594
Participants
Start Date
September 3, 2013
Primary Completion Date
November 1, 2017
Study Completion Date
November 1, 2017
Roxadustat
Roxadustat was administered initially according to the tiered weight-based dosing, where participants with weight from ≥ 45 to ≤ 70 kg received 70 mg and participants with \> 70 to ≤ 160 kg received 100 mg of roxadustat. Dose-titration based upon regular measurement of Hb levels was performed until participants achieved central Hb value of ≥ 11.0 g/dL and Hb increase from baseline (BL) of ≥ 1.0 g/dL at two consecutive study visits, separated by at least 5 days. Once target Hb level was reached participants entered maintenance period during which roxadustat dosage was adjusted every 4 weeks to maintain participants Hb level within the target range of 10.0 g/dL and 12.0 g/dL.
Placebo
Placebo was administered initially according to the tiered weight-based dosing, where participants with weight from ≥ 45 to ≤ 70 kg received 70 mg and participants with \> 70 to ≤ 160 kg received 100 mg of roxadustat. Dose-titration based upon regular measurement of Hb levels was performed until participants achieved central Hb value of ≥ 11.0 g/dL and Hb increase from baseline (BL) of ≥ 1.0 g/dL at two consecutive study visits, separated by at least 5 days. Once target Hb level was reached participants entered maintenance period during which roxadustat dosage was adjusted every 4 weeks to maintain participants Hb level within the target range of 10.0 g/dL and 12.0 g/dL.
Site BE32004, Brussels
Site BG35906, Sofia
Site BG35908, Sofia
Site BG35910, Sofia
Site BE32002, Antwerp
Site HU36027, Kistarcsa
Site BE32017, Bonheiden
Site BE32013, Liège
Site ZA27002, Durban
Site ZA27008, Durban
Site BG35923, Pazardzhik
Site BG35903, Veliko Tarnovo
Site DO17101, La Fe Santo Domingo
Site BG35907, Stara Zagora
Site ZA27007, Port Elizabeth
Site TR90003, Ankara
Site BE32012, Baudour
Site ZA27006, Parow
Site ZA27001, Observatory
Site BE32014, Ieper
Site HU36003, Zalsaegerszeg
Site ES34002, Badalona-Barcelona
Site BG35916, Varna
Site HU36025, Győr
Site ZA27004, Bloemfontein
Site DO17104, Santo Domingo
Site RO40012, Bucharest
Site RS38102, Belgrade
Site RS38104, Belgrade
Site RS38105, Belgrade
Site RS38103, Belgrade
Site PE51002, Trujillo
Site ES34007, Ciudad Real
Site EE37201, Tallinn
Site PE51001, Iquitos
Site RS38101, Niš
Site UA38021, Cherkasy
Site IT39006, Milan
Site TR90016, Edirne
Site RO40003, Bucharest
Site RS38116, Zrenjanin
Site IT39008, Lecco
Site GR30002, Pátrai
Site IT39036, Pavia
Site ES34010, Alcorcón
Site RS38117, Kruševac
Site IT39037, Modena
Site TR90024, Kocaeli
Site TR90020, Malatya
Site UA38001, Ternopil
Site ES34011, Galdakao
Site UA38006, Dnipro
Site DO17102, Santiago de los Caballeros
Site UA38007, Mykolaiv
Site GR30001, Thessaloniki
Site UA38003, Chernivtsi
Site UA38011, Kharkiv
Site UA38008, Odesa
Site UA38019, Odesa
Site UA38002, Zaporizhzhya
Site IT39001, Bari
Site GR30003, Heraklion
Site UA38015, Kherson
Site UA38016, Ivano-Frankivsk
Site UA38009, Lviv
Site UA38018, Uzhhorod
Site PL48012, Lodz
Site DO17103, Santo Domingo
Site RU70051, Moscow
Site RU70007, Moscow
Site RU70005, Moscow
Site RU70048, Moscow
Site RU70047, Moscow
Site RU70057, Yaroslavl
Site RU70001, Yaroslavl
Site RU70043, Petrozavodsk
Site RU70022, Saint Petersburg
Site RU70045, Saint Petersburg
Site RU70011, Saint Petersburg
Site RU70002, Saint Petersburg
Site BY37502, Vitebsk
Site RU70006, Smolensk
Site BY37506, Minsk
Site BY37507, Minsk
Site BY37505, Minsk
Site BY37503, Brest
Site BY37501, Grodno
Site BY37504, Homyel
Site RU70008, Kaluga
Site RO40005, Timișoara
Site RU70014, Rostov-on-Don
Site RU70060, Saratov
Site RO40004, Oradea
Site RU70024, Chelyabinsk
Site RO40001, Brasov
Site RU70003, Nizhny Novgorod
Site RU70004, Omsk
Site RU70054, Irkutsk
Site CO57007, Barranquilla
Site CO57008, Barranquilla
Site CO57002, Pereira
Site PA50701, Panama City
Site GE99503, Tbilisi
Site GE99504, Tbilisi
Site GE99502, Tbilisi
Site GT50209, Chiquimula
Site GT50205, Guatemala City
Site GT50206, Guatemala City
Site GT50203, Guatemala City
Site GT50202, Guatemala City
Site GT50208, Guatemala City
Site GT50207, Guatemala City
Site GT50201, Guatemala City
Site HU36029, Budapest
Site HU36026, Kaposvár
Site HU36008, Pécs
Site HU36028, Szent
Site PA50703, Colón
Site PL48001, Krakow
Site PL48002, Katowice
Site PL48008, Lodz
Site PL48057, Nowy Tomyśl
Site PL48013, Szczecin
Site PL48007, Tarnów
Site PL48005, Warsaw
Site PL48004, Warsaw
Site PL48006, Wroclaw
Site PL48014, Zamość
Site RO40021, Bucharest
Site ES34003, Barcelona
Site ES34006, Barcelona
Site UA38010, Kyiv
Site UA38012, Kyiv
Site UA38017, Kyiv
Site GB44008, Cambridge
Site GB44001, Swansea
Site GB44005, Welwyn Garden City
Site GB44004, Westcliff-on-Sea
Collaborators (1)
FibroGen
INDUSTRY
Astellas Pharma Europe B.V.
INDUSTRY