Clinical trial 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Heart Transplantation
Liver Transplantation
Kidney Transplantation
Keywords: FK506E
Heart Transplantation
MR4
Tacrolimus
Advagraf
Kidney Transplantation
Renal Transplantation
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2014-04-21
Enrollment: 850
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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 had 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.

Primary outcomes:
measure: Participant Survival
timeFrame: Up to 5.5 years (66 months (phase II) and 24 months (phase III)).
measure: Graft Survival
timeFrame: Up to 5.5 years ((66 months (phase II) and 30 months (phase III)).
Secondary outcomes:
measure: Biopsy-confirmed Acute Rejection (BCAR) Episodes
timeFrame: Up to 6 years.
measure: Time to First BCAR Episode
timeFrame: Up to 1344 days (3.75 years).
measure: Number of Participants With Adverse Events
timeFrame: From first dose to duration of participation in the study (up to 6 years and 28 days after EOS).
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University Hospital
state: Ohio
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Brisbane
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Heidelberg
country: Australia
facility: Austin Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Innsbruck
country: Austria
facility: Landeskrankenhaus Innsbruck
city: Wien
country: Austria
facility: AKN Wien
city: Bruxelles
country: Belgium
facility: Hospital Erasme
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires St. Luc
city: Gent
country: Belgium
facility: Departement Heelkunde
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Gasthuisberg
city: Liege
country: Belgium
facility: Domaine Universitaire du Sart Tillman
city: Campinas
country: Brazil
facility: Hospital da Clínicas da UNICAMP
city: Porto Alegre
country: Brazil
facility: Hospital São Francisco
city: Porto Alegre
country: Brazil
facility: Irmandade da Santa Casa de Misericordia de Porto Alegre
city: Rio de Janeiro
country: Brazil
facility: Hospital Geral de Bonsucesso
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Universite de Montreal (CHUM)
state: Quebec
city: Montreal
country: Canada
facility: Royal Victoria Hospital
state: Quebec
city: Montréal
country: Canada
facility: Institut de Cardiologie de Montréal
state: Quebec
city: Vancouver
country: Canada
facility: Vancouver Hospital & Health Sciences Centre
city: Praha 4
country: Czechia
facility: IKEM
city: Århus N
country: Denmark
facility: Skejby University Hospital
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
city: Le Kremlin-Bicêtre
country: France
facility: Hôpital Bicêtre
state: Bicetre Cedex
city: Montpellier
country: France
facility: Hopital Saint-Eloi
state: Cedex 05
city: Nantes
country: France
facility: Hopital Laennec
state: Cedex 1
city: Nantes
country: France
facility: Hotel Dieu
state: Cedex 1
city: Nice
country: France
facility: Service de Nephrologie
state: Cedex 1
city: Lyon
country: France
facility: Hôpital Edouard Hérriot
state: Cedex 3
city: Montpellier
country: France
facility: Hôpital Lapeyronie
state: Cedex 5
city: Toulouse
country: France
facility: Hôpital Rangueil
state: Cedex 9
city: Lille
country: France
facility: Hôpital Calmette
state: Cedex
city: Rennes
country: France
facility: Hopital Pontchaillou
state: Cedex
city: Clichy
country: France
facility: Hôpital Beaujon
city: Creteil
country: France
facility: Hôpital Henri Mondor
city: Créteil
country: France
facility: Hôpital Henri Mondor
city: Grenoble
country: France
facility: Chu Nord
city: St Etienne
country: France
facility: CHU Saint-Etienne
city: Strasbourg
country: France
facility: Hôpital Hautepierre
city: Villejuif
country: France
facility: Hopital Paul Brousse
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum NRW
city: Berlin
country: Germany
facility: Universitätsklinik Charité
city: Berlin
country: Germany
facility: Charite Campus Virchow Klinikum
city: Bochum
country: Germany
facility: Knappschaftskrankenhaus Bochum-Langendreer
city: Erlangen
country: Germany
facility: Medizinische Klink IV
city: Essen
country: Germany
