Study summary

This study was conducted to explore a new therapy for anemia in participants with end stage renal disease (ESRD) on dialysis. Anemia is a reduced number of red blood cells or hemoglobin. Hemoglobin (which contains iron) is important for the transport of oxygen in your blood. The purpose of this study was to evaluate if roxadustat is effective and safe in the maintenance treatment of anemia in ESRD participants on stable dialysis. Roxadustat was compared to epoetin alfa and darbepoetin alfa, commercially available medicines for treatment of anemia.

Additional Study Details

Phase
3
Product
  • Roxadustat
  • Epoetin alfa
  • Darbepoetin alfa
  • Iron
  • Type
    Interventional
    Masking
    None (Open Label)
    Enrollment number
    838
    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 End Stage Renal Disease (ESRD) Patients on Stable Dialysis? Contact us by filling out your information to the right and we’ll respond to you.

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      Locations

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      Contact Us
      Withdrawn
      Site HU36007
      Budapest, Hungary, H 1115
      Completed
      Site GB44001
      Swansea, United Kingdom, SA6 6NL
      Completed
      Site GB44081
      Leicester, United Kingdom, LE5 4PW
      Completed
      Site ES34002
      Badalona-Barcelona, Spain, 8916
      Completed
      Site ES34030
      Majadahonda, Madrid, Spain, 28222
      Completed
      Site BE32004
      Brussels, Flemish Brabant, Belgium, 1200
      Withdrawn
      Site FR33050
      Angers, France, 49033
      Completed
      Site RU70005
      Moscow, Russian Federation, 125284
      Terminated
      Site PT35139
      Cascais, Portugal, 2750-663
      Withdrawn
      Site ES34035
      Barcelona, Barcelona, Spain, 08036
      Completed
      Site PT35127
      Aveiro, Portugal, 3800-266
      Completed
      Site RS38105
      Belgrade, Serbia, 11000
      Completed
      Site ES34011
      Galdakao, Vizcaya, Spain, 48960
      Completed
      Site PT35121
      Almada, Portugal, 2800-455
      Completed
      Site RS38117
      Krusevac, Serbia, 37000
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      Site RO40015
      Bucharest, Romania
      Completed
      Site RO40004
      Oradea, Romania, 410562
      Completed
      Site BG35919
      Plovdiv, Plovdiv, Bulgaria, 4003
      Terminated
      Site BE32017
      Bonheiden, Belgium, 2820
      Terminated
      Site ES34008
      Barcelona, Barcelona, Spain, 08025
      Terminated
      Site HU36046
      Szekesfehervar, Hungary, 8000
      Terminated
      Site HR38508
      Cakovec, Croatia, 40000
      Completed
      Site BE32003
      Leuven, Belgium, 3000
      Completed
      Site HU36026
      Kaposvar, Hungary, H 7400
      Withdrawn
      Site PL48004
      Warszawa, Poland, 04 749
      Terminated
      Site GB44079
      Liverpool, United Kingdom, L9 7AL
      Completed
      Site SK42119
      Levice, Slovakia, 93401
      Terminated
      Site HR38501
      Zadar, Croatia, 23 000
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      Site DE49049
      Trier, Germany, 54292
      Completed
      Site HR38504
      Slavonski Brod, Croatia, 35000
      Completed
      Site RS38104
      Belgrade, Serbia
      Completed
      Site RU70037
      Volgograd, Russian Federation, 404120
      Completed
      Site BG35907
      Stara Zagora, Bulgaria, 6000
      Completed
      Site BG35916
      Varna, Bulgaria, 9000
      Completed
      Site IT39032
      Trieste, Italy, 34142
      Completed
      Site DE49073
      Cloppenburg, Germany, 49661
      Completed
      Site DE49054
      Dusseldorf, Germany, 40210
      Completed
      Site RO40018
      Bucharest, Romania, 011794
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      Site SK42102
      Koshice, Slovakia, 04001
      Withdrawn
      Site FR33063
      Quincy sous Senart, France, 91480
      Completed
      Site BE32002
      Antwerp, Belgium, 2060
      Terminated
      Site GE99503
      Tbilisi, Georgia, 0144
      Completed
      Site ES34009
      El Ejido, Almeria, Spain, 04700
      Completed
      Site SK42113
      Puchov, Slovakia, 020 01
      Terminated
      Site IT39010
      Brescia, Italy, 25123
      Completed
      Site BG35920
      Rousse, Bulgaria, 7002
      Completed
      Site BE32011
      Roeselare, Belgium, 8800
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      Site BG35906
      Sofia, Bulgaria, 1431
      Completed
      Site RU70014
      Rostov-on-Don, Russian Federation, 344029
      Terminated
      Site ES34010
      Alcorcon, Madrid, Spain, 28922
      Terminated
      Site DE49002
      Solingen, Germany, 42653
      Completed
      Site PT35128
      Gaeiras, Portugal, 2510-702
      Completed
      Site IT39008
