Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Dialysis (ASCEND-D)

PHASE3CompletedINTERVENTIONAL
Enrollment

2,964

Participants

Timeline

Start Date

September 28, 2016

Primary Completion Date

November 9, 2020

Study Completion Date

November 9, 2020

Conditions
AnaemiaAspergillosis, Allergic Bronchopulmonary
Interventions
DRUG

Daprodustat

Daprodustat dose is based on prior ESA dose, the dose is adjusted thereafter in order to achieve the target range.

DRUG

rhEPO

The initial ESA dose is based on converting the prior ESA dose to the nearest available study rhEPO dose and is administered IV. The dose is adjusted thereafter in order to achieve the target range.

DRUG

Placebo

Oral placebo tablets will be taken from Week -4 up to randomization (Day 1).

DRUG

Iron therapy

Participants will receive supplemental iron therapy if ferritin is \<=100 ng/mL or TSAT is \<=20%. The investigator will choose the route of administration and dose of iron.

Trial Locations (462)

112

GSK Investigational Site, Taipei

116

GSK Investigational Site, Taipei

204

GSK Investigational Site, Keelung

220

GSK Investigational Site, New Taipei City

237

GSK Investigational Site, New Taipei City

333

GSK Investigational Site, Taoyuan Hsien

704

GSK Investigational Site, Tainan City

807

GSK Investigational Site, Kaohsiung City

1020

GSK Investigational Site, Brussels

1030

GSK Investigational Site, Vienna

1077

GSK Investigational Site, Budapest

1200

GSK Investigational Site, Brussels

1233

GSK Investigational Site, Sofia

1309

GSK Investigational Site, Sofia

1425

GSK Investigational Site, Buenos Aires

1629

GSK Investigational Site, Pilar

1640

GSK Investigational Site, Otahuhu

1709

GSK Investigational Site, Sofia

2001

GSK Investigational Site, Hamilton

2065

GSK Investigational Site, St Leonards

2139

GSK Investigational Site, Concord

2145

GSK Investigational Site, Westmead

2170

GSK Investigational Site, Liverpool

2217

GSK Investigational Site, Kogarah

2500

GSK Investigational Site, Wollongong

GSK Investigational Site, Esztergom

2700

GSK Investigational Site, Blagoevgrad

2750

GSK Investigational Site, Kingswood

3000

GSK Investigational Site, Leuven

3004

GSK Investigational Site, Melbourne

3021

GSK Investigational Site, St Albans

3100

GSK Investigational Site, Sankt Pölten

3168

GSK Investigational Site, Clayton

3300

GSK Investigational Site, Eger

3400

GSK Investigational Site, Montana

3500

GSK Investigational Site, Hasselt

3526

GSK Investigational Site, Miskolc

3600

GSK Investigational Site, Lom

3801

GSK Investigational Site, Portsmouth

4000

GSK Investigational Site, Liège

GSK Investigational Site, Plovdiv

