- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02057484
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)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Innsbruck, Austria, 6020
- Site AT43001
-
Linz, Austria, 4010
- Site AT43003
-
Vienna, Austria, 1090
- Site AT43002
-
-
-
-
-
Minsk, Belarus, 220116
- Site BY37501
-
-
-
-
-
Brussels, Belgium, 1070
- Site BE32002
-
Gent, Belgium, 9000
- Site BE32001
-
Leuven, Belgium, 3000
- Site BE32005
-
Leuven, Belgium, 3000
- Site BE32003
-
Liege, Belgium, 4000
- Site BE32008
-
Liege, Belgium, 4000
- Site BE32009
-
-
Brussels Hoofdstedelijk Gewest
-
Brussels, Brussels Hoofdstedelijk Gewest, Belgium, 1090
- Site BE32007
-
-
-
-
Nova Scotia
-
Halifax, Nova Scotia, Canada, B3H2Y9
- Site CA15001
-
-
Quebec
-
Montreal, Quebec, Canada, H2X3J4
- Site CA15003
-
-
-
-
-
Brno, Czechia, 65691
- Site CZ42006
-
Hradec Kralove, Czechia, 500 05
- Site CZ42004
-
Olomouc, Czechia, 775 00
- Site CZ42003
-
Ostrava, Czechia, 70852
- Site CZ42005
-
Prague 4, Czechia, 140 21
- Site CZ42001
-
Prague 4, Czechia, 140 21
- Site CZ42002
-
-
-
-
-
Tartu, Estonia, 51014
- Site EE37201
-
-
-
-
-
Helsinki, Finland, 00029
- Site FI35801
-
Helsinki, Finland, 00029
- Site FI35802
-
-
-
-
-
Angers Cedex 09, France, 49933
- Site FR33020
-
Besancon, France, 25030
- Site FR33007
-
Bordeaux, France, 33076
- Site FR33012
-
Brest, France, 29609
- Site FR33025
-
Clermont-Ferrand, France, 63003
- Site FR33027
-
Clichy, Paris, France, 92118
- Site FR33003
-
Creteil, France, 94000
- Site FR33001
-
Creteil, France, 94010
- Site FR33029
-
Dijon, France, 21079
- Site FR33032
-
Le Kremlin Bicetre, France, 94275
- Site FR33026
-
Limoges Cedex 1, France, 87042
- Site FR33018
-
Marseille Cedex 05, France, 13385
- Site FR33011
-
Montpellier Cedex 05, France, 34295
- Site FR33014
-
Nantes Cedex 01, France, 44093
- Site FR33023
-
Nice Cedex 1, France, 6002
- Site FR33015
-
Nice Cedex 3, France, 06202
- Site FR33004
-
Paris, France, 75571
- Site FR33008
-
Paris Cedex 15, France, 75743
- Site FR33031
-
Paris Cedex 20, France, 75970
- Site FR33019
-
Paris cedex 13, France, 75651
- Site FR33010
-
Rouen Cedex, France, 76233
- Site FR33024
-
Saint Etienne, France, 42055
- Site FR33022
-
Strasbourg, France, 67091
- Site FR33017
-
Toulouse Cedex 4, France, 31403
- Site FR33034
-
Tours, France, 37044
- Site FR33009
-
Tours Cedex, France, 37044
- Site FR33030
-
Vandoeuvre les Nancy, France, 54511
- Site FR33028
-
Villejuif, France, 94804
- Site FR33002
-
-
-
-
-
Aachen, Germany, 52074
- Site DE49011
-
Berlin, Germany, 13353
- Site DE49004
-
Bochum, Germany, 44892
- Site DE49019
-
Dusseldorf, Germany, 40225
- Site DE49013
-
Essen, Germany, 45147
- Site DE49030
-
Frankfurt am Main, Germany, 60596
- Site DE49001
-
Halle, Germany, 6120
- Site DE49014
-
Hannover, Germany, 30625
- Site DE49005
-
Hannover, Germany, 30625
- Site DE49018
-
Hannoversch Munden, Germany, 34346
- Site DE49022
-
Jena, Germany, 07747
- Site DE49008
-
Kaiserslautern, Germany, 67655
- Site DE49015
-
Kiel, Germany, 24105
- Site DE49002
-
Mannheim, Germany, 68167
- Site DE49027
-
Munich, Germany, 81377
- Site DE49025
-
Munich, Germany, 81675
- Site DE49016
-
Regensburg, Germany, 93042
- Site DE49010
-
Rostock, Germany, 18057
- Site DE49017
-
Tubingen, Germany, 72076
- Site DE49006
-
-
-
-
-
Budapest, Hungary, 1082
- Site HU36001
-
Debrecen, Hungary, 4012
- Site HU36003
-
Szeged, Hungary, 6720
- Site HU36002
-
-
-
-
-
Dublin, Ireland, 4
- Site IE35301
-
-
-
-
-
Ancona, Italy, 60126
- Site IT39015
-
Bergamo, Italy, 24122