      Lecco, Italy, 23900
      Completed
      Site ES34041
      Santiago de Compostela, A Coruna, Spain, 15706
      Completed
      Site FR33055
      Saint Ouen, France, 93400
      Completed
      Site RS38102
      Belgrade, Serbia, 11000
      Completed
      Site PT35114
      Leiria, Portugal, 2400-441
      Withdrawn
      Site PT35120
      Almada, Portugal, 2801-951
      Withdrawn
      Site RU70073
      Nizhniy Novgorod, Russian Federation, 603126
      Completed
      Site PL48013
      Szczecin, Poland, 70-111
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      Site FR33008
      Nantes Cedex 1, France, 44093
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      Site RO40020
      Odorheiu Secuiesc, Harghita, Romania, 535600
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      Site DE49070
      Muenchen, Germany, 81695
      Completed
      Site SK42120
      Lučenec, Slovakia, 984 01
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      Site RU70050
      Saint-Petersburg, Russian Federation, 197374
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      Site FR33010
      La Tronche, France, 38701
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      Site BG35924
      Sofia, Bulgaria, 1309
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      Site DE49072
      Herne, Germany, 44626
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      Site IT39040
      San Fermodella Battaglia, Como, Italy, 22020
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      Site PT35140
      Corroios, Portugal, 2855 -227
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      Site RU70008
      Kaluga, Russian Federation, 248007
      Completed
      Site ES34017
      Jaen, Jaen, Spain, 23007
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      Site PT35117
      Faro, Portugal, 8005-546
      Terminated
      Site PL48009
      Wroclaw, Poland, 51 124
      Completed
      Site IT39028
      Prato, Frazione di Galciana, Italy, 59100
      Completed
      Site RS38101
      Nis, Serbia
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      Site RU70030
      Sankt-Peterburg, Russian Federation, 197110
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      Site CZ42015
      Rakovnik, Czech Republic, 26929
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      Site ES34039
      Cordoba, Cordoba, Spain, 14004
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      Sofia, Bulgaria, 1527
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      Site BG35903
      Veliko Tarnovo, Bulgaria, 5000
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      Site HU36006
      Szombathely, Hungary, H 9700
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      Site BG35909
      Plovdiv, Bulgaria, 4000
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      Site PL48014
      Zamosc, Poland, 20-400
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      Site BE32019
      Antwerpen, Belgium, 2020
      Terminated
      Site GB44080
      Stoke on Trent, Staffordshire, United Kingdom, ST4 6QG
      Completed
      Site RU70011
      Saint-Petersburg, Russian Federation, 196247
      Completed
      Site CZ42008
      Liberec, Czech Republic, 46063
      Withdrawn
      Site RS38103
      Belgrade, Serbia, 11080
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      Site HU36027
      Kistarcsa, Hungary, 2143
      Terminated
      Site ES34037
      Madrid, Madrid, Spain, 28046
      Withdrawn
      Site BG35923
      Pazardjik, Bulgaria
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      Site BG35915
      Pleven, Bulgaria, 5800
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      Site RU70002
      Saint Petersburg, Russian Federation, 197089
      Completed
      Site HU36003
      Zalsaegerszeg, Hungary, 8900
      Completed
      Site IT39006
      Milano, Italy, 20162
      Completed
      Site HU36036
      Esztergom, Hungary, 2500
      Completed
      Site BG35918
      Varna, Bulgaria, 9010
      Completed
      Site IT39022
      Padova, Italy, 35128
      Terminated
      Site RU70051
      Moscow, Russian Federation, 119992
      Completed
      Site IT39036
      Pavia, Italy, 27100
      Completed
      Site HU36004
      Szeged, Hungary, 6724
      Completed
      Site BE32013
      Liege, Belgium, 4000
      Completed
      Site RS38116
      Zrenjanin, Serbia
      Completed
      Site RO40003
      Bucuresti, Romania, 22328
      Completed
      Site BG35925
      Blagoevgrad, Bulgaria, 2700
      Completed
      Site RU70004
      Omsk, Russian Federation, 644112
      Completed
      Site IT39035
      Torino, Italy, 10126
      Completed
      Site RU70001
      Yaroslavl, Russian Federation, 150062
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      Site DE49071
