A 5 Year Follow-up of Patients Who Were Previously Enrolled Into an Advagraf Trial Following a Liver or Kidney Transplant (ADDRESS)

December 26, 2018 updated by: Astellas Pharma Europe Ltd.

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)

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.

Study Overview

Status

Completed

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

Observational

Enrollment (Actual)

2300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • Advagraf

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

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2014

Primary Completion (Actual)

October 17, 2017

Study Completion (Actual)

October 17, 2017

Study Registration Dates

First Submitted

February 5, 2014

First Submitted That Met QC Criteria

February 5, 2014

First Posted (Estimate)

February 7, 2014

Study Record Updates

Last Update Posted (Actual)

December 28, 2018

Last Update Submitted That Met QC Criteria

December 26, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."

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.

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