Study Details

Roxadustat in the treatment of anemia in Chronic Kidney Disease (CKD) patients, not on dialysis, in comparison to darbepoetin alfa

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).





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

Mar 2014 - Nov 2019


None (Open Label)

Enrollment number


A Phase 3, Randomized, Open-Label, Active-Controlled Study to Evaluate the Efficacy and Safety of Roxadustat in the Treatment of Anemia in Chronic Kidney Disease Patients Not on Dialysis

Study summary

Study documents

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

Get More Information

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Site RS38104

Belgrade, Serbia

Site GB44099

Dartford, United Kingdom, DA2 8DA

Site IE35303

Galway, Ireland

Site GB44101

Preston, United Kingdom, PR2 9HT

Site PL48008

Lodz, Poland, 92-213

Site ES34047

Barcelona, Spain, 08025

Site MK38901

Skopje, Macedonia, 1000

Site PT35112

Carnaxide, Portugal, 2795-523

Site NL31006

Almelo, Netherlands, 7609PP

Site AT43006

Linz, Austria, 4001

Site RS38103

Belgrade, Serbia, 11080

Site LV37103

Valmiera, Latvia, LV-1002

Site GB44098

Dorchester, United Kingdom, DT1 2JY

Site SK42116

Senica, Slovakia, 905 01

Site RU70006

Moscow, Russian Federation, 125284

Site ES34049

Ferrol, Spain, 15405

Site CZ42003

Praque, Czech Republic, 14021

Site AT43007

Graz, Austria, 8036

Site SI38617

Ljubljana, Slovenia, 1000

Site DE49057

Hoyerswerda, Germany, 02977

Site GB44006

London, United Kingdom, SE5 9RS

Site RU70057

Yaroslavl, Russian Federation, 150000

Site FR33005

Amiens, France, 80054

Site DE49075

Heilbronn, Germany, 74076

Site IL97214

Holon, Israel, 58100

Site DE49065

Hamburg, Germany, 23397

Site BY37506

Minsk, Belarus, 220036

Site DE49003

Ulm, Germany, 89081

Site BY37501

Grodno, Belarus, 230017

Site ES34039

Cordoba, Spain, 14004

Site UA38007

Mykolaiv, Ukraine

Site AT43005

Innsbruck, Austria, 6002

Site HR38502

Zagreb, Croatia, 10000

Site PL48059

Zamosc, Poland, 22-400

Site CZ42014

Zdar nad Sazavou, Czech Republic, 59101

Site PT35117

Faro, Portugal, 8000-386

Site NL31002

Rotterdam, Netherlands, 3079 DZ

Site UA38016

Ivano-Frankivsk, Ukraine, 76018

Site UA38010

Kyiv, Ukraine, 01016

Site SE46012

Gothenburg, Sweden, 413 45

Site ES34056

Lugo, Spain, 27003

Site NL31007

Breda, Netherlands, 4818 CK

Site ES34054

Girona, Spain, 17007

Site PT35115

Lisboa, Portugal, 1649-035

Site DE49058

Nettetal, Germany, 41334

Site FR33012

Lyon, France, 69437

Site RU70008

Kaluga, Russian Federation, 248007

Site GE99504

Tbilisi, Georgia, 144

Site RU70004

Omsk, Russian Federation, 644112

Site BA38701

Tuzla, Bosnia And Herzegovina, 753000

Site BA38702

Sarajevo, Bosnia And Herzegovina, 713000

Site BY37507

Minsk, Belarus, 220116

Site BY37503

Brest, Belarus, 224027

Site ES34002

Barcelona, Spain, 8916

Site GB44103

Edinburgh, United Kingdom

Site PL48018

Opole, Poland

Site ES34017

Jaen, Spain, 23007

Site BY37502

Vitebsk, Belarus, 210037

Site RU70003

Nizhny Novgorod, Russian Federation, 603032

Site GB44097

Nottingham, United Kingdom, NG5 1PB

Site HU36046

Velence, Hungary

Site DK45009

Hillerød, Denmark, 3400

Site FR33004

Avignon, France, 84900

