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

NCT ID: NCT02057484

Last Updated: 2024-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-03-03

Study Completion Date

2017-10-17

Brief Summary

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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

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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.

Conditions

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Liver Transplant Kidney Transplant

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Organ transplant patients treated with Advagraf

To evaluate long-term graft survival in patients treated with Advagraf

Tacrolimus

Intervention Type DRUG

oral

Interventions

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Tacrolimus

oral

Intervention Type DRUG

Other Intervention Names

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Advagraf

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Europe Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Astellas Pharma Europe Ltd.

Locations

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Site AT43001

Innsbruck, , Austria

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Site AT43003

Linz, , Austria

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Site AT43002

Vienna, , Austria

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Site BY37501

Minsk, , Belarus

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Site BE32007

Brussels, Brussels Capital, Belgium

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Site BE32002

Brussels, , Belgium

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Site BE32001

Ghent, , Belgium

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Site BE32003

Leuven, , Belgium

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Site BE32005

Leuven, , Belgium

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Site BE32008

Liège, , Belgium

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Site BE32009

Liège, , Belgium

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Site CA15001

Halifax, Nova Scotia, Canada

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Site CA15003

Montreal, Quebec, Canada

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Site CZ42006

Brno, , Czechia

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Site CZ42004

Hradec Králové, , Czechia

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Site CZ42003

Olomouc, , Czechia

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Site CZ42005

Ostrava, , Czechia

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Site CZ42001

Prague, , Czechia

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Site CZ42002

Prague, , Czechia

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Site EE37201

Tartu, , Estonia

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Site FI35801

Helsinki, , Finland

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Site FI35802

Helsinki, , Finland

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Site FR33020

Angers, , France

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Site FR33007

Besançon, , France

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Site FR33012

Bordeaux, , France

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Site FR33025

Brest, , France

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Site FR33027

Clermont-Ferrand, , France

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Site FR33003

Clichy, Paris, , France

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Site FR33001

Créteil, , France

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Site FR33029

Créteil, , France

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Site FR33032

Dijon, , France

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Site FR33026

Le Kremlin-Bicêtre, , France

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Site FR33018

Limoges, , France

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Site FR33011

Marseille, , France

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Site FR33014

Montpellier, , France

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Site FR33023

Nantes, , France

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Site FR33004

Nice, , France

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Site FR33015

Nice, , France

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Site FR33008

Paris, , France

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Site FR33010

Paris, , France

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Site FR33031

Paris, , France

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Site FR33019

Paris, , France

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Site FR33024

Rouen, , France

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Site FR33022

Saint-Etienne, , France

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Site FR33017

Strasbourg, , France

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Site FR33034

Toulouse, , France

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Site FR33009

Tours, , France

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Site FR33030

Tours, , France

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Site FR33028

Vandœuvre-lès-Nancy, , France

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Site FR33002

Villejuif, , France

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Site DE49011

Aachen, , Germany

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Site DE49004

Berlin, , Germany

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Site DE49019

Bochum, , Germany

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Site DE49013

Düsseldorf, , Germany

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Site DE49030

Essen, , Germany

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Site DE49001

Frankfurt am Main, , Germany

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Site DE49014

Halle, , Germany

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Site DE49022

Hannoversch Münden, , Germany

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Site DE49005

Hanover, , Germany

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Site DE49018

Hanover, , Germany

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Site DE49008

Jena, , Germany

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Site DE49015

Kaiserslautern, , Germany

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Site DE49002

Kiel, , Germany

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Site DE49027

Mannheim, , Germany

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Site DE49025

Munich, , Germany

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Site DE49016

Munich, , Germany

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Site DE49010

Regensburg, , Germany

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Site DE49017

Rostock, , Germany

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Site DE49006

Tübingen, , Germany

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Site HU36001

Budapest, , Hungary

