Safety and Efficacy Study of Roxadustat to Treat Anemia in Patients With Chronic Kidney Disease, on Dialysis.

PHASE3CompletedINTERVENTIONAL
Enrollment

2,133

Participants

Timeline

Start Date

July 1, 2014

Primary Completion Date

September 26, 2018

Study Completion Date

September 26, 2018

Conditions
Anemia
Interventions
DRUG

Roxadustat

Roxadustat will be administered orally three times a week (TIW) to achieve an Hb level of 11 g/dL and maintain a Hb level of 11±1 g/dL.

DRUG

Epoetin alfa

Epoetin alfa will be administered TIW consistent with approved prescribing information for epoetin alfa to achieve an Hb level of 11 g/dL and maintain a Hb level of 11±1 g/dL.

Trial Locations (188)

14

Research Site, Lima

1076

Research Site, Budapest

1077

Research Site, Budapest

1097

Research Site, Budapest

2000

Research Site, Samokov

2050

Research Site, Camperdown

2065

Research Site, St Leonards

2076

Research Site, Wahroonga

2139

Research Site, Concord

2140

Research Site, Botevgrad

2600

Research Site, Dupnitsa

2760

Research Site, Razlog

2800

Research Site, Sandanski

Research Site, Tatabánya

2900

Research Site, Gotse Delchev

3004

Research Site, Prahan

3168

Research Site, Clayton

3526

Research Site, Miskolc

3700

Research Site, Smolyan

4043

Research Site, Debrecen

5000

Research Site, Iloilo City

6000

Research Site, Cebu City

6300

Research Site, Haskovo

7250

Research Site, Launceston

8000

Research Site, Székesfehérvár

8400

Research Site, Ajka

8600

Research Site, Yambol

8800

Research Site, Sliven

Research Site, Nagykanizsa

9700

Research Site, Shumen

10330

Research Site, Bangkok

10400

Research Site, Bangkok

10461

Research Site, The Bronx

11021

Research Site, Great Neck

14127

Research Site, Orchard Park

18017

Research Site, Bethlehem

19106

Research Site, Philadelphia

20164

Research Site, Sterling

20219

Research Site, Aguascalientes

20706

Research Site, Lanham

21018

Research Site, Vinnytsia

23605

Research Site, Newport News

24701

Research Site, Bluefield

28207

Research Site, Charlotte

28401

Research Site, Wilmington

28805

Research Site, Asheville

29010

Research Site, Málaga

33169

Research Site, Miami Gardens

35805

Research Site, Huntsville

36024

Research Site, Poltava

39501

Research Site, Gulfport

41013

Research Site, Seville

41071

Research Site, Seville

43007

Research Site, Tarragona

44670

Research Site, Guadalajara

45206

Research Site, Cincinnati

46002

Research Site, Ternopil

46017

Research Site, Valencia

48066

Research Site, Roseville

49005

Research Site, Dnipro

58002

Research Site, Chernivtsi

60305

Research Site, River Forest

64111

Research Site, Kansas City

65025

Research Site, Odesa

65074

Research Site, Odesa

67214

Research Site, Wichita

69001

Research Site, Zaporizhzhya

69118

Research Site, Zaporizhzhya

69600

Research Site, Zaporizhzhya

70808

Research Site, Baton Rouge

74804

Research Site, Shawnee

76008

Research Site, Ivano-Frankivsk

76018

Research Site, Ivano-Frankivsk

77004

Research Site, Houston

77091

Research Site, Houston

78212

Research Site, San Antonio

78222

Research Site, San Antonio

78229

Research Site, San Antonio

78756

Research Site, Austin

78758

Research Site, Austin

80230

Research Site, Denver

82606

Research Site, Bratislava

88006

Research Site, Uzhhorod

89511

Research Site, Reno

90022

Research Site, Los Angeles

90025

Research Site, Los Angeles

