Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat in Non-Dialysis Subjects Evaluating Hemoglobin (Hgb) and Quality of Life (ASCEND-NHQ)

PHASE3CompletedINTERVENTIONAL
Enrollment

614

Participants

Timeline

Start Date

March 5, 2018

Primary Completion Date

October 7, 2020

Study Completion Date

October 7, 2020

Conditions
Anaemia
Interventions
DRUG

Daprodustat (GSK1278863)

Daprodustat will be available as 9 millimeter (mm) or 7 mm film-coated tablets. Daprodustat will be administered once daily via oral route and can be taken without regard to food.

DRUG

Placebo

Daprodustat matching placebo will be available as 9 mm or 7 mm film coated tablets. Placebo will be administered once daily via oral route and can be taken without regard to food.

DRUG

Iron therapy

Iron therapy will be administered if ferritin is \<50 Nano gram per milliliter and/or TSAT is \<15 percent.

Trial Locations (168)

2010

GSK Investigational Site, Sydney

3000

GSK Investigational Site, Santa Fe

3050

GSK Investigational Site, Parkville

3065

GSK Investigational Site, Fitzroy

3084

GSK Investigational Site, Heidelberg

5003

GSK Investigational Site, Córdoba

6150

GSK Investigational Site, Murdoch

7600

GSK Investigational Site, Mar del Plata

13385

GSK Investigational Site, Marseille

13620

GSK Investigational Site, Seongnam-si, Gyeonggi-do

15009

GSK Investigational Site, Beaver

15478

GSK Investigational Site, Smithfield

15683

GSK Investigational Site, Scottdale

15890

GSK Investigational Site, Santiago de Compostela

16132

GSK Investigational Site, Genoa

16635

GSK Investigational Site, Duncansville

19611

GSK Investigational Site, West Reading

23502

GSK Investigational Site, Norfolk

24290

GSK Investigational Site, Boca del Rio

27100

GSK Investigational Site, Pavia

27704

GSK Investigational Site, Durham

28040

GSK Investigational Site, Madrid

28262

GSK Investigational Site, Charlotte

28801

GSK Investigational Site, Asheville

29118

GSK Investigational Site, Orangeburg

30103

GSK Investigational Site, Adairsville

30174

GSK Investigational Site, Mestre

30458

GSK Investigational Site, Statesboro

30510

GSK Investigational Site, Krakow

31201

GSK Investigational Site, Macon

31217

GSK Investigational Site, Macon

33024

GSK Investigational Site, Hollywood

33028

GSK Investigational Site, Pembroke Pines

33067

GSK Investigational Site, Coral Springs

33313

GSK Investigational Site, Lauderdale Lakes

33614

GSK Investigational Site, Tampa

34741

GSK Investigational Site, Kissimmee

35209

GSK Investigational Site, Homewood

37530

GSK Investigational Site, León

37660

GSK Investigational Site, Kingsport

38043

GSK Investigational Site, Grenoble

38163

GSK Investigational Site, Memphis

39601

GSK Investigational Site, Brookhaven

40138

GSK Investigational Site, Bologna

41124

GSK Investigational Site, Modena

42270

GSK Investigational Site, Saint-Priest-en-Jarez

42415

GSK Investigational Site, Daegu

42601

GSK Investigational Site, Daegu

44093

GSK Investigational Site, Nantes

44150

GSK Investigational Site, Guadalajara

44600

GSK Investigational Site, Guadalajara

46260

GSK Investigational Site, Indianapolis

48081

GSK Investigational Site, Saint Clair Shores

48202

GSK Investigational Site, Detroit

49201

GSK Investigational Site, Busan

49241

GSK Investigational Site, Busan

49620

GSK Investigational Site, Buckley

63136

GSK Investigational Site, St Louis

64060

GSK Investigational Site, Monterrey

66210

GSK Investigational Site, Overland Park

68070

GSK Investigational Site, Mulhouse

72037

GSK Investigational Site, Le Mans

72204

GSK Investigational Site, Little Rock

73112

GSK Investigational Site, Oklahoma City

73130

GSK Investigational Site, Midwest City

75115

GSK Investigational Site, DeSoto

75165

GSK Investigational Site, Waxahachie

77000

GSK Investigational Site, Melun

78503

GSK Investigational Site, McAllen

79935

GSK Investigational Site, El Paso

80131

GSK Investigational Site, Napoli

80230

GSK Investigational Site, Denver

82503

GSK Investigational Site, Riverside

88100

GSK Investigational Site, Catanzaro

90242

GSK Investigational Site, Downey

90262

GSK Investigational Site, Lynwood

91324

GSK Investigational Site, Northridge

91325

GSK Investigational Site, Northridge

91900