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Site HU36003

Debrecen, , Hungary

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Site HU36002

Szeged, , Hungary

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Site IE35301

Dublin, , Ireland

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Site IT39015

Ancona, , Italy

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Site IT39003

Bergamo, , Italy

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Site IT39005

Bologna, , Italy

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Site IT39013

Bologna, , Italy

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Site IT39006

Genova, , Italy

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Site IT39014

L’Aquila, , Italy

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Site IT39012

Milan, , Italy

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Site IT39009

Milan, , Italy

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Site IT39008

Naples, , Italy

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Site IT39002

Padua, , Italy

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Site IT39010

Padua, , Italy

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Site IT39016

Palermo, , Italy

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Site IT39004

Rome, , Italy

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Site IT39020

Rome, , Italy

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Site IT39017

Salerno, , Italy

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Site IT39019

Siena, , Italy

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Site IT39021

Treviso, , Italy

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Site IT39001

Udine, , Italy

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Site IT39011

Vicenza, , Italy

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Site LV37101

Riga, , Latvia

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Site NL31001

Maastricht, , Netherlands

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Site PL48003

Gdansk, , Poland

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Site PL48006

Katowice, , Poland

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Site PL48005

Lodz, , Poland

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Site PL48007

Poznan, , Poland

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Site PL48004

Szczecin, , Poland

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Site PL48001

Warsaw, , Poland

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Site PT35102

Lisbon, , Portugal

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Site RO40001

Bucharest, , Romania

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Site RO40003

Bucharest, , Romania

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Site RU70014

Kemerovo, , Russia

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Site RU70005

Moscow, , Russia

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Site RU70002

Moscow, , Russia

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Site RU70004

Moscow, , Russia

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Site RU70007

Moscow, , Russia

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Site RU70010

Omsk, , Russia

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Site RU70011

Volzhskiy, , Russia

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Site RU70013

Volzhskiy, , Russia

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Site RU70012

Yekaterinburg, , Russia

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Site SK42101

Banská Bystrica, , Slovakia

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Site SK42102

Bratislava, , Slovakia

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Site KR82007

Busan, , South Korea

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Site KR82006

Daegu, , South Korea

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Site KR82002

Seoul, , South Korea

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Site KR82005

Seoul, , South Korea

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Site KR82001

Seoul, , South Korea

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Site ES34001

L'Hospitalet de Llobregat, Barcelona, Spain

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Site ES34019

Barakaldo, Vizcaya, Spain

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Site ES34005

A Coruña, , Spain

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Site ES34017

Alicante, , Spain

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Site ES34012

Badalona-Barcelona, , Spain

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Site ES34004

Barcelona, , Spain

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Site ES34011

Barcelona, , Spain

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Site ES34003

Barcelona, , Spain

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Site ES34010

Córdoba, , Spain

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Site ES34018

L'Hospitalet de Llobregat, , Spain

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Site ES34006

Madrid, , Spain

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Site ES34013

Madrid, , Spain

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Site ES34015

Madrid, , Spain

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Site ES34009

Santa Cruz de Tenerife, , Spain

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Site ES34020

Santander, , Spain

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Site ES34014

Seville, , Spain

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Site ES34021

Valencia, , Spain

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Site ES34016

Valladolid, , Spain

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Site ES34007

Zaragoza, , Spain

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Site SE46001

Gothenburg, , Sweden

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Site SE46002

Stockholm, , Sweden

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Site SE46004

Uppsala, , Sweden

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Site CH41002

Bern, , Switzerland

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Site GB44001

Birmingham, , United Kingdom

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Site GB44003

Leeds, , United Kingdom

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Site GB44002

London, , United Kingdom

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Countries

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Austria Belarus Belgium Canada Czechia Estonia Finland France Germany Hungary Ireland Italy Latvia Netherlands Poland Portugal Romania Russia Slovakia South Korea Spain Sweden Switzerland United Kingdom

Related Links

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https://astellasclinicalstudyresults.com/study.aspx?ID=278

Link to results on the Astellas Clinical Study Results Web site

Other Identifiers

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PMR-EC-1213

Identifier Type: -

Identifier Source: org_study_id

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