Safety and Efficacy Study of Roxadustat to Treat Anemia in Patients With Chronic Kidney Disease (CKD), Not on Dialysis

PHASE3CompletedINTERVENTIONAL
Enrollment

2,781

Participants

Timeline

Start Date

June 26, 2014

Primary Completion Date

October 4, 2018

Study Completion Date

October 4, 2018

Conditions
Anemia
Interventions
DRUG

Roxadustat

The initial study drug dose is 70 mg three times a week (TIW). The dose is subsequently adjusted to achieve and maintain Hb 11±1 g/dL.

DRUG

Placebo

The initial study drug dose is 70 mg three times a week (TIW). The dose is subsequently adjusted to achieve and maintain Hb 11±1 g/dL.

Trial Locations (359)

14

Research Site, Lima

220

Research Site, New Taipei City

231

Research Site, New Taipei City

333

Research Site, Taoyuan District

402

Research Site, Taichung

1096

Research Site, Budapest

1101

Research Site, Quezon City

1134

Research Site, Budapest

1605

Research Site, Munro

1702

Research Site, Ciudadela

1900

Research Site, La Plata

2000

Research Site, Rosario

Research Site, Samokov

2140

Research Site, Botevgrad

2481

Research Site, Velence

2600

Research Site, Dupnitsa

2800

Research Site, Sandanski

Research Site, Tatabánya

2900

Research Site, Gotse Delchev

3000

Research Site, Hatvan

3100

Research Site, Salgótarján

3320

Research Site, Kozloduy

3700

Research Site, Smolyan

4000

Research Site, San Miguel de Tucumán

4090

Research Site, Polgár

4400

Research Site, Nyíregyháza

5000

Research Site, Iloilo City

5700

Research Site, Gyula

6000

Research Site, Kecskemét

Research Site, Cebu City

6300

Research Site, Santa Rosa

Research Site, Haskovo

7500

Research Site, Silistra

7600

Research Site, Mar del Plata

7623

Research Site, Pécs

8400

Research Site, Ajka

8600

Research Site, Yambol

Research Site, Siófok

8800

Research Site, Sliven

10117

Research Site, Berlin

10300

Research Site, Bangkok

10330

Research Site, Bangkok

10380

Research Site, Goyang-si

10400

Research Site, Bangkok

10444

Research Site, Goyang-si

10491

Research Site, Taipei

10700

Research Site, Bangkok

10990

Research Site, George Town

11021

Research Site, Great Neck

11355

Research Site, Flushing

11765

Research Site, Uijeongbu-si

13620

Research Site, Seongnam-si

15355

Research Site, Ansan-si

15401

Research Site, Uniontown

15706

Research Site, Santiago de Compostela

16150

Research Site, Kubang Kerian

18017

Research Site, Bethlehem

19104

Research Site, Philadelphia

19446

Research Site, Lansdale

20219

Research Site, Aguascalientes

20401

Research Site, Keelung

20770

Research Site, Greenbelt

20852

Research Site, Rockville

21018

Research Site, Vinnytsia

21029

Research Site, Vinnytsia

22191

Research Site, Woodbridge

23507

Research Site, Norfolk

23561

Research Site, New Taipei City

24153

Research Site, Salem

25006

Research Site, Kirovograd

27262

Research Site, High Point

28207

Research Site, Charlotte

28401

Research Site, Wilmington

28546

Research Site, Jacksonville

28562

Research Site, New Bern

29000

Research Site, Khmelnytsky

29010

Research Site, Málaga

29203

Research Site, Columbia

30342

Research Site, Atlanta

31901

Research Site, Columbus

31904

Research Site, Columbus

32132

Research Site, Edgewater

33021

Research Site, Hollywood

33027

Research Site, Rivne

33071

Research Site, Coral Springs

33126

Research Site, Miami

33130

Research Site, Miami

33133

Research Site, Miami

33134

Research Site, Coral Gables

33145

Research Site, Miami

33150

Research Site, Miami

33165

Research Site, Miami

33169

Research Site, Miami

33173

Research Site, Miami

33180

Research Site, Aventura

33313

Research Site, Lauderdale Lakes

33607

Research Site, Tampa

33952

Research Site, Port Charlotte

34000

Research Site, Taiping

34093

Research Site, Istanbul

34098

Research Site, Istanbul

34741

Research Site, Kissimmee

35015

Research Site, Daejeon

35040

Research Site, Izmir

35209

Research Site, Birmingham

35805

Research Site, Huntsville

37923

Research Site, Knoxville

39501

Research Site, Gulfport

40000

Research Site, Khon Kaen

40002

Research Site, Khon Kaen

41013

Research Site, Seville

42415

Research Site, Daegu

43005

Research Site, Lutsk

43215

Research Site, Columbus

44670

Research Site, Guadalajara

44676

Research Site, Guadalajara

45206

Research Site, Cincinnati

45220

Research Site, Cincinnati

46010

Research Site, Valencia

46017

Research Site, Valencia

46026

