Clinical trial NCT02057484: A 5 Year Follow-up of Patients Who Were Previously Enrolled Into an Advagraf Trial Following a Liver or Kidney Transplant
Official title: A Long-term Follow-up of Adult Kidney and Liver Allograft Recipients Previously Enrolled Into a Tacrolimus (Advagraf) Trial. A Multicentre Non-interventional Post Authorization Study (PAS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Transplant
Kidney Transplant
Keywords: long-term follow-up
liver transplant
kidney transplant
Advagraf
Tacrolimus
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2014-02-07
Enrollment: 2300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who had previously participated in the following Astellas sponsored clinical trial also known as "feeder trials":

DIAMOND / PMR-EC1106 ADVANCE / PMR-EC-1211 ADHERE / PMR-EC-1212 Any potential new Astellas-sponsored Advagraf trial

Brief summary: The purpose of this study is to evaluate the impact of Advagraf, prolonged-release, once daily tacrolimus formulation, on long-term graft survival in kidney and liver allograft recipients. This study will also evaluate the overall long-term impact of Advagraf on kidney and liver allograft recipients.

Detailed description: Prograf is one of the medications taken by a patient after they have had a liver or kidney transplant to prevent their body from rejecting the new liver or kidney transplant. Prograf is taken by the patient twice a day. Advagraf is a similar medication but is taken by the patient only once a day. There is some evidence emerging that may show that this once-a-day medication may show additional benefits over the twice a day medication, such as, patients more likely to remember to take this medication. Also, this once a day medication is slowly released in the body through the course of a day which in turn may provide better protection against the body rejecting the new transplanted organ over a longer period.

This study will follow up adult patients who were previously enrolled in an Advagraf trial after they have had a liver or kidney transplant. The information collected for this study will be information that the patient's doctor will normally collect when he/she sees the patient for their regular check-ups. Information will be collected once a year for a period of 5 years from when the patient received their new organ transplant. It is hoped that patient information collected during the study will provide prescribers with useful information in treatment of organ transplant patients.

Eligibility criteria: Inclusion Criteria:

* Participated in one of the selected Astellas sponsored clinical trials :

  * DIAMOND - PMR-EC-1106
  * ADVANCE - PMR-EC-1211
  * ADHERE - PMR-EC-1212
  * Or, any potential new Astellas-sponsored Advagraf trial
* Assigned to treatment with Advagraf in one of the selected Astellas sponsored clinical trials and received a kidney or liver organ transplant.

NOTE: The primary objective is to study long-term graft survival in patients currently or previously treated with Advagraf. Therefore patients do not have to be currently receiving Advagraf to be included, nor do they have to have completed a previous Astellas clinical trial.

Exclusion Criteria:

