Global, Multicentre, Non Interventional Advagraf Conversion Registry in Kidney Transplant Patients

NCT ID: NCT02555787

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

4430 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-05

Study Completion Date

2022-09-30

Brief Summary

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A study to evaluate changes over time in renal function from baseline (time of conversion) up until five years post conversion in kidney transplant patients converted from tacrolimus twice daily (BD) formulations to a once daily formulation as Advagraf.

Detailed Description

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This is a multicenter long-term (up to five years post-conversion), non-interventional registry in kidney transplant patients who have been converted from tacrolimus BD to Advagraf. Centers that are providing medical care for kidney transplant patients who may convert patients from tacrolimus BD to Advagraf will be identified and requested to approach patients for consent to participate.

Conditions

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Kidney Transplantation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients converted from tacrolimus BD to Advagraf

Oral

Tacrolimus

Intervention Type DRUG

oral

Interventions

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Tacrolimus

oral

Intervention Type DRUG

Other Intervention Names

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FK506E Advagraf Astagraf XL Prograf XL

Eligibility Criteria

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Inclusion Criteria

* Adult kidney transplant patients who are on tacrolimus BD and identified for conversion to Advagraf. Patients will only be approached about participating in the registry after their physician has made the decision to convert them to Advagraf. Patients previously treated with Advagraf and who have stopped for any reason will not be excluded from the registry provided that the physician has decided to convert.

Exclusion Criteria

* Patients currently taking Advagraf treatment
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 Affairs Europe

Role: STUDY_DIRECTOR

Astellas Pharma Europe Ltd.