Research Site, Valencia

48060

Research Site, Port Huron

49005

Research Site, Dnipro

49241

Research Site, Busan

49661

Research Site, Cloppenburg

50937

Research Site, Cologne

58002

Research Site, Chernivtsi

60435

Research Site, Joliet

60525

Research Site, La Grange

61002

Research Site, Kharkiv

61039

Research Site, Kharkiv

61058

Research Site, Kharkiv

61103

Research Site, Kharkiv

62250

Research Site, Putrajaya

64111

Research Site, Kansas City

65009

Research Site, Odesa

68124

Research Site, Omaha

69001

Research Site, Zaporizhzhya

69068

Research Site, Zaporizhzhya

69118

Research Site, Zaporizhzhya

69600

Research Site, Zaporizhzhya

70006

Research Site, Metairie

71101

Research Site, Shreveport

73116

Research Site, Oklahoma City

75231

Research Site, Dallas

75904

Research Site, Lufkin

76008

Research Site, Ivano-Frankivsk

77004

Research Site, Houston

77024

Research Site, Houston

77074

Research Site, Houston

77084

Research Site, Houston

77090

Research Site, Houston

77099

Research Site, Houston

77429

Research Site, Cypress

78207

Research Site, San Antonio

78212

Research Site, San Antonio

78229

Research Site, San Antonio

78258

Research Site, San Antonio

78404

Research Site, Corpus Christi

79010

Research Site, Lviv

80002

Research Site, Arvada

80230

Research Site, Culiacán

82445

Research Site, Kaohsiung City

82606

Research Site, Bratislava

84115

Research Site, Salt Lake City

84790

Research Site, St. George

85027

Research Site, Phoenix

89106

Research Site, Las Vegas

89128

Research Site, Las Vegas

89511

Research Site, Reno

90022

Research Site, Los Angeles

90095

Research Site, Los Angeles

90262

Research Site, Lynwood

90806

Research Site, Long Beach

90807

Research Site, Long Beach

91020

Research Site, Xalapa

91204

Research Site, Glendale

91324

Research Site, Northridge

91773

Research Site, San Dimas

91786

Research Site, Upland

91900

Research Site, Veracruz

91950

Research Site, National City

92025

Research Site, Escondido

92103

Research Site, San Diego

92243

Research Site, El Centro

92868

Research Site, Orange

93309

Research Site, Bakersfield

93401

Research Site, San Luis Obispo

94110

Research Site, San Francisco

95825

Research Site, Sacramento

95831

Research Site, Sacramento

96730

Research Site, Minatitlán

100000

Research Site, Hanoi

105229

Research Site, Moscow

109263

Research Site, Moscow

110017

Research Site, New Delhi

110060

Research Site, New Delhi

129344

Research Site, Moscow

163001

Research Site, Arkhangelsk

191015

Research Site, Saint Petersburg

194354

Research Site, Saint Petersburg

196601

Research Site, Saint Petersburg

201012

Research Site, Ghaziabad NCR

226003

Research Site, Lucknow

250008

Research Site, Chía

250258

Research Site, Zipaquirá

300736

Research Site, Timișoara

310017

Research Site, Arad

380016

Research Site, Ahmedabad

390027

Research Site, Ryazan

400008

Research Site, Mumbai

404120

Research Site, Volgograd

411001

Research Site, Pune

411013

Research Site, Maharashtra

420012

Research Site, Nagpur

426035

Research Site, Izhevsk

440003

Research Site, Nagpur

440012

Research Site, Nagpur

450000

Research Site, Ufa

450005

Research Site, Ufa

450071

Research Site, Ufa

500018

Research Site, Hyderabad

500072

Research Site, Hyderabad

522002

Research Site, Vijayawada

530000

Research Site, Huế

530002

Research Site, Visakhapatnam

540000

Research Site, Târgu Mureş

550000

Research Site, Hochiminh

560052

Research Site, Bangalore

560068

Research Site, Bangalore

560070

Research Site, Bangalore

570004

Research Site, Mysore

600006

Research Site, Chennai

603076

Research Site, Nizhny Novgorod

603126

Research Site, Nizhny Novgorod

614000

Research Site, Perm

650066

Research Site, Kemerovo

656024

Research Site, Barnaul

660062

Research Site, Krasnoyarsk

664049

Research Site, Irkutsk

700000

Research Site, Ho Chi Minh City

Research Site, Hochiminh

700027

Research Site, Kolkata

760032

Research Site, Santiago de Cali

900000

Research Site, Can Tho

5001000

Research Site, Medellín

60115282

Research Site, Fortaleza

06708

Research Site, Waterbury

04856

Research Site, Rockport

03867

Research Site, Rochester

02908

Research Site, Providence

02915

Research Site, Providence

C1012AAR

Research Site, CABA

C1440AAD

Research Site, CABA

C1425AGC

Research Site, Capital Federal

C1199ABB

Research Site, Ciudad Autónoma de Bs. As.