* No exclusion criteria

Primary outcomes:
measure: Overall graft survival (time to graft loss)
timeFrame: Annually from date of transplant and for 5 five years
Secondary outcomes:
measure: Overall patient survival
timeFrame: Annually from date of transplant and for 5 five years
measure: Renal Function
timeFrame: Annually from date of transplant and for 5 five years
measure: Emergence of de novo Donor Specific Antibody
timeFrame: Annually from date of transplant and for 5 five years
measure: Biopsy proven acute rejection episodes
timeFrame: Annually from date of transplant and for 5 five years
measure: Immunosuppression regimen
timeFrame: Annually from date of transplant and for 5 five years
measure: Medical conditions of interest
timeFrame: Annually from date of transplant and for 5 five years
measure: Infections of interest
timeFrame: Annually from date of transplant and for 5 five years
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Site AT43001
city: Linz
country: Austria
facility: Site AT43003
city: Vienna
country: Austria
facility: Site AT43002
city: Minsk
country: Belarus
facility: Site BY37501
city: Brussels
country: Belgium
facility: Site BE32007
state: Brussels Hoofdstedelijk Gewest
city: Brussels
country: Belgium
facility: Site BE32002
city: Gent
country: Belgium
facility: Site BE32001
city: Leuven
country: Belgium
facility: Site BE32003
city: Leuven
country: Belgium
facility: Site BE32005
city: Liege
country: Belgium
facility: Site BE32008
city: Liege
country: Belgium
facility: Site BE32009
city: Halifax
country: Canada
facility: Site CA15001
state: Nova Scotia
city: Montreal
country: Canada
facility: Site CA15003
state: Quebec
city: Brno
country: Czechia
facility: Site CZ42006
city: Hradec Kralove
country: Czechia
facility: Site CZ42004
city: Olomouc
country: Czechia
facility: Site CZ42003
city: Ostrava
country: Czechia
facility: Site CZ42005
city: Prague 4
country: Czechia
facility: Site CZ42001
city: Prague 4
country: Czechia
facility: Site CZ42002
city: Tartu
country: Estonia
facility: Site EE37201
city: Helsinki
country: Finland
facility: Site FI35801
city: Helsinki
country: Finland
facility: Site FI35802
city: Angers Cedex 09
country: France
facility: Site FR33020
city: Besancon
country: France
facility: Site FR33007
city: Bordeaux
country: France
facility: Site FR33012
city: Brest
country: France
facility: Site FR33025
city: Clermont-Ferrand
country: France
facility: Site FR33027
city: Clichy, Paris
country: France
facility: Site FR33003
city: Creteil
country: France
facility: Site FR33001
city: Creteil
country: France
facility: Site FR33029
city: Dijon
country: France
facility: Site FR33032
city: Le Kremlin Bicetre
country: France
facility: Site FR33026
city: Limoges Cedex 1
country: France
facility: Site FR33018
city: Marseille Cedex 05
country: France
facility: Site FR33011
city: Montpellier Cedex 05
country: France
facility: Site FR33014
city: Nantes Cedex 01
country: France
facility: Site FR33023
city: Nice Cedex 1
country: France
facility: Site FR33015
city: Nice Cedex 3
country: France
facility: Site FR33004
city: Paris cedex 13
country: France
facility: Site FR33010
city: Paris Cedex 15
country: France
facility: Site FR33031
city: Paris Cedex 20
country: France
facility: Site FR33019
city: Paris
country: France
facility: Site FR33008
city: Rouen Cedex
country: France
facility: Site FR33024
city: Saint Etienne
country: France
facility: Site FR33022
city: Strasbourg
country: France
facility: Site FR33017
city: Toulouse Cedex 4
country: France
facility: Site FR33034
city: Tours Cedex
country: France
facility: Site FR33030
city: Tours
country: France
facility: Site FR33009
city: Vandoeuvre les Nancy
country: France
facility: Site FR33028
city: Villejuif
country: France
facility: Site FR33002
city: Aachen
country: Germany
facility: Site DE49011
city: Berlin
country: Germany
facility: Site DE49004
city: Bochum
country: Germany
facility: Site DE49019
city: Dusseldorf
country: Germany
facility: Site DE49013
city: Essen
country: Germany
facility: Site DE49030
city: Frankfurt am Main
country: Germany
facility: Site DE49001
city: Halle
country: Germany
facility: Site DE49014
city: Hannoversch Munden
country: Germany
facility: Site DE49022
city: Hannover
country: Germany
facility: Site DE49005
city: Hannover
country: Germany
facility: Site DE49018
city: Jena
country: Germany
facility: Site DE49008
city: Kaiserslautern
country: Germany
facility: Site DE49015
city: Kiel
country: Germany
facility: Site DE49002
city: Mannheim
country: Germany
facility: Site DE49027
city: Munich
country: Germany
facility: Site DE49025