4003

GSK Investigational Site, Plovdiv

4006

GSK Investigational Site, Herston

4011

GSK Investigational Site, Stavanger

4102

GSK Investigational Site, Woolloongabba

4156

GSK Investigational Site, Hastings

4400

GSK Investigational Site, Pazardzhik

4575

GSK Investigational Site, Birtinya

4700

GSK Investigational Site, Smolyan

5000

GSK Investigational Site, Adelaide

GSK Investigational Site, Veliko Tarnovo

GSK Investigational Site, Odense C

5300

GSK Investigational Site, Gabrovo

5500

GSK Investigational Site, Lovech

5700

GSK Investigational Site, Svendborg

6000

GSK Investigational Site, Kolding

6001

GSK Investigational Site, Kecskemét

6009

GSK Investigational Site, Nedlands

6150

GSK Investigational Site, Murdoch

7002

GSK Investigational Site, Rousse

7331

GSK Investigational Site, Baudour

7500

GSK Investigational Site, Holstebro

GSK Investigational Site, Cape Town

7624

GSK Investigational Site, Pécs

7633

GSK Investigational Site, Pécs

7900

GSK Investigational Site, Szigetvár

7925

GSK Investigational Site, Cape Town

8036

GSK Investigational Site, Graz

8310

GSK Investigational Site, Bruges

8800

GSK Investigational Site, Roeselare

8900

GSK Investigational Site, Ieper

9000

GSK Investigational Site, Varna

9300

GSK Investigational Site, Dobrich

10002

GSK Investigational Site, Zhongzheng Dist., Taipei

GSK Investigational Site, Zhytomyr

10029

GSK Investigational Site, New York

10154

GSK Investigational Site, Turin

10461

GSK Investigational Site, The Bronx

10475

GSK Investigational Site, Goyang-si

10710

GSK Investigational Site, Yonkers

10990

GSK Investigational Site, George Town

11203

GSK Investigational Site, Brooklyn

11355

GSK Investigational Site, Flushing

11385

GSK Investigational Site, Ridgewood

11501

GSK Investigational Site, Mineola

11527

GSK Investigational Site, Athens

11765

GSK Investigational Site, Uijeongbu-si

13005

GSK Investigational Site, Ciudad Real

14000

GSK Investigational Site, Ciudad de México

14021

GSK Investigational Site, Prague

14029

GSK Investigational Site, Chernihiv

14033

GSK Investigational Site, Caen

14068

GSK Investigational Site, Anyang-Si, Gyeonggi-do

14080

GSK Investigational Site, México, D.F.

14215

GSK Investigational Site, Buffalo

14647

GSK Investigational Site, Bucheon-si

15706

GSK Investigational Site, Santiago de Compostela

16132

GSK Investigational Site, Genoa

17007

GSK Investigational Site, Girona

18017

GSK Investigational Site, Bethlehem

18059

GSK Investigational Site, Rostock

19002

GSK Investigational Site, Guadalajara

19140

GSK Investigational Site, Philadelphia

20037

GSK Investigational Site, Washington D.C.