Site PT35133

Matosinhos, Portugal, 4464-513

Site HR38509

Zagreb, Croatia, 10000

Site AT43009

Vienna, Austria

Site FI35810

Helsinki, Finland, 290

Site UA38015

Kherson, Ukraine, 73000

Site PL48006

Wroclaw, Poland

Site RS38105

Belgrade, Serbia, 11000

Site LV37104

Ventspils, Latvia, LV-3601

Site NL31003

Leeuwarden, Netherlands, 8934 AD

Site SI38603

Maribor, Slovenia, 2000

Site DE49001

Kaiserslautern, Germany, 67655

Site RO40004

Oradea, Romania, 410469

Site CZ42018

Novy Jicin, Czech Republic, 741 01

Site UA38018

Uzhgorod, Ukraine, 88018

Site UA38017

Kiev, Ukraine, 4053

Site NL31004

Dordrecht, Netherlands, 3318 AT

Site UA38008

Odessa, Ukraine, 6500

Site RU70060

Saratov, Russian Federation, 410039

Site FR33009

Colmar, France, 68024

Site PT35122

Setubal, Portugal, 2910-446

Site CZ42021

Prague, Czech Republic

Site DK45007

Roskilde, Denmark, 4000

Site CZ42002

Klatovy, Czech Republic, 33938

Site FR33008

Nantes, France, 44093

Site PL48001

Krakow, Poland, 31-559

Site FI35803

Tampere, Finland, 33520

Site PT35118

Lisboa, Portugal, 1069-166

Site DE49054

Düsseldorf, Germany, 40210

Site HR38507

Osijek, Croatia, 31 000

Site SK42102

Košice, Slovakia, 04001

Site DE49060

Regensburg, Germany, 93053

Site IL97212

Petah-Tiqva, Israel, 49100

Site NL31008

Den Haag, Netherlands, 2545 CH

Site GB44010

Hull, United Kingdom, HU3 2JZ

Site PT35102

Porto, Portugal, 4099-001

Site RU70002

Saint Petersburg, Russian Federation, 197089

Site ES34041

Santiago de Compostela, Spain, 15706

Site ES34010

Madrid, Spain, 28922

Site IL97213

Kfar-Saba, Israel, 44228

Site BG35908

Sofia, Bulgaria, 1431

Site RS38117

Krusevac, Serbia, 37000

Site BY37504

Gomel, Belarus, 246027

Site RU70054

Irkutsk, Russian Federation, 664079

Site GE99502

Tbilisi, Georgia, 159

Site IL97202

Be'er Ya'akov, Israel, 70300

Site LV37101

Riga, Latvia, LV-1002

Site DE49076

Neckarsulm, Germany, 74172

Site PT35119

Evora, Portugal, 7000-811

Site HR38504

Slavonski Brod, Croatia, 35000

Site DE49056

Dormagen, Germany, 40210

Site RU70011

Saint Petersburg, Russian Federation, 196247

Site BG35923

Pazardzhik, Bulgaria

Site SE46017

Jonkoping, Sweden, 551 85

Site PL48004

Warszawa, Poland, 04-749

Site FR33062

Limoges, France, 87042

Site DE49070

Munich, Germany, 81695

Site RO40021

Bucharest, Romania, 22328

Site PL48013

Szczecin, Poland, 70-111

Site FR33010

Grenoble, France

Site RU70047

Moscow, Russian Federation, 119992

Site GB44100

Orpington, United Kingdom, BR6 8ND

Site CZ42015

Rakovnik, Czech Republic, 26929

Site SI38609

Šempeter pri Gorici, Slovenia, 5290

Site UA38009

Lviv, Ukraine, 79010

Site DE49008

Dresden, Germany, 01307

Site BG35916

Varna, Bulgaria, 9000

Site SK42118

Bratislava, Slovakia, 83305

Site BG35907

Sofia, Bulgaria, 1113

Site ES34044

Avila, Spain, 5004

Site PT35134

Viseu, Portugal, 3504-509

Site PT35120

Almada, Portugal, 2801-951

Site GB44081

Leicester, United Kingdom, LE5 4PW

Site SI38619

Slovenj Gradec, Slovenia, SI 2380

Site HU36027

Kistarcsa, Hungary, 2143

Site HU36007

Budapest, Hungary, H 1115

Site HR38505

Karlovac, Croatia, 47000

Site PT35131

Braga, Portugal, 4710-243

Site LV37105

Daugavpils, Latvia, LV-5417

Site GB44008

