Study summary

This study was conducted to treat anemia in patients with chronic kidney disease. Anemia is a reduced number of red blood cells or hemoglobin. Hemoglobin is important for the transport of oxygen in your blood. The purpose of the study was to see if Roxadustat is both effective and safe as a treatment for anemia in patients with chronic kidney disease.

Additional Study Details

Phase
Phase 3
Product
roxadustat
Product
Roxadustat
Placebo
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment number
594
Show Additional Study Details

Study documents

Scientific Results Summary
Available Language(s): English
Plain Language Summary
Available Language(s): English
Protocol
Available Language(s): English
Statistical Analysis Plan (SAP)
Available Language(s): English

Get more information

Would you like more information about clinical trial sites that are recruiting participants for Roxadustat in the Treatment of Anemia in Chronic Kidney Disease Patients Not Requiring Dialysis? Contact us by filling out your information to the right and we’ll respond to you.

  • A caregiver
  • A healthcare provider
  • A parent
  • A patient
  • A patient advocate
  • Algeria
  • Argentina
  • Armenia
  • Australia
  • Austria
  • Belarus
  • Belgium
  • Bosnia And Herzegovina
  • Brazil
  • Bulgaria
  • Canada
  • Chile
  • China
  • Colombia
  • Croatia
  • Czech Republic
  • Denmark
  • Dominican Republic
  • Egypt
  • Estonia
  • Finland
  • Former Serbia and Montenegro
  • France
  • Georgia
  • Germany
  • Greece
  • Guatemala
  • Hong Kong
  • Hungary
  • Iceland
  • India
  • Indonesia
  • Ireland
  • Israel
  • Italy
  • Japan
  • Jordan
  • Kazakhstan
  • Latvia
  • Lebanon
  • Lithuania
  • Macedonia
  • Malaysia
  • Mexico
  • Montenegro
  • Morocco
  • Netherlands
  • New Zealand
  • Norway
  • Panama
  • Peru
  • Philippines
  • Poland
  • Portugal
  • Puerto Rico
  • Republic of Korea
  • Republic of Moldova
  • Romania
  • Russian Federation
  • Saudi Arabia
  • Serbia
  • Singapore
  • Slovakia
  • Slovenia
  • South Africa
  • Spain
  • Sweden
  • Switzerland
  • Taiwan, Province of China
  • Thailand
  • Turkey
  • Ukraine
  • United Kingdom
  • United States
  • Vietnam

By clicking ["Continue/Submit"], you agree that Astellas may contact you by email with information to help you connect with clinical trial sites. While we can connect you to clinical trial sites, we cannot answer questions about any investigational therapy through email. Your consent to receiving emails is not a requirement to participate in a clinical trial or study. For more information, including how to unsubscribe at any time, see our Privacy Notice & Cookies Policy.

