Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat-Three-times Weekly Dosing in Dialysis (ASCEND-TD)

PHASE3CompletedINTERVENTIONAL
Enrollment

407

Participants

Timeline

Start Date

September 5, 2018

Primary Completion Date

June 19, 2020

Study Completion Date

June 19, 2020

Conditions
Anaemia
Interventions
DRUG

Daprodustat tablets

Round, biconvex, white, film-coated tablet in unit dose strengths 2 and 4 milligrams (7 millimeter tablets), 6, 8 and 10 milligrams (9 millimeter tablets) administered by the oral route.

DRUG

Matching placebo tablets

Matching placebo to daprodustat tablets supplied as round, biconvex, white, film-coated tablet in unit dose strengths 2 and 4 milligrams (7 millimeter tablets), 6, 8 and 10 milligrams (9 millimeter tablets) administered by the oral route.

DRUG

Epoetin alfa vials

Single-dose, preservative-free vials in unit dose strengths of 2000, 3000, 4000 and 10,000 Units/milliliter administered by the IV route.

DRUG

Saline vials or bags

0.9% sodium chloride saline vials or bags administered by the IV route.

Trial Locations (91)

2000

GSK Investigational Site, Rosario

3050

GSK Investigational Site, Parkville

3084

GSK Investigational Site, Heidelberg

7600

GSK Investigational Site, Mar del Plata

10326

GSK Investigational Site, Goyang-si, Gyeonggi-do

11356

GSK Investigational Site, College Point

11540

GSK Investigational Site, Sanlúcar de Barrameda (Cádiz)

14068

GSK Investigational Site, Anyang-Si, Gyeonggi-do

17007

GSK Investigational Site, Girona

22304

GSK Investigational Site, Alexandria

23510

GSK Investigational Site, Norfolk

23666

GSK Investigational Site, Hampton

27100

GSK Investigational Site, Pavia

27103

GSK Investigational Site, Winston-Salem

28100

GSK Investigational Site, Madrid

31201

GSK Investigational Site, Macon

33024

GSK Investigational Site, Hollywood

33169

GSK Investigational Site, Miami

33614

GSK Investigational Site, Tampa

37126

GSK Investigational Site, Verona

40138

GSK Investigational Site, Bologna

41124

GSK Investigational Site, Modena

46940

GSK Investigational Site, Manises (Valencia)

49201

GSK Investigational Site, Busan

63110

GSK Investigational Site, St Louis

64109

GSK Investigational Site, Bayonne

64111

GSK Investigational Site, Kansas City

67000

GSK Investigational Site, Strasbourg

72037

GSK Investigational Site, Le Mans

73116

GSK Investigational Site, Oklahoma City

74370

GSK Investigational Site, Epagny Metz-Tessy

75904

GSK Investigational Site, Lufkin

77004

GSK Investigational Site, Houston

77099

GSK Investigational Site, Houston

83642

GSK Investigational Site, Meridian

85210

GSK Investigational Site, Mesa

87109

GSK Investigational Site, Albuquerque

90025

GSK Investigational Site, Los Angeles

90723

GSK Investigational Site, Paramount

93720

GSK Investigational Site, Fresno

140407

GSK Investigational Site, Kolomna

141009

GSK Investigational Site, Mytischi

142110

GSK Investigational Site, Podolsk

143400

GSK Investigational Site, Krasnogorsk

150062

GSK Investigational Site, Yaroslavl

193318

GSK Investigational Site, Saint Petersburg

194104

GSK Investigational Site, Saint Petersburg

194354

GSK Investigational Site, Saint Petersburg

196247

GSK Investigational Site, Saint Petersburg

197110

GSK Investigational Site, Saint Petersburg

197374

GSK Investigational Site, Saint Petersburg

320166

GSK Investigational Site, Reşiţa

350029

GSK Investigational Site, Krasnodar

353915

GSK Investigational Site, Novorossiysk

420012

GSK Investigational Site, Kazan'

440034

GSK Investigational Site, Penza

450071

GSK Investigational Site, Ufa

460040

GSK Investigational Site, Orenburg

630087

GSK Investigational Site, Novosibirsk

644111

GSK Investigational Site, Omsk

900591

GSK Investigational Site, Constanța

06762

GSK Investigational Site, Middlebury

01201

GSK Investigational Site, Pittsfield

B2700CPM

GSK Investigational Site, Pergamino

B1872EEB

GSK Investigational Site, Sarandí

40415-065

GSK Investigational Site, Salvador

80440-020

GSK Investigational Site, Curitiba

99010-080

GSK Investigational Site, Passo Fundo

90610-000

GSK Investigational Site, Porto Alegre

15090-000

GSK Investigational Site, São José do Rio Preto

30150-221

GSK Investigational Site, Belo Horizonte, Minas Gerais

04039-000

GSK Investigational Site, São Paulo

L1G 2B9

GSK Investigational Site, Oshawa

06001

GSK Investigational Site, Nice

40-027

GSK Investigational Site, Katowice

92-213

GSK Investigational Site, Lodz

27-600

GSK Investigational Site, Sandomierz

42-612

GSK Investigational Site, Tarnowskie Góry

96-300

GSK Investigational Site, Żyrardów

405-760

GSK Investigational Site, Incheon

07061

GSK Investigational Site, Seoul

07441

GSK Investigational Site, Seoul

134-727

GSK Investigational Site, Seoul

04009

GSK Investigational Site, Almería

08916

GSK Investigational Site, Badalona

08036

GSK Investigational Site, Barcelona

08041

GSK Investigational Site, Granollers, Barcelona

BD5 0NA

GSK Investigational Site, Bradford

SE5 9RS

GSK Investigational Site, London

S5 7AU

GSK Investigational Site, Sheffield

SA6 6NL

GSK Investigational Site, Swansea

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY