Efficacy and Safety Study to Evaluate Vadadustat for the Maintenance Treatment of Anemia in Participants With Dialysis-dependent Chronic Kidney Disease (DD-CKD)

PHASE3CompletedINTERVENTIONAL
Enrollment

3,554

Participants

Timeline

Start Date

August 31, 2016

Primary Completion Date

January 16, 2020

Study Completion Date

March 30, 2020

Conditions
AnemiaDialysis-Dependent Chronic Kidney Disease
Interventions
DRUG

Vadadustat

Oral dose administered once daily for ≥36 weeks. Dose adjustment based on hemoglobin level as defined in the protocol.

DRUG

Darbepoetin alfa

Subcutaneous or intravenous dose administered for ≥36 weeks. Initial dose based on the current package insert for investigational sites in the United States (US), and the Summary of Product Characteristics for all other investigational sites (non-US) for adult participants with chronic kidney disease not on dialysis. For participants already on Darbepoetin alfa, the initial dosing regimen in the study was based on the prior dosing regimen.

Trial Locations (278)

168

Research Site, Roma

1233

Research Site, Sofia

1407

Research Site, Sofia

1750

Research Site, Sofia

2076

Research Site, Wahroonga

2125

Research Site, Kyiv

2170

Research Site, Liverpool

2305

Research Site, New Lambton Heights

2600

Research Site, Dupnitsa

2841

Research Site, Seoul

3000

Research Site, Vratsa

3065

Research Site, Fitzroy

3080

Research Site, Seoul

3128

Research Site, Box Hill

3400

Research Site, Corrientes

3700

Research Site, Vidin

4002

Research Site, Plovdiv

4870

Research Site, Cairns

5000

Research Site, Córdoba

Research Site, Veliko Tarnovo

5700

Research Site, San Luis

5980

Research Site, Cherven Bryag

6000

Research Site, Junín

6009

Research Site, Nedlands

6300

Research Site, Haskovo

6351

Research Site, Seoul

6591

Research Site, Seoul

7002

Research Site, Rousse

7100

Research Site, Byala

7250

Research Site, Launceston

7345

Research Site, Seoul

7400

Research Site, Brovary

7500

Research Site, Silistra

8800

Research Site, Sliven

9002

Research Site, Varna

9300

Research Site, Dobrich

9700

Research Site, Shumen

10002

Research Site, Zhytomyr

10010

Research Site, New York

10016

Research Site, New York

10117

Research Site, Berlin

10380

Research Site, Goyang-si

10444

Research Site, Goyang-si

10461

Research Site, The Bronx

10710

Research Site, Yonkers

11000

Research Site #1, Belgrade

Research Site #2, Belgrade

Research Site #3, Belgrade

Research Site #4, Belgrade

11021

Research Site, Great Neck

11102

Research Site, Astoria

11355

Research Site, Flushing

11923

Research Site, Guri-si

13005

Research Site, Marseille

13496

Research Site, Seongnam-si

14647

Research Site, Bucheon-si

16132

Research Site, Genova

16247

Research Site, Suwon

18000

Research Site, Niš

18009

Research Site #1, Cherkassy

18057

Research Site, Rostock

19000

Research Site, Zaječar

19106

Research Site, Philadelphia

20110

Research Site, Manassas

20912

Research Site, Takoma Park

21018

Research Site, Vinnytsia

23502

Research Site, Norfolk

23666

Research Site, Hampton

23900

Research Site, Lecco

27100

Research Site, Pavia

27103

Research Site, Winston-Salem

27704

Research Site, Durham

27834

Research Site, Greenville

28204

Research Site #1, Charlotte

Research Site #2, Charlotte

28562

Research Site #1, New Bern

Research Site #2, New Bern

28801

Research Site, Asheville

30046

Research Site #1, Lawrenceville

Research Site #2, Lawrenceville

