Study to Evaluate Vadadustat for the Correction of Anemia in Participants With Non-dialysis-dependent Chronic Kidney Disease

PHASE3CompletedINTERVENTIONAL
Enrollment

1,751

Participants

Timeline

Start Date

December 31, 2015

Primary Completion Date

June 4, 2020

Study Completion Date

July 31, 2020

Conditions
AnemiaNon-Dialysis-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.

Trial Locations (439)

1076

Research Site, Budapest

1145

Research Site, Budapest

1233

Research Site, Sofia

1407

Research Site, Sofia

1431

Research Site #1, Sofia

Research Site #2, Sofia

1606

Research Site, Sofia

1692

Research Site, Pretoria

1784

Research Site, Sofia

1834

Research Site, Temperley

1935

Research Site, Vereeniging

2050

Research Site, Camperdown

2143

Research Site, Kistarcsa

2170

Research Site, Liverpool

3128

Research Site, Box Hill

3200

Research Site, Hamilton

3400

Research Site, Corrientes

3600

Research Site, Lom

3700

Research Site, Vidin

4000

Research Site, San Miguel de Tucumán

4001

Research Site #1, Durban

Research Site #2, Durban

4006

Research Site, Herston

4032

Research Site, Debrecen

4092

Research Site, Durban

4096

Research Site, Durban

4320

Research Site, Durban

4342

Research Site, New Plymouth

4399

Research Site, Tongaat

4400

Research Site, Nyíregyháza

4406

Research Site, Salta

4700

Research Site, Smolyan

4870

Research Site, Cairns

5000

Research Site, Córdoba

Research Site, Adelaide

Research Site #1, Veliko Tarnovo

Research Site #2, Veliko Tarnovo

5042

Research Site, Bedford Park

5501

Research Site, Godoy Cruz

5700

Research Site, San Luis

6000

Research Site, Junín

Research Site, Perth

Research Site, Stara Zagora

Research Site, Kecskemét

6001

Research Site, Port Elizabeth

6003

Research Site, Stara Zagora

6009

Research Site, Nedlands

6300

Research Site, Kalocsa

6500

Research Site #1, Baja

Research Site #2, Baja

6529

Research Site, George

6720

Research Site, Szeged

6800

Research Site, Hódmezővásárhely

6850

Research Site, Worcester

7130

Research Site, Somerset West

7400

Research Site, Kaposvár

7500

Research Site, Silistra

7623

Research Site, Pécs

7900

Research Site, Szigetvár

7925

Research Site, Cape Town

8230

Research Site, Balatonfüred

8800

Research Site, Sliven

9000

Research Site, Varna

9002

Research Site, Varna

9300

Research Site, Dobrich

9301

Research Site, Bloemfontein

9400

Research Site, Winnie Mandela

9726

Research Site, Gold Coast

10002

Research Site, Zhytomyr

10010

Research Site, New York

10467

Research Site, The Bronx

11355

Research Site, Flushing

11413

Research Site, Laurelton

11923

Research Site, Guri-si

14647

Research Site, Bucheon-si

15586

Research Site, Kota Bharu

16132

Research Site, Genova

19140

Research Site, Philadelphia

20142

Research Site, Milan

20176

Research Site, Lansdowne Town Center

20770

Research Site, Greenbelt

20912

Research Site, Takoma Park

21001

Research Site, Vinnytsia

21005

Research Site, Vinnytsia

21018

Research Site, Vinnytsia

21218

Research Site, Baltimore

22191

Research Site, Woodbridge

22207

Research Site, Arlington

22304

Research Site, Alexandria

23507

Research Site, Norfolk

23606

Research Site, Newport News

23666

Research Site, Hampton

23900

Research Site, Lecco

24127

Research Site, Bergamo

24153

Research Site, Salem

24541

Research Site, Danville

25006

Research Site, Kropyvnytskyi

25100

Research Site, Kuantan

26100

Research Site, Cremona

27100

Research Site, Pavia

27103

Research Site, Winston-Salem

27834

Research Site #1, Greenville

Research Site #2, Greenville

28041

Research Site, Madrid

28504

Research Site, Kinston

28557

Research Site, Morehead City