20153

GSK Investigational Site, Milan

20230

GSK Investigational Site, Aguascalientes

20770

GSK Investigational Site, Greenbelt

20900

GSK Investigational Site, Monza

22030

GSK Investigational Site, Edirne

22033

GSK Investigational Site, Fairfax

22304

GSK Investigational Site, Alexandria

23561

GSK Investigational Site, New Taipei City

23666

GSK Investigational Site, Hampton

23900

GSK Investigational Site, Lecco

24068

GSK Investigational Site, Seriate

24105

GSK Investigational Site, Kiel

24127

GSK Investigational Site, Bergamo

24153

GSK Investigational Site, Salem

24701

GSK Investigational Site, Bluefield

26426

GSK Investigational Site, Wŏnju

26480

GSK Investigational Site, Eskişehir

26500

GSK Investigational Site, Pátrai

26601

GSK Investigational Site, Beroun

27100

GSK Investigational Site, Pavia

27103

GSK Investigational Site, Winston-Salem

27517

GSK Investigational Site, Winston-Salem

27609

GSK Investigational Site, Raleigh

28000

GSK Investigational Site, Kuala Pahang

28007

GSK Investigational Site, Madrid

28020

GSK Investigational Site, Madrid

28040

GSK Investigational Site, Madrid

28222

GSK Investigational Site, Majadahonda

28721

GSK Investigational Site, Clyde

28801

GSK Investigational Site, Asheville

28805

GSK Investigational Site, Alcalá de Henares

29100

GSK Investigational Site, Piacenza

29150

GSK Investigational Site, Sumter

29425

GSK Investigational Site, Charleston

29530

GSK Investigational Site, Málaga

29621

GSK Investigational Site, Anderson

30122

GSK Investigational Site, Mestre

30904

GSK Investigational Site, Augusta

30912

GSK Investigational Site, Augusta

30990

GSK Investigational Site, Ipoh

31203

GSK Investigational Site, Chihuahua City

31217

GSK Investigational Site, Chihuahua City

31904

GSK Investigational Site, Columbus

32224

GSK Investigational Site, Jacksonville

32429

GSK Investigational Site, Minden

32789

GSK Investigational Site, Winter Park

33024

GSK Investigational Site, Hollywood

33076

GSK Investigational Site, Bordeaux

33126

GSK Investigational Site, Miami

33134

GSK Investigational Site, Coral Gables

33143

GSK Investigational Site, Miami

33150

GSK Investigational Site, Miami

33156

GSK Investigational Site, Miami

33169

GSK Investigational Site, Miami Gardens

33180

GSK Investigational Site, Aventura

33313

GSK Investigational Site, Lauderdale Lakes

33952

GSK Investigational Site, Port Charlotte

34000

GSK Investigational Site, Durango

34471

GSK Investigational Site, Ocala

34608

GSK Investigational Site, Spring Hill

35233

GSK Investigational Site, Daejeon

35805

GSK Investigational Site, Huntsville

37044

GSK Investigational Site, Tours

37205

GSK Investigational Site, Nashville

37923

GSK Investigational Site, Knoxville

37924

GSK Investigational Site, Knoxville

38018

GSK Investigational Site, Cordova

38039

GSK Investigational Site, Kayseri

38801

GSK Investigational Site, Tupelo

39501

GSK Investigational Site, Gulfport

40026

GSK Investigational Site, Imola

40202

GSK Investigational Site, Louisville

40210

GSK Investigational Site, Düsseldorf

41071

GSK Investigational Site, Seville

41110

GSK Investigational Site, Larissa

42601

GSK Investigational Site, Daegu

44620

GSK Investigational Site, Guadalajara

44650

GSK Investigational Site, Guadalajara

44718

GSK Investigational Site, Canton

45001

GSK Investigational Site, Ioannina

45030

GSK Investigational Site, Zapopan, Jalisco

45206

GSK Investigational Site, Cincinnati

45220

GSK Investigational Site, Cincinnati

45500

GSK Investigational Site, Ioannina

46002

GSK Investigational Site, Ternopil

46360

GSK Investigational Site, Michigan City

46410

GSK Investigational Site, Merrillville

46804

GSK Investigational Site, Fort Wayne

46940

GSK Investigational Site, Manises (Valencia)