      Villingen-Schwenningen, Germany, 78052
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      Site FR33007
      St Priez en Jarez, France, 42270
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      Site FR33057
      Le Mans, France, 72037
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      Site ES34052
      Valencia, Valencia, Spain, 46017
      Terminated
      Site RU70006
      Smolensk, Russian Federation, 214006
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      Site GB44007
      London, United Kingdom, SM5 1AA
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      Site DE49031
      Bonn, Germany, 53127
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      Site FR33005
      Amiens cedex 1, France, 80054
      Completed
      Site IT39039
      Cremona, Lombardia, Italy, 26100
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      Site FR33009
      Colmar Cedex, France, 68024
      Completed
      Site IT39014
      Mestre, Venezia, Italy, 30174
      Completed
      Site PL48006
      Wroclaw, Poland, 50-556
      Terminated
      Site DE49008
      Dresden, Germany, 01307
      Completed
      Site HU36035
      Pecs, Hungary, 7633
      Completed
      Site HU36032
      Pecs, Hungary, 7624
      Completed
      Site BG35938
      Shumen, Bulgaria, 9700
      Completed
      Site HR38506
      Rijeka, Croatia, 51000
      Completed
      Site PL48001
      Krakow, Poland, 30 501
      Withdrawn
      Site ES34001
      Bilbao, Bizkaia, Spain, 48013
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      Site RU70072
      Saint Petersburg, Russian Federation, 190103
      Terminated
      Site PL48002
      Katowice, Poland, 40 027
      Completed
      Site GB44087
      Brighton, EastSussex, United Kingdom, BN2 5BD
      Completed
      Site SK42116
      Senica, Slovakia, 90501
      Terminated
      Site PT35102
      Porto, Portugal, 4099-001
      Completed
      Site RU70003
      Nizhny Novgorod, Russian Federation, 603032
      Completed
      Site BG35931
      Haskovo, Bulgaria, 6300
      Completed
      Site RS38120
      Belgrade, Serbia, 11000
      Completed
      Site DE49067
      Berlin, Germany, 10117
      Withdrawn
      Site FR33004
      Avignon, France, 84900
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      Site GB44077
      Portsmouth, United Kingdom, PO63LY
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      Site HU36034
      Salgotarjan, Hungary, 3100
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      Site HU36031
      Gyor, Hungary, 9002
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      Site RO40019
      Bucharest, Romania
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      Site FR33056
      Valenciennes, France, 59300
      Completed
      Site GB44011
      Canterbury, Kent, United Kingdom, CT1 3NG
      Completed
      Site GB44010
      Hull, United Kingdom, HU3 2JZ
      Completed
      Site PT35122
      Setubal, Portugal, 2900-655
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      Site BE32012
      Baudour, Belgium, 7331
      Terminated
      Site PL48005
      Warszawa, Poland, 00 507
      Completed
      Site GE99504
      Tbilisi, Georgia, 0144
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      Site HR38505
      Karlovac, Croatia, 47000
      Terminated
      Site IT39005
      Roma, Italy, 122
      Terminated
      Site ES34006
      Barcelona, Barcelona, Spain, 08035
      Completed
      Site HU36033
      Baja, Hungary, 6500
      Completed
      Site DE49075
      Heilbronn, Germany, 74076
      Completed
      Site GE99508
      Tbilisi, Georgia, 159
      Completed
      Site DE49056
      Dormagen, Nordrhein-Westfalen, Germany, 41540
      Completed
      Site CZ42021
      Praha 6, Czech Republic, 169 00
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      Site FR33001
      Creteil, France, 94010
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      Site HR38507
      Osijek, Croatia, 31 000
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      Site BG35937
      Yambol, Bulgaria, 8600
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      Site GB44008
      Cambridge, United Kingdom, CB2 0QQ
      Terminated
      Site DE49001
      Kaiserslautern, Germany, 67655
      Completed
      Site HR38509
      Zagreb, Grad Zagreb, Croatia, 10000
      Completed
      Site DE49020
      Frankfurt am Main, Germany, 60590
      Completed
      Site BE32001
      Aalst, Belgium, 9300
      Completed
      Site DE49065
      Hamburg, Germany, 23397
      Completed
      Site IT39037
      Modena, Italy, 41124

      Frequently Asked Questions

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      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.

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