A 5 Year Follow-up of Patients Who Were Previously Enrolled Into an Advagraf Trial Following a Liver or Kidney Transplant
ADDRESS
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)
1 other identifier
observational
2,300
22 countries
137
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2014
Typical duration for all trials
137 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 5, 2014
CompletedFirst Posted
Study publicly available on registry
February 7, 2014
CompletedStudy Start
First participant enrolled
March 3, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 17, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 17, 2017
CompletedOctober 31, 2024
October 1, 2024
3.6 years
February 5, 2014
October 29, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall graft survival (time to graft loss)
At each annual visit there will be a simple assessment to determine if the graft has survived or not.
Annually from date of transplant and for 5 five years
Secondary Outcomes (7)
Overall patient survival
Annually from date of transplant and for 5 five years
Renal Function
Annually from date of transplant and for 5 five years
Emergence of de novo Donor Specific Antibody
Annually from date of transplant and for 5 five years
Biopsy proven acute rejection episodes
Annually from date of transplant and for 5 five years
Immunosuppression regimen
Annually from date of transplant and for 5 five years
- +2 more secondary outcomes
Study Arms (1)
Organ transplant patients treated with Advagraf
To evaluate long-term graft survival in patients treated with Advagraf
Interventions
Eligibility Criteria
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
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (145)
Site AT43001
Innsbruck, 6020, Austria
Site AT43003
Linz, 4010, Austria
Site AT43002
Vienna, 1090, Austria
Site BY37501
Minsk, 220116, Belarus
Site BE32007
Brussels, Brussels Capital, 1090, Belgium
Site BE32002
Brussels, 1070, Belgium
Site BE32001
Ghent, 9000, Belgium
Site BE32003
Leuven, 3000, Belgium
Site BE32005
Leuven, 3000, Belgium
Site BE32008
Liège, 4000, Belgium
Site BE32009
Liège, 4000, Belgium
Site CA15001
Halifax, Nova Scotia, B3H2Y9, Canada
Site CA15003
Montreal, Quebec, H2X3J4, Canada
Site CZ42006
Brno, 65691, Czechia
Site CZ42004
Hradec Králové, 500 05, Czechia
Site CZ42003
Olomouc, 775 00, Czechia
Site CZ42005
Ostrava, 70852, Czechia
Site CZ42001
Prague, 140 21, Czechia
Site CZ42002
Prague, 140 21, Czechia
Site EE37201
Tartu, 51014, Estonia
Site FI35801
Helsinki, 00029, Finland
Site FI35802
Helsinki, 00029, Finland
Site FR33020
Angers, 49933, France
Site FR33007
Besançon, 25030, France
Site FR33012
Bordeaux, 33076, France
Site FR33025
Brest, 29609, France
Site FR33027
Clermont-Ferrand, 63003, France
Site FR33003
Clichy, Paris, 92118, France
Site FR33001
Créteil, 94000, France
Site FR33029
Créteil, 94010, France
Site FR33032
Dijon, 21079, France
Site FR33026
Le Kremlin-Bicêtre, 94275, France
Site FR33018
Limoges, 87042, France
Site FR33011
Marseille, 13385, France
Site FR33014
Montpellier, 34295, France
Site FR33023
Nantes, 44093, France
Site FR33004
Nice, 06202, France
Site FR33015
Nice, 6002, France
Site FR33008
Paris, 75571, France
Site FR33010
Paris, 75651, France
Site FR33031
Paris, 75743, France
Site FR33019
Paris, 75970, France
Site FR33024
Rouen, 76233, France
Site FR33022
Saint-Etienne, 42055, France
Site FR33017
Strasbourg, 67091, France
Site FR33034
Toulouse, 31403, France
Site FR33009
Tours, 37044, France
Site FR33030
Tours, 37044, France
Site FR33028
Vandœuvre-lès-Nancy, 54511, France
Site FR33002
Villejuif, 94804, France
Site DE49011
Aachen, 52074, Germany
Site DE49004
Berlin, 13353, Germany
Site DE49019
Bochum, 44892, Germany
Site DE49013
Düsseldorf, 40225, Germany
Site DE49030
Essen, 45147, Germany
Site DE49001
