Study Details

Roxadustat in the Treatment of Anemia in Chronic Kidney Disease Patients Not Requiring 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).

Clinicaltrials.gov ID

The unique identification code given to each clinical study upon registration at ClinicalTrials.gov.
NCT01887600

Astellas Study ID

The unique identification code given by the study sponsor.

1517-CL-0608

EudraCT ID

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

2012-005180-27

Condition

Anemia

Phase

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

Age

18 years - N/A

Sex

Female & Male

Product

roxadustat

Type

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.

Interventional

Trial Dates

Sep 2013 - Nov 2017

Masking

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Enrollment number

594

A Phase 3, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of Roxadustat for 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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Locations

Site GT50202

Ciudad de Guatemala, Guatemala, AP 01015

Site GT50206

Guatemala, Guatemala, 01010

Site ES34003

Barcelona, Spain, 08003

Site DO17102

Santiago de los Caballeros, Dominican Republic, 51000

Site PL48057

Nowy Tomyśl, Poland, 64-300

Site IT39027

Bollate, Italy, 20021

Site IT39037

Modena, Italy, 41124

Site HU36026

Kaposvar, Hungary, H 7400

Site BY37506

Minsk, Belarus, 220036

Site PA50705

Ciudad de Panama, Panama, 0843-2007

Site BG35904

Ruse, Bulgaria, 7000

Site UA38012

Kyiv, Ukraine, 02125

Site BE32017

Bonheiden, Belgium, 2820

Site BE32012

Baudour, Belgium, 7331

Site DO17103

Santo Domingo, Dominican Republic, 103201

Site GR30001

Thessaloniki, Greece, 54642

Site RS38116

Zrenjanin, Serbia, 23000

Site UA38017

Kyiv, Ukraine, 04050

Site PE51002

Trujillo, Peru, 13001

Site HU36003

Zalsaegerszeg, Hungary, 8900

Site IT39003

Chieti, Italy, 66013

Site BE32004

Brussels, Belgium, 1200

Site UA38016

Ivano-Frankivsk, Ukraine, 76018

Site BE32020

Brussels, Belgium, B-1020

Site GT50204

Quetzaltenango, Guatemala, CP 09001

Site UA38021

Cherkasy, Ukraine, 18009

Site TR90024

Kocaeli, Turkey, 41380

Site RU70047

Moscow, Russian Federation, 129327

Site TR90002

Balcova, Turkey, 35340

Site UA38004

Donetsk, Ukraine, 83114

Site RS38101

Nis, Serbia, 18000

Site UA38009

Lviv, Ukraine, 79010

Site CO57002

Pereira, Colombia

Site PL48058

Kutno, Poland, 99-300

Site RO40002

Bucuresti, Romania, 50098

Site RU70012

Moskva, Russian Federation, 119991

Site RS38117

Krusevac, Serbia, 37000

Site GT50208

Ciudad de Guatemala, Guatemala, CP 01001

Site BY37503

Brest, Belarus, 224027

Site RU70046

Ulyanovsk, Russian Federation, 432005

Site UA38011

Kharkiv, Ukraine, 61103

Site UA38015

Kherson, Ukraine, 73000

Site RO40005

Timisoara, Romania, 300736

Site GB44083

Glasgow, United Kingdom, G51 4TF

Site RU70048

Moscow, Russian Federation, 129301

Site RU70014

Rostov-on-don, Russian Federation, 344029

Site RU70051

Moscow, Russian Federation, 119992

Site BY37502

Vitebsk, Belarus, 210037

Site PA50701

Ciudad de Panama, Panama

Site ES34010

Alcorcon, Spain, 28922

Site RU70057

Yaroslavl, Russian Federation, 150045

Site ZA27006

Parow, South Africa, 7500

Site BG35907

Stara Zagora, Bulgaria, 6000

Site ES34011

Galdakao, Spain, 48960

Site RO40001

Brasov, Romania, 500366

Site ZA27004

Bloemfontein, South Africa, 9324

Site ZA27002

Durban, South Africa, 4001

Site GE99503

Tbilisi, Georgia, 0144

Site IT39005

Roma, Italy, 122

Site TR90016

Edirne, Turkey, 22030

Site PL48011

Rzeszow, Poland, 35055

Site ES34002

Badalona-Barcelona, Spain, 8916

Site BG35908

Sofia, Bulgaria, 1431

Site HU36025

Gyor, Hungary, 9002

Site BY37507

Minsk, Belarus, 220116

Site CO57003

Medellin, Colombia

Site ZA27008

Durban, South Africa, 4001

Site IT39009

Padova, Italy, 35128

Site PL48018

Opole, Poland, 45-418

Site PA50703

Ciudad de Colon, Panama, 0302-00504 Z.L.