28560

Research Site, New Bern

28801

Research Site, Asheville

29010

Research Site, Málaga

29118

Research Site, Orangeburg

29169

Research Site, West Columbia

29625

Research Site, Anderson

30046

Research Site #1, Lawrenceville

Research Site #2, Lawrenceville

30338

Research Site, Atlanta

30342

Research Site, Atlanta

30350

Research Site, Atlanta

30909

Research Site #1, Augusta

Research Site #2, Augusta

31203

Research Site, Chihuahua City

31217

Research Site, Macon

Research Site, Chihuahua City

31901

Research Site, Columbus

31904

Research Site #1, Columbus

Research Site #2, Columbus

32204

Research Site, Jacksonville

32216

Research Site #1, Jacksonville

Research Site #2, Jacksonville

33010

Research Site, Hialeah

33012

Research Site #1, Hialeah

Research Site #2, Hialeah

Research Site #3, Hialeah

33014

Research Site, Miami Lakes

33016

Research Site, Miami Lakes

33018

Research Site, Hialeah

33024

Research Site, Cooper City

Research Site #1, Hollywood

Research Site #2, Hollywood

33026

Research Site, Pembroke Pines

33060

Research Site, Pompano Beach

33065

Research Site, Coral Springs

33071

Research Site, Coral Springs

33122

Research Site, Miami

33126

Research Site #1, Miami

Research Site #2, Miami

33133

Research Site, Miami

33134

Research Site #1, Coral Gables

Research Site #2, Coral Gables

Research Site, Miami

33135

Research Site, Miami

33140

Research Site, Miami Beach

33143

Research Site, Miami

33144

Research Site, Miami

33145

Research Site, Miami

33150

Research Site, Miami

33157

Research Site, Miami

33165

Research Site, Miami

33166

Research Site, Doral

Research Site, Miami Springs

33169

Research Site, Miami

33172

Research Site, Sweetwater

33175

Research Site #1, Miami

Research Site #2, Miami

33313

Research Site, Lauderdale Lakes

33467

Research Site, Lake Worth

33511

Research Site, Brandon

33604

Research Site, Tampa

33612

Research Site, Tampa

33614

Research Site, Tampa

33901

Research Site, Fort Myers

34000

Research Site, Durango

34209

Research Site, Bradenton

35674

Research Site, Tuscumbia

35805

Research Site, Huntsville

37205

Research Site, Nashville

37408

Research Site, Chattanooga

37923

Research Site, Knoxville

38104

Research Site, Memphis

39501

Research Site, Gulfport

39670

Research Site, Acapulco de Juárez

41013

Research Site, Seville

41071

Research Site, Seville

41944

Research Site, Daegu

42070

Research Site, Pachuca

42090

Research Site, Pachuca

43100

Research Site, Parma

43302

Research Site, Marion

43537

Research Site, Maumee

44130

Research Site, Guadalajara

44302

Research Site, Akron

45116

Research Site, Zapopan

45200

Research Site, Zapopan

45206

Research Site, Cincinnati

45417

Research Site, Dayton

46011

Research Site, Anderson

46014

Research Site, Valencia

46026

Research Site, Valencia

46360

Research Site, Michigan City

46410

Research Site #1, Merrillville

Research Site #2, Merrillville

46804

Research Site, Fort Wayne

47130

Research Site, Jeffersonville

47392

Research Site, Busan

48066

Research Site, Roseville

48202

Research Site, Detroit

48341

Research Site, Pontiac

49005

Research Site, Dnipro

49201

Research Site, Busan

52363

Research Site, Ramat Gan

53100

Research Site, Siena

53705

Research Site, Madison

54058

Research Site, Mykolaiv

55102

Research Site, Saint Paul

58260

Research Site, Morelia

59701

Research Site, Butte

60050

Research Site, McHenry

60201

Research Site, Evanston

60637

Research Site, Chicago

61037

Research Site, Kharkiv

61039

Research Site, Kharkiv

61103

Research Site, Kharkiv

61157

Research Site, Kharkiv

61603

Research Site, Peoria

63128

Research Site, St Louis

