Study Details

Roxadustat in the Treatment of Anemia in End Stage Renal Disease (ESRD) Patients on Stable Dialysis

This trial is complete
The study has ended normally, and participants are no longer being examined or treated (that is, the last participant's last visit has occurred). ID

The unique identification code given to each clinical study upon registration at

Astellas Study ID

The unique identification code given by the study sponsor.


EudraCT ID

The unique identification code given to each clinical study upon registration at EudraCT (European Union Drug Regulating Authorities Clinical Trials Database).



Anemia, Kidney Disease


These clinical trials are done to confirm that an experimental treatment helps participants who have a specific condition. These clinical trials often compare the experimental treatment to another treatment or, if appropriate, a placebo.

Phase 3


18 years - N/A


Female & Male




A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


Trial Dates

Nov 2014 - Jul 2018


None (Open Label)

Enrollment number


A Phase 3, Randomized, Open-Label, Active-Controlled Study to Evaluate the Efficacy and Safety of Roxadustat in the Maintenance Treatment of Anemia in End Stage Renal Disease Patients on Stable Dialysis

Study summary

Study documents

Study Documents, including study results, are available after a study is completed or terminated, according to Astellas Transparency policy.

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Site HU36007

Budapest, Hungary, H 1115

Site GB44001

Swansea, United Kingdom, SA6 6NL

Site GB44081

Leicester, United Kingdom, LE5 4PW

Site ES34002

Badalona-Barcelona, Spain, 8916

Site ES34030

Majadahonda, Spain, 28222

Site BE32004

Brussels, Belgium, 1200

Site FR33050

Angers, France, 49033

Site RU70005

Moscow, Russian Federation, 125284

Site PT35139

Cascais, Portugal, 2750-663

Site ES34035

Barcelona, Spain, 08036

Site PT35127

Aveiro, Portugal, 3800-266

Site RS38105

Belgrade, Serbia, 11000

Site ES34011

Galdakao, Spain, 48960

Site PT35121

Almada, Portugal, 2800-455

Site RS38117

Krusevac, Serbia, 37000

Site RO40015

Bucharest, Romania

Site RO40004

Oradea, Romania, 410562

Site BG35919

Plovdiv, Bulgaria, 4003

Site BE32017

Bonheiden, Belgium, 2820

Site ES34008

Barcelona, Spain, 08025

Site HU36046

Szekesfehervar, Hungary, 8000

Site HR38508

Cakovec, Croatia, 40000

Site BE32003

Leuven, Belgium, 3000

Site HU36026

Kaposvar, Hungary, H 7400

Site PL48004

Warszawa, Poland, 04 749

Site GB44079

Liverpool, United Kingdom, L9 7AL

Site SK42119

Levice, Slovakia, 93401

Site HR38501

Zadar, Croatia, 23 000

Site DE49049

Trier, Germany, 54292

Site HR38504

Slavonski Brod, Croatia, 35000

Site RS38104

Belgrade, Serbia

Site RU70037

Volgograd, Russian Federation, 404120

Site BG35907

Stara Zagora, Bulgaria, 6000

Site BG35916

Varna, Bulgaria, 9000

Site IT39032

Trieste, Italy, 34142

Site DE49073

Cloppenburg, Germany, 49661

Site DE49054

Dusseldorf, Germany, 40210

Site RO40018

Bucharest, Romania, 011794

Site SK42102

Koshice, Slovakia, 04001

Site FR33063

Quincy sous Senart, France, 91480

Site BE32002

Antwerp, Belgium, 2060

Site GE99503

Tbilisi, Georgia, 0144

Site ES34009

El Ejido, Spain, 04700

Site SK42113

Puchov, Slovakia, 020 01

Site IT39010

Brescia, Italy, 25123

Site BG35920

Rousse, Bulgaria, 7002

Site BE32011

Roeselare, Belgium, 8800

Site BG35906

Sofia, Bulgaria, 1431

Site RU70014

Rostov-on-Don, Russian Federation, 344029

Site ES34010

Alcorcon, Spain, 28922

Site DE49002

Solingen, Germany, 42653

Site PT35128

Gaeiras, Portugal, 2510-702

Site IT39008

Lecco, Italy, 23900

Site ES34041

Santiago de Compostela, Spain, 15706

Site FR33055

Saint Ouen, France, 93400

Site RS38102

Belgrade, Serbia, 11000

Site PT35114

Leiria, Portugal, 2400-441

Site PT35120

Almada, Portugal, 2801-951

Site RU70073

Nizhniy Novgorod, Russian Federation, 603126

Site PL48013

Szczecin, Poland, 70-111

Site FR33008

Nantes Cedex 1, France, 44093

Site RO40020

Odorheiu Secuiesc, Romania, 535600

Site DE49070

Muenchen, Germany, 81695

Site SK42120

Lučenec, Slovakia, 984 01

Site RU70050

Saint-Petersburg, Russian Federation, 197374