    Locations

    Contact Us
    Contact Us
    Completed
    Site GT50202
    Ciudad de Guatemala, Guatemala, AP 01015
    Completed
    Site GT50206
    Guatemala, Guatemala, 01010
    Completed
    Site ES34003
    Barcelona, Barcelona, Spain, 08003
    Completed
    Site DO17102
    Santiago de los Caballeros, Dominican Republic, 51000
    Completed
    Site PL48057
    Nowy Tomyśl, Poland, 64-300
    Withdrawn
    Site IT39027
    Bollate, Italy, 20021
    Completed
    Site IT39037
    Modena, Italy, 41124
    Completed
    Site HU36026
    Kaposvar, Hungary, H 7400
    Completed
    Site BY37506
    Minsk, Belarus, 220036
    Withdrawn
    Site PA50705
    Ciudad de Panama, Panama, 0843-2007
    Withdrawn
    Site BG35904
    Ruse, Bulgaria, 7000
    Completed
    Site UA38012
    Kyiv, Ukraine, 02125
    Completed
    Site BE32017
    Bonheiden, Belgium, 2820
    Completed
    Site BE32012
    Baudour, Belgium, 7331
    Completed
    Site DO17103
    Santo Domingo, Dominican Republic, 103201
    Completed
    Site GR30001
    Thessaloniki, Greece, 54642
    Completed
    Site RS38116
    Zrenjanin, Serbia, 23000
    Completed
    Site UA38017
    Kyiv, Ukraine, 04050
    Completed
    Site PE51002
    Trujillo, Peru, 13001
    Completed
    Site HU36003
    Zalsaegerszeg, Hungary, 8900
    Withdrawn
    Site IT39003
    Chieti, Italy, 66013
    Completed
    Site BE32004
    Brussels, Flemish Brabant, Belgium, 1200
    Completed
    Site UA38016
    Ivano-Frankivsk, Ukraine, 76018
    Withdrawn
    Site BE32020
    Brussels, Belgium, B-1020
    Withdrawn
    Site GT50204
    Quetzaltenango, Guatemala, CP 09001
    Completed
    Site UA38021
    Cherkasy, Ukraine, 18009
    Completed
    Site TR90024
    Kocaeli, Turkey, 41380
    Completed
    Site RU70047
    Moscow, Russian Federation, 129327
    Withdrawn
    Site TR90002
    Balcova, Turkey, 35340
    Withdrawn
    Site UA38004
    Donetsk, Ukraine, 83114
    Completed
    Site RS38101
    Nis, Serbia, 18000
    Completed
    Site UA38009
    Lviv, Lvivska, Ukraine, 79010
    Completed
    Site CO57002
    Pereira, Colombia
    Withdrawn
    Site PL48058
    Kutno, Poland, 99-300
    Withdrawn
    Site RO40002
    Bucuresti, Romania, 50098
    Withdrawn
    Site RU70012
    Moskva, Russian Federation, 119991
    Completed
    Site RS38117
    Krusevac, Serbia, 37000
    Completed
    Site GT50208
    Ciudad de Guatemala, Guatemala, CP 01001
    Completed
    Site BY37503
    Brest, Belarus, 224027
    Withdrawn
    Site RU70046
    Ulyanovsk, Russian Federation, 432005
    Completed
    Site UA38011
    Kharkiv, Ukraine, 61103
    Completed
    Site UA38015
    Kherson, Ukraine, 73000
    Completed
    Site RO40005
    Timisoara, Timis, Romania, 300736
    Withdrawn
    Site GB44083
    Glasgow, United Kingdom, G51 4TF
    Completed
    Site RU70048
    Moscow, Russian Federation, 129301
    Completed
    Site RU70014
    Rostov-on-don, Russian Federation, 344029
    Terminated
    Site RU70051
    Moscow, Russian Federation, 119992
    Completed
    Site BY37502
    Vitebsk, Belarus, 210037
    Completed
    Site PA50701
    Ciudad de Panama, Panama
    Completed
    Site ES34010
    Alcorcon, Madrid, Spain, 28922
    Completed
    Site RU70057
    Yaroslavl, Russian Federation, 150045
    Completed
    Site ZA27006
    Parow, South Africa, 7500
    Completed
    Site BG35907
    Stara Zagora, Bulgaria, 6000
    Completed
    Site ES34011
    Galdakao, Vizcaya, Spain, 48960
    Completed
    Site RO40001
    Brasov, BRASOV, Romania, 500366
    Completed
    Site ZA27004
    Bloemfontein, Free State, South Africa, 9324
    Completed
    Site ZA27002
    Durban, Kwa Zulu Natal, South Africa, 4001
    Completed
    Site GE99503
    Tbilisi, Georgia, 0144
    Withdrawn
    Site IT39005
    Roma, Italy, 122
    Completed
    Site TR90016
    Edirne, Turkey, 22030
    Withdrawn
    Site PL48011
    Rzeszow, Poland, 35055
    Completed
    Site ES34002
    Badalona-Barcelona, Spain, 8916
    Completed
    Site BG35908
    Sofia, Bulgaria, 1431
    Completed
    Site HU36025
    Gyor, Hungary, 9002
    Completed
    Site BY37507
    Minsk, Belarus, 220116