city: Munich
country: Germany
facility: Site DE49016
city: Regensburg
country: Germany
facility: Site DE49010
city: Rostock
country: Germany
facility: Site DE49017
city: Tubingen
country: Germany
facility: Site DE49006
city: Budapest
country: Hungary
facility: Site HU36001
city: Debrecen
country: Hungary
facility: Site HU36003
city: Szeged
country: Hungary
facility: Site HU36002
city: Dublin
country: Ireland
facility: Site IE35301
city: Ancona
country: Italy
facility: Site IT39015
city: Bergamo
country: Italy
facility: Site IT39003
city: Bologna
country: Italy
facility: Site IT39005
city: Bologna
country: Italy
facility: Site IT39013
city: Genova
country: Italy
facility: Site IT39006
city: L'Aquila
country: Italy
facility: Site IT39014
city: Milan
country: Italy
facility: Site IT39012
city: Milan
country: Italy
facility: Site IT39009
city: Naples
country: Italy
facility: Site IT39008
city: Padova
country: Italy
facility: Site IT39002
city: Padova
country: Italy
facility: Site IT39010
city: Palermo
country: Italy
facility: Site IT39016
city: Rome
country: Italy
facility: Site IT39004
city: Rome
country: Italy
facility: Site IT39020
city: Salerno
country: Italy
facility: Site IT39017
city: Siena
country: Italy
facility: Site IT39019
city: Treviso
country: Italy
facility: Site IT39021
city: Udine
country: Italy
facility: Site IT39001
city: Vicenza
country: Italy
facility: Site IT39011
city: Busan
country: Korea, Republic of
facility: Site KR82007
city: Daegu
country: Korea, Republic of
facility: Site KR82006
city: Seoul
country: Korea, Republic of
facility: Site KR82002
city: Seoul
country: Korea, Republic of
facility: Site KR82005
city: Seoul
country: Korea, Republic of
facility: Site KR82001
city: Riga
country: Latvia
facility: Site LV37101
city: Maastricht
country: Netherlands
facility: Site NL31001
city: Gdansk
country: Poland
facility: Site PL48003
city: Katowice
country: Poland
facility: Site PL48006
city: Lodz
country: Poland
facility: Site PL48005
city: Poznan
country: Poland
facility: Site PL48007
city: Szczecin
country: Poland
facility: Site PL48004
city: Warsaw
country: Poland
facility: Site PL48001
city: Lisbon
country: Portugal
facility: Site PT35102
city: Bucharest
country: Romania
facility: Site RO40001
city: Bucharest
country: Romania
facility: Site RO40003
city: Ekaterinburg
country: Russian Federation
facility: Site RU70012
city: Kemerovo
country: Russian Federation
facility: Site RU70014
city: Moscow
country: Russian Federation
facility: Site RU70005
city: Moscow
country: Russian Federation
facility: Site RU70002
city: Moscow
country: Russian Federation
facility: Site RU70004
city: Moscow
country: Russian Federation
facility: Site RU70007
city: Omsk
country: Russian Federation
facility: Site RU70010
city: Volzhskiy
country: Russian Federation
facility: Site RU70011
city: Volzhskiy
country: Russian Federation
facility: Site RU70013
city: Banska Bystrica
country: Slovakia
facility: Site SK42101
city: Bratislava
country: Slovakia
facility: Site SK42102
city: Hospitalet de Llobregat
country: Spain
facility: Site ES34001
state: Barcelona
city: Barakaldo
country: Spain
facility: Site ES34019
state: Vizcaya
city: A Coruna
country: Spain
facility: Site ES34005
city: Alicante
country: Spain
facility: Site ES34017
city: Badalona-Barcelona
country: Spain
facility: Site ES34012
city: Barcelona
country: Spain
facility: Site ES34004
city: Barcelona
country: Spain
facility: Site ES34011
city: Barcelona
country: Spain
facility: Site ES34003
city: Cordoba
country: Spain
facility: Site ES34010
city: Hospitalet de Llobregat
country: Spain
facility: Site ES34018
city: Madrid
country: Spain
facility: Site ES34006
city: Madrid
country: Spain
facility: Site ES34013
city: Madrid
country: Spain
facility: Site ES34015
city: Santander
country: Spain
facility: Site ES34020
city: Sevilla
country: Spain
facility: Site ES34014
city: Tenerife
country: Spain
facility: Site ES34009
city: Valencia
country: Spain
facility: Site ES34021
city: Valladolid
country: Spain
facility: Site ES34016
city: Zaragoza
country: Spain
facility: Site ES34007
city: Gothenburg
country: Sweden
facility: Site SE46001
city: Stockholm
country: Sweden
facility: Site SE46002
city: Uppsala
country: Sweden
facility: Site SE46004
city: Bern
country: Switzerland
facility: Site CH41002
city: Birmingham
country: United Kingdom
facility: Site GB44001
city: Leeds
country: United Kingdom
facility: Site GB44003
city: London
country: United Kingdom
facility: Site GB44002
Study officials:
affiliation: Astellas Pharma Europe Ltd.
name: Medical Director
role: STUDY_DIRECTOR
References: