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

June 7, 2022 updated by: Akebia Therapeutics

Phase 3, Randomized, Open-Label, Active-Controlled Study Evaluating the Efficacy and Safety of Oral Vadadustat for the Correction of Anemia in Subjects With Non-Dialysis-Dependent Chronic Kidney Disease (NDD-CKD) (PRO2TECT-CORRECTION)

A multicenter, randomized, open-label, active-controlled Phase 3 study for the correction of anemia and maintenance of hemoglobin (Hb) in participants with Non-Dialysis-Dependent Chronic Kidney Disease (NDD-CKD)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a multicenter, randomized, open-label, active-controlled Phase 3 study of the efficacy and safety of vadadustat versus Darbepoetin alfa for the correction of anemia and maintenance of Hb in participants with NDD-CKD

Study Type

Interventional

Enrollment (Actual)

1751

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- - Ciudad Autonoma Buenos Aires, Argentina, C1093AAS
    - Research Site
  - Ciudad Autonoma Buenos Aires, Argentina, C1430CKE
    - Research Site
  - Cordoba, Argentina, 5000
    - Research Site
  - Cordoba, Argentina, X5000EVQ
    - Research Site
  - Cordoba, Argentina, X5000AAW
    - Research Site
  - Cordoba, Argentina, X5020AAA
    - Research Site
  - Corrientes, Argentina, 3400
    - Research Site
  - Salta, Argentina, 4406
    - Research Site
  - San Luis, Argentina, 5700
    - Research Site
- Buenos Aires
  - Bahia Blanca, Buenos Aires, Argentina, B8001HXM
    - Research Site
  - Junin, Buenos Aires, Argentina, 6000
    - Research Site
  - Junin, Buenos Aires, Argentina, B6000BHA
    - Research Site
  - Mar del Plata, Buenos Aires, Argentina, B7600FZ
    - Research Site
  - Mar del Plata, Buenos Aires, Argentina, B7600FYK
    - Research Site
  - Pergamino, Buenos Aires, Argentina, B2700CPM
    - Research Site
  - Ramos Mejia, Buenos Aires, Argentina, B1704ETD
    - Research Site
  - San Miguel, Buenos Aires, Argentina, B1663CNJ
    - Research Site
  - San Nicolas, Buenos Aires, Argentina, B2900DMH
    - Research Site
  - Sarandi, Buenos Aires, Argentina, B1872EEA
    - Research Site
  - Temperley, Buenos Aires, Argentina, 1834
    - Research Site
- Mendoza
  - Godoy Cruz, Mendoza, Argentina, 5501
    - Research Site
- Santa Fe
  - Rosario, Santa Fe, Argentina, S2000DIF
    - Research Site
- Tucuman
  - San Miguel de Tucuman, Tucuman, Argentina, 4000
    - Research Site
  - San Miguel de Tucuman, Tucuman, Argentina, T4000AXL
    - Research Site
  - San Miguel de Tucuman, Tucuman, Argentina, T4000ICL
    - Research Site
  - San Miguel de Tucuman, Tucuman, Argentina, T4000
    - Research Site
Australia
- New South Wales
  - Camperdown, New South Wales, Australia, 2050
    - Research Site
  - Liverpool, New South Wales, Australia, 2170
    - Research Site
- Queensland
  - Cairns, Queensland, Australia, 4870
    - Research Site
  - Gold Coast, Queensland, Australia, 9726
    - Research Site
  - Herston, Queensland, Australia, 4006
    - Research Site
- South Australia
  - Adelaide, South Australia, Australia, 5000
    - Research Site
  - Bedford Park, South Australia, Australia, 5042
    - Research Site
- Victoria
  - Box Hill, Victoria, Australia, 3128
    - Research Site
- Western Australia
  - Nedlands, Western Australia, Australia, 6009
    - Research Site
  - Perth, Western Australia, Australia, 6000
    - Research Site
Brazil
- Bahia
  - Feira de Santana, Bahia, Brazil, 44001-584
    - Research Site
  - Itabuna, Bahia, Brazil, 45600-625
    - Research Site
- Ceará
  - Fortaleza, Ceará, Brazil, 60430-370
    - Research Site
  - Fortaleza, Ceará, Brazil, 60115-282
    - Research Site
- Espírito Santo
  - Vitória, Espírito Santo, Brazil, 29055-450
    - Research Site
- Minas Gerais
  - Belo Horizonte, Minas Gerais, Brazil, 30150-320
    - Research Site
  - Juiz de Fora, Minas Gerais, Brazil, 36036-330
    - Research Site
- Paraná
  - Curitiba, Paraná, Brazil, 80230-130
    - Research Site
  - Curitiba, Paraná, Brazil, 80810-040
    - Research Site #1
  - Curitiba, Paraná, Brazil, 80810-040
    - Research Site #2
  - Maringá, Paraná, Brazil, 87060-040
    - Research Site
- Rio Do Janeiro
  - Rio de Janeiro, Rio Do Janeiro, Brazil, 20551-030
    - Research Site
- Rio Grande Do Sul
  - Canoas, Rio Grande Do Sul, Brazil, 92425-900
    - Research Site
  - Caxias do Sul, Rio Grande Do Sul, Brazil, 95010-005
    - Research Site
  - Passo Fundo, Rio Grande Do Sul, Brazil, 99010-080
    - Research Site
  - Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
    - Research Site
  - Porto Alegre, Rio Grande Do Sul, Brazil, 90035-074
    - Research Site
  - Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
    - Research Site
  - Porto Alegre, Rio Grande Do Sul, Brazil, 90160-093
    - Research Site
- Santa Catarina
  - Criciúma, Santa Catarina, Brazil, 88801-250
    - Research Site
  - Joinville, Santa Catarina, Brazil, 89202-050
    - Research Site
- Sao Paulo
  - Botucatu, Sao Paulo, Brazil, 18618-970
    - Research Site
  - Campinas, Sao Paulo, Brazil, 13087-567
    - Research Site
  - Santo André, Sao Paulo, Brazil, 09080-110
    - Research Site
  - Santo André, Sao Paulo, Brazil, 09090-790
    - Research Site
  - São Bernardo do Campo, Sao Paulo, Brazil, 09715-090
    - Research Site
  - São Paulo, Sao Paulo, Brazil, 04039-000
    - Research Site
  - São Paulo, Sao Paulo, Brazil, 01141-020
    - Research Site
  - São Paulo, Sao Paulo, Brazil, 01406-200
    - Research Site
Bulgaria
- - Dobrich, Bulgaria, 9300
    - Research Site
  - Lom, Bulgaria, 3600
    - Research Site
  - Silistra, Bulgaria, 7500
    - Research Site
  - Sliven, Bulgaria, 8800
    - Research Site
  - Smolyan, Bulgaria, 4700
    - Research Site
  - Sofia, Bulgaria, 1784
    - Research Site
  - Sofia, Bulgaria, 1407
    - Research Site
  - Sofia, Bulgaria, 1233
    - Research Site
  - Sofia, Bulgaria, 1606
    - Research Site
  - Sofia, Bulgaria, 1431
    - Research Site #1
  - Sofia, Bulgaria, 1431
    - Research Site #2
  - Stara Zagora, Bulgaria, 6003
    - Research Site
  - Stara Zagora, Bulgaria, 6000
    - Research Site
  - Varna, Bulgaria, 9000
    - Research Site
  - Varna, Bulgaria, 9002
    - Research Site
  - Veliko Tarnovo, Bulgaria, 5000
    - Research Site #1
  - Veliko Tarnovo, Bulgaria, 5000
    - Research Site #2
  - Vidin, Bulgaria, 3700
    - Research Site
France
- Val d'Oise
  - Pontoise, Val d'Oise, France, 95300
    - Research Site
Hungary
- - Baja, Hungary, 6500
    - Research Site #1
  - Baja, Hungary, 6500
    - Research Site #2
  - Balatonfured, Hungary, 8230
    - Research Site
  - Budapest, Hungary, 1145
    - Research Site
  - Budapest, Hungary, 1076
    - Research Site
  - Debrecen, Hungary, 4032
    - Research Site
  - Hodmezovasarhely, Hungary, 6800
    - Research Site
  - Kalocsa, Hungary, 6300
    - Research Site
  - Kaposvar, Hungary, 7400
    - Research Site
  - Kecskemet, Hungary, 6000
    - Research Site
  - Kistarcsa, Hungary, 2143
    - Research Site
  - Nyiregyhaza, Hungary, 4400
    - Research Site
  - Pecs, Hungary, 7623
    - Research Site
  - Szeged, Hungary, 6720
    - Research Site
  - Szigetvar, Hungary, 7900
    - Research Site
Israel
- - Ashkelon, Israel, 78278
    - Research Site
  - Haifa, Israel, 3109601
    - Research Site
  - Nahariya, Israel, 2210001
    - Research Site
  - Ramat Gan, Israel, 52363
    - Research Site
  - Rishon Lezion, Israel, 75141
    - Research Site
Italy
- - Bari, Italy, 70124
    - Research Site
  - Bergamo, Italy, 24127
    - Research Site
  - Cremona, Italy, 26100
    - Research Site
  - Genova, Italy, 16132
    - Research Site
  - Lecco, Italy, 23900
    - Research Site
  - Milano, Italy, 20142
    - Research Site
  - Napoli, Italy, 80131
    - Research Site
  - Napoli, Italy, 80138
    - Research Site
  - Parma, Italy, 43100
    - Research Site
  - Pavia, Italy, 27100
    - Research Site
  - Roma, Italy, 00168
    - Research Site
  - Siena, Italy, 53100
    - Research Site
- Caserta
  - Piedimonte Matese, Caserta, Italy, 81016
    - Research Site
- Foggia
  - San Giovanni Rotondo, Foggia, Italy, 71013
    - Research Site
Korea, Republic of
- - Busan, Korea, Republic of, 47392
    - Research Site
  - Busan, Korea, Republic of, 49201
    - Research Site
  - Daegu, Korea, Republic of, 41944
    - Research Site
  - Seoul, Korea, Republic of, 03080
    - Research Site
  - Seoul, Korea, Republic of, 02841
    - Research Site
- Gyeonggi-do
  - Bucheon-si, Gyeonggi-do, Korea, Republic of, 14647
    - Research Site
  - Guri-si, Gyeonggi-do, Korea, Republic of, 11923
    - Research Site
Malaysia
- Kelantan
  - Kota Bahru, Kelantan, Malaysia, 15586
    - Research Site
- Pahang
  - Kuantan, Pahang, Malaysia, 25100
    - Research Site
Mexico
- - Chihuahua, Mexico, 31217
    - Research Site
  - Chihuahua, Mexico, 31203
    - Research Site
  - Durango, Mexico, 34000
    - Research Site
  - Veracruz, Mexico, 91900
    - Research Site
- Distrito Federal
  - Mexico, Distrito Federal, Mexico, 06100
    - Research Site
  - Mexico, Distrito Federal, Mexico, 06700
    - Research Site
- Guerrero
  - Acapulco de Juarez, Guerrero, Mexico, 39670
    - Research Site
- Hidalgo
  - Pachuca, Hidalgo, Mexico, 42070
    - Research Site
  - Pachuca, Hidalgo, Mexico, 42090
    - Research Site
- Jalisco
  - Guadalajara, Jalisco, Mexico, 44130
    - Research Site
  - Zapopan, Jalisco, Mexico, 45200
    - Research Site
  - Zapopan, Jalisco, Mexico, 45116
    - Research Site
- Michoacán
  - Morelia, Michoacán, Mexico, 58260
    - Research Site
- Nuevo León
  - Monterrey, Nuevo León, Mexico, 64710
    - Research Site
- Queretaro
  - San Juan del Rio, Queretaro, Mexico, 76800
    - Research Site
- Sinaloa
  - Culiacan, Sinaloa, Mexico, 80230
    - Research Site
  - Culiacan, Sinaloa, Mexico, 80200
    - Research Site
  - Culiacán, Sinaloa, Mexico, 80030
    - Research Site
  - Mazatlan, Sinaloa, Mexico, 82110
    - Research Site
New Zealand
- - Hamilton, New Zealand, 3200
    - Research Site
  - New Plymouth, New Zealand, 4342
    - Research Site
Poland
- - Lodz, Poland, 90-153
    - Research Site
  - Lodz, Poland, 93-338
    - Research Site
  - Nowa Sol, Poland, 67-100
    - Research Site
  - Warszawa, Poland, 04-749
    - Research Site
  - Wroclaw, Poland, 50-414
    - Research Site
Puerto Rico
- - Caguas, Puerto Rico, 00725
    - Research Site
Russian Federation
- - Kazan, Russian Federation, 420012
    - Research Site
  - Kemerovo, Russian Federation, 650066
    - Research Site
  - Krasnoyarsk, Russian Federation, 660062
    - Research Site
  - Moscow, Russian Federation, 115516
    - Research Site
  - Nizhniy Novgorod, Russian Federation, 603076
    - Research Site
  - Novosibirsk, Russian Federation, 630008
    - Research Site
  - Novosibirsk, Russian Federation, 630054
    - Research Site
  - Novosibirsk, Russian Federation, 630091
    - Research Site
  - Petrozavodsk, Russian Federation, 185019
    - Research Site
  - Pushkin, Russian Federation, 196603
    - Research Site
  - Saint-Petersburg, Russian Federation, 197022
    - Research Site
  - Saint-Petersburg, Russian Federation, 199106
    - Research Site
  - Saint-Petersburg, Russian Federation, 199226
    - Research Site
  - Saint-Petersburg, Russian Federation, 195271
    - Research Site
  - Tomsk, Russian Federation, 634050
    - Research Site
  - Tosno, Russian Federation, 187000
    - Research Site
  - Yaroslavl, Russian Federation, 150062
    - Research Site
South Africa
- Eastern Cape
  - Port Elizabeth, Eastern Cape, South Africa, 6001
    - Research Site
- Free State
  - Bloemfontein, Free State, South Africa, 9301
    - Research Site
  - Brandfort, Free State, South Africa, 9400
    - Research Site
- Gauteng
  - Pretoria, Gauteng, South Africa, 0002
    - Research Site #1
  - Pretoria, Gauteng, South Africa, 0002
    - Research Site #2
  - Pretoria, Gauteng, South Africa, 1692
    - Research Site
  - Vereeniging, Gauteng, South Africa, 1935
    - Research Site
- KwaZulu-Natal
  - Durban, KwaZulu-Natal, South Africa, 4001
    - Research Site #1
  - Durban, KwaZulu-Natal, South Africa, 4001
    - Research Site #2
  - Durban, KwaZulu-Natal, South Africa, 4092
    - Research Site
  - Durban, KwaZulu-Natal, South Africa, 4096
    - Research Site
  - Durban, KwaZulu-Natal, South Africa, 4320
    - Research Site
  - Tongaat, KwaZulu-Natal, South Africa, 4399
    - Research Site
- Western Cape
  - Cape Town, Western Cape, South Africa, 7925
    - Research Site
  - George, Western Cape, South Africa, 6529
    - Research Site
  - Somerset West, Western Cape, South Africa, 7130
    - Research Site
  - Worcester, Western Cape, South Africa, 6850
    - Research Site
Spain
- - Almeria, Spain, 04007
    - Research Site
  - Almeria, Spain, 04009
    - Research Site
  - Badajoz, Spain, 06006
    - Research Site
  - Barcelona, Spain, 08003
    - Research Site
  - Madrid, Spain, 28041