Site FR33010

La Tronche, France, 38701

Site BG35924

Sofia, Bulgaria, 1309

Site DE49072

Herne, Germany, 44626

Site IT39040

San Fermodella Battaglia, Italy, 22020

Site PT35140

Corroios, Portugal, 2855 -227

Site RU70008

Kaluga, Russian Federation, 248007

Site ES34017

Jaen, Spain, 23007

Site PT35117

Faro, Portugal, 8005-546

Site PL48009

Wroclaw, Poland, 51 124

Site IT39028

Prato, Italy, 59100

Site RS38101

Nis, Serbia

Site RU70030

Sankt-Peterburg, Russian Federation, 197110

Site CZ42015

Rakovnik, Czech Republic, 26929

Site ES34039

Cordoba, Spain, 14004

Site BG35921

Sofia, Bulgaria, 1527

Site BG35903

Veliko Tarnovo, Bulgaria, 5000

Site HU36006

Szombathely, Hungary, H 9700

Site BG35909

Plovdiv, Bulgaria, 4000

Site PL48014

Zamosc, Poland, 20-400

Site BE32019

Antwerpen, Belgium, 2020

Site GB44080

Stoke on Trent, United Kingdom, ST4 6QG

Site RU70011

Saint-Petersburg, Russian Federation, 196247

Site CZ42008

Liberec, Czech Republic, 46063

Site RS38103

Belgrade, Serbia, 11080

Site HU36027

Kistarcsa, Hungary, 2143

Site ES34037

Madrid, Spain, 28046

Site BG35923

Pazardjik, Bulgaria

Site BG35915

Pleven, Bulgaria, 5800

Site RU70002

Saint Petersburg, Russian Federation, 197089

Site HU36003

Zalsaegerszeg, Hungary, 8900

Site IT39006

Milano, Italy, 20162

Site HU36036

Esztergom, Hungary, 2500

Site BG35918

Varna, Bulgaria, 9010

Site IT39022

Padova, Italy, 35128

Site RU70051

Moscow, Russian Federation, 119992

Site IT39036

Pavia, Italy, 27100

Site HU36004

Szeged, Hungary, 6724

Site BE32013

Liege, Belgium, 4000

Site RS38116

Zrenjanin, Serbia

Site RO40003

Bucuresti, Romania, 22328

Site BG35925

Blagoevgrad, Bulgaria, 2700

Site RU70004

Omsk, Russian Federation, 644112

Site IT39035

Torino, Italy, 10126

Site RU70001

Yaroslavl, Russian Federation, 150062

Site DE49071

Villingen-Schwenningen, Germany, 78052

Site FR33007

St Priez en Jarez, France, 42270

Site FR33057

Le Mans, France, 72037

Site ES34052

Valencia, Spain, 46017

Site RU70006

Smolensk, Russian Federation, 214006

Site GB44007

London, United Kingdom, SM5 1AA

Site DE49031

Bonn, Germany, 53127

Site FR33005

Amiens cedex 1, France, 80054

Site IT39039

Cremona, Italy, 26100

Site FR33009

Colmar Cedex, France, 68024

Site IT39014

Mestre, Italy, 30174

Site PL48006

Wroclaw, Poland, 50-556

Site DE49008

Dresden, Germany, 01307

Site HU36035

Pecs, Hungary, 7633

Site HU36032

Pecs, Hungary, 7624

Site BG35938

Shumen, Bulgaria, 9700

Site HR38506

Rijeka, Croatia, 51000

Site PL48001

Krakow, Poland, 30 501

Site ES34001

Bilbao, Spain, 48013

Site RU70072

Saint Petersburg, Russian Federation, 190103

Site PL48002

Katowice, Poland, 40 027

Site GB44087

Brighton, United Kingdom, BN2 5BD

Site SK42116

Senica, Slovakia, 90501

Site PT35102

Porto, Portugal, 4099-001

Site RU70003

Nizhny Novgorod, Russian Federation, 603032

Site BG35931

Haskovo, Bulgaria, 6300

Site RS38120

Belgrade, Serbia, 11000

Site DE49067

Berlin, Germany, 10117

Site FR33004

Avignon, France, 84900

Site GB44077

Portsmouth, United Kingdom, PO63LY

Site HU36034

Salgotarjan, Hungary, 3100

Site HU36031

Gyor, Hungary, 9002

Site RO40019

Bucharest, Romania

Site FR33056

Valenciennes, France, 59300

Site GB44011

Canterbury, United Kingdom, CT1 3NG

Site GB44010

Hull, United Kingdom, HU3 2JZ

Site PT35122

Setubal, Portugal, 2900-655

Site BE32012

Baudour, Belgium, 7331

Site PL48005

Warszawa, Poland, 00 507

Site GE99504

Tbilisi, Georgia, 0144

Site HR38505

Karlovac, Croatia, 47000

Site IT39005

Roma, Italy, 122

Site ES34006

Barcelona, Spain, 08035

Site HU36033

Baja, Hungary, 6500

Site DE49075

Heilbronn, Germany, 74076

Site GE99508

Tbilisi, Georgia, 159

Site DE49056

Dormagen, Germany, 41540

Site CZ42021

Praha 6, Czech Republic, 169 00

Site FR33001

Creteil, France, 94010

Site HR38507

Osijek, Croatia, 31 000

Site BG35937

Yambol, Bulgaria, 8600

Site GB44008

Cambridge, United Kingdom, CB2 0QQ

Site DE49001

Kaiserslautern, Germany, 67655

Site HR38509

Zagreb, Croatia, 10000

Site DE49020

Frankfurt am Main, Germany, 60590

Site BE32001

Aalst, Belgium, 9300

Site DE49065

Hamburg, Germany, 23397

Site IT39037

Modena, Italy, 41124