GSK Investigational Site, Veracruz

92704

GSK Investigational Site, Santa Ana

93720

GSK Investigational Site, Fresno

93901

GSK Investigational Site, Salinas

94550

GSK Investigational Site, Córdoba

97000

GSK Investigational Site, Mérida

97070

GSK Investigational Site, Mérida

121359

GSK Investigational Site, Moscow

150000

GSK Investigational Site, Yaroslavl

150030

GSK Investigational Site, Yaroslavl

150062

GSK Investigational Site, Yaroslavl

194355

GSK Investigational Site, Saint Petersburg

197022

GSK Investigational Site, Saint Petersburg

200642

GSK Investigational Site, Craiova

236016

GSK Investigational Site, Kaliningrad

300723

GSK Investigational Site, Timișoara

330084

GSK Investigational Site, Deva

344022

GSK Investigational Site, Rostov-on-Don

355017

GSK Investigational Site, Stavropol

357500

GSK Investigational Site, Pyatigorsk

357538

GSK Investigational Site, Pyatigorsk

390037

GSK Investigational Site, Ryazan

400139

GSK Investigational Site, Cluj-Napoca

410469

GSK Investigational Site, Oradea

426061

GSK Investigational Site, Izhevsk

500283

GSK Investigational Site, Brasov

540096

GSK Investigational Site, Târgu Mureş

603126

GSK Investigational Site, Nizhny Novgorod

650066

GSK Investigational Site, Kemerovo

660022

GSK Investigational Site, Krasnoyarsk

14025170

GSK Investigational Site, Ribeirão Preto

15015200

GSK Investigational Site, São José do Rio Preto

29055450

GSK Investigational Site, Vitória

06112

GSK Investigational Site, Hartford

06762

GSK Investigational Site, Middlebury

03867

GSK Investigational Site, Rochester

C1128AAF

GSK Investigational Site, Ciudad Autonoma de Buenos Aires

C1425AGC

GSK Investigational Site, Ciudad Autonoma de Buenos Aires

B7600FZN

GSK Investigational Site, Mar del Plata

B2900DMH

GSK Investigational Site, San Nicolás de los Arroyos

S2000DEJ

GSK Investigational Site, Rosario

44001-584

GSK Investigational Site, Feira de Santana

40415-065

GSK Investigational Site, Salvador

09080-110

GSK Investigational Site, Santo André - SP

09715090

GSK Investigational Site, São Bernardo do Campo

15090-000

GSK Investigational Site, São José do Rio Preto

04038002

GSK Investigational Site, São Paulo

V8V 4A1

GSK Investigational Site, Victoria

L6T 0G1

GSK Investigational Site, Brampton

P3A-1W8

GSK Investigational Site, Greater Sudbury

N1H 1B1

GSK Investigational Site, Guelph

N2H 5Z8

GSK Investigational Site, Kitchener

K1H 1A2

GSK Investigational Site, Ottawa

N7T 4X3

GSK Investigational Site, Sarnia

M5B 1W8

GSK Investigational Site, Toronto

M9N 1N8

GSK Investigational Site, Toronto

M9V 4B4

GSK Investigational Site, Toronto

H1M 1B1

GSK Investigational Site, Montreal

G2J 0C4

GSK Investigational Site, Québec

G3K 2P8

GSK Investigational Site, Québec

J6E 2B4

GSK Investigational Site, Saint-Charles-Borromée

06001

GSK Investigational Site, Nice

15-276

GSK Investigational Site, Bialystok

06-400

GSK Investigational Site, Ciechanów

31-513

GSK Investigational Site, Krakow

31-559

GSK Investigational Site, Krakow

92-213

GSK Investigational Site, Lodz

20-064

GSK Investigational Site, Lublin

55-200

GSK Investigational Site, Oława

63-300

GSK Investigational Site, Pleszew

41-200

GSK Investigational Site, Sosnowiec

70-111

GSK Investigational Site, Szczecin

21-040

GSK Investigational Site, Świdnik

83-110

GSK Investigational Site, Tczew

01-868

GSK Investigational Site, Warsaw

02-801

GSK Investigational Site, Warsaw

04-749

GSK Investigational Site, Warsaw

022328

GSK Investigational Site, Bucharest

042122

GSK Investigational Site, Bucharest

463-712

GSK Investigational Site, Gyeonggi-do

03312

GSK Investigational Site, Seoul

08308

GSK Investigational Site, Seoul

08916

GSK Investigational Site, Badalona

CT1 3NG

GSK Investigational Site, Canterbury

DE22 3NE

GSK Investigational Site, Derby

SE5 9RS

GSK Investigational Site, London

PE3 9GZ

GSK Investigational Site, Peterborough

PL6 8DH

GSK Investigational Site, Plymouth

SY3 8XQ

GSK Investigational Site, Shrewsbury

SA6 6NL

GSK Investigational Site, Swansea

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT03409107 - Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat in Non-Dialysis Subjects Evaluating Hemoglobin (Hgb) and Quality of Life (ASCEND-NHQ) | Biotech Hunter | Biotech Hunter