NCT03029208 - Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat-in Incident Dialysis (ASCEND-ID) | Biotech Hunter

Enrollment

312

Participants

Timeline

Start Date

May 11, 2017

Primary Completion Date

September 24, 2020

Study Completion Date

September 24, 2020

Conditions

Anaemia

Interventions

DRUG

Daprodustat

Daprodustat will be supplied as film coated tablets for oral administration containing 1, 2, 4, 6, 8, or 10 mg of daprodustat. Doses of 12, 16, and 24 mg of daprodustat will be provided using multiples of these tablet strengths.

DRUG

Darbepoetin alfa

Darbepoetin alfa will be supplied as prefilled syringes (PFS) for SC/IV injection available in strengths: 20, 30, 40, 60, 80, 100 and 150 mcg.

DRUG

Iron therapy

Iron therapy will be administered if ferritin is \<=100 ng/mL and/or TSAT is \<=20%.

Trial Locations (111)

1425

GSK Investigational Site, Buenos Aires

1629

GSK Investigational Site, Pilar

3004

GSK Investigational Site, Melbourne

3021

GSK Investigational Site, St Albans

5000

GSK Investigational Site, Adelaide

6510

GSK Investigational Site, Incheon

7410

GSK Investigational Site, Ostrołęka

7925

GSK Investigational Site, Cape Town

10029

GSK Investigational Site, New York

10461

GSK Investigational Site, The Bronx

10990

GSK Investigational Site, George Town

11203

GSK Investigational Site, Brooklyn

11501

GSK Investigational Site, Mineola

11510

GSK Investigational Site, Puerto Real

14000

GSK Investigational Site, Ciudad de México

14068

GSK Investigational Site, Anyang-Si, Gyeonggi-do

14215

GSK Investigational Site, Buffalo

14647

GSK Investigational Site, Bucheon-si

16132

GSK Investigational Site, Genoa

16499

GSK Investigational Site, Suwon

20153

GSK Investigational Site, Milan

20259

GSK Investigational Site, Aguascalientes

21287

GSK Investigational Site, Baltimore

23666

GSK Investigational Site, Hampton

27000

GSK Investigational Site, Torreón

27100

GSK Investigational Site, Pavia

28040

GSK Investigational Site, Madrid

30450

GSK Investigational Site, Ipoh

30912

GSK Investigational Site, Augusta

33126

GSK Investigational Site, Miami

33134

GSK Investigational Site, Coral Gables

33169

GSK Investigational Site, Miami

39216

GSK Investigational Site, Jackson

40210

GSK Investigational Site, Düsseldorf

41009

GSK Investigational Site, Seville

44600

GSK Investigational Site, Guadalajara

45030

GSK Investigational Site, Zapopan

46360

GSK Investigational Site, Michigan City

46410

GSK Investigational Site, Merrillville

46804

GSK Investigational Site, Fort Wayne

52242

GSK Investigational Site, Iowa City

54055

GSK Investigational Site, Tlalnepantla

59100

GSK Investigational Site, Kuala Lumpur

60014

GSK Investigational Site, Crystal Lake

60637

GSK Investigational Site, Chicago

63110

GSK Investigational Site, St Louis

64111

GSK Investigational Site, Kansas City

65191

GSK Investigational Site, Wiesbaden

67655

GSK Investigational Site, Kaiserslautern

70112

GSK Investigational Site, New Orleans

70809

GSK Investigational Site, Baton Rouge

75904

GSK Investigational Site, Lufkin

77004

GSK Investigational Site, Houston

78229

GSK Investigational Site, San Antonio

90022

GSK Investigational Site, Los Angeles

90095

GSK Investigational Site, Los Angeles

90262

GSK Investigational Site, Lynwood

90603

GSK Investigational Site, Whittier

90623

GSK Investigational Site, La Palma

90703

GSK Investigational Site, Cerritos

91204

GSK Investigational Site, Glendale

92025

GSK Investigational Site, Escondido

92801

GSK Investigational Site, Anaheim

95825

GSK Investigational Site, Sacramento

97130

GSK Investigational Site, Mérida

110060

GSK Investigational Site, New Delhi

110076

GSK Investigational Site, Delhi

122001

GSK Investigational Site, Gūrgaon

141007

GSK Investigational Site, Mytishchi

191104

GSK Investigational Site, Saint Petersburg

194354

GSK Investigational Site, Saint Petersburg

196247

GSK Investigational Site, Saint Petersburg

197110

GSK Investigational Site, Saint Petersburg

214006

GSK Investigational Site, Smolensk

404120

GSK Investigational Site, Volzhskiy

411004

GSK Investigational Site, Pune

560020

GSK Investigational Site, Secunderabad

560055

GSK Investigational Site, Bangalore

600037

GSK Investigational Site, Chennai

644112

GSK Investigational Site, Omsk

664049

GSK Investigational Site, Irkutsk

673008

GSK Investigational Site, Kozhikode

695011

GSK Investigational Site, Thiruvananthapuram

06762

GSK Investigational Site, Middlebury

B1778IFA

GSK Investigational Site, Ciudad Evita

B1902COS

GSK Investigational Site, La Plata

B1708DPO

GSK Investigational Site, Morón

B2700CPM

GSK Investigational Site, Pergamino

P3600LLD

GSK Investigational Site, Formosa

M5500AFA

GSK Investigational Site, Mendoza

T4000AHL

GSK Investigational Site, San Miguel de Tucumán

N6A 5A5

GSK Investigational Site, London

M3M 0B2

GSK Investigational Site, Toronto

J4V 2H1

GSK Investigational Site, Greenfield Park

09100

GSK Investigational Site, Cagliari

CP 97070

GSK Investigational Site, Mérida

80-952

GSK Investigational Site, Gdansk

62-600

GSK Investigational Site, Koło

31-826

GSK Investigational Site, Krakow

92-213

GSK Investigational Site, Lodz

96-300

GSK Investigational Site, Lodz

14-100

GSK Investigational Site, Ostróda

70-780

GSK Investigational Site, Szczecin

05030

GSK Investigational Site, Seoul

08308

GSK Investigational Site, Seoul

08916

GSK Investigational Site, Badalona

08035

GSK Investigational Site, Barcelona

B9 5SS

GSK Investigational Site, Birmingham

DN2 5LT

GSK Investigational Site, Doncaster

SE5 9RS

GSK Investigational Site, London

TS4 3BW

GSK Investigational Site, Middlesbrough