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

PHASE3CompletedINTERVENTIONAL
Enrollment

369

Participants

Timeline

Start Date

July 31, 2016

Primary Completion Date

January 31, 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 (118)

168

Research Site, Roma

1834

Research Site, Temperley

2125

Research Site, Kyiv

3400

Research Site, Corrientes

5000

Research Site, Córdoba

5700

Research Site, San Luis

6000

Research Site, Junín

6591

Research Site, Seoul

7345

Research Site, Seoul

7400

Research Site, Brovary

10002

Research Site, Zhytomyr

11102

Research Site, Astoria

13496

Research Site, Seongnam-si

16132

Research Site, Genova

18009

Research Site, Cherkassy

18057

Research Site, Rostock

19106

Research Site, Philadelphia

20912

Research Site, Takoma Park

21018

Research Site, Vinnytsia

23666

Research Site, Hampton

23900

Research Site, Lecco

27100

Research Site, Pavia

27103

Research Site, Winston-Salem

30046

Research Site #2, Lawrenceville

30458

Research Site, Statesboro

30904

Research Site, Augusta

31904

Research Site, Columbus

32789

Research Site, Winter Park

33071

Research Site, Coral Springs

33125

Research Site, Miami

33134

Research Site, Coral Gables

33140

Research Site, Miami Beach

33150

Research Site, Miami

33313

Research Site, Lauderdale Lakes

35805

Research Site, Huntsville

37205

Research Site, Nashville

37408

Research Site #1, Chattanooga

Research Site #2, Chattanooga

37923

Research Site, Knoxville

40210

Research Site, Düsseldorf

45030

Research Site, Zapopan

46002

Research Site, Ternopil

47392

Research Site, Busan

48066

Research Site, Roseville

49005

Research Site, Dnipro

53100

Research Site, Siena

54058

Research Site, Mykolaiv

58260

Research Site, Morelia

61037

Research Site, Kharkiv

64111

Research Site, Kansas City

69600

Research Site, Zaporizhzhia

71013

Research Site, San Giovanni Rotondo

76008

Research Site, Ivano-Frankivsk

76015

Research Site, Arlington

77054

Research Site, Houston

77099

Research Site, Houston

78054

Research Site, Villingen-Schwenningen

78229

Research Site, San Antonio

79935

Research Site, El Paso

80002

Research Site, Arvada

80031

Research Site, Westminster

80138

Research Site, Napoli

80230

Research Site, Culiacán

83642

Research Site, Meridian

85210

Research Site, Mesa

87109

Research Site, Albuquerque

88018

Research Site, Uzhhorod

90022

Research Site, Los Angeles

90240

Research Site, Downey

90603

Research Site, Whittier

90640

Research Site, Montebello

91204

Research Site, Glendale

91321

Research Site, Newhall

91324

Research Site #1, Northridge

Research Site #2, Northridge

91344

Research Site, Granada Hills

91387

Research Site, Canyon Country

91754

Research Site, Monterey Park

91773

Research Site, San Dimas

91942

Research Site, La Mesa

92115

Research Site, San Diego

92503

Research Site, Riverside

92505

Research Site, Riverside

92801

Research Site, Anaheim

92886

Research Site, Long Beach

95825

Research Site, Sacramento

125466

Research Site, Moscow

197022

Research Site, Saint Petersburg

197110

Research Site, Saint Petersburg

198205

Research Site, Saint Petersburg

199004

Research Site, Saint Petersburg

650066

Research Site #2, Kemerovo

660022

Research Site, Krasnoyarsk

06902

Research Site, Stamford

78212-4740

Research Site, San Antonio

B8001HXM

Research Site, Bahía Blanca

C1181ACH

Research Site, Ciudad Autonoma Buenos Aires

B2700CPM

Research Site, Pergamino

A4400AXO

Research Site, Salta

60430-370

Research Site, Fortaleza

30150-221

Research Site, Belo Horizonte

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

89202-050

Research Site, Joinville

09090-790

Research Site, Santo André

09715-090

Research Site, São Bernardo do Campo

04039-000

Research Site, São Paulo

87-400

Research Site, Golub-Dobrzyń

90-153

Research Site, Lodz

92-213

Research Site, Lodz

2400-441

Research Site, Leiria

2674-514

Research Site, Loures

200-702

Research Site, Chuncheon

Sponsors
All Listed Sponsors
lead

Akebia Therapeutics

INDUSTRY