64128

Research Site, Kansas City

64710

Research Site, Monterrey

65025

Research Site, Odesa

65201

Research Site, Columbia

68124

Research Site, Omaha

68510

Research Site, Lincoln

69118

Research Site, Zaporizhzhia

69600

Research Site, Zaporizhzhia

70115

Research Site, New Orleans

70124

Research Site, Bari

71013

Research Site, San Giovanni Rotondo

71101

Research Site #1, Shreveport

71103

Research Site, Shreveport

71201

Research Site, Monroe

75057

Research Site, Lewisville

75069

Research Site, McKinney

75071

Research Site, McKinney

75090

Research Site, Sherman

75093

Research Site, Plano

75115

Research Site, DeSoto

75141

Research Site, Rishon LeZiyyon

75246

Research Site, Dallas

75390

Research Site, Dallas

75401

Research Site, Greenville

75402

Research Site, Greenville

76008

Research Site, Ivano-Frankivsk

76015

Research Site, Arlington

76018

Research Site, Ivano-Frankivsk

76104

Research Site, Fort Worth

76800

Research Site, San Juan del Río

77004

Research Site #1, Houston

Research Site #2, Houston

77030

Research Site, Houston

77040

Research Site, Houston

77901

Research Site, Victoria

78207

Research Site, San Antonio

78224

Research Site, San Antonio

78229

Research Site, San Antonio

78278

Research Site, Ashkelon

78503

Research Site #1, McAllen

Research Site #2, McAllen

78629

Research Site, Gonzales

79010

Research Site, Lviv

79013

Research Site, Lviv

79935

Research Site, El Paso

80002

Research Site, Arvada

80030

Research Site, Culiacán

80031

Research Site, Westminster

80131

Research Site, Napoli

80138

Research Site, Napoli

80200

Research Site, Culiacán

80230

Research Site, Denver

Research Site, Culiacán

81016

Research Site, Piedimonte Matese

82110

Research Site, Mazatlán

83642

Research Site, Meridian

84015

Research Site, Clinton

84115

Research Site, Salt Lake City

85027

Research Site, Phoenix

85210

Research Site, Mesa

85306

Research Site, Glendale

85718

Research Site, Tucson

85724

Research Site, Tucson

87106

Research Site, Albuquerque

87108

Research Site, Albuquerque

87109

Research Site, Albuquerque

87505

Research Site, Santa Fe

89106

Research Site #1, Las Vegas

Research Site #2, Las Vegas

90020

Research Site, Los Angeles

90262

Research Site, Lynwood

90404

Research Site, Santa Monica

90603

Research Site #1, Whittier

Research Site #2, Whittier

90807

Research Site, Long Beach

91206

Research Site, Glendale

91324

Research Site #2, Northridge

Research Site, Northridge

91344

Research Site, Granada Hills

91360

Research Site, Thousand Oaks

91403

Research Site, Sherman Oaks

91773

Research Site #1, San Dimas

Research Site #2, San Dimas

91786

Research Site, Upland

91900

Research Site, Veracruz

91910

Research Site #1, Chula Vista

Research Site #2, Chula Vista

91942

Research Site, La Mesa

92505

Research Site, Riverside

92653

Research Site, Laguna Hills

92704

Research Site, Santa Ana

92708

Research Site #1, Fountain Valley

Research Site #2, Fountain Valley

92801

Research Site, Anaheim

92886

Research Site, Long Beach

93309

Research Site, Bakersfield

93901

Research Site, Salinas

95300

Research Site, Pontoise

95661

Research Site, Roseville

95825

Research Site, Sacramento

97216

Research Site, Portland

98405

Research Site, Tacoma

98801

Research Site, Wenatchee

115516

Research Site, Moscow

150062

Research Site, Yaroslavl

185019

Research Site, Petrozavodsk

187000

Research Site, Tosno

195271

Research Site, Saint Petersburg

196603

Research Site, Pushkin

197022

Research Site, Saint Petersburg

199106

Research Site, Saint Petersburg

199226

Research Site, Saint Petersburg

420012

Research Site, Kazan'