47005

GSK Investigational Site, Valladolid

47130

GSK Investigational Site, Jeffersonville

48066

GSK Investigational Site, Roseville

48108

GSK Investigational Site, Busan

48341

GSK Investigational Site, Pontiac

49007

GSK Investigational Site, Kalamazoo

49661

GSK Investigational Site, Cloppenburg

50501

GSK Investigational Site, Tartu

50603

GSK Investigational Site, Kuala Lumpur

51092

GSK Investigational Site, Reims

52242

GSK Investigational Site, Iowa City

53203

GSK Investigational Site, Pardubice

53211

GSK Investigational Site, Shorewood

54058

GSK Investigational Site, Mykolaiv

54636

GSK Investigational Site, Thessaloniki

54769

GSK Investigational Site, Cuautitlán Izcalli

56403

GSK Investigational Site, Thessaloniki

57001

GSK Investigational Site, Thessaloniki

58005

GSK Investigational Site, Chernivtsi

60014

GSK Investigational Site, Crystal Lake

60262

GSK Investigational Site, Lynwood

63033

GSK Investigational Site, Florissant

63110

GSK Investigational Site, St Louis

64111

GSK Investigational Site, Kansas City

64732

GSK Investigational Site, Bad König

64807

GSK Investigational Site, Dieburg

65191

GSK Investigational Site, Wiesbaden

67655

GSK Investigational Site, Kaiserslautern

68100

GSK Investigational Site, Mulhouse

GSK Investigational Site, Alexandroupoli

GSK Investigational Site, Batu Caves

68167

GSK Investigational Site, Mannheim

69001

GSK Investigational Site, Zaporizhzhia

69100

GSK Investigational Site, Komotini

69600

GSK Investigational Site, Zaporizhzhia

70808

GSK Investigational Site, Baton Rouge

70836

GSK Investigational Site, Baton Rouge

71100

GSK Investigational Site, Foggia

71110

GSK Investigational Site, Heraklion-Crete

71603

GSK Investigational Site, Pine Bluff

73039

GSK Investigational Site, Kherson

75904

GSK Investigational Site, Lufkin

76000

GSK Investigational Site, Querétaro City

76008

GSK Investigational Site, Ivano-Frankivsk

76230

GSK Investigational Site, Bois-Guillaume

77004

GSK Investigational Site, Houston

77030

GSK Investigational Site, Houston

77099

GSK Investigational Site, Houston

77701

GSK Investigational Site, Beaumont

78207

GSK Investigational Site, San Antonio

78221

GSK Investigational Site, San Antonio

78251

GSK Investigational Site, San Antonio

78258

GSK Investigational Site, San Antonio

79110

GSK Investigational Site, Freiburg im Breisgau

80011

GSK Investigational Site, Pärnu

80100

GSK Investigational Site, Johor Bahru

80131

GSK Investigational Site, Napoli

83301

GSK Investigational Site, Kaohsiung City

83642

GSK Investigational Site, Meridian

86021

GSK Investigational Site, Poitiers

87301

GSK Investigational Site, Gallup

88100

GSK Investigational Site, Catanzaro

89102

GSK Investigational Site, Las Vegas

89107

GSK Investigational Site, Las Vegas

89124

GSK Investigational Site, Reggio Calabria

90022

GSK Investigational Site, Los Angeles

90095

GSK Investigational Site, Los Angeles

90211

GSK Investigational Site, Beverly Hills

90602

GSK Investigational Site, Whittier

90603

GSK Investigational Site, Whittier

90623

GSK Investigational Site, La Palma

90640

GSK Investigational Site, Montebello

90703

GSK Investigational Site, Cerritos

90712

GSK Investigational Site, Lakewood

90806

GSK Investigational Site, Long Beach

90807

GSK Investigational Site, Long Beach

90813

GSK Investigational Site, Long Beach

91205

GSK Investigational Site, Glendale

91324

GSK Investigational Site, Northridge

91344

GSK Investigational Site, Granada Hills

91356

GSK Investigational Site, Tarzana

91387

GSK Investigational Site, Santa Clarita

91745

GSK Investigational Site, Hacienda Heights

91754

GSK Investigational Site, Monterey Park

91762

GSK Investigational Site, Ontario

91910

GSK Investigational Site, Chula Vista

91942

GSK Investigational Site, La Mesa

92025

GSK Investigational Site, Escondido

92100

GSK Investigational Site, Boulogne-Billancourt

92103

GSK Investigational Site, San Diego

92111

GSK Investigational Site, San Diego

92243

GSK Investigational Site, El Centro