    Withdrawn
    Site CO57003
    Medellin, Antioquia, Colombia
    Completed
    Site ZA27008
    Durban, South Africa, 4001
    Withdrawn
    Site IT39009
    Padova, Italy, 35128
    Withdrawn
    Site PL48018
    Opole, Poland, 45-418
    Completed
    Site PA50703
    Ciudad de Colon, Panama, 0302-00504 Z.L.
    Withdrawn
    Site IT39035
    Torino, Italy, 10126
    Completed
    Site RU70054
    Irkutsk, Russian Federation, 664079
    Completed
    Site BY37505
    Minsk, Belarus, 223040
    Completed
    Site TR90003
    Ankara, Turkey, 6340
    Completed
    Site PL48006
    Wroclaw, Poland, 50-556
    Completed
    Site PL48007
    Tarnow, Poland, 33 100
    Withdrawn
    Site BG35905
    Varna, Bulgaria, 9010
    Withdrawn
    Site BG35927
    Sofia, Bulgaria, 1709
    Completed
    Site RU70004
    Omsk, Russian Federation, 644112
    Completed
    Site GB44008
    Cambridge, United Kingdom, CB5 8QD
    Completed
    Site RU70008
    Kaluga, Russian Federation, 248007
    Completed
    Site PL48012
    Lodz, Poland, 90549
    Withdrawn
    Site IT39002
    Monza, Italy, 20900
    Completed
    Site BG35923
    Pazardjik, Bulgaria, 4400
    Withdrawn
    Site TR90001
    Istanbul, Turkey, 34390
    Completed
    Site BE32014
    Ieper, Belgium, 8900
    Withdrawn
    Site GB44007
    London, United Kingdom, SM5 1AA
    Withdrawn
    Site ZA27003
    Goodwood, Cape Town, South Africa, 7460
    Withdrawn
    Site IT39028
    Prato, Frazione di Galciana, Italy, 59100
    Completed
    Site RU70060
    Saratov, Russian Federation, 410039
    Completed
    Site UA38001
    Ternopil, Ukraine, 46002
    Withdrawn
    Site RU70049
    Moscow, Russian Federation, 115432
    Completed
    Site PL48008
    Lodz, Poland, 92-213
    Completed
    Site RU70002
    Saint Petersburg, Russian Federation, 197089
    Completed
    Site UA38018
    Uzhgorod, Ukraine, 88018
    Completed
    Site RO40021
    Bucharest, Romania, 022328
    Completed
    Site UA38003
    Chernivtsi, Ukraine, 58002
    Completed
    Site ZA27001
    Observatory, Cape Town, South Africa, 7925
    Completed
    Site HU36029
    Budapest, Hungary, H-1036
    Withdrawn
    Site RU70013
    Moscow, Russian Federation, 115093
    Completed
    Site RS38105
    Belgrade, Serbia, 11000
    Completed
    Site IT39001
    Bari, Italy, 70124
    Completed
    Site BG35910
    Sofia, Bulgaria, 1431
    Completed
    Site PL48005
    Warszawa, Poland, 02-507
    Completed
    Site BY37504
    Gomel, Belarus, 246027
    Withdrawn
    Site HU36001
    Szekesfehervar, Hungary, H 8000
    Withdrawn
    Site BE32001
    Aalst, Belgium, 9300
    Completed
    Site CO57008
    Barranquilla, Colombia
    Withdrawn
    Site HU36010
    Veszprem, Hungary, 8200
    Completed
    Site PL48001
    Krakow, Malopolska, Poland, 31-559
    Withdrawn
    Site PE51008
    Lima, Lima, Peru, LIMA 10
    Completed
    Site RU70006
    Smolensk, Russian Federation, 214006
    Withdrawn
    Site EE37202
    Tartu, Estonia, 51014
    Completed
    Site IT39006
    Milano, Italy, 20162
    Completed
    Site GT50201
    Ciudad de Guatemala, Guatemala, CP 01016
    Completed
    Site RO40004
    Oradea, Romania, 410469
    Withdrawn
    Site PL48003
    Lublin, Poland, 20-954
    Withdrawn
    Site BE32015
    Edegem, Antwerp, Belgium, 2650
    Completed
    Site TR90020
    Malatya, Turkey, 44300
    Completed
    Site RU70022
    Saint Petersburg, Russian Federation, 192242
    Withdrawn
    Site IT39010
    Brescia, Italy, 25123
    Completed
    Site CO57007
    Barranquilla, Colombia
    Withdrawn
    Site RO40019
    Bucharest, Romania, 319
    Completed
    Site RU70003
    Nizhny Novgorod, Russian Federation, 603032
    Completed
    Site BG35916
    Varna, Bulgaria, 9000
    Completed
    Site RU70024
    Chelyabinsk, Russian Federation, 454047
    Completed
    Site RU70005
    Moscow, Russian Federation, 125284
    Completed
    Site RO40012
    Bucuresti, Romania, 10825
    Completed
    Site UA38019
    Odessa, Ukraine, 65026
    Completed
    Site GR30002
    Patras, Greece, 26504
    Completed
    Site BE32013
    Liege, Belgium, 4000
    Completed