Frankfurt am Main, 60596, Germany
Site DE49014
Halle, 6120, Germany
Site DE49022
Hannoversch Münden, 34346, Germany
Site DE49005
Hanover, 30625, Germany
Site DE49018
Hanover, 30625, Germany
Site DE49008
Jena, 07747, Germany
Site DE49015
Kaiserslautern, 67655, Germany
Site DE49002
Kiel, 24105, Germany
Site DE49027
Mannheim, 68167, Germany
Site DE49025
Munich, 81377, Germany
Site DE49016
Munich, 81675, Germany
Site DE49010
Regensburg, 93042, Germany
Site DE49017
Rostock, 18057, Germany
Site DE49006
Tübingen, 72076, Germany
Site HU36001
Budapest, 1082, Hungary
Site HU36003
Debrecen, 4012, Hungary
Site HU36002
Szeged, 6720, Hungary
Site IE35301
Dublin, 4, Ireland
Site IT39015
Ancona, 60126, Italy
Site IT39003
Bergamo, 24122, Italy
Site IT39005
Bologna, 40138, Italy
Site IT39013
Bologna, 40138, Italy
Site IT39006
Genova, 16132, Italy
Site IT39014
L’Aquila, 67100, Italy
Site IT39012
Milan, 20132, Italy
Site IT39009
Milan, 20162, Italy
Site IT39008
Naples, 80131, Italy
Site IT39002
Padua, 35127, Italy
Site IT39010
Padua, 35128, Italy
Site IT39016
Palermo, 90127, Italy
Site IT39004
Rome, 00133, Italy
Site IT39020
Rome, 00168, Italy
Site IT39017
Salerno, 84131, Italy
Site IT39019
Siena, 53100, Italy
Site IT39021
Treviso, 31100, Italy
Site IT39001
Udine, 33100, Italy
Site IT39011
Vicenza, 36100, Italy
Site LV37101
Riga, LV-1002, Latvia
Site NL31001
Maastricht, 6229 HX, Netherlands
Site PL48003
Gdansk, 80211, Poland
Site PL48006
Katowice, 40 027, Poland
Site PL48005
Lodz, 91-153, Poland
Site PL48007
Poznan, 60-479, Poland
Site PL48004
Szczecin, 70-111, Poland
Site PL48001
Warsaw, 02-097, Poland
Site PT35102
Lisbon, 1069-166, Portugal
Site RO40001
Bucharest, 22328, Romania
Site RO40003
Bucharest, 22328, Romania
Site RU70014
Kemerovo, 650066, Russia
Site RU70005
Moscow, 119992, Russia
Site RU70002
Moscow, 129090, Russia
Site RU70004
Moscow, 129090, Russia
Site RU70007
Moscow, 129110, Russia
Site RU70010
Omsk, 644112, Russia
Site RU70011
Volzhskiy, 404120, Russia
Site RU70013
Volzhskiy, 404120, Russia
Site RU70012
Yekaterinburg, 620102, Russia
Site SK42101
Banská Bystrica, 975 01, Slovakia
Site SK42102
Bratislava, 833 05, Slovakia
Site KR82007
Busan, 614-735, South Korea
Site KR82006
Daegu, 700-721, South Korea
Site KR82002
Seoul, 05505, South Korea
Site KR82005
Seoul, 110-744, South Korea
Site KR82001
Seoul, 120-752, South Korea
Site ES34001
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Site ES34019
Barakaldo, Vizcaya, 48903, Spain
Site ES34005
A Coruña, 15006, Spain
Site ES34017
Alicante, 03010, Spain
Site ES34012
Badalona-Barcelona, 8916, Spain
Site ES34004
Barcelona, 08035, Spain
Site ES34011
Barcelona, 08035, Spain
Site ES34003
Barcelona, 08036, Spain
Site ES34010
Córdoba, 14004, Spain
Site ES34018
L'Hospitalet de Llobregat, 08907, Spain
Site ES34006
Madrid, 28034, Spain
Site ES34013
Madrid, 28034, Spain
Site ES34015
Madrid, 28041, Spain
Site ES34009
Santa Cruz de Tenerife, 38320, Spain
Site ES34020
Santander, 39008, Spain
Site ES34014
Seville, 41013, Spain
Site ES34021
Valencia, 46009, Spain
Site ES34016
Valladolid, 47011, Spain
Site ES34007
Zaragoza, 50009, Spain
Site SE46001
Gothenburg, 41345, Sweden
Site SE46002
Stockholm, 14186, Sweden
Site SE46004
Uppsala, 75185, Sweden
Site CH41002
Bern, 3010, Switzerland
Site GB44001
Birmingham, B15 2TH, United Kingdom
Site GB44003
Leeds, LS7 9TF, United Kingdom
Site GB44002
London, SE5 9RS, United Kingdom
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Astellas Pharma Europe Ltd.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2014
First Posted
February 7, 2014
Study Start
March 3, 2014
Primary Completion
October 17, 2017
Study Completion
October 17, 2017
Last Updated
October 31, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share
Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.