    - Research Site
  - Sevilla, Spain, 41013
    - Research Site
  - Sevilla, Spain, 41071
    - Research Site
  - Valencia, Spain, 46026
    - Research Site
  - Valencia, Spain, 46014
    - Research Site
- Alicante
  - Elche, Alicante, Spain, 03293
    - Research Site
  - Torrevieja, Alicante, Spain, 03186
    - Research Site
- Baleares
  - Palma de Mallorca, Baleares, Spain, 07120
    - Research Site
- Barcelona
  - L'Hospitalet de Llobregat, Barcelona, Spain, 08907
    - Research Site
- Málaga
  - Malaga, Málaga, Spain, 29010
    - Research Site
Ukraine
- - Dnipro, Ukraine, 49005
    - Research Site
  - Ivano-Frankivsk, Ukraine, 76018
    - Research Site
  - Ivano-Frankivsk, Ukraine, 76008
    - Research Site
  - Kharkiv, Ukraine, 61039
    - Research Site
  - Kharkiv, Ukraine, 61103
    - Research Site
  - Kharkiv, Ukraine, 61037
    - Research Site
  - Kharkiv, Ukraine, 61157
    - Research Site
  - Kropyvnytskyi, Ukraine, 25006
    - Research Site
  - Kyiv, Ukraine, 02125
    - Research Site
  - Kyiv, Ukraine, 04050
    - Research Site
  - Lviv, Ukraine, 79010
    - Research Site
  - Lviv, Ukraine, 79013
    - Research Site
  - Mykolaiv, Ukraine, 54058
    - Research Site
  - Odesa, Ukraine, 65025
    - Research Site
  - Vinnytsia, Ukraine, 21018
    - Research Site
  - Vinnytsia, Ukraine, 21001
    - Research Site
  - Vinnytsia, Ukraine, 21005
    - Research Site
  - Zaporizhzhia, Ukraine, 69600
    - Research Site
  - Zaporizhzhia, Ukraine, 69118
    - Research Site
  - Zhytomyr, Ukraine, 10002
    - Research Site
United Kingdom
- - Swansea, United Kingdom, SA6 6NL
    - Research Site
- Grampian Region
  - Aberdeen, Grampian Region, United Kingdom, AB25 2ZB
    - Research Site
- Greater London
  - London, Greater London, United Kingdom, E1 1BB
    - Research Site
  - London, Greater London, United Kingdom, SE5 9RS
    - Research Site
- Greater Manchester
  - Salford, Greater Manchester, United Kingdom, M6 8HD
    - Research Site
- Hertfordshire
  - Stevenage, Hertfordshire, United Kingdom, SG1 4AB
    - Research Site
- Leicestershire
  - Leicester, Leicestershire, United Kingdom, LE5 4PW
    - Research Site
- South Yorkshire
  - Doncaster, South Yorkshire, United Kingdom, DN2 5LT
    - Research Site
  - Sheffield, South Yorkshire, United Kingdom, S5 7AU
    - Research Site
United States
- Alabama
  - Huntsville, Alabama, United States, 35805
    - Research Site
  - Tuscumbia, Alabama, United States, 35674
    - Research Site
- Arizona
  - Glendale, Arizona, United States, 85306
    - Research Site
  - Mesa, Arizona, United States, 85210
    - Research Site
  - Phoenix, Arizona, United States, 85027
    - Research Site
  - Tucson, Arizona, United States, 85724
    - Research Site
  - Tucson, Arizona, United States, 85718
    - Research Site
- California
  - Anaheim, California, United States, 92801
    - Research Site
  - Bakersfield, California, United States, 93309
    - Research Site
  - Chula Vista, California, United States, 91910
    - Research Site #1
  - Chula Vista, California, United States, 91910
    - Research Site #2
  - Fountain Valley, California, United States, 92708
    - Research Site #1
  - Fountain Valley, California, United States, 92708
    - Research Site #2
  - Glendale, California, United States, 91206
    - Research Site
  - Granada Hills, California, United States, 91344
    - Research Site
  - La Mesa, California, United States, 91942
    - Research Site
  - Laguna Hills, California, United States, 92653
    - Research Site
  - Long Beach, California, United States, 90807
    - Research Site
  - Long Beach, California, United States, 92886
    - Research Site
  - Los Angeles, California, United States, 90020
    - Research Site
  - Lynwood, California, United States, 90262
    - Research Site
  - Northridge, California, United States, 91324
    - Research Site
  - Northridge, California, United States, 91324
    - Research Site #2
  - Riverside, California, United States, 92505
    - Research Site
  - Roseville, California, United States, 95661
    - Research Site
  - Sacramento, California, United States, 95825
    - Research Site
  - Salinas, California, United States, 93901
    - Research Site
  - San Diego, California, United States, 92103-6204
    - Research Site