    Site EE37201
    Tallinn, Estonia, 13419
    Completed
    Site ZA27007
    Port Elizabeth, South Africa, 6001
    Withdrawn
    Site GB44003
    Exeter, United Kingdom, EX2 5DW
    Withdrawn
    Site RO40007
    Lasi, Romania, 700506
    Completed
    Site RO40003
    Bucuresti, Romania, 22328
    Completed
    Site RU70011
    Saint Petersburg, Russian Federation, 196247
    Withdrawn
    Site BE32003
    Leuven, Belgium, 3000
    Completed
    Site GB44004
    Westcliff-on-Sea, United Kingdom, SS0 0RY
    Completed
    Site GT50205
    Guatemala, Guatemala, 01010
    Withdrawn
    Site ES34001
    Bilbao, Bizkaia, Spain, 48013
    Completed
    Site HU36008
    Pecs, Hungary, H 7624
    Completed
    Site RU70007
    Moscow, Russian Federation, 123182
    Completed
    Site UA38010
    Kyiv, Ukraine, 01016
    Completed
    Site HU36027
    Kistarcsa, Hungary, 2143
    Completed
    Site GT50209
    Chiquimula, Guatemala, 01001
    Withdrawn
    Site BE32005
    Liege, Belgium, 4000
    Withdrawn
    Site ZA27005
    Potchefstroom, North West, South Africa, 2531
    Withdrawn
    Site ES34044
    Avila, Avila, Spain, 05004
    Completed
    Site PE51001
    Iquitos, Peru, 16001
    Completed
    Site BE32002
    Antwerp, Belgium, 2060
    Completed
    Site GE99504
    Tbilisi, Georgia, 0144
    Withdrawn
    Site IT39004
    Torino, Italy, 10128
    Withdrawn
    Site GB44077
    Portsmouth, United Kingdom, PO63LY
    Completed
    Site GR30003
    Heraklion, Greece, 71409
    Completed
    Site DO17101
    La Fe Santo Domingo, Dominican Republic, 5072
    Withdrawn
    Site CO57005
    Bogota, Cundinamarca, Colombia
    Completed
    Site ES34006
    Barcelona, Barcelona, Spain, 08035
    Completed
    Site UA38002
    Zaporizhzhya, Ukraine, 69600
    Withdrawn
    Site HU36006
    Szombathely, Hungary, H 9700
    Completed
    Site IT39008
    Lecco, Italy, 23900
    Completed
    Site HU36028
    Szent, Hungary, H-1097
    Withdrawn
    Site GB44002
    Coventry, United Kingdom, CV2 2DX
    Completed
    Site IT39036
    Pavia, Italy, 27100
    Completed
    Site RU70043
    Petrozavodsk, Russian Federation, 185019
    Completed
    Site BG35906
    Sofia, Bulgaria, 1431
    Withdrawn
    Site BG35902
    Sofia, Bulgaria, 1527
    Completed
    Site DO17104
    Santo Domingo, Dominican Republic, 10124
    Completed
    Site BG35903
    Veliko Tarnovo, Bulgaria, 5000
    Withdrawn
    Site TR90004
    Adana, Turkey, 1330
    Withdrawn
    Site BG35909
    Plovdiv, Bulgaria, 4000
    Completed
    Site PL48014
    Zamosc, Poland, 20-400
    Completed
    Site RU70001
    Yaroslavl, Russian Federation, 150062
    Completed
    Site PL48002
    Katowice, Poland, 40 027
    Completed
    Site PL48013
    Szczecin, Poland, 70-111
    Withdrawn
    Site BG35901
    Sofia, Bulgaria, 1606
    Completed
    Site GT50203
    Guatemala, Guatemala, 01014
    Completed
    Site RU70045
    Saint-Petersburg, Russian Federation, 194354
    Completed
    Site GT50207
    Ciudad de Guatemala, Guatemala, CP 01010
    Completed
    Site RS38104
    Belgrade, Serbia, 11000
    Completed
    Site GB44001
    Swansea, United Kingdom, SA6 6NL
    Completed
    Site UA38006
    Dnepropetrovsk, Ukraine, 49005
    Completed
    Site RS38102
    Belgrade, Serbia, 11000
    Completed
    Site RS38103
    Belgrade, Serbia, 11080
    Withdrawn
    Site PE51004
    Lima, Peru, 41
    Completed
    Site UA38007
    Mykolaiv, Ukraine, 54058
    Completed
    Site GE99502
    Tbilisi, Georgia, 0159
    Completed
    Site BY37501
    Grodno, Belarus, 230017
    Completed
    Site ES34007
    Ciudad Real, Ciudad Real, Spain, 13005
    Completed
    Site PL48004
    Warszawa, Poland, 04 749
    Completed
    Site GB44005
    Welwyn Garden City, United Kingdom, AL7 4HQ
    Withdrawn
    Site RU70058
    Tomsk, Russian Federation, 634063
    Withdrawn
    Site HU36007
    Budapest, Hungary, H 1115
    Withdrawn
    Site HU36004
    Szeged, Hungary, 6724
    Withdrawn
    Site PL48009
    Wroclaw, Poland, 51 124
    Completed
    Site UA38008
    Odessa, Ukraine, 65000
    Withdrawn
    Site GB44078
    Bradford, United Kingdom, BD50NA