Cambridge, United Kingdom, CB2 0QQ

Site DE49002

Solingen, Germany, 42653

Site RU70014

Rostov-on-Don, Russian Federation, 344029

Site CZ42008

Liberec, Czech Republic, 46063

Site GB44082

London, United Kingdom, SW17 0QT

Site HR38508

Cakovec, Croatia, 40000

Site RO40003

Bucharest, Romania, 11234

Site GB44001

Swansea, United Kingdom, SA6 6NL

Site DE49055

Demmin, Germany, 17109

Site FR33007

Saint-Priest-en-Jarez, France, 42270

Site HR38501

Zadar, Croatia, 23 000

Site PT35132

Vila Nova de Gaia, Portugal, 4434-502

Site BG35927

Sofia, Bulgaria, 1709

Site HU36026

Kistarcsa, Hungary, 2143

Site IE35301

Cork, Ireland

Site FR33051

Brest, France, 29609

Site IL97211

Jerusalem, Israel, 91120

Site HU36008

Pecs, Hungary, H 7624

Site DE49063

Berlin, Germany, 10117

Site NL31005

Utrecht, Netherlands, 3584 CX

Site UA38021

Cherkasy, Ukraine, 18009

Site ES34040

Zaragoza, Spain, 50009

Site HR38510

Zagreb, Croatia, 10 000

Site UA38006

Dnipropetrovsk, Ukraine, 49005

Site PL48066

Pulawy, Poland, 24-100

Site PL48007

Tarnow, Poland, 33-100

Site BY37505

Minsk, Belarus, 223040

Site FR33013

Boulogne sur Mer, France, 62231

Site GE99503

Tbilisi, Georgia, 144

Site RU70024

Chelyabinsk, Russian Federation, 454047

Site UA38001

Ternopil, Ukraine, 46002

Site RU70001

Yaroslavl, Russian Federation, 150062

Site ME38203

Berane, Montenegro

Site ES34037

Madrid, Spain, 28046

Site DE49073

Cloppenburg, Germany, 49661

Site SK42115

Myjava, Slovakia, 907 01

Site RU70048

Moscow, Russian Federation

Site RU70043

Petrozavodsk, Russian Federation, 185019

Site CZ42010

Prague, Czech Republic, 12808

Site DK45005

Rønne, Denmark, 3700

Site ES34030

Majadahonda, Spain, 28222

Site GB44064

Birmingham, United Kingdom, B9 5SS

Site GB44102

Kings Lynn, United Kingdom, PE30 4ET

Site SE46008

Lund, Sweden, 22185

Site ME38201

Podgorica, Montenegro, 81000

Site HR38506

Rijeka, Croatia, 51000

Site BA38703

Mostar, Bosnia And Herzegovina, 88000

Site FR33058

Le Kremlin Bicetre, France, 94270

Site GB44079

Liverpool, United Kingdom, L9 7AL

Site PL48005

Warszawa, Poland, 00-507

Site ME38202

Niksic, Montenegro, 81400

Site IL97209

Ramat Gan, Israel, 52621

Site SK42113

Puchov, Slovakia, 02001

Site GB44086

London, United Kingdom, E1 1BB

Site RS38101

Nis, Serbia, 11070

Site ES34026

Barcelona, Spain, 08907

Site FR33022

Clermont-Ferrand, France, 63003

Site ES34052

Valencia, Spain, 46017

Site PT35125

Amadora, Portugal, 2720-276

Site GB44080

Stoke-on-Trent, United Kingdom, ST4 6QG

Site DE49064

Hannover, Germany, 30159

Site FI35801

Lohja, Finland, 08200

Site RS38102

Belgrade, Serbia, 11000

Site PT35107

Porto, Portugal, 4202-451

Site SI38615

Jesenice, Slovenia, SI-4270

Site IL97215

Haifa, Israel, 34362

Site SK42109

Kosice, Slovakia, 04001

Site GB44004

Westcliff-on-Sea, United Kingdom

Site HU36029

Budapest, Hungary

Site BG35910

Sofia, Bulgaria

Site RO40012

Bucuresti, Romania, 10825

Site ES34022

Sevilla, Spain, 41013

Site UA38011

Kharkiv, Ukraine, 61103

Site HU36028

Budapest, Hungary, 1097

Site DK45001

Holstebro, Denmark, 7500

Site MK38903

Struga, Macedonia, 6330

Site DE49009

Jena, Germany, 7747

Site IL97210

Jerusalem, Israel, 91031

Site PL48009

Wroclaw, Poland