  - San Dimas, California, United States, 91773
    - Research Site #1
  - San Dimas, California, United States, 91773
    - Research Site #2
  - Santa Ana, California, United States, 92704
    - Research Site
  - Santa Monica, California, United States, 90404
    - Research Site
  - Sherman Oaks, California, United States, 91403
    - Research Site
  - Thousand Oaks, California, United States, 91360
    - Research Site
  - Upland, California, United States, 91786
    - Research Site
  - Whittier, California, United States, 90603
    - Research Site #1
  - Whittier, California, United States, 90603
    - Research Site #2
- Colorado
  - Arvada, Colorado, United States, 80002
    - Research Site
  - Denver, Colorado, United States, 80230
    - Research Site
  - Westminster, Colorado, United States, 80031
    - Research Site
- Connecticut
  - New Haven, Connecticut, United States, 06511
    - Research Site
  - Stamford, Connecticut, United States, 06902
    - Research Site
  - Waterbury, Connecticut, United States, 06708
    - Research Site
- Florida
  - Bradenton, Florida, United States, 34209
    - Research Site
  - Brandon, Florida, United States, 33511
    - Research Site
  - Cooper City, Florida, United States, 33024
    - Research Site
  - Coral Gables, Florida, United States, 33134
    - Research Site #1
  - Coral Gables, Florida, United States, 33134
    - Research Site #2
  - Coral Springs, Florida, United States, 33065
    - Research Site
  - Coral Springs, Florida, United States, 33071
    - Research Site
  - Doral, Florida, United States, 33166
    - Research Site
  - Fort Myers, Florida, United States, 33901
    - Research Site
  - Hialeah, Florida, United States, 33010
    - Research Site
  - Hialeah, Florida, United States, 33012
    - Research Site #1
  - Hialeah, Florida, United States, 33012
    - Research Site #2
  - Hialeah, Florida, United States, 33012
    - Research Site #3
  - Hialeah, Florida, United States, 33018
    - Research Site
  - Hollywood, Florida, United States, 33024
    - Research Site #1
  - Hollywood, Florida, United States, 33024
    - Research Site #2
  - Jacksonville, Florida, United States, 32204
    - Research Site
  - Jacksonville, Florida, United States, 32216
    - Research Site #1
  - Jacksonville, Florida, United States, 32216
    - Research Site #2
  - Lake Worth, Florida, United States, 33467
    - Research Site
  - Lauderdale Lakes, Florida, United States, 33313
    - Research Site
  - Miami, Florida, United States, 33165
    - Research Site
  - Miami, Florida, United States, 33134
    - Research Site
  - Miami, Florida, United States, 33133
    - Research Site
  - Miami, Florida, United States, 33144
    - Research Site
  - Miami, Florida, United States, 33150
    - Research Site
  - Miami, Florida, United States, 33145
    - Research Site
  - Miami, Florida, United States, 33169
    - Research Site
  - Miami, Florida, United States, 33135
    - Research Site
  - Miami, Florida, United States, 33157
    - Research Site
  - Miami, Florida, United States, 33122
    - Research Site
  - Miami, Florida, United States, 33143
    - Research Site
  - Miami, Florida, United States, 33125-4141
    - Research Site
  - Miami, Florida, United States, 33126
    - Research Site #1
  - Miami, Florida, United States, 33126
    - Research Site #2
  - Miami, Florida, United States, 33175
    - Research Site #1
  - Miami, Florida, United States, 33175
    - Research Site #2
  - Miami Beach, Florida, United States, 33140
    - Research Site
  - Miami Lakes, Florida, United States, 33014
    - Research Site
  - Miami Lakes, Florida, United States, 33016
    - Research Site
  - Miami Springs, Florida, United States, 33166
    - Research Site
  - Pembroke Pines, Florida, United States, 33026
    - Research Site
  - Pompano Beach, Florida, United States, 33060
    - Research Site
  - Sweetwater, Florida, United States, 33172
    - Research Site
  - Tampa, Florida, United States, 33612
    - Research Site
  - Tampa, Florida, United States, 33614
    - Research Site
  - Tampa, Florida, United States, 33604
    - Research Site
- Georgia
  - Atlanta, Georgia, United States, 30338
    - Research Site
  - Atlanta, Georgia, United States, 30342
    - Research Site
  - Atlanta, Georgia, United States, 30350
    - Research Site