    Frequently Asked Questions

    Are clinical trials only for people with advanced cancer?

    While some clinical trials may focus on more advanced cancers, many trials are open to patients at various stages of their cancer. Each study has rules about who can take part. For example, only patients in a certain age group or those who have a certain type of tumor may be able to join.

    Will I have to stop my current treatment to participate in a clinical trial?

    Sometimes researchers want participants to keep taking their current treatments during a clinical trial. Other times, you may need to stop your current treatments for a while. If the investigational treatment doesn't work, you can usually go back to your original treatment plan.

    Should I be worried about getting a placebo?

    In cancer clinical trials, a placebo is only used if there is no other treatment for that type of cancer. This helps compare an investigational treatment to the placebo. Placebos are rarely used in cancer trials because the best available treatment, called the “standard of care”, is usually given instead.

    Do I need a referral from my doctor to take part in a study?

    Your doctor may not know about all the opportunities for clinical trials that are available to you. Talk to your doctor or other medical provider about clinical trial information that you find. They can help you decide if a clinical trial is right for you. If you do not find any options on this website, we recommend you visit an online public registry website like clinicaltrials.gov to see a wide variety of available clinical trials.

    Explore More

    1

    What are clinical trials?

    2

    Why are Clinical Trials Important?

    3

    Why Participate in a Clinical Trial?