- Site IT39003
-
Bologna, Italy, 40138
- Site IT39005
-
Bologna, Italy, 40138
- Site IT39013
-
Genova, Italy, 16132
- Site IT39006
-
L'Aquila, Italy, 67100
- Site IT39014
-
Milan, Italy, 20132
- Site IT39012
-
Milan, Italy, 20162
- Site IT39009
-
Naples, Italy, 80131
- Site IT39008
-
Padova, Italy, 35127
- Site IT39002
-
Padova, Italy, 35128
- Site IT39010
-
Palermo, Italy, 90127
- Site IT39016
-
Rome, Italy, 00133
- Site IT39004
-
Rome, Italy, 00168
- Site IT39020
-
Salerno, Italy, 84131
- Site IT39017
-
Siena, Italy, 53100
- Site IT39019
-
Treviso, Italy, 31100
- Site IT39021
-
Udine, Italy, 33100
- Site IT39001
-
Vicenza, Italy, 36100
- Site IT39011
-
-
-
-
-
Busan, Korea, Republic of, 614-735
- Site KR82007
-
Daegu, Korea, Republic of, 700-721
- Site KR82006
-
Seoul, Korea, Republic of, 05505
- Site KR82002
-
Seoul, Korea, Republic of, 110-744
- Site KR82005
-
Seoul, Korea, Republic of, 120-752
- Site KR82001
-
-
-
-
-
Riga, Latvia, LV-1002
- Site LV37101
-
-
-
-
-
Maastricht, Netherlands, 6229 HX
- Site NL31001
-
-
-
-
-
Gdansk, Poland, 80211
- Site PL48003
-
Katowice, Poland, 40 027
- Site PL48006
-
Lodz, Poland, 91-153
- Site PL48005
-
Poznan, Poland, 60-479
- Site PL48007
-
Szczecin, Poland, 70-111
- Site PL48004
-
Warsaw, Poland, 02-097
- Site PL48001
-
-
-
-
-
Lisbon, Portugal, 1069-166
- Site PT35102
-
-
-
-
-
Bucharest, Romania, 22328
- Site RO40001
-
Bucharest, Romania, 22328
- Site RO40003
-
-
-
-
-
Ekaterinburg, Russian Federation, 620102
- Site RU70012
-
Kemerovo, Russian Federation, 650066
- Site RU70014
-
Moscow, Russian Federation, 119992
- Site RU70005
-
Moscow, Russian Federation, 129090
- Site RU70002
-
Moscow, Russian Federation, 129090
- Site RU70004
-
Moscow, Russian Federation, 129110
- Site RU70007
-
Omsk, Russian Federation, 644112
- Site RU70010
-
Volzhskiy, Russian Federation, 404120
- Site RU70011
-
Volzhskiy, Russian Federation, 404120
- Site RU70013
-
-
-
-
-
Banska Bystrica, Slovakia, 975 01
- Site SK42101
-
Bratislava, Slovakia, 833 05
- Site SK42102
-
-
-
-
-
A Coruna, Spain, 15006
- Site ES34005
-
Alicante, Spain, 03010
- Site ES34017
-
Badalona-Barcelona, Spain, 8916
- Site ES34012
-
Barcelona, Spain, 08035
- Site ES34011
-
Barcelona, Spain, 08035
- Site ES34004
-
Barcelona, Spain, 08036
- Site ES34003
-
Cordoba, Spain, 14004
- Site ES34010
-
Hospitalet de Llobregat, Spain, 08907
- Site ES34018
-
Madrid, Spain, 28034
- Site ES34006
-
Madrid, Spain, 28034
- Site ES34013
-
Madrid, Spain, 28041
- Site ES34015
-
Santander, Spain, 39008
- Site ES34020
-
Sevilla, Spain, 41013
- Site ES34014
-
Tenerife, Spain, 38320
- Site ES34009
-
Valencia, Spain, 46009
- Site ES34021
-
Valladolid, Spain, 47011
- Site ES34016
-
Zaragoza, Spain, 50009
- Site ES34007
-
-
Barcelona
-
Hospitalet de Llobregat, Barcelona, Spain, 08907
- Site ES34001
-
-
Vizcaya
-
Barakaldo, Vizcaya, Spain, 48903
- Site ES34019
-
-
-
-
-
Gothenburg, Sweden, 41345
- Site SE46001
-
Stockholm, Sweden, 14186
- Site SE46002
-
Uppsala, Sweden, 75185
- Site SE46004
-
-
-
-
-
Bern, Switzerland, 3010
- Site CH41002
-
-
-
-
-
Birmingham, United Kingdom, B15 2TH
- Site GB44001
-
Leeds, United Kingdom, LS7 9TF
- Site GB44003
-
London, United Kingdom, SE5 9RS
- Site GB44002
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Organ transplant patients treated with Advagraf
To evaluate long-term graft survival in patients treated with Advagraf
|
oral
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall graft survival (time to graft loss)
Time Frame: 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.