90262

Research Site, Lynwood

90602

Research Site, Whittier

90606

Research Site, Whittier

90802

Research Site, Long Beach

90807

Research Site, Long Beach

91205

Research Site, Glendale

91324

Research Site, Northridge

91352

Research Site, Sun Valley

91762

Research Site, Ontario

91900

Research Site, Veracruz

92243

Research Site, El Centro

92503

Research Site, Riverside

92868

Research Site, Orange

94534

Research Site, Fairfield

95825

Research Site, Sacramento

97517

Research Site, Banská Bystrica

100000

Research Site, Hanoi

105229

Research Site, Moscow

110017

Research Site, New Delhi

110060

Research Site, New Delhi

123182

Research Site, Moscow

163001

Research Site, Arkhangelsk

191015

Research Site, Saint Petersburg

201012

Research Site, Ghaziabad NCR

226003

Research Site, Lucknow

357500

Research Site, Pyatigorsk

387001

Research Site, Nadiād

390027

Research Site, Ryazan

400008

Research Site, Mumbai

411001

Research Site, Pune

411013

Research Site, Maharashtra

426035

Research Site, Izhevsk

440034

Research Site, Penza

450071

Research Site, Ufa

500018

Research Site, Hyderabad

530000

Research Site, Huế

570004

Research Site, Mysore

600006

Research Site, Chennai

603126

Research Site, Nizhny Novgorod

614000

Research Site, Perm

632004

Research Site, Vellore

650066

Research Site, Kemerovo

656024

Research Site, Barnaul

664049

Research Site, Irkutsk

700000

Research Site, Hochiminh

700027

Research Site, Kolkata

900000

Research Site, Can Tho

06510

Research Site, New Haven

02360

Research Site, Plymouth

07504

Research Site, Paterson

02914

Research Site, East Providence

Unknown

Research Site, Silistra

Research Site, Banská Bystrica

T6G 2B7

Research Site, Edmonton

V2C 2T1

Research Site, Kamloops

E2L 4L2

Research Site, Saint John

B1P 1P3

Research Site, Sydney

L6R 3J7

Research Site, Brampton

L1G 2B9

Research Site, Oshawa

M1P 2V5

Research Site, Scarborough Village

M3M 0B2

Research Site, Toronto

J4V 2H1

Research Site, Greenfield Park

H2X 3J4

Research Site, Montreal

H4J 1C5

Research Site, Montreal

G1R 2J6

Research Site, Québec

625 00

Research Site, Brno

140 00

Research Site, Prague

140 21

Research Site, Prague

190 61

Research Site, Prague

516 01

Research Site, Rychnov nad Kněžnou

274 01

Research Site, Slaný

390 03

Research Site, Tábor

401 13

Research Site, Ústí nad Labem

520 008

Research Site, Vijayawada

06700

Research Site, México

L27

Research Site, Lima

LIMA 01

Research Site, Lima

06-400

Research Site, Ciechanów

26-200

Research Site, Gmina Końskie

40-752

Research Site, Katowice

90-153

Research Site, Lodz

92-213

Research Site, Lodz

43-200

Research Site, Pszczyna

16-400

Research Site, Suwałki

33-100

Research Site, Tarnów

02-758

Research Site, Warsaw

831 03

Research Site, Bratislava

04011

Research Site, Košice

077 01

Research Site, Kráľovský Chlmec

940 34

Research Site, Nové Zámky

960 01

Research Site, Zvolen

04009

Research Site, Almería

08029

Research Site, Barcelona

08400

Research Site, Granollers (Barcelona)

651 85

Research Site, Karlstad

141 86

Research Site, Stockholm

751 85

Research Site, Uppsala

721 89

Research Site, Västerås

01601

Research Site, Kyiv

02125

Research Site, Kyiv

04050

Research Site, Kyiv

04107

Research Site, Kyiv

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

FibroGen

INDUSTRY

lead

AstraZeneca

INDUSTRY