facility: Universitätklinikum Essen
city: Frankfurt/Main
country: Germany
facility: Funktionsbereich Nephrologie
city: Halle
country: Germany
facility: Univ. Klinik und Poliklinik fuer Urologie
city: Hamburg
country: Germany
facility: Universitäts-Krankenhaus Eppendorf
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Heidelberg
country: Germany
facility: Leiter Viszerale Organtransplantation
city: Koeln
country: Germany
facility: DR MED Wolfgang Arns
city: Munchen
country: Germany
facility: Klinikum Rechts der Isar
city: Regensburg
country: Germany
facility: Klinik und Poliklinik fuer Chirurgie
city: Regensburg
country: Germany
facility: Klinikum der Universität Regensburg
city: Budapest
country: Hungary
facility: Semmelweis University of Medicine
city: Dublin
country: Ireland
facility: National Liver Transplantation Unit
city: Dublin
country: Ireland
facility: Beaumont Private Clinic
city: Bergamo
country: Italy
facility: Ospedali Riuniti di Bergamo
city: Bologna
country: Italy
facility: Unita Operativa Trapianto di Fegato e Multiorgano
city: Genova
country: Italy
facility: DISCAT - Centro Trapianti
city: Milano
country: Italy
facility: Azienda Ospedaliera Ospedale Maggiore di Milano
city: Modena
country: Italy
facility: Azienda Ospedaliera Policlinico di Modena
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
city: Palermo
country: Italy
facility: ISMETT
city: Roma
country: Italy
facility: Policlinico Universitario Agostino Gemelli
city: Siena
country: Italy
facility: Unita Operativa Complessa di Chirurgia dei Trapianti
city: Udine
country: Italy
facility: Clinica Chirurgica Universitaria
city: Morelos
country: Mexico
facility: Instituto Mexicano de Transplantes Cuernava
city: Tlalpan
country: Mexico
facility: Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán"
city: Maastricht
country: Netherlands
facility: Akademisch Ziekenhuis Maastricht
city: Auckland
country: New Zealand
facility: New Zealand Liver Transplant Unit
city: Bydgoszcz
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny
city: Szczecin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny
city: Cape Town
country: South Africa
facility: Groote Schuur Hospital
city: Cape Town
country: South Africa
facility: Christiaan Barnard Memorial Hospital
city: Durban
country: South Africa
facility: St Augustine's Hospital
city: Pretoria
country: South Africa
facility: Jacaranda Hospital
city: Tygerberg
country: South Africa
facility: University of Stellenbosch, Tygerberg Hospital
city: Barakaldo
country: Spain
facility: Hospital de Cruces
state: Vizcaya
city: Barcelona
country: Spain
facility: Servicio de Nefrologia
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Barcelona
country: Spain
facility: Servicio de Nefrologia
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial
city: Barcelona
country: Spain
facility: Unidad de Trasplante Hepatico
city: Barcelona
country: Spain
facility: Servicio de Nefrologia
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranón
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal
city: Madrid
country: Spain
facility: Consultas de Trasplante Renal
city: Oviedo
country: Spain
facility: Hospital Central de Asturias
city: Pamplona
country: Spain
facility: Clinica de Navarra
city: Santiago de Compostela
country: Spain
facility: Hospital Clinico Universitario de Santiago
city: Gothenburg
country: Sweden
facility: SU/Sahlgrenska University Hospital
city: Stockholm
country: Sweden
facility: Karolinska University Hospital Huddinge
city: Zurich
country: Switzerland
facility: Universitätsspital Zürich
city: Coventry
country: United Kingdom
facility: Walsgrove Hospital
city: Edgbaston
country: United Kingdom
facility: Queen Elizabeth Hospital
city: Glasgow
country: United Kingdom
facility: Western Infirmary
city: London
country: United Kingdom
facility: Kings College Hospital
city: Manchester
country: United Kingdom
facility: Department of Renal Medicine
city: Manchester
country: United Kingdom
facility: Wythenshaw Hospital
city: Newcastle upon Tyne
country: United Kingdom
facility: The Freeman Hospital
Study officials:
affiliation: Astellas Pharma Europe Ltd.
name: Central Contact
role: STUDY_CHAIR
References: