Safety and Efficacy Study of Roxadustat (FG-4592) for the Treatment of Anemia in End-Stage Renal Disease (ESRD) Newly Initiated Dialysis Participants

PHASE3CompletedINTERVENTIONAL
Enrollment

1,043

Participants

Timeline

Start Date

February 11, 2014

Primary Completion Date

September 21, 2018

Study Completion Date

September 21, 2018

Conditions
Anemia in Incident Dialysis Patients
Interventions
DRUG

Roxadustat

Roxadustat will be administered per dose and schedule specified in the arm.

DRUG

Epoetin Alfa

Epoetin alfa will be administered TIW according to the epoetin alfa USPI or SmPC, or local SOC.

Trial Locations (113)

235

Investigational Site,, New Taipei City

433

Investigational Site, Taichung

1233

Investigational Site, Sofia

1407

Investigational Site, Sofia

1431

Investigational site, Sofia

1504

Investigational Site, Sofia

1872

Investigational Site, Serandi

2300

Investigational site, Pernik

4003

Investigational Site, Plovdiv

4400

Investigational site, Pazardzhik

5800

Investigational Site, Pleven

6000

Invesigational Site, Stara Zagora

7000

Investigational site, Rousse

8000

Investigational Site, Burgas

9000

Investigational Site, Varna

9300

Investigational site, Dobrich

10330

Investigational Site, Bangkok

10990

Investigational Site, George Town

20230

Investigational Site, Aguascalientes

27704

Investigational Site, Durham

28562

Investigational Site, New Bern

29118

Investigational Site, Orangeburg

29150

Investigational Site, Sumter

29203

Investigational Site, Columbia

33071

Investigational Site, Coral Springs

33143

Investigational Site, Miami

33173

Investigational Site, Miami

33614

Investigational Site, Tampa

34000

Investigational Site, Taiping

37923

Investigational Site, Knoxville

38801

Investigational Site, Tupelo

38815

Investigational Site, Portsmouth

39501

Investigational Site, Gulfport

39601

Investigational Site, Brookhaven

39705

Investigational Site, Columbus

40447

Investigational Site, Taichung

43000

Investigational Site, Kuala Lumpur

43215

Investigational Site, Columbus

46002

Investigational Site, Ternopil

48236

Investigational Site, Detroit

48341

Investigational Site, Pontiac

50200

Investigational Site, Chiang Mai

50586

Investigational Site, Kuala Lumpur

54058

Investigational Site, Mykolayiv

61037

Investigational Site, Karkiev

63074

Investigational Site, Saint Ann

63136

Investigational Site, St Louis

69118

Investigational Site, Zaporizhzhya

69600

Investigational Site, Zaporizhzhya

71101

Investigational Site, Shreveport

76008

Investigational Site, Ivano

77099

Investigational Site, Houston

77450

Investigational Site, Houston

78240

Investigational Site, San Luis Potosí City

78539

Investigational Site, Edinburg

83301

Investigational Site, Kaohsiung City

83642

Meridian, Meridian

87109

Investigational Site, Albuquerque

91910

Investigational Site, Chula Vista

91942

Investigational Site, La Mesa

92111

Investigational Site, San Diego

98000

Investigational Site, Miri

115446

Investigational Site, Moscow

125284

Investigational Site, Moscow

129327

investigational Site, Moscow

140407

Investigational Site, Kolomna

142100

Investigational Site, Rostov-on-Don

185019

Investigational Site, Petrozavodsk

191104

Investigational Site, Saint Petersburg

192242

Investigational Site, Saint Petersburg

193318

Investigational Site, Saint Petersburg

194354

Investigational Site, Saint Petersburg

195257

Investigational Site, Saint Petersburg

196247

Investigational site, Saint Petersburg

197110

Investigational Site, Saint Petersburg

200349

Investigational Site, Craiova

214006

Investigational Site, Smolensk

230108

Investigational Site, Slatina

248007

Investigational Site, Kaluga

350029

Investigational Site, Krasnodar

350051

Investigational Site, Krasnodar

353915

Investigational Site, Novorossiysk

460040

Investigational Site, Orenburg

540098

Investigational Site, Târgu Mureş

603076

Investigational Site, Nizhny Novgorod

644112

Investigational site, Omsk

1720421

Investigational Site, La Serena

4781151

Investigational Site, Temuco

33313-1638

Investigational Site, Lauderdale Lakes

S3000EPU

Investigational Site, Santa Fe

Unknown

Investigational Site, Barranquilla

Investigational Site, Barranquilla

LV-1038

Investigational Site, Riga

LV1001

Invetigational Site, Riga

LV3601

Investigational Site, Ventspils

05460

Investigational Site, Alor Star

41-500

Investigational Site, Chorzów

87-400

Investigational Site, Golub-Dobrzyń

88-100

Investigational Site, Inowrocław

40-027

Investigational Site, Katowice

05-804

Investigational Drug, Pruszków

031422

Investigational Site, Bucharest

020475

Investigational Site, Bucharest

022305

Investigational Site, Bucharest

022325

Investigational Site, Bucharest

022329

Investigational Site, Bucharest

410-719

Investigational site, Goyang-si

471-701

Investigational Site, Guri-si

463-712

Investigational Site, Seongnam-si

431-796

Investigational Site, Anyang-si

130-872

Investigational Site, Seoul

134-727

Investigational Site, Seoul

02125

Investigational Site, Kiev

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Astellas Pharma Europe B.V.

INDUSTRY

collaborator

AstraZeneca

INDUSTRY

lead

FibroGen

INDUSTRY