Locations

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Site AU6107

Camperdown, New South Wales, Australia

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Site AU6106

Gosford, New South Wales, Australia

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Site AU6104

New Lambton, New South Wales, Australia

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Site AU6103

Westmead, New South Wales, Australia

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Site AU6111

Harvey Bay, Queensland, Australia

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Site AU6108

North Adelaide, South Australia, Australia

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Site AU6110

Nedlands, Western Australia, Australia

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Site AU6105

Perth, Western Australia, Australia

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Site AT4301

Graz, Styria, Austria

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Site AT4302

Innsbruck, Tyrol, Austria

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Site AT4303

Innsbruck, Tyrol, Austria

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Site AT4304

Linz, Upper Austria, Austria

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Site BE3201

Leuven, Vlaams Brabant, Belgium

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Site CA1001

Vancouver, British Columbia, Canada

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Site CZ4202

Olomouc, , Czechia

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Site FR3310

Nice, Alpes-Maritimes, France

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Site FR3318

Strasbourg, Alsace, France

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Site FR3324

Lyon, Auvergne-Rhône-Alpes, France

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Site FR3315

Marseille, Bouches-du-Rhône, France

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Site FR3303

Caen, Calvados, France

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Site FR3306

Besançon, Doubs, France

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Site FR3311

Brest, Finistère, France

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Site FR3302

Bordeaux, Gironde, France

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Site FR3313

Toulouse, Haute-Garonne, France

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Site FR3307

Rouen, Haute-Normandie, France

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Site FR3321

Limoges, Hautte-Vienne, France

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Site FR3317

Rennes, Ille-et-Vilaine, France

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Site FR3305

Tours, Indre-et-Loire, France

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Site FR3312

Nantes, Loire-Atlantique, France

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Site FR3314

Angers, Maine-et-Loire, France

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Site FR3325

Lille, Nord, France

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Site FR3309

Saint-Étienne-de-Montluc, Pays de la Loire Region, France

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Site FR3308

Amiens, Picardie, France

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Site FR3319

Clermont-Ferrand, Puy-de-Dôme, France

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Site FR3322

Poitiers, Vienne, France

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Site FR3323

Paris, , France

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Site FR3301

Créteil, Île-de-France Region, France

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Site FR3316

Le Kremlin-Bicêtre, Île-de-France Region, France

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Site DE4902

Mannheim, Baden-Wurttemberg, Germany

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Site DE4901

Würzburg, Bavaria, Germany

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Site DE4903

Hanover, Lower Saxony, Germany

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Site GR3002

Athens, , Greece

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Site GR3004

Athens, , Greece

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Site HK8201

Hong Kong, , Hong Kong

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Site HK8521

Hong Kong, , Hong Kong

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Site HU3601

Debrecen, Hajdú-Bihar, Hungary

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Site HU3602

Budapest, , Hungary

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Site IT3903

Napoli, Campania, Italy

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Site IT3907

Verona, Veneto, Italy

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Site IT3905

Bari, , Italy

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Site IT3902

Bologna, , Italy

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Site IT3914

Bolzano, , Italy

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Site IT3901

Genova, , Italy

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Site IT3904

L’Aquila, , Italy

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Site IT3911

Novara, , Italy

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Site IT3916

Novara, , Italy

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Site IT3910

Padua, , Italy

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Site IT3909

Perugia, , Italy

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Site IT3912

Salerno, , Italy

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Site IT39013

Salerno, , Italy

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Site IT3913

Salerno, , Italy

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Site IT3908

Sassari, , Italy

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Site IT3915

Udine, , Italy

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Site IT3906

Venezia, , Italy

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Site JP8108

Nagoya, Aiti, Japan

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Site JP8109

Toyoake, Aiti, Japan

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Site JP8107

Chiba, Chiba, Japan

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Site JP8110

Nishinomiya, Hyôgo, Japan

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Site JP8111

Nishinomiya, Hyôgo, Japan

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Site JP8106

Kawasaki-shi, Kanagawa, Japan

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Site JP8105

Ōta-ku, Tôkyô, Japan

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Site JP8104

Shinjuku-Ku, Tôkyô, Japan

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Site JP8101

Akita, , Japan

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Site JP8102

Niigata, , Japan

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Site MY6001

Kuala Lumpur, Wilayah Persekutuan Kuala Lump, Malaysia

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Site NL3103

Nijmegen, Gelderland, Netherlands

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Site NL3104

Amsterdam, North Holland, Netherlands

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Site NL3105

Groningen, , Netherlands

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Site NL3101

Utrecht, , Netherlands

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Site PH6303

Quezon City, National Capital Region, Philippines

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Site PL4806

Poznan, Greater Poland Voivodeship, Poland

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Site PL4808

Lublin, Lublin Voivodeship, Poland

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Site PL4801

Warsaw, Masovian Voivodeship, Poland

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Site PL4807

Szczecin, West Pomeranian Voivodeship, Poland

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Site PT3511

Porto, , Portugal

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Site RO4004

Cluj-Napoca, Cluj, Romania

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Site RO4001

Bucharest, , Romania

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Site RO4002

Bucharest, , Romania

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Site RO4003

Bucharest, , Romania

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Site SB3804

Niš, Nišavski Okrug, Serbia

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Site SB3801

Belgrade, , Serbia

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Site SB3802

Belgrade, , Serbia

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Site SB3803

Novi Sad, , Serbia

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Site KR8214

Busan, Busan Gwang'yeogsi [Pusan-Kwan, South Korea

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Site KR8205

Busan, Busan Gwang'yeogsi [Pusan-Kwan, South Korea

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Site KR8203

Pusan, Busan Gwang'yeogsi [Pusan-Kwan, South Korea

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Site KR8202

Daegu, Daegu Gwang'yeogsi [Taegu-Kwan, South Korea

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Site KR8219

Daegu, Daegu Gwang'yeogsi, South Korea

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Site KR8207

Daejeon, Daejeon Gwang'yeogsi [Taejon-K, South Korea

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Site KR8212

Gwangju, Gwangju Gwang'yeogsi, South Korea

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Site KR8218

Suwon, Gyeonggido [Kyonggi-do], South Korea

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Site KR8216

Bucheon-si, Gyeonggido, South Korea

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Site KR8201

Incheon, Incheon Gwang'yeogsi [Inch'n-K, South Korea

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Site KR8211

Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, South Korea

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Site KR8210

Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, South Korea

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Site KR8206

Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, South Korea

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Site KR8209

Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, South Korea

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Site KR8204

Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, South Korea

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Site KR8208

Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, South Korea

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Site KR8213

Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, South Korea

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Site KR8215

Ulsan, Ulsan Gwang'yeogsi [Ulsan-Kwan, South Korea

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Site ES3410

Santiago de Compostela, A Coruña, Spain

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Site ES3401

Barcelona, , Spain

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Site ES3403

Barcelona, , Spain

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Site TW8862

Kaohsiung City, Kaohsiung, Taiwan

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Site TW8863

Taichung, Taichung Municipality, Taiwan

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Site TW8861

Tainan City, , Taiwan

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Site TH6601

Bangkok, Krung Thep Maha Nakhon [Bangko, Thailand

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Site TH6602

Bangkok, Krung Thep Maha Nakhon [Bangko, Thailand

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Site TH6603

Khon Kaen, , Thailand

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Site GB4403

Peterborough, Cambridgeshire, United Kingdom

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Site GB4405

Exeter, Devon, United Kingdom

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Site GB4406

Manchester, Lancashire, United Kingdom

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Site GB4407

Ipswich, Suffolk, United Kingdom

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Site GB4401

Leeds, , United Kingdom

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Site GB4402

Liverpool, , United Kingdom

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Site GB4408

London, , United Kingdom

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Site VN8401

Hà Nội, Ha Noi, Thanh Pho, Vietnam

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Site VN8402

Ho Chi Minh City, Ho Chi Minh, Thanh Pho, Vietnam

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Countries

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Australia Austria Belgium Canada Czechia France Germany Greece Hong Kong Hungary Italy Japan Malaysia Netherlands Philippines Poland Portugal Romania Serbia South Korea Spain Taiwan Thailand United Kingdom Vietnam

Other Identifiers

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506-MA-1002

Identifier Type: -

Identifier Source: org_study_id

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