Site IT39035

Torino, Italy, 10126

Site RU70054

Irkutsk, Russian Federation, 664079

Site BY37505

Minsk, Belarus, 223040

Site TR90003

Ankara, Turkey, 6340

Site PL48006

Wroclaw, Poland, 50-556

Site PL48007

Tarnow, Poland, 33 100

Site BG35905

Varna, Bulgaria, 9010

Site BG35927

Sofia, Bulgaria, 1709

Site RU70004

Omsk, Russian Federation, 644112

Site GB44008

Cambridge, United Kingdom, CB5 8QD

Site RU70008

Kaluga, Russian Federation, 248007

Site PL48012

Lodz, Poland, 90549

Site IT39002

Monza, Italy, 20900

Site BG35923

Pazardjik, Bulgaria, 4400

Site TR90001

Istanbul, Turkey, 34390

Site BE32014

Ieper, Belgium, 8900

Site GB44007

London, United Kingdom, SM5 1AA

Site ZA27003

Goodwood, South Africa, 7460

Site IT39028

Prato, Italy, 59100

Site RU70060

Saratov, Russian Federation, 410039

Site UA38001

Ternopil, Ukraine, 46002

Site RU70049

Moscow, Russian Federation, 115432

Site PL48008

Lodz, Poland, 92-213

Site RU70002

Saint Petersburg, Russian Federation, 197089

Site UA38018

Uzhgorod, Ukraine, 88018

Site RO40021

Bucharest, Romania, 022328

Site UA38003

Chernivtsi, Ukraine, 58002

Site ZA27001

Observatory, South Africa, 7925

Site HU36029

Budapest, Hungary, H-1036

Site RU70013

Moscow, Russian Federation, 115093

Site RS38105

Belgrade, Serbia, 11000

Site IT39001

Bari, Italy, 70124

Site BG35910

Sofia, Bulgaria, 1431

Site PL48005

Warszawa, Poland, 02-507

Site BY37504

Gomel, Belarus, 246027

Site HU36001

Szekesfehervar, Hungary, H 8000

Site BE32001

Aalst, Belgium, 9300

Site CO57008

Barranquilla, Colombia

Site HU36010

Veszprem, Hungary, 8200

Site PL48001

Krakow, Poland, 31-559

Site PE51008

Lima, Peru, LIMA 10

Site RU70006

Smolensk, Russian Federation, 214006

Site EE37202

Tartu, Estonia, 51014

Site IT39006

Milano, Italy, 20162

Site GT50201

Ciudad de Guatemala, Guatemala, CP 01016

Site RO40004

Oradea, Romania, 410469

Site PL48003

Lublin, Poland, 20-954

Site BE32015

Edegem, Belgium, 2650

Site TR90020

Malatya, Turkey, 44300

Site RU70022

Saint Petersburg, Russian Federation, 192242

Site IT39010

Brescia, Italy, 25123

Site CO57007

Barranquilla, Colombia

Site RO40019

Bucharest, Romania, 319

Site RU70003

Nizhny Novgorod, Russian Federation, 603032

Site BG35916

Varna, Bulgaria, 9000

Site RU70024

Chelyabinsk, Russian Federation, 454047

Site RU70005

Moscow, Russian Federation, 125284

Site RO40012

Bucuresti, Romania, 10825

Site UA38019

Odessa, Ukraine, 65026

Site GR30002

Patras, Greece, 26504

Site BE32013

Liege, Belgium, 4000

Site EE37201

Tallinn, Estonia, 13419

Site ZA27007

Port Elizabeth, South Africa, 6001

Site GB44003

Exeter, United Kingdom, EX2 5DW

