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Liver TransplantADDRESSNCT02057484

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

An observational study of Liver Transplant and Kidney Transplant, run by Astellas Pharma Europe Ltd. at 145 sites in 24 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Liver Transplant, Kidney Transplant
What is being tested?
Tacrolimus
Type of treatment
Pill or oral medicine
How many people
2,300 participants
Where
145 sitesin 24 countries
Study dates
3 Mar 2014to 17 Oct 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • No exclusion criteria

Trial locations and contacts

145 sites in 24 countries.

145 sites in 24 countries

France28 sites

  • Site FR33020

    Angers, 49933

  • Site FR33007

    Besançon, 25030

  • Site FR33012

    Bordeaux, 33076

  • Site FR33025

    Brest, 29609

  • Site FR33027

    Clermont-Ferrand, 63003

  • Site FR33003

    Clichy, Paris, 92118

  • Site FR33001

    Créteil, 94000

  • Site FR33029

    Créteil, 94010

  • Site FR33032

    Dijon, 21079

  • Site FR33026

    Le Kremlin-Bicêtre, 94275

  • Site FR33018

    Limoges, 87042

  • Site FR33011

    Marseille, 13385

  • Site FR33014

    Montpellier, 34295

  • Site FR33023

    Nantes, 44093

  • Site FR33004

    Nice, 06202

  • Site FR33015

    Nice, 6002

  • Site FR33008

    Paris, 75571

  • Site FR33010

    Paris, 75651

  • Site FR33031

    Paris, 75743

  • Site FR33019

    Paris, 75970

  • Site FR33024

    Rouen, 76233

  • Site FR33022

    Saint-Etienne, 42055

  • Site FR33017

    Strasbourg, 67091

  • Site FR33034

    Toulouse, 31403

  • Site FR33009

    Tours, 37044

  • Site FR33030

    Tours, 37044

  • Site FR33028

    Vandœuvre-lès-Nancy, 54511

  • Site FR33002

    Villejuif, 94804

Other trials in France

Germany19 sites

  • Site DE49011

    Aachen, 52074

  • Site DE49004

    Berlin, 13353

  • Site DE49019

    Bochum, 44892

  • Site DE49013

    Düsseldorf, 40225

  • Site DE49030

    Essen, 45147

  • Site DE49001

    Frankfurt am Main, 60596

  • Site DE49014

    Halle, 6120

  • Site DE49022

    Hannoversch Münden, 34346

  • Site DE49005

    Hanover, 30625

  • Site DE49018

    Hanover, 30625

  • Site DE49008

    Jena, 07747

  • Site DE49015

    Kaiserslautern, 67655

  • Site DE49002

    Kiel, 24105

  • Site DE49027

    Mannheim, 68167

  • Site DE49025

    Munich, 81377

  • Site DE49016

    Munich, 81675

  • Site DE49010

    Regensburg, 93042

  • Site DE49017

    Rostock, 18057

  • Site DE49006

    Tübingen, 72076

Other trials in Germany

Italy19 sites

  • Site IT39015

    Ancona, 60126

  • Site IT39003

    Bergamo, 24122

  • Site IT39005

    Bologna, 40138

  • Site IT39013

    Bologna, 40138

  • Site IT39006

    Genova, 16132

  • Site IT39014

    L’Aquila, 67100

  • Site IT39012

    Milan, 20132

  • Site IT39009

    Milan, 20162

  • Site IT39008

    Naples, 80131

  • Site IT39002

    Padova, 35127

  • Site IT39010

    Padova, 35128

  • Site IT39016

    Palermo, 90127

  • Site IT39004

    Rome, 00133

  • Site IT39020

    Rome, 00168

  • Site IT39017

    Salerno, 84131

  • Site IT39019

    Siena, 53100

  • Site IT39021

    Treviso, 31100

  • Site IT39001

    Udine, 33100

  • Site IT39011

    Vicenza, 36100

Other trials in Italy

Spain19 sites

  • Site ES34005

    A Coruña, 15006

  • Site ES34017

    Alicante, 03010

  • Site ES34012

    Badalona-Barcelona, 8916

  • Site ES34019

    Barakaldo, Vizcaya, 48903

  • Site ES34004

    Barcelona, 08035

  • Site ES34011

    Barcelona, 08035

  • Site ES34003

    Barcelona, 08036

  • Site ES34010

    Córdoba, 14004

  • Site ES34001

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Site ES34018

    L'Hospitalet de Llobregat, 08907

  • Site ES34006

    Madrid, 28034

  • Site ES34013

    Madrid, 28034

  • Site ES34015

    Madrid, 28041

  • Site ES34009

    Santa Cruz de Tenerife, 38320

  • Site ES34020

    Santander, 39008

  • Site ES34014

    Seville, 41013

  • Site ES34021

    Valencia, 46009

  • Site ES34016

    Valladolid, 47011

  • Site ES34007

    Zaragoza, 50009

Other trials in Spain

Russia9 sites

  • Site RU70014

    Kemerovo, 650066

  • Site RU70005

    Moscow, 119992

  • Site RU70002

    Moscow, 129090

  • Site RU70004

    Moscow, 129090

  • Site RU70007

    Moscow, 129110

  • Site RU70010

    Omsk, 644112

  • Site RU70011

    Volzhskiy, 404120

  • Site RU70013

    Volzhskiy, 404120

  • Site RU70012

    Yekaterinburg, 620102

Other trials in Russia

Belgium7 sites

  • Site BE32007

    Brussels, Brussels Capital, 1090

  • Site BE32002

    Brussels, 1070

  • Site BE32001

    Ghent, 9000

  • Site BE32003

    Leuven, 3000

  • Site BE32005

    Leuven, 3000

  • Site BE32008

    Liège, 4000

  • Site BE32009

    Liège, 4000

Other trials in Belgium

Czechia6 sites

  • Site CZ42006

    Brno, 65691

  • Site CZ42004

    Hradec Králové, 500 05

  • Site CZ42003

    Olomouc, 775 00

  • Site CZ42005

    Ostrava, 70852

  • Site CZ42001

    Prague, 140 21

  • Site CZ42002

    Prague, 140 21

Other trials in Czechia

Poland6 sites

  • Site PL48003

    Gdansk, 80211

  • Site PL48006

    Katowice, 40 027

  • Site PL48005

    Lodz, 91-153

  • Site PL48007

    Poznan, 60-479

