838
Participants
Start Date
November 21, 2014
Primary Completion Date
June 8, 2017
Study Completion Date
July 6, 2018
Roxadustat
Participants received initial dose of roxadustat orally as a tablet in doses of 100 mg, 150 mg or 200 mg, according to the average weekly dose of epoetin or darbepoetin alfa prior to randomization. Participants' roxadustat dosage was adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps were as follows: 20, 40, 50, 70, 100, 150, 200, 250, 300, and 400 mg. Oral iron treatment of 200 mg was allowed for supplementation to support erythropoiesis. Treatment with intravenous iron was allowed only if certain protocol criteria were met.
Epoetin alfa
Participants received epoetin alfa via intravenous or subcutaneous injection, once a week, twice a week, or three times a week (TIW). Epoetin alfa dosage was adjusted to maintain Hb level within the target range. Dosing of epoetin alfa was per UK SmPC of Eprex®. Participants received IV iron supplementation according to the standard of care.
Darbepoetin alfa
Participants received darbepoetin alfa via intravenous or subcutaneous injection, once a week or once every other week. Darbepoetin alfa dosage was adjusted to maintain Hb level within the target range. Dosing of darbepoetin alfa was per EU SmPC of Aranesp®. Participants received IV iron supplementation according to the standard of care.
Iron
Oral iron treatment was recommended for supplementation to support erythropoiesis and as first-line treatment for iron deficiency, unless participant was intolerant to this treatment. For participants receiving roxadustat the recommended daily dose was 200 mg of elemental iron. Participants were advised to take roxadustat at least 1 hour before or 1 hour after oral iron. Intravenous iron supplementation for participants receiving roxadustat was allowed if all of the following criteria were met: The participant's Hb level had not responded adequately to roxadustat following two consecutive dose increases or reached the maximum dose limit, and participant's ferritin was \< 100 ng/mL (\< 220 pmol/L) or TSAT \< 20%, or the participant was intolerant of oral iron therapy. For participants treated with epoetin alfa or darbepoetin alfa, IV iron supplementation was given according to standard of care.
Site IT39005, Roma
Site GE99508, Tbilisi
Site BE32004, Brussels
Site BG35924, Sofia
Site BG35906, Sofia
Site BG35921, Sofia
Site BE32019, Antwerp
Site BE32002, Antwerp
Site HU36027, Kistarcsa
Site HU36036, Esztergom
Site BG35925, Blagoevgrad
Site BE32017, Bonheiden
Site BE32003, Leuven
Site HU36034, Salgótarján
Site BE32013, Liège
Site BG35909, Plovdiv
Site BG35919, Plovdiv
Site BG35903, Veliko Tarnovo
Site BG35915, Pleven
Site BG35907, Stara Zagora
Site BG35931, Haskovo
Site HU36033, Baja
Site HU36004, Szeged
Site BG35920, Rousse
Site BE32012, Baudour
Site HU36032, Pécs
Site HU36035, Pécs
Site HU36046, Székesfehérvár
Site BG35937, Yambol
Site BE32011, Roeselare
Site HU36003, Zalsaegerszeg
Site ES34002, Badalona-Barcelona
Site BG35916, Varna
Site HU36031, Győr
Site BG35918, Varna
Site BE32001, Aalst
Site BG35938, Shumen
Site HR38509, Zagreb
Site DE49067, Berlin
Site IT39035, Torino
Site RS38102, Belgrade
Site RS38105, Belgrade
Site RS38120, Belgrade
Site ES34041, Santiago de Compostela
Site IT39006, Milan
Site RO40003, Bucharest
Site ES34017, Jaén
Site DE49065, Hamburg
Site IT39008, Lecco
Site IT39010, Brescia
Site IT39039, Cremona
Site CZ42015, Rakovník
Site IT39036, Pavia
Site ES34037, Madrid
Site ES34030, Majadahonda
Site ES34010, Alcorcón
Site IT39014, Mestre
Site IT39032, Trieste
Site HR38504, Slavonski Brod
Site IT39022, Padua
Site RS38117, Kruševac
Site FR33010, La Tronche
Site HR38508, Čakovec
Site DE49054, Düsseldorf
Site IT39037, Modena
Site DE49056, Dormagen
Site FR33007, Saint Priez En Jarez
Site DE49002, Solingen
Site ES34052, Valencia
Site CZ42008, Liberec
Site HR38505, Karlovac
Site ES34011, Galdakao
Site DE49073, Cloppenburg
Site HR38506, Rijeka
Site IT39028, Prato
Site FR33056, Valenciennes
Site DE49020, Frankfurt am Main
Site DE49001, Kaiserslautern
Site DE49075, Heilbronn
Site DE49071, Villingen-Schwenningen
Site FR33005, Amiens
Site DE49070, München
Site SK42116, Senica
Site FR33055, Saint-Ouen
Site SK42119, Levice
Site RU70051, Moscow
Site RU70005, Moscow
Site RU70001, Yaroslavl
Site RU70072, Saint Petersburg
Site RU70011, Saint Petersburg
Site RU70002, Saint Petersburg
Site RU70030, Saint Petersburg
Site RU70050, Saint Petersburg
Site RU70006, Smolensk
Site RU70008, Kaluga
Site RU70014, Rostov-on-Don
Site RU70037, Volgograd
Site RO40004, Oradea
Site RU70003, Nizhny Novgorod
Site RU70004, Omsk
Site HR38507, Osijek
Site HR38501, Zadar
Site CZ42021, Prague
Site GE99503, Tbilisi
Site GE99504, Tbilisi
Site DE49008, Dresden
Site HU36026, Kaposvár
Site HU36006, Szombathely
Site PL48002, Katowice
Site PL48001, Krakow
Site PL48013, Szczecin
Site PL48005, Warsaw
Site PL48006, Wroclaw
Site PL48009, Wroclaw
Site PL48014, Zamość
Site PT35121, Almada
Site PT35127, Aveiro
Site PT35139, Cascais
Site PT35117, Faro
Site PT35128, Gaeiras
Site PT35114, Leiria
Site PT35102, Porto
Site PT35122, Setúbal
Site RO40018, Bucharest
Site RO40015, Bucharest
Site RO40019, Bucharest
Site RS38104, Belgrade
Site RS38101, Niš
Site RS38116, Zrenjanin
Site SK42102, Košice
Site SK42120, Lučenec
Site SK42113, Púchov
Site ES34009, El Ejido
Site ES34008, Barcelona
Site ES34006, Barcelona
Site GB44087, Brighton
Site GB44011, Canterbury
Site GB44080, Stoke-on-Trent
Site GB44008, Cambridge
Site GB44010, Hull
Site GB44081, Leicester
Site GB44079, Liverpool
Site GB44001, Swansea
Collaborators (1)
FibroGen
INDUSTRY
Astellas Pharma Europe B.V.
INDUSTRY