hospital Clinico Universitario de Santiago

Santiago de Compostela, Spain, 15706

Queen Elizabeth Hospital

Edgbaston, United Kingdom, B15 2TH

Royal Victoria Hospital

Montreal, Canada, H3A 1A1

Akademisch Ziekenhuis Maastricht

Maastricht, Netherlands, 6229

Unita Operativa Trapianto di Fegato e Multiorgano

Bologna, Italy, 40138

National Liver Transplantation Unit

Dublin, Ireland, 4

Hopital Saint-Eloi

Montpellier, France, 34295

Medizinische Klink IV

Erlangen, Germany, 91504

DISCAT - Centro Trapianti

Genova, Italy, 16132

Hôpital Edouard Hérriot

Lyon, France, 69437

Charite Campus Virchow Klinikum

Berlin, Germany, 13353

University of Stellenbosch, Tygerberg Hospital

Tygerberg, South Africa, 7505

Universitair Ziekenhuis Gasthuisberg

Leuven, Belgium, 3000

Royal Melbourne Hospital

Melbourne, Australia, 3050

Service de Nephrologie

Nice, France, 06002

Royal Prince Alfred Hospital

Camperdown, Australia, 2050

Vancouver Hospital & Health Sciences Centre

Vancouver, Canada, V5Z 1L7

Irmandade da Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Brazil, 90020-090

Servicio de Nefrologia

Barcelona, Spain, 08916

Klinikum der Universität Regensburg

Regensburg, Germany, 93053

Western Infirmary

Glasgow, United Kingdom, G11 6NT

Knappschaftskrankenhaus Bochum-Langendreer

Bochum, Germany, 44892

Universitäts-Krankenhaus Eppendorf

Hamburg, Germany, 20246

Christiaan Barnard Memorial Hospital

Cape Town, South Africa, 8001

Hospital Clinic i Provincial

Barcelona, Spain, 08036

Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán"

Tlalpan, Mexico, 14000

Samodzielny Publiczny Szpital Kliniczny

Szczecin, Poland, 70-111

Hôpital Rangueil

Toulouse, France, 31059

University of Alberta

Edmonton, Canada, T6G 2B7

Hospital da Clínicas da UNICAMP

Campinas, Brazil, 13083-888

Servicio de Nefrologia

Barcelona, Spain, 08035

Hopital Paul Brousse

Villejuif, France, 94804

Unidad de Trasplante Hepatico

Barcelona, Spain, 08036

Servicio de Nefrologia

Barcelona, Spain, 08025

Groote Schuur Hospital

Cape Town, South Africa, 7925

Hôpital Beaujon

Clichy, France, 92118

DR MED Wolfgang Arns

Koeln, Germany, 51109

Hospital General Universitario Gregorio Maranón

Madrid, Spain, 28007

Hôpital Bicêtre

Le Kremlin-Bicêtre, France, 94275

Clinica de Navarra

Pamplona, Spain, 31008

Ospedali Riuniti di Bergamo

Bergamo, Italy, 24122

Semmelweis University of Medicine

Budapest, Hungary, 1082

Funktionsbereich Nephrologie

Frankfurt/Main, Germany, 60590

Chu Nord

Grenoble, France, 38043

Kings College Hospital

London, United Kingdom, SE5 9RS

Medizinische Hochschule Hannover

Hannover, Germany, 30625

University of Ottawa Heart Institute

Ottawa, Canada, K1Y 4W7

Helsinki University Central Hospital

Helsinki, Finland, 00130

Consultas de Trasplante Renal

Madrid, Spain, 28041

Policlinico Universitario Agostino Gemelli

Roma, Italy, 00168

Samodzielny Publiczny Szpital Kliniczny

Bydgoszcz, Poland, 85-094

Hospital Central de Asturias

Oviedo, Spain, 33006

Wythenshaw Hospital

Manchester, United Kingdom, M23 9LT

Azienda Ospedaliera di Padova

Padova, Italy, 35128

University Hospital

Cincinnati, United States, 45267-0542

Hôpital Lapeyronie

Montpellier, France, 34295

AKN Wien

Wien, Austria, 1090

St Augustine's Hospital

Durban, South Africa, 4001

Princess Alexandra Hospital

Brisbane, Australia, 4102

Institut de Cardiologie de Montréal

Montréal, Canada, H1T 1C8

Austin Hospital

Heidelberg, Australia, 3084

SU/Sahlgrenska University Hospital

Gothenburg, Sweden, 41345

Azienda Ospedaliera Policlinico di Modena

Modena, Italy, 41100

IKEM

Praha 4, Czech Republic, 14021

Hotel Dieu

Nantes, France, 44093

New Zealand Liver Transplant Unit

Auckland, New Zealand

Klinikum Rechts der Isar

Munchen, Germany, 81675

Universitätklinikum Essen

Essen, Germany, 45122

Hôpital Henri Mondor

Creteil, France, 94010

Cliniques Universitaires St. Luc

Bruxelles, Belgium, 1200

Beaumont Private Clinic

Dublin, Ireland, 9

CHU Saint-Etienne

St Etienne, France, 42055

ISMETT

Palermo, Italy, 90134

Hospital Vall d'Hebron

Barcelona, Spain, 08035

Klinik und Poliklinik fuer Chirurgie

Regensburg, Germany, 93042

Hôpital Calmette

Lille, France, 59037

Domaine Universitaire du Sart Tillman

Liege, Belgium, 4000

Jacaranda Hospital

Pretoria, South Africa, 0181

Universitätsklinik Charité

Berlin, Germany, 10117

Instituto Mexicano de Transplantes Cuernava

Morelos, Mexico, 62448

Unita Operativa Complessa di Chirurgia dei Trapianti

Siena, Italy, 53100

Clinica Chirurgica Universitaria

Udine, Italy, 33100

Department of Renal Medicine

Manchester, United Kingdom, M13 9WL

Landeskrankenhaus Innsbruck

Innsbruck, Austria, 6020

Hospital de Cruces

Barakaldo, Spain, 48903

Hôpital Hautepierre

Strasbourg, France, 67098

Centre Hospitalier de l'Universite de Montreal (CHUM)

Montreal, Canada, H2X 3J4

Universitätsspital Zürich

Zurich, Switzerland, 8091

Hopital Laennec

Nantes, France, 44093

Hospital São Francisco

Porto Alegre, Brazil, 90020-090

Univ. Klinik und Poliklinik fuer Urologie

Halle, Germany, 06120

Hospital Ramon y Cajal

Madrid, Spain, 28034

Leiter Viszerale Organtransplantation

Heidelberg, Germany, 69120

Azienda Ospedaliera Ospedale Maggiore di Milano

Milano, Italy, 20122

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