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

PHASE3CompletedINTERVENTIONAL
Enrollment

1,725

Participants

Timeline

Start Date

February 29, 2016

Primary Completion Date

June 18, 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. For participants already on Darbepoetin alfa, the initial dosing regimen in the study was based on the prior dosing regimen.

Trial Locations (503)

1030

Research Site, Vienna

1076

Research Site, Budapest

1145

Research Site, Budapest

1220

Research Site, Vienna

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

2145

Research Site, Westmead

2170

Research Site, Liverpool

2500

Research Site, Esztergom

3000

Research Site, Vratsa

3065

Research Site, Fitzroy

3100

Research Site, Sankt Pölten

3128

Research Site, Box Hill

3165

Research Site, Bentleigh East

3200

Research Site, Hamilton

3400

Research Site, Corrientes

3600

Research Site, Lom

4000

Research Site, San Miguel de Tucumán

4001

Research Site #1, Durban

Research Site #2, Durban

4032

Research Site, Debrecen

4092

Research Site, Durban

4320

Research Site, Durban

4342

Research Site, New Plymouth

4399

Research Site, Tongaat

4406

Research Site, Salta

4700

Research Site, Smolyan

4870

Research Site, Cairns

5000

Research Site, Córdoba

Research Site, Adelaide

Research Site, Veliko Tarnovo

5501

Research Site, Godoy Cruz

5700

Research Site, San Luis

5980

Research Site, Cherven Bryag

6000

Research Site, Junín

Research Site, Perth

Research Site, Stara Zagora

Research Site, Kecskemét

6009

Research Site, Nedlands

6300

Research Site, Kalocsa

6500

Research Site #1, Baja

Research Site #2, Baja

6720

Research Site, Szeged

6800

Research Site, Hódmezővásárhely

6850

Research Site, Worcester

7100

Research Site, Byala

7250

Research Site, Launceston

7400

Research Site, Kaposvár

7500

Research Site, Silistra

7623

Research Site, Pécs

7900

Research Site, Szigetvár

8230

Research Site, Balatonfüred

8800

Research Site, Sliven

9000

Research Site, Varna

9002

Research Site, Varna

9301

Research Site, Bloemfontein

9400

Research Site, Winnie Mandela

9726

Research Site, Gold Coast

10010

Research Site, New York

10117

Research Site, Berlin

10380

Research Site, Goyang-si

10467

Research Site, The Bronx

10990

Research Site, Pulau Pinang

11000

Research Site #1, Belgrade

Research Site #2, Belgrade

Research Site #3, Belgrade

Research Site, Lazarevac

11355

Research Site, Flushing

11413

Research Site, Laurelton

11501

Research Site, Mineola

11923

Research Site, Guri-si

12627

Research Site, Berlin

13620

Research Site, Seongnam-si

14647

Research Site, Bucheon-si

17740

Research Site, Jersey Shore

18000

Research Site, Niš

18057

Research Site, Rostock

18901

Research Site, Doylestown

19000

Research Site, Zaječar

19140

Research Site, Philadelphia

20142

Research Site, Milan

20162

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

22297

Research Site, Hamburg

22304

Research Site, Alexandria

23507

Research Site, Norfolk

23666

Research Site, Hampton

23900

Research Site, Lecco

24153

Research Site, Salem

24541

Research Site, Danville

25006

Research Site, Kropyvnytskyi

27000

Research Site, Torreón

27100

Research Site, Pavia

27103

Research Site, Winston-Salem

27834

Research Site #1, Greenville

Research Site #2, Greenville

28007

Research Site, Madrid

28040

Research Site, Madrid

28041

Research Site, Madrid

28401

Research Site, Wilmington

28504

Research Site, Kinston

28546

Research Site, Jacksonville

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

29203

Research Site, 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, Augusta

31001

Research Site, Pamplona

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

32132

Research Site, Edgewater

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 #1, Miami Lakes

Research Site #2, 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

Research Site, Houston

33144

Research Site #1, Miami

Research Site #2, Miami

33145