92501

GSK Investigational Site, Riverside

92553

GSK Investigational Site, Moreno Valley

92708

GSK Investigational Site, Fountain Valley

92801

GSK Investigational Site, Anaheim

92860

GSK Investigational Site, Norco

92886

GSK Investigational Site, Yorba Linda

93308

GSK Investigational Site, Bakersfield

93309

GSK Investigational Site, Bakersfield

93405

GSK Investigational Site, San Luis Obispo

94534

GSK Investigational Site, Fairfield

95825

GSK Investigational Site, Sacramento

97070

GSK Investigational Site, Mérida

97471

GSK Investigational Site, Roseburg

110017

GSK Investigational Site, New Delhi

110025

GSK Investigational Site, New Delhi

110060

GSK Investigational Site, New Delhi

110076

GSK Investigational Site, Delhi

119074

GSK Investigational Site, Singapore

122001

GSK Investigational Site, Gūrgaon

141009

GSK Investigational Site, Mytischi

150062

GSK Investigational Site, Yaroslavl

169608

GSK Investigational Site, Singapore

191104

GSK Investigational Site, Saint Petersburg

194354

GSK Investigational Site, Saint Petersburg

196247

GSK Investigational Site, Saint Petersburg

197110

GSK Investigational Site, Saint Petersburg

210146

GSK Investigational Site, Târgu Jiu

302004

GSK Investigational Site, Jaipur

308433

GSK Investigational Site, Singapore

310141

GSK Investigational Site, Arad

320166

GSK Investigational Site, Reşiţa

350029

GSK Investigational Site, Krasnodar

380059

GSK Investigational Site, Ahmedabad

387001

GSK Investigational Site, Nadiād

400016

GSK Investigational Site, Mumbai

404120

GSK Investigational Site, Volzhsky

411004

GSK Investigational Site, Pune

411033

GSK Investigational Site, Pune

411706

GSK Investigational Site, Goyang-si, Gyeonggi-do

440010

GSK Investigational Site, Nagpur

440034

GSK Investigational Site, Penza

460040

GSK Investigational Site, Orenburg

500034

GSK Investigational Site, Hyderabad

560020

GSK Investigational Site, Secunderabad

560054

GSK Investigational Site, Bangalore

560055

GSK Investigational Site, Bangalore

603126

GSK Investigational Site, Nizhny Novgorod

630087

GSK Investigational Site, Novosibirsk

644112

GSK Investigational Site, Omsk

664049

GSK Investigational Site, Irkutsk

673008

GSK Investigational Site, Calicut

695011

GSK Investigational Site, Trivandrum

2855227

GSK Investigational Site, Corroios

93065-091

GSK Investigational Site, Simi Valley

06762

GSK Investigational Site, Middlebury

20912-6385

GSK Investigational Site, Takoma Park

02903

GSK Investigational Site, Providence

B1852FZD

GSK Investigational Site, Burzaco

B1778IFA

GSK Investigational Site, Ciudad Evita

B2700CPM

GSK Investigational Site, Pergamino

X5016KEH

GSK Investigational Site, Córdoba

C1181ACH

GSK Investigational Site, Buenos Aires

CP1431FWO

GSK Investigational Site, Buenos Aires

P3600LLD

GSK Investigational Site, Formosa

M5500AFA

GSK Investigational Site, Mendoza

B1708DPO

GSK Investigational Site, Morón

T4000AHL

GSK Investigational Site, San Miguel de Tucumán

A-1130

GSK Investigational Site, Vienna

40415-065

GSK Investigational Site, Salvador

80440-020

GSK Investigational Site, Curitiba

CEP 80230-130

GSK Investigational Site, Curitiba

99010-080

GSK Investigational Site, Passo Fundo

90610-000

GSK Investigational Site, Porto Alegre

89227-680

GSK Investigational Site, Joinville

15090-000

GSK Investigational Site, São José do Rio Preto

30150-221

GSK Investigational Site, Belo Horizonte, Minas Gerais

44001-584

GSK Investigational Site, Feira de Santana

90035-070

GSK Investigational Site, Porto Alegre

90035-903

GSK Investigational Site, Porto Alegre

01323-001

GSK Investigational Site, São Paulo

01323903

GSK Investigational Site, São Paulo

04005-000

GSK Investigational Site, São Paulo

04039-000

GSK Investigational Site, São Paulo

08270-070

GSK Investigational Site, São Paulo

T6G 2B7

GSK Investigational Site, Edmonton

N6A 5A5

GSK Investigational Site, London

M3M 0B2

GSK Investigational Site, Toronto

738 18

GSK Investigational Site, Frýdek-mistek