30076

Research Site, Roswell

30458

Research Site, Statesboro

30904

Research Site, Augusta

31904

Research Site #1, Columbus

Research Site #2, Columbus

32789

Research Site, Winter Park

33024

Research Site, Hollywood

33026

Research Site, Pembroke Pines

33065

Research Site, Coral Springs

33071

Research Site, Coral Springs

33125

Research Site, Miami

33134

Research Site, Coral Gables

33140

Research Site, Miami Beach

33145

AMPM Research Clinic, Miami

33150

Research Site, Miami

33173

Research Site, Miami

33300

Research Site, Bordeaux

33313

Research Site #1, Lauderdale Lakes

33614

Research Site, Tampa

34000

Research Site, Kragujevac

34209

Research Site, Bradenton

34362

Research Site, Haifa

34471

Research Site, Ocala

35805

Research Site, Huntsville

37205

Research Site, Nashville

37408

Research Site #1, Chattanooga

Research Site #2, Chattanooga

37923

Research Site, Knoxville

39705

Research Site, Columbus

40210

Research Site, Düsseldorf

42055

Research Site, Saint-Priest-En-Jarez

42070

Research Site, Pachuca

45030

Research Site, Zapopan

46002

Research Site, Ternopil

46410

Research Site, Merrillville

46804

Research Site, Fort Wayne

47392

Research Site, Busan

48066

Research Site, Roseville

48202

Research Site, Detroit

48341

Research Site, Pontiac

49005

Research Site, Dnipro

49201

Research Site, Busan

51092

Research Site, Reims

53100

Research Site, Siena

54058

Research Site, Mykolaiv

58260

Research Site, Morelia

61037

Research Site, Kharkiv

63136

Research Site, St Louis

64111

Research Site, Kansas City

69600

Research Site, Zaporizhzhia

70124

Research Site, Bari

71101

Research Site, Shreveport

71201

Research Site, Monroe

71603

Research Site, Pine Bluff

75015

Research Site, Paris

75020

Research Site, Paris

75137

Research Site, Duncanville

75141

Research Site, Rishon LeZiyyon

75231

Research Site, Dallas

75235

Research Site, Dallas

75402

Research Site, Greenville

76008

Research Site, Ivano-Frankivsk

76015

Research Site, Arlington

77030

Research Site, Houston

77054

Research Site, Houston

77099

Research Site, Houston

77429

Research Site, El Paso

78054

Research Site, Villingen-Schwenningen

78202

Research Site, San Antonio

78207

Research Site, San Antonio

78221

Research Site, San Antonio

78229

Research Site #2, San Antonio

78251

Research Site, San Antonio

78278

Research Site, Ashkelon

78503

Research Site, McAllen

78705

Research Site, Austin

78751

Research Site, Austin

78758

Research Site, Austin

80002

Research Site, Arvada

80031

Research Site, Westminster

80230

Research Site, Denver

Research Site, Culiacán

83642

Research Site, Meridian

84790

Research Site, St. George

85210

Research Site, Mesa

87109

Research Site, Albuquerque

87301

Research Site, Gallup

87505

Research Site, Santa Fe

88018

Research Site, Uzhhorod

90022

Research Site, Los Angeles

90240

Research Site, Downey

90603

Research Site, Whittier

90606

Research Site, Whittier

90631

Research Site, La Habra

90640

Research Site #1, Montebello

90807

Research Site, Long Beach

90813

Research Site, Long Beach

91031

Research Site, Jerusalem

91206

Research Site, Glendale

91321

Research Site, Newhall

91324

Research Site #1, Northridge

Research Site #2, Northridge

91344

Research Site #1, Granada Hills

Research Site #2, Granada Hills

Research Site, Port Huron

91356

Research Site, Tarzana

91387

Research Site, Canyon Country

91754

Research Site, Monterey Park