Research Site, Miami

33150

Research Site, Miami

33157

Research Site, Miami

33165

Research Site, Miami

33166

Research Site, Doral

33169

Research Site, Miami

33173

Research Site, Miami

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

33952

Research Site, Port Charlotte

34000

Research Site, Durango

Research Site, Kragujevac

34098

Research Site, Istanbul

34209

Research Site, Bradenton

34722

Research Site, Istanbul

35211

Research Site, Birmingham

35674

Research Site, Tuscumbia

35805

Research Site, Huntsville

37205

Research Site, Nashville

37408

Research Site, Chattanooga

37923

Research Site, Knoxville

38039

Research Site, Erciyes

38104

Research Site, Memphis

39501

Research Site, Gulfport

39670

Research Site, Acapulco de Juárez

40210

Research Site, Düsseldorf

41013

Research Site, Seville

41071

Research Site, Seville

41380

Research Site, Kocaeli

41944

Research Site, Daegu

42055

Research Site, Saint-Priest-En-Jarez

42070

Research Site #1, Pachuca

Research Site #2, Pachuca

43005

Research Site, Lutsk

43100

Research Site, Parma

43203

Research Site, Columbus

43302

Research Site, Marion

43537

Research Site, Maumee

44130

Research Site, Guadalajara

44302

Research Site, Akron

45030

Research Site, Zapopan

45116

Research Site, Zapopan

45200

Research Site, Zapopan

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

47304

Research Site, Muncie

47392

Research Site, Busan

48066

Research Site, Roseville

48202

Research Site, Detroit

48341

Research Site, Pontiac

49005

Research Site, Dnipro

49201

Research Site, Busan

50333

Research Site, Hradec Králové

51090

Research Site, Reims

52363

Research Site, Ramat Gan

53100

Research Site, Siena

53705

Research Site, Madison

54058

Research Site, Mykolaiv

55102

Research Site, Saint Paul

55404

Research Site, Minneapolis

56000

Research Site, Kuala Lumpur

58260

Research Site, Morelia

59000

Research Site, Lille

59100

Research Site, Kuala Lumpur

59701

Research Site, Butte

60007

Research Site, Elk Grove Village

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

64111

Research Site, Kansas City

64128

Research Site, Kansas City

64620

Research Site, Monterrey

64710

Research Site, Monterrey

65025

Research Site, Odesa

65201

Research Site, Columbia

68124

Research Site, Omaha

68510

Research Site, Lincoln

69118

Research Site, Zaporizhzhia

70115

Research Site, New Orleans

70124

Research Site, Bari

71013

Research Site, San Giovanni Rotondo

71101

Research Site, Shreveport

71103

Research Site, Shreveport

71201

Research Site, Monroe

75015

Research Site, Paris

75020

Research Site, Paris

75057

Research Site, Lewisville

75069

Research Site, McKinney

75071

Research Site, McKinney

75090

Research Site, Sherman

75115

Research Site, DeSoto

75141

Research Site, Rishon LeZiyyon

75220

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

77054

Research Site, Houston

77901

Research Site, Victoria

78052

Research Site, Villingen-Schwenningen

78207

Research Site, San Antonio

78224

Research Site, San Antonio

78278

Research Site, Ashkelon

78503

Research Site #1, McAllen

Research Site #2, McAllen

78629

Research Site, Gonzales

79013

Research Site, Lviv

79935

Research Site, El Paso

80002

Research Site, Arvada

80030

Research Site, Culiacán

80031

Research Site, Westminster

80138

Research Site #1, Napoli

Research Site #2, Napoli

80200

Research Site, Culiacán

80230

Research Site, Denver

Research Site, Culiacán

81016

Research Site, Piedimonte Matese

82110

Research Site, Mazatlán

83103

Research Site, Bratislava

83642

Research Site, Meridian

84015

Research Site, Clinton

84115

Research Site, Salt Lake City

84790

Research Site, St. George

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

90048

Research Site, Los Angeles

90260

Research Site, Lynwood

90404

Research Site, Santa Monica

90603

Research Site, Whittier

90807

Research Site, Long Beach

91206

Research Site, Glendale

91324

Research Site #1, Northridge