  - Augusta, Georgia, United States, 30909
    - Research Site #1
  - Augusta, Georgia, United States, 30909
    - Research Site #2
  - Columbus, Georgia, United States, 31901
    - Research Site
  - Columbus, Georgia, United States, 31904
    - Research Site #1
  - Columbus, Georgia, United States, 31904
    - Research Site #2
  - Lawrenceville, Georgia, United States, 30046
    - Research Site #1
  - Lawrenceville, Georgia, United States, 30046
    - Research Site #2
  - Macon, Georgia, United States, 31217
    - Research Site
- Idaho
  - Meridian, Idaho, United States, 83642
    - Research Site
- Illinois
  - Chicago, Illinois, United States, 60637
    - Research Site
  - Evanston, Illinois, United States, 60201
    - Research Site
  - McHenry, Illinois, United States, 60050
    - Research Site
  - Peoria, Illinois, United States, 61603
    - Research Site
- Indiana
  - Anderson, Indiana, United States, 46011
    - Research Site
  - Fort Wayne, Indiana, United States, 46804
    - Research Site
  - Jeffersonville, Indiana, United States, 47130
    - Research Site
  - Merrillville, Indiana, United States, 46410
    - Research Site #1
  - Merrillville, Indiana, United States, 46410
    - Research Site #2
  - Michigan City, Indiana, United States, 46360
    - Research Site
- Louisiana
  - Monroe, Louisiana, United States, 71201
    - Research Site
  - New Orleans, Louisiana, United States, 70115
    - Research Site
  - Shreveport, Louisiana, United States, 71103
    - Research Site
  - Shreveport, Louisiana, United States, 71101
    - Research Site #1
- Maine
  - Portland, Maine, United States, 04102
    - Research Site
- Maryland
  - Baltimore, Maryland, United States, 21218
    - Research Site
  - Greenbelt, Maryland, United States, 20770
    - Research Site
  - Takoma Park, Maryland, United States, 20912
    - Research Site
- Massachusetts
  - Methuen, Massachusetts, United States, 01844
    - Research Site
  - Plymouth, Massachusetts, United States, 02360
    - Research Site
- Michigan
  - Detroit, Michigan, United States, 48202
    - Research Site
  - Pontiac, Michigan, United States, 48341
    - Research Site
  - Roseville, Michigan, United States, 48066
    - Research Site
- Minnesota
  - Saint Paul, Minnesota, United States, 55102
    - Research Site
- Mississippi
  - Gulfport, Mississippi, United States, 39501
    - Research Site
- Missouri
  - Columbia, Missouri, United States, 65201
    - Research Site
  - Kansas City, Missouri, United States, 64128
    - Research Site
  - Saint Louis, Missouri, United States, 63128
    - Research Site
- Montana
  - Butte, Montana, United States, 59701
    - Research Site
- Nebraska
  - Lincoln, Nebraska, United States, 68510
    - Research Site
  - Omaha, Nebraska, United States, 68124
    - Research Site
- Nevada
  - Las Vegas, Nevada, United States, 89106
    - Research Site #1
  - Las Vegas, Nevada, United States, 89106
    - Research Site #2
- New Hampshire
  - Portsmouth, New Hampshire, United States, 03801
    - Research Site
- New Jersey
  - Berlin, New Jersey, United States, 08009
    - Research Site
  - Voorhees, New Jersey, United States, 08043
    - Research Site
- New Mexico
  - Albuquerque, New Mexico, United States, 87106
    - Research Site
  - Albuquerque, New Mexico, United States, 87108
    - Research Site
  - Albuquerque, New Mexico, United States, 87109
    - Research Site
  - Santa Fe, New Mexico, United States, 87505
    - Research Site
- New York
  - Bronx, New York, United States, 10467
    - Research Site
  - Flushing, New York, United States, 11355
    - Research Site
  - Laurelton, New York, United States, 11413
    - Research Site
  - New York, New York, United States, 10010
    - Research Site
- North Carolina
  - Asheville, North Carolina, United States, 28801
    - Research Site
  - Greenville, North Carolina, United States, 27834
    - Research Site #1
  - Greenville, North Carolina, United States, 27834
    - Research Site #2
  - Kinston, North Carolina, United States, 28504
    - Research Site
  - Morehead City, North Carolina, United States, 28557
    - Research Site
  - New Bern, North Carolina, United States, 28560
    - Research Site
  - Winston-Salem, North Carolina, United States, 27103
    - Research Site
- Ohio
  - Akron, Ohio, United States, 44302