  • Site PL48004

    Szczecin, 70-111

  • Site PL48001

    Warsaw, 02-097

Other trials in Poland

South Korea5 sites

  • Site KR82007

    Busan, 614-735

  • Site KR82006

    Daegu, 700-721

  • Site KR82002

    Seoul, 05505

  • Site KR82005

    Seoul, 110-744

  • Site KR82001

    Seoul, 120-752

Other trials in South Korea

Austria3 sites

  • Site AT43001

    Innsbruck, 6020

  • Site AT43003

    Linz, 4010

  • Site AT43002

    Vienna, 1090

Other trials in Austria

Hungary3 sites

  • Site HU36001

    Budapest, 1082

  • Site HU36003

    Debrecen, 4012

  • Site HU36002

    Szeged, 6720

Other trials in Hungary

Sweden3 sites

  • Site SE46001

    Gothenburg, 41345

  • Site SE46002

    Stockholm, 14186

  • Site SE46004

    Uppsala, 75185

Other trials in Sweden

United Kingdom3 sites

  • Site GB44001

    Birmingham, B15 2TH

  • Site GB44003

    Leeds, LS7 9TF

  • Site GB44002

    London, SE5 9RS

Other trials in United Kingdom

Canada2 sites

  • Site CA15001

    Halifax, Nova Scotia, B3H2Y9

  • Site CA15003

    Montreal, Quebec, H2X3J4

Other trials in Canada

Finland2 sites

  • Site FI35801

    Helsinki, 00029

  • Site FI35802

    Helsinki, 00029

Other trials in Finland

Romania2 sites

  • Site RO40001

    Bucharest, 22328

  • Site RO40003

    Bucharest, 22328

Other trials in Romania

Slovakia2 sites

  • Site SK42101

    Banská Bystrica, 975 01

  • Site SK42102

    Bratislava, 833 05

Other trials in Slovakia

Belarus1 site

  • Site BY37501

    Minsk, 220116

Other trials in Belarus

Estonia1 site

  • Site EE37201

    Tartu, 51014

Other trials in Estonia

Ireland1 site

  • Site IE35301

    Dublin, 4

Other trials in Ireland

Latvia1 site

  • Site LV37101

    Riga, LV-1002

Other trials in Latvia

Netherlands1 site

  • Site NL31001

    Maastricht, 6229 HX

Other trials in Netherlands

Portugal1 site

  • Site PT35102

    Lisbon, 1069-166

Other trials in Portugal

Switzerland1 site

  • Site CH41002

    Bern, 3010

Other trials in Switzerland

About this study

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)

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.

Read the 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.

Being tested
Tacrolimus
Keywords
long-term follow-up, liver transplant, kidney transplant, Advagraf, Tacrolimus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02057484
Study groupRoleWhat they receive
Organ transplant patients treated with AdvagrafTo evaluate long-term graft survival in patients treated with Advagraf
Receives: Drug: Tacrolimus

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Annually from date of transplant and for 5 five years

Secondary outcomes (7)

  1. Overall patient survival

    At each annual visit there will be a simple assessment to determine if the patient has survived or not.

    Measured: Annually from date of transplant and for 5 five years

  2. Renal Function

    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.

    Measured: Annually from date of transplant and for 5 five years

  3. Emergence of de novo Donor Specific Antibody

    If the site collects this information as part of routine clinical practice, only then will this information be collected.

    Measured: Annually from date of transplant and for 5 five years

  4. Biopsy proven acute rejection episodes

    All rejection episodes captured in the medical records of the patient from one annual visit to the next will be collected for this study

    Measured: Annually from date of transplant and for 5 five years

  5. Immunosuppression regimen

    Any immunosuppression regimen, doses and changes in doses from one annual visit to another, as well any annual trough levels of tacrolimus.

    Measured: Annually from date of transplant and for 5 five years

  6. Medical conditions of interest

    Medical conditions of interest include, diabetes mellitus, and cardiovascular conditions such as myocardial infarction and strokes.

    Measured: Annually from date of transplant and for 5 five years

  7. Infections of interest

    Infections of interest include cytomegalovirus and BK virus

    Measured: Annually from date of transplant and for 5 five years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2014 (estimated)
  2. Study start3 Mar 2014
  3. Primary completion17 Oct 2017
  4. Study completion17 Oct 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02057484
Sponsor's protocol ID
PMR-EC-1213
Acronym
ADDRESS
Status last verified
Oct 2024
First submitted
5 Feb 2014
Last updated
31 Oct 2024
Results posted
No
Data monitoring committee
No
Individual data sharing
No: 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/.

Questions about this trial

What is this clinical trial studying?

An observational study of Liver Transplant and Kidney Transplant, run by Astellas Pharma Europe Ltd. at 145 sites in 24 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 145 sites in France, Germany, Italy, Spain, Russia and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall graft survival (time to graft loss) (time frame: Annually from date of transplant and for 5 five years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02057484.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2024.

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