664 95

GSK Investigational Site, Ivančice

514 01

GSK Investigational Site, Jilemnice

353 01

GSK Investigational Site, Mariánské Lázně

128 08

GSK Investigational Site, Prague

142 00

GSK Investigational Site, Prague

356 01

GSK Investigational Site, Sokolov

DK-9000

GSK Investigational Site, Aalborg

EE-13419

GSK Investigational Site, Tallinn

07103

GSK Investigational Site, Annonay

471 00

GSK Investigational Site, Arta

546 42

GSK Investigational Site, Thessaloniki

600 034

GSK Investigational Site, Chennai

600 006

GSK Investigational Site, Chennai, Tamil Nadu

09100

GSK Investigational Site, Cagliari

CP 25230

GSK Investigational Site, Saltillo

1081 HV

GSK Investigational Site, Amsterdam

7416 SE

GSK Investigational Site, Deventer

3079 DZ

GSK Investigational Site, Rotterdam

0405

GSK Investigational Site, Oslo

21-500

GSK Investigational Site, Biała Podlaska

80-462

GSK Investigational Site, Gdansk

05-600

GSK Investigational Site, Grójec

25-736

GSK Investigational Site, Kielce

62-600

GSK Investigational Site, Koło

78-100

GSK Investigational Site, Kołobrzeg

90-262

GSK Investigational Site, Lodz

92-213

GSK Investigational Site, Lodz

32-300

GSK Investigational Site, Olkusz

05-800

GSK Investigational Site, Pruszków

97-200

GSK Investigational Site, Tomaszów Mazowiecki

02-758

GSK Investigational Site, Warsaw

68-200

GSK Investigational Site, Żary

2700-391

GSK Investigational Site, Amadora

6200-000

GSK Investigational Site, Covilha

2625-437

GSK Investigational Site, Forte Da Casa

1069-166

GSK Investigational Site, Lisbon

1250-203

GSK Investigational Site, Lisbon

1400-195

GSK Investigational Site, Lisbon

1750-130

GSK Investigational Site, Lisbon

5370-530

GSK Investigational Site, Mirandela

8500-311

GSK Investigational Site, Portimão

2600-076

GSK Investigational Site, Vila Franca de Xira

5000-668

GSK Investigational Site, Vila Real (Lordelo)

022328

GSK Investigational Site, Bucharest

410-719

GSK Investigational Site, Goyang-si

463-707

GSK Investigational Site, Gyeonggi-do

405-760

GSK Investigational Site, Incheon

05030

GSK Investigational Site, Seoul

05355

GSK Investigational Site, Seoul

07061

GSK Investigational Site, Seoul

07441

GSK Investigational Site, Seoul

134-727

GSK Investigational Site, Seoul

135-720

GSK Investigational Site, Seoul

150-713

GSK Investigational Site, Seoul

158-710

GSK Investigational Site, Seoul

442-723

GSK Investigational Site, Suwon

09400

GSK Investigational Site, Aranda de Duero

08036

GSK Investigational Site, Badalona

08916

GSK Investigational Site, Badalona

08003

GSK Investigational Site, Barcelona

08025

GSK Investigational Site, Barcelona

08100

GSK Investigational Site, Mollet del Vallès

07120

GSK Investigational Site, Palma de Mallorca

08208

GSK Investigational Site, Sabadell

SE-701 85

GSK Investigational Site, Örebro

SE-141 86

GSK Investigational Site, Stockholm

SE-182 88

GSK Investigational Site, Stockholm

756 55

GSK Investigational Site, Uppsala

01330

GSK Investigational Site, Adana

06100

GSK Investigational Site, Ankara

07059

GSK Investigational Site, Antalya

04107

GSK Investigational Site, Kiev

01023

GSK Investigational Site, Kyiv

04050

GSK Investigational Site, Kyiv

04112

GSK Investigational Site, Kyiv

SG1 4AB

GSK Investigational Site, Stevenage

PR2 9HT

GSK Investigational Site, Preston

WV10 0QP

GSK Investigational Site, Wolverhampton

B9 5SS

GSK Investigational Site, Birmingham

DE22 3NE

GSK Investigational Site, Derby

DN2 5LT

GSK Investigational Site, Doncaster

DD1 9SY

GSK Investigational Site, Dundee

KY2 5AH

GSK Investigational Site, Fife

G51 4TF

GSK Investigational Site, Glasgow

HU3 2JZ

GSK Investigational Site, Hull

E1 1BB

GSK Investigational Site, London

SE5 9RS

GSK Investigational Site, London

OX3 7LE

GSK Investigational Site, Oxford

M6 8HD

GSK Investigational Site, Salford

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT02879305 - Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Dialysis (ASCEND-D) | Biotech Hunter | Biotech Hunter