A 5 Year Follow-up of Patients Who Were Previously Enrolled Into an Advagraf Trial Following a Liver or Kidney Transplant
- Registration Number
- NCT02057484
- Lead Sponsor
- Astellas Pharma Europe Ltd.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2300
-
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.
- No exclusion criteria
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Organ transplant patients treated with Advagraf Tacrolimus To evaluate long-term graft survival in patients treated with Advagraf
- Primary Outcome Measures
Name Time Method Overall graft survival (time to graft loss) Annually from date of transplant and for 5 five years At each annual visit there will be a simple assessment to determine if the graft has survived or not.
- Secondary Outcome Measures
Name Time Method Medical conditions of interest Annually from date of transplant and for 5 five years Medical conditions of interest include, diabetes mellitus, and cardiovascular conditions such as myocardial infarction and strokes.
Emergence of de novo Donor Specific Antibody Annually from date of transplant and for 5 five years If the site collects this information as part of routine clinical practice, only then will this information be collected.
Immunosuppression regimen Annually from date of transplant and for 5 five years Any immunosuppression regimen, doses and changes in doses from one annual visit to another, as well any annual trough levels of tacrolimus.
Overall patient survival Annually from date of transplant and for 5 five years At each annual visit there will be a simple assessment to determine if the patient has survived or not.
Renal Function Annually from date of transplant and for 5 five years At each annual visit serum creatinine results, which is part of routine clinical practice will be collected from the patient's medical records. This will be used by the sponsor to calculate estimated glomerular filtration rate.
Biopsy proven acute rejection episodes Annually from date of transplant and for 5 five years All rejection episodes captured in the medical records of the patient from one annual visit to the next will be collected for this study
Infections of interest Annually from date of transplant and for 5 five years Infections of interest include cytomegalovirus and BK virus
Trial Locations
- Locations (145)
Site PL48005
🇵🇱Lodz, Poland
Site PL48004
🇵🇱Szczecin, Poland
Site BE32002
🇧🇪Brussels, Belgium
Site NL31001
🇳🇱Maastricht, Netherlands
Site RU70012
🇷🇺Ekaterinburg, Russian Federation
Site RO40003
🇷🇴Bucharest, Romania
Site SK42102
🇸🇰Bratislava, Slovakia
Site IT39010
🇮🇹Padova, Italy
Site FR33018
🇫🇷Limoges Cedex 1, France
Site RU70005
🇷🇺Moscow, Russian Federation
Site RU70011
🇷🇺Volzhskiy, Russian Federation
Site ES34019
🇪🇸Barakaldo, Vizcaya, Spain
Site ES34010
🇪🇸Cordoba, Spain
Site ES34003
🇪🇸Barcelona, Spain
Site DE49013
🇩🇪Dusseldorf, Germany
Site DE49022
🇩🇪Hannoversch Munden, Germany
Site FR33008
🇫🇷Paris, France
Site BE32003
🇧🇪Leuven, Belgium
Site AT43003
🇦🇹Linz, Austria
Site AT43001
🇦🇹Innsbruck, Austria
Site BE32001
🇧🇪Gent, Belgium
Site BE32008
🇧🇪Liege, Belgium
Site CZ42006
🇨🇿Brno, Czechia
Site BE32009
🇧🇪Liege, Belgium
Site CA15003
🇨🇦Montreal, Quebec, Canada
Site CZ42003
🇨🇿Olomouc, Czechia
Site CZ42004
🇨🇿Hradec Kralove, Czechia
Site CZ42005
🇨🇿Ostrava, Czechia
Site EE37201
🇪🇪Tartu, Estonia
Site CZ42002
🇨🇿Prague 4, Czechia
Site CZ42001
🇨🇿Prague 4, Czechia
Site FI35802
🇫🇮Helsinki, Finland
Site FR33020
🇫🇷Angers Cedex 09, France
Site FR33007
🇫🇷Besancon, France
Site FR33025
🇫🇷Brest, France
Site FR33001
🇫🇷Creteil, France
Site FR33027
🇫🇷Clermont-Ferrand, France
Site FR33012
🇫🇷Bordeaux, France
Site FR33003