    - Research Site
  - Cincinnati, Ohio, United States, 45206
    - Research Site
  - Dayton, Ohio, United States, 45417
    - Research Site
  - Marion, Ohio, United States, 43302
    - Research Site
  - Maumee, Ohio, United States, 43537
    - Research Site
- Oregon
  - Portland, Oregon, United States, 97216
    - Research Site
- Pennsylvania
  - Philadelphia, Pennsylvania, United States, 19140
    - Research Site
- Rhode Island
  - East Providence, Rhode Island, United States, 02915
    - Research Site
- South Carolina
  - Anderson, South Carolina, United States, 29625
    - Research Site
  - Orangeburg, South Carolina, United States, 29118
    - Research Site
  - West Columbia, South Carolina, United States, 29169
    - Research Site
- Tennessee
  - Chattanooga, Tennessee, United States, 37408
    - Research Site
  - Knoxville, Tennessee, United States, 37923
    - Research Site
  - Memphis, Tennessee, United States, 38104
    - Research Site
  - Nashville, Tennessee, United States, 37205
    - Research Site
- Texas
  - Arlington, Texas, United States, 76015
    - Research Site
  - Dallas, Texas, United States, 75246
    - Research Site
  - Dallas, Texas, United States, 75390
    - Research Site
  - DeSoto, Texas, United States, 75115
    - Research Site
  - El Paso, Texas, United States, 79935
    - Research Site
  - Fort Worth, Texas, United States, 76104
    - Research Site
  - Gonzales, Texas, United States, 78629
    - Research Site
  - Greenville, Texas, United States, 75402
    - Research Site
  - Greenville, Texas, United States, 75401
    - Research Site
  - Houston, Texas, United States, 77030
    - Research Site
  - Houston, Texas, United States, 77004
    - Research Site #1
  - Houston, Texas, United States, 77004
    - Research Site #2
  - Houston, Texas, United States, 77040
    - Research Site
  - Lewisville, Texas, United States, 75057
    - Research Site
  - McAllen, Texas, United States, 78503
    - Research Site #1
  - McAllen, Texas, United States, 78503
    - Research Site #2
  - McKinney, Texas, United States, 75069
    - Research Site
  - McKinney, Texas, United States, 75071
    - Research Site
  - Plano, Texas, United States, 75093
    - Research Site
  - San Antonio, Texas, United States, 78229
    - Research Site
  - San Antonio, Texas, United States, 78207
    - Research Site
  - San Antonio, Texas, United States, 78212-4740
    - Research Site
  - San Antonio, Texas, United States, 78224
    - Research Site
  - San Antonio, Texas, United States, 78240-1501
    - Research Site
  - Sherman, Texas, United States, 75090
    - Research Site
  - Victoria, Texas, United States, 77901
    - Research Site
- Utah
  - Clinton, Utah, United States, 84015
    - Research Site
  - Salt Lake City, Utah, United States, 84115
    - Research Site
- Virginia
  - Alexandria, Virginia, United States, 22304
    - Research Site
  - Arlington, Virginia, United States, 22207
    - Research Site
  - Danville, Virginia, United States, 24541
    - Research Site
  - Hampton, Virginia, United States, 23666
    - Research Site
  - Lansdowne Town Center, Virginia, United States, 20176
    - Research Site
  - Newport News, Virginia, United States, 23606
    - Research Site
  - Norfolk, Virginia, United States, 23507
    - Research Site
  - Salem, Virginia, United States, 24153
    - Research Site
  - Woodbridge, Virginia, United States, 22191
    - Research Site
- Washington
  - Tacoma, Washington, United States, 98405
    - Research Site
  - Wenatchee, Washington, United States, 98801
    - Research Site
- Wisconsin
  - Madison, Wisconsin, United States, 53705
    - Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

≥18 years of age
Diagnosis of chronic kidney disease (CKD) with an estimated glomerular filtration rate ≤60 milliliters per minute per 1.73 square meter (mL/min/1.73 m^2) at Screening and not expected to start dialysis within 6 months of Screening
Mean Screening hemoglobin <10.0 grams per deciliter (g/dL)
Serum ferritin ≥100 nanograms per milliliter (ng/mL) and transferrin saturation (TSAT) ≥20% during Screening

Exclusion Criteria:

Anemia due to a cause other than CKD or participants with active bleeding or recent blood loss
Red blood cell transfusion within 8 weeks prior to randomization.