91773

Research Site #1, San Dimas

Research Site #2, San Dimas

91910

Research Site, Chula Vista

91942

Research Site, La Mesa

92025

Research Site, Escondido

92111

Research Site, San Diego

92115

Research Site, San Diego

92243

Research Site, El Centro

92503

Research Site, Riverside

92505

Research Site, Riverside

92801

Research Site, Anaheim

92886

Research Site, Long Beach

93065

Research Site, Simi Valley

93309

Research Site #1, Bakersfield

Research Site #2, Bakersfield

94534

Research Site, Fairfield

95661

Research Site, Roseville

95825

Research Site, Sacramento

123182

Research Site, Moscow

125466

Research Site, Moscow

195067

Research Site, Saint Petersburg

197022

Research Site, Saint Petersburg

197110

Research Site, Saint Petersburg

198205

Research Site, Saint Petersburg

199004

Research Site, Saint Petersburg

353915

Research Site, Novorossiysk

603001

Research Site, Nizhny Novgorod

603076

Research Site, Nizhny Novgorod

620102

Research Site, Yekaterinburg

650066

Research Site #2, Kemerovo

3109601

Research Site, Haifa

4428164

Research Site, Kfar Saba

90712-2512

Research Site, Lakewood

06902

Research Site, Stamford

01107

Research Site, Springfield

02903

Research Site, Providence

78212-4740

Research Site, San Antonio

05403

Research Site, South Burlington

C1181ACH

Research Site, Ciudad Autonoma Buenos Aires

B2700CPM

Research Site, Pergamino

B1872EEA

Research Site, Sarandí

X5000EVQ

Research Site, Córdoba

A4400AXO

Research Site, Salta

60430-370

Research Site, Fortaleza

29055-450

Research Site, Vitória

44001-584

Research Site, Feira de Santana

45600-625

Research Site, Itabuna

30130-100

Research Site, Belo Horizonte

30150-221

Research Site, Belo Horizonte

36025-330

Research Site, Juiz de Fora

36036-330

Research Site, Juiz de Fora

80010-030

Research Site, Curitiba

87060-040

Research Site, Maringá

92425-900

Research Site, Canoas

99010-080

Research Site, Passo Fundo

90035-074

Research Site, Porto Alegre

90035-903

Research Site, Porto Alegre

90160-093

Research Site, Porto Alegre

90610-000

Research Site, Porto Alegre

88801-250

Research Site, Criciúma

89202-050

Research Site, Joinville

09080-110

Research Site, Santo André

09090-790

Research Site, Santo André

09715-090

Research Site, São Bernardo do Campo

15015-200

Research Site, São José do Rio Preto

01232-010

Research Site, São Paulo

04039-000

Research Site, São Paulo

05403-000

Research Site, São Paulo

B3H 2Y0

Research Site, Halifax

B1P 1P3

Research Site, Sydney

P3E 5J1

Research Site, Greater Sudbury

L1H 1B9

Research Site, Oshawa

J4V 2H1

Research Site, Greenfield Park

H2X 3J4

Research Site, Montreal

21-500

Research Site, Biała Podlaska

87-400

Research Site, Golub-Dobrzyń

78-100

Research Site, Kołobrzeg

90-153

Research Site, Lodz

92-213

Research Site, Lodz

93-338

Research Site, Lodz

04-749

Research Site, Warsaw

7800-309

Research Site, Beja

2400-441

Research Site, Leiria

2674-514

Research Site, Loures

200-702

Research Site, Chuncheon

CB2 0QQ

Research Site, Cambridge

SE5 9RS

Research Site, London

SG1 4AB

Research Site, Stevenage

NN16 8DB

Research Site, Kettering

DN2 5LT

Research Site, Doncaster

Sponsors
All Listed Sponsors
lead

Akebia Therapeutics

INDUSTRY

NCT02892149 - Efficacy and Safety Study to Evaluate Vadadustat for the Maintenance Treatment of Anemia in Participants With Dialysis-dependent Chronic Kidney Disease (DD-CKD) | Biotech Hunter | Biotech Hunter