Site RO40007

Lasi, Romania, 700506

Site RO40003

Bucuresti, Romania, 22328

Site RU70011

Saint Petersburg, Russian Federation, 196247

Site BE32003

Leuven, Belgium, 3000

Site GB44004

Westcliff-on-Sea, United Kingdom, SS0 0RY

Site GT50205

Guatemala, Guatemala, 01010

Site ES34001

Bilbao, Spain, 48013

Site HU36008

Pecs, Hungary, H 7624

Site RU70007

Moscow, Russian Federation, 123182

Site UA38010

Kyiv, Ukraine, 01016

Site HU36027

Kistarcsa, Hungary, 2143

Site GT50209

Chiquimula, Guatemala, 01001

Site BE32005

Liege, Belgium, 4000

Site ZA27005

Potchefstroom, South Africa, 2531

Site ES34044

Avila, Spain, 05004

Site PE51001

Iquitos, Peru, 16001

Site BE32002

Antwerp, Belgium, 2060

Site GE99504

Tbilisi, Georgia, 0144

Site IT39004

Torino, Italy, 10128

Site GB44077

Portsmouth, United Kingdom, PO63LY

Site GR30003

Heraklion, Greece, 71409

Site DO17101

La Fe Santo Domingo, Dominican Republic, 5072

Site CO57005

Bogota, Colombia

Site ES34006

Barcelona, Spain, 08035

Site UA38002

Zaporizhzhya, Ukraine, 69600

Site HU36006

Szombathely, Hungary, H 9700

Site IT39008

Lecco, Italy, 23900

Site HU36028

Szent, Hungary, H-1097

Site GB44002

Coventry, United Kingdom, CV2 2DX

Site IT39036

Pavia, Italy, 27100

Site RU70043

Petrozavodsk, Russian Federation, 185019

Site BG35906

Sofia, Bulgaria, 1431

Site BG35902

Sofia, Bulgaria, 1527

Site DO17104

Santo Domingo, Dominican Republic, 10124

Site BG35903

Veliko Tarnovo, Bulgaria, 5000

Site TR90004

Adana, Turkey, 1330

Site BG35909

Plovdiv, Bulgaria, 4000

Site PL48014

Zamosc, Poland, 20-400

Site RU70001

Yaroslavl, Russian Federation, 150062

Site PL48002

Katowice, Poland, 40 027

Site PL48013

Szczecin, Poland, 70-111

Site BG35901

Sofia, Bulgaria, 1606

Site GT50203

Guatemala, Guatemala, 01014

Site RU70045

Saint-Petersburg, Russian Federation, 194354

Site GT50207

Ciudad de Guatemala, Guatemala, CP 01010

Site RS38104

Belgrade, Serbia, 11000

Site GB44001

Swansea, United Kingdom, SA6 6NL

Site UA38006

Dnepropetrovsk, Ukraine, 49005

Site RS38102

Belgrade, Serbia, 11000

Site RS38103

Belgrade, Serbia, 11080

Site PE51004

Lima, Peru, 41

Site UA38007

Mykolaiv, Ukraine, 54058

Site GE99502

Tbilisi, Georgia, 0159

Site BY37501

Grodno, Belarus, 230017

Site ES34007

Ciudad Real, Spain, 13005

Site PL48004

Warszawa, Poland, 04 749

Site GB44005

Welwyn Garden City, United Kingdom, AL7 4HQ

Site RU70058

Tomsk, Russian Federation, 634063

Site HU36007

Budapest, Hungary, H 1115

Site HU36004

Szeged, Hungary, 6724

Site PL48009

Wroclaw, Poland, 51 124

Site UA38008

Odessa, Ukraine, 65000

Site GB44078

Bradford, United Kingdom, BD50NA