Research Site #2, Northridge

91344

Research Site, Granada Hills

Research Site, Port Huron

91360

Research Site, Thousand Oaks

91403

Research Site, Sherman Oaks

91773

Research Site #1, San Dimas

Research Site #2, San Dimas

91900

Research Site, Veracruz

91910

Research Site #1, Chula Vista

Research Site #2, Chula Vista

91942

Research Site, La Mesa

92243

Research Site, El Centro

92505

Research Site, Riverside

92653

Research Site, Laguna Hills

92704

Research Site, Santa Ana

92708

Research Site, Fountain Valley

92801

Research Site, Anaheim

92886

Research Site, Long Beach

93309

Research Site, Bakersfield

93901

Research Site, Salinas

94010

Research Site, Créteil

95300

Research Site, Pontoise

95661

Research Site, Roseville

97216

Research Site, Portland

98405

Research Site, Tacoma

98801

Research Site, Wenatchee

99999

Research Site, Whittier

110221

Research Site, Bogotá

150062

Research Site, Yaroslavl

170004

Research Site, Manizales

185019

Research Site, Petrozavodsk

195271

Research Site, Saint Petersburg

196603

Research Site, Pushkin

197022

Research Site, Saint Petersburg

300182

Research Site, Timișoara

410469

Research Site, Oradea

420012

Research Site, Kazan'

500515

Research Site, Medellín

603076

Research Site, Nizhny Novgorod

630054

Research Site, Novosibirsk

630091

Research Site, Novosibirsk

650066

Research Site, Kemerovo

660062

Research Site, Krasnoyarsk

2210001

Research Site, Nahariya

3109601

Research Site, Haifa

4030000

Research Site, Concepción

4780000

Research Site, Temuco

5550170

Research Site, Puerto Varas

8431657

Research Site, Santiago

92103-6204

Research Site, San Diego

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

01107

Research Site, Springfield

03801

Research Site, Portsmouth

08009

Research Site, Berlin

08043

Research Site, Voorhees Township

02915

Research Site, East Providence

02908

Research Site, Providence

29150-1900

Research Site, Sumter

75024-5327

Research Site, Plano

78212-4740

Research Site, San Antonio

78240-1501

Research Site, San Antonio

05401

Research Site, Burlington

B8001HXM

Research Site, Bahía Blanca

B6000BHA

Research Site, Junín

B7600FYK

Research Site, Mar del Plata

B7600FZ

Research Site, Mar del Plata

B7602DCK

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

S2000DNM

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

40451-065

Research Site, Salvador

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

95010-005

Research Site, Caxias do Sul

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

04025-011

Research Site, São Paulo

05403-000

Research Site, São Paulo

M1H 3G4

Research Site, Scarborough Village

080020

Research Site, Barranquilla

00000

Research Site, Espinal

050021

Research Site #1, Medellín

Research Site #2, Medellín

370 01

Research Site, České Budějovice

128 08

Research Site, Prague

140 21

Research Site, Prague

00168

Research Site, Roma

05460

Research Site, Alor Star

06100

Research Site, Mexico City

Research Site, Ankara

06700

Research Site, Mexico City

67-100

Research Site, Nowa Sól

00725

Research Site, Caguas

010719

Research Site, Bucharest

011794

Research Site, Bucharest

022328

Research Site #1, Bucharest

Research Site #2, Bucharest

042122

Research Site, Bucharest

08501

Research Site, Bardejov

924 22

Research Site, Galanta

08901

Research Site, Svidník

02801

Research Site, Trstená

0002

Research Site, Pretoria

02841

Research Site, Seoul

03080

Research Site, Seoul

06591

Research Site, Seoul

07345

Research Site, Seoul

135-710

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

08025

Research Site, Barcelona

08035

Research Site, Barcelona

02125

Research Site, Kyiv

04050

Research Site, Kyiv

EX2 5DW

Research Site, Exeter

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

PE30 4ET

Research Site, Kings Lynn

DN2 5LT

Research Site, Doncaster

SA6 6NL

Research Site, Swansea

Sponsors
All Listed Sponsors
lead

Akebia Therapeutics

INDUSTRY