C1427ARO

Research Site, La Plata

B1824KAJ

Research Site, Lanús

B1704ETD

Research Site, Ramos Mejía

S2000DNM

Research Site, Rosario

B1642DCD

Research Site, San Isidro

80230-130

Research Site, Curitiba

80440-020

Research Site, Curitiba

80810-040

Research Site, Curitiba

44001-584

Research Site, Feira de Santana

60430-350

Research Site, Fortaleza

60430-370

Research Site, Fortaleza

74043-011

Research Site, Goiânia

Unknown

Research Site, Joinville

Research Site, Slavkov u Brna

Research Site, Ica

Research Site, Taipei

Research Site, Antalya

36036-330

Research Site, Juiz de Fora

87083-240

Research Site, Maringá

90035-003

Research Site, Porto Alegre

90160-093

Research Site, Porto Alegre

90610-000

Research Site, Porto Alegre

09715090

Research Site, São Bernardo do Campo

01323-030

Research Site, São Paulo

04039-000

Research Site, São Paulo

05403-000

Research Site, São Paulo

08270-070

Research Site, São Paulo

T6G 2B7

Research Site, Edmonton

V2C 2T1

Research Site, Kamloops

V3L 0A6

Research Site, New Westminster

R2V 3M3

Research Site, Winnipeg

E2L 4L2

Research Site, Saint John

B1P 1P3

Research Site, Sydney

L6R 3J7

Research Site, Brampton

L6T 0G1

Research Site, Brampton

N2H 5Z8

Research Site, Kitchener

N6A 5A5

Research Site, London

L6K 3V3

Research Site, Oakville

M1H 3G4

Research Site, Scarborough Village

M4C 5T2

Research Site, Toronto

M4S 1Y2

Research Site, Toronto

M5C 2T2

Research Site, Toronto

M9N 1N8

Research Site, Toronto

L1N 5T2

Research Site, Whitby

J8Y 6S8

Research Site, Gatineau

J4V 2H1

Research Site, Greenfield Park

H1T 2M4

Research Site, Montreal

H4J 1C5

Research Site, Montreal

G1R 2J6

Research Site, Québec

625 00

Research Site, Brno

580 22

Research Site, Havlíčkův Brod

664 91

Research Site, Ivančice

190 61

Research Site, Prague

516 01

Research Site, Rychnov nad Kněžnou

274 01

Research Site, Slaný

787 01

Research Site, Šumperk

401 13

Research Site, Ústí nad Labem

562 18

Research Site, Ústí nad Orlicí

520 008

Research Site, Vijayawada

06726

Research Site, México

CALLAO 2

Research Site, Bellavista

L17

Research Site, Lima

LIMA 01

Research Site, Lima

LIMA 1

Research Site, Lima

LIMA 27

Research Site, Lima

LIMA 31

Research Site, Lima

044

Research Site, Trujillo

06-400

Research Site, Ciechanów

26-200

Research Site, Gmina Końskie

90-141

Research Site, Lodz

60-355

Research Site, Poznan

96-500

Research Site, Sochaczew

83-110

Research Site, Tczew

00739

Research Site, Cidra

00935

Research Site, Rio Piedras

00745

Research Site, Río Grande

00909

Research Site, San Juan

00917

Research Site, San Juan

00921

Research Site, San Juan

00927

Research Site, San Juan

00949

Research Site, Toa Baja

010731

Research Site, Bucharest

020475

Research Site, Bucharest

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

403-720

Research Site, Incheon

03312

Research Site, Seoul

06273

Research Site, Seoul

08308

Research Site, Seoul

139-711

Research Site, Seoul

04009

Research Site, Almería

0116

Research Site, Taipei

01330

Research Site, Adana

06230

Research Site, Ankara

06490

Research Site, Ankara

01601

Research Site, Kyiv

02125

Research Site, Kyiv

04050

Research Site, Kyiv

04107

Research Site, Kyiv

04114

Research Site, Kyiv

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

FibroGen

INDUSTRY

lead

AstraZeneca

INDUSTRY