603076

Research Site, Nizhny Novgorod

630008

Research Site, Novosibirsk

630054

Research Site, Novosibirsk

630091

Research Site, Novosibirsk

634050

Research Site, Tomsk

650066

Research Site, Kemerovo

660062

Research Site, Krasnoyarsk

2210001

Research Site, Nahariya

3109601

Research Site, Haifa

92103-6204

Research Site, San Diego

06511

Research Site, New Haven

06902

Research Site, Stamford

06708

Research Site, Waterbury

33125-4141

Research Site, Miami

04102

Research Site, Portland

01844

Research Site, Methuen

02360

Research Site, Plymouth

03801

Research Site, Portsmouth

08009

Research Site, Berlin

08043

Research Site, Voorhees Township

02915

Research Site, East Providence

78212-4740

Research Site, San Antonio

78240-1501

Research Site, San Antonio

B8001HXM

Research Site, Bahía Blanca

B6000BHA

Research Site, Junín

B7600FYK

Research Site, Mar del Plata

B7600FZ

Research Site, Mar del Plata

B2700CPM

Research Site, Pergamino

B1704ETD

Research Site, Ramos Mejía

B1663CNJ

Research Site, San Miguel

B2900DMH

Research Site, San Nicolás de los Arroyos

B1872EEA

Research Site, Sarandí

S2000DIF

Research Site, Rosario

T4000AXL

Research Site, San Miguel de Tucumán

T4000ICL

Research Site, San Miguel de Tucumán

T4000

Research Site, San Miguel de Tucumán

C1093AAS

Research Site, Ciudad Autonoma Buenos Aires

C1430CKE

Research Site, Ciudad Autonoma Buenos Aires

X5000AAW

Research Site, Córdoba

X5000EVQ

Research Site, Córdoba

X5020AAA

Research Site, Córdoba

60115-282

Research Site, Fortaleza

60430-370

Research Site, Fortaleza

29055-450

Research Site, Vitória

44001-584

Research Site, Feira de Santana

45600-625

Research Site, Itabuna

30150-320

Research Site, Belo Horizonte

36036-330

Research Site, Juiz de Fora

80230-130

Research Site, Curitiba

80810-040

Research Site #1, Curitiba

Research Site #2, Curitiba

87060-040

Research Site, Maringá

20551-030

Research Site, Rio de Janeiro

92425-900

Research Site, Canoas

95010-005

Research Site, Caxias do Sul

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

18618-970

Research Site, Botucatu

13087-567

Research Site, Campinas

09080-110

Research Site, Santo André

09090-790

Research Site, Santo André

09715-090

Research Site, São Bernardo do Campo

01141-020

Research Site, São Paulo

01406-200

Research Site, São Paulo

04039-000

Research Site, São Paulo

00168

Research Site, Roma

06100

Research Site, Mexico City

06700

Research Site, Mexico City

90-153

Research Site, Lodz

93-338

Research Site, Lodz

67-100

Research Site, Nowa Sól

04-749

Research Site, Warsaw

50-414

Research Site, Wroclaw

00725

Research Site, Caguas

0002

Research Site #1, Pretoria

Research Site #2, Pretoria

02841

Research Site, Seoul

03080

Research Site, Seoul

03293

Research Site, Elche

03186

Research Site, Torrevieja

07120

Research Site, Palma de Mallorca

08907

Research Site, L'Hospitalet de Llobregat

04007

Research Site, Almería

04009

Research Site, Almería

06006

Research Site, Badajoz

08003

Research Site, Barcelona

02125

Research Site, Kyiv

04050

Research Site, Kyiv

AB25 2ZB

Research Site, Aberdeen

E1 1BB

Research Site, London

SE5 9RS

Research Site, London

M6 8HD

Research Site, Salford

SG1 4AB

Research Site, Stevenage

LE5 4PW

Research Site, Leicester

DN2 5LT

Research Site, Doncaster

S5 7AU

Research Site, Sheffield

SA6 6NL

Research Site, Swansea

Sponsors
All Listed Sponsors
lead

Akebia Therapeutics

INDUSTRY