🇫🇷Clichy, Paris, France
Site FR33026
🇫🇷Le Kremlin Bicetre, France
Site FR33032
🇫🇷Dijon, France
Site FR33011
🇫🇷Marseille Cedex 05, France
Site FR33014
🇫🇷Montpellier Cedex 05, France
Site FR33023
🇫🇷Nantes Cedex 01, France
Site FR33015
🇫🇷Nice Cedex 1, France
Site FR33031
🇫🇷Paris Cedex 15, France
Site FR33004
🇫🇷Nice Cedex 3, France
Site FR33010
🇫🇷Paris cedex 13, France
Site FR33022
🇫🇷Saint Etienne, France
Site FR33034
🇫🇷Toulouse Cedex 4, France
Site FR33024
🇫🇷Rouen Cedex, France
Site FR33030
🇫🇷Tours Cedex, France
Site FR33009
🇫🇷Tours, France
Site FR33017
🇫🇷Strasbourg, France
Site DE49004
🇩🇪Berlin, Germany
Site DE49011
🇩🇪Aachen, Germany
Site DE49019
🇩🇪Bochum, Germany
Site DE49014
🇩🇪Halle, Germany
Site DE49030
🇩🇪Essen, Germany
Site DE49001
🇩🇪Frankfurt am Main, Germany
Site DE49005
🇩🇪Hannover, Germany
Site DE49018
🇩🇪Hannover, Germany
Site DE49015
🇩🇪Kaiserslautern, Germany
Site DE49008
🇩🇪Jena, Germany
Site DE49002
🇩🇪Kiel, Germany
Site DE49025
🇩🇪Munich, Germany
Site DE49017
🇩🇪Rostock, Germany
Site DE49016
🇩🇪Munich, Germany
Site DE49006
🇩🇪Tubingen, Germany
Site HU36001
ðŸ‡ðŸ‡ºBudapest, Hungary
Site HU36003
ðŸ‡ðŸ‡ºDebrecen, Hungary
Site IT39015
🇮🇹Ancona, Italy
Site IT39013
🇮🇹Bologna, Italy
Site HU36002
ðŸ‡ðŸ‡ºSzeged, Hungary
Site IT39012
🇮🇹Milan, Italy
Site IT39003
🇮🇹Bergamo, Italy
Site IT39005
🇮🇹Bologna, Italy
Site IT39006
🇮🇹Genova, Italy
Site IT39014
🇮🇹L'Aquila, Italy
Site IT39009
🇮🇹Milan, Italy
Site IT39008
🇮🇹Naples, Italy
Site IT39002
🇮🇹Padova, Italy
Site IT39016
🇮🇹Palermo, Italy
Site IT39020
🇮🇹Rome, Italy
Site IT39004
🇮🇹Rome, Italy
Site IT39017
🇮🇹Salerno, Italy
Site IT39019
🇮🇹Siena, Italy
Site IT39021
🇮🇹Treviso, Italy
Site IT39001
🇮🇹Udine, Italy
Site IT39011
🇮🇹Vicenza, Italy
Site KR82007
🇰🇷Busan, Korea, Republic of
Site KR82006
🇰🇷Daegu, Korea, Republic of
Site KR82002
🇰🇷Seoul, Korea, Republic of
Site LV37101
🇱🇻Riga, Latvia
Site KR82005
🇰🇷Seoul, Korea, Republic of
Site PL48003
🇵🇱Gdansk, Poland
Site PL48006
🇵🇱Katowice, Poland
Site PL48007
🇵🇱Poznan, Poland
Site RO40001
🇷🇴Bucharest, Romania
Site PL48001
🇵🇱Warsaw, Poland
Site PT35102
🇵🇹Lisbon, Portugal
Site RU70002
🇷🇺Moscow, Russian Federation
Site RU70010
🇷🇺Omsk, Russian Federation
Site RU70004
🇷🇺Moscow, Russian Federation
Site RU70013
🇷🇺Volzhskiy, Russian Federation
Site RU70007
🇷🇺Moscow, Russian Federation
Site ES34001
🇪🇸Hospitalet de Llobregat, Barcelona, Spain
Site ES34018
🇪🇸Hospitalet de Llobregat, Spain
Site ES34017
🇪🇸Alicante, Spain
Site ES34005
🇪🇸A Coruna, Spain
Site ES34013
🇪🇸Madrid, Spain
Site ES34009
🇪🇸Tenerife, Spain
Site ES34006
🇪🇸Madrid, Spain
Site ES34007
🇪🇸Zaragoza, Spain
Site ES34016
🇪🇸Valladolid, Spain
Site SE46002
🇸🇪Stockholm, Sweden
Site SE46001
🇸🇪Gothenburg, Sweden
Site SE46004
🇸🇪Uppsala, Sweden
Site GB44003
🇬🇧Leeds, United Kingdom
Site CH41002
🇨ðŸ‡Bern, Switzerland
Site GB44001
🇬🇧Birmingham, United Kingdom
Site FR33002
🇫🇷Villejuif, France
Site CA15001
🇨🇦Halifax, Nova Scotia, Canada
Site FR33028
🇫🇷Vandoeuvre les Nancy, France
Site ES34021
🇪🇸Valencia, Spain
Site FR33019
🇫🇷Paris Cedex 20, France
Site DE49010
🇩🇪Regensburg, Germany
Site ES34012
🇪🇸Badalona-Barcelona, Spain
Site FR33029
🇫🇷Creteil, France
Site ES34020
🇪🇸Santander, Spain
Site ES34004
🇪🇸Barcelona, Spain
Site ES34011
🇪🇸Barcelona, Spain
Site DE49027
🇩🇪Mannheim, Germany
Site KR82001
🇰🇷Seoul, Korea, Republic of
Site RU70014
🇷🇺Kemerovo, Russian Federation
Site ES34014
🇪🇸Sevilla, Spain
Site ES34015
🇪🇸Madrid, Spain
Site GB44002
🇬🇧London, United Kingdom
Site AT43002
🇦🇹Vienna, Austria
Site BY37501
🇧🇾Minsk, Belarus
Site FI35801
🇫🇮Helsinki, Finland
Site IE35301
🇮🇪Dublin, Ireland
Site SK42101
🇸🇰Banska Bystrica, Slovakia
Site BE32005
🇧🇪Leuven, Belgium
Site BE32007
🇧🇪Brussels, Brussels Hoofdstedelijk Gewest, Belgium