|
Annually from date of transplant and for 5 five years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall patient survival
Time Frame: 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.
|
Annually from date of transplant and for 5 five years
|
Renal Function
Time Frame: 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.
|
Annually from date of transplant and for 5 five years
|
Emergence of de novo Donor Specific Antibody
Time Frame: 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.
|
Annually from date of transplant and for 5 five years
|
Biopsy proven acute rejection episodes
Time Frame: 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
|
Annually from date of transplant and for 5 five years
|
Immunosuppression regimen
Time Frame: 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.
|
Annually from date of transplant and for 5 five years
|
Medical conditions of interest
Time Frame: 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.
|
Annually from date of transplant and for 5 five years
|
Infections of interest
Time Frame: Annually from date of transplant and for 5 five years
|
Infections of interest include cytomegalovirus and BK virus
|
Annually from date of transplant and for 5 five years
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PMR-EC-1213
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Liver Transplant
-
Oslo University HospitalSouth-Eastern Norway Regional Health AuthorityNot yet recruitingLiver Metastases | Liver Transplant; Complications | Liver Cancer | Transplant | Transplant; Failure, Liver | Transplant; Complication, Rejection | Transplant Dysfunction
-
University Health Network, TorontoNot yet recruitingSolid Organ Transplant | Liver Transplant | Kidney Transplant | Heart Transplant
-
National Institute of Allergy and Infectious Diseases...PPD; Rho Federal Systems Division, Inc.; Immune Tolerance Network (ITN)TerminatedLiver Transplant | Kidney TransplantUnited States
-
Memorial Bahçelievler HospitalCompletedLiver Diseases | Liver Failure | Liver Cirrhosis | Liver Transplant; Complications | Liver Transplant Rejection | Organ Transplant Failure or Rejection | Liver Transplant FailureTurkey
-
University of FloridaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedLiver Transplant | Kidney TransplantUnited States, Singapore
-
National Taiwan University HospitalUnknownRenal Transplant | Liver TransplantTaiwan
-
Paragonix TechnologiesEnrolling by invitationLiver Diseases | Liver Transplant Disorder | Liver Dysfunction | Liver Transplant RejectionUnited States
-
PilloxaTerminatedLiver Transplant; Complications | Kidney Transplant; ComplicationsSweden
-
National Institute of Allergy and Infectious Diseases...Rho Federal Systems Division, Inc.; Clinical Trials in Organ Transplantation...CompletedLiver Transplant Recipient | Living Donor (of the Respective Liver Transplant Recipient)United States
-
University of CincinnatiUniversity of Colorado, Denver; Children's Hospital Medical Center, CincinnatiCompletedLiver Transplant Recipients | Kidney Transplant RecipientsUnited States
Clinical Trials on Tacrolimus
-
Novartis PharmaceuticalsCompletedLiver Transplant RecipientBelgium, Spain, Germany, Italy, Australia, United States, Netherlands, Ireland, Sweden, Brazil, Colombia, France, Russian Federation, Argentina, Czechia, United Kingdom
-
Novartis PharmaceuticalsCompletedLiver TransplantationUnited States, Belgium, Colombia, Spain, Germany, Italy, Australia, Israel, France, Hungary, Netherlands, Argentina, Canada, Ireland, Sweden, Brazil, United Kingdom, Russian Federation, Czech Republic
-
Astellas Pharma IncAstellas Pharma Korea, Inc.CompletedLiver TransplantationKorea, Republic of
-
Heleen GrootjansChiesi Farmaceutici S.p.A.RecruitingLung Transplant; ComplicationsNetherlands
-
The Methodist Hospital Research InstituteVeloxis PharmaceuticalsWithdrawnAcute Rejection of Renal Transplant | Kidney Disease, End-Stage | Donor Specific Antibodies
-
Taro Pharmaceuticals USACompleted
-
Peking Union Medical College HospitalUnknown
-
Technical University of MunichCompleted
-
Limerick BioPharmaCompleted
-
University of British ColumbiaPaladin Labs Inc.RecruitingLiver Transplantation | Neurotoxicity | Tremor | Tacrolimus | ImmunosuppressionCanada