Any erythropoietic stimulating agent within 8 weeks prior to randomization
Uncontrolled hypertension
Severe heart failure at Screening (New York Heart Association Class IV)
Acute coronary syndrome (hospitalization for unstable angina or myocardial infarction), surgical or percutaneous intervention for coronary, cerebrovascular, or peripheral artery disease (aortic or lower extremity), surgical or percutaneous valvular replacement or repair, sustained ventricular tachycardia, hospitalization for heart failure, or stroke within 12 weeks prior to or during Screening
Hypersensitivity to Darbepoetin or Vadadustat or to any of their excipients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Darbepoetin alfa	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. Other Names: Aranesp
EXPERIMENTAL: Vadadustat	Drug: Vadadustat Oral dose administered once daily for ≥36 weeks. Dose adjustment based on hemoglobin level as defined in the protocol. Other Names: AKB-6548

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Hemoglobin (Hb) to the Average Over the Primary Efficacy Period (Weeks 24 to 36) Time Frame: Baseline; Weeks 24 to 36	The Baseline average was calculated as the average of the Hb values obtained at the screening visit closest to the date of randomization and the randomization visit. The average for the Primary Efficacy Period was calculated as the average Hb value over Weeks 24 to 36. Analysis was conducted using an analysis of covariance (ANCOVA) model with multiple imputation for missing data with Baseline Hb concentration (<9.5 versus ≥9.5 grams per deciliter [g/dL]), geographic region (United States [US] versus European Union [EU] versus Rest of World [ROW]), and New York Heart Association congestive heart failure (NYHA CHF) class (Class 0 [no CHF] or I versus II or III) as covariates.	Baseline; Weeks 24 to 36
Median Time to First Major Adverse Cardiovascular Event (MACE) Time Frame: Up to Week 208	MACE was defined as all-cause mortality, non-fatal myocardial infarction (MI), or non-fatal stroke. The primary safety outcome was positively adjudicated first MACE, which was defined as any death, Endpoint Adjudication Committee (EAC)-confirmed non-fatal MI, or EAC-confirmed non-fatal stroke occurring between the first dose date and each participant's last participation date. PROTECT MACE results and analysis, by design, was performed on pooled data from studies AKB-6548-CI-0014 (NCT02648347) and AKB-6548-CI-0015 (NCT02680574). Results and statistical analysis from study AKB-6548-CI-0014 has been reported in below table and under section "Statistical Analysis 1". Results and statistical analysis of the pooled data from studies AKB-6548-CI-0014 and AKB-6548-CI-0015 has been reported under section "Statistical Analysis 2" of this outcome measure.	Up to Week 208

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Hb to the Average Over the Secondary Efficacy Period (Weeks 40 to 52) Time Frame: Baseline; Weeks 40 to 52	The Baseline average was calculated as the average of the Hb values obtained at the screening visit closest to the date of randomization and the randomization visit. The average for the Secondary Efficacy Period was calculated as the average Hb value over Weeks 40 to 52. Analysis was conducted using an ANCOVA model with multiple imputation for missing data with Baseline Hb concentration (<9.5 versus ≥9.5 g/dL), geographic region (US versus EU versus ROW), and NYHA CHF class (Class 0 [no CHF] or I versus II or III) as covariates.	Baseline; Weeks 40 to 52
Median Time to First MACE Plus Hospitalization for Heart Failure or Thromboembolic Event Excluding Vascular Access Thrombosis Time Frame: Up to Week 208	MACE was defined as all-cause mortality, non-fatal MI, or non-fatal stroke. Hospitalization for EAC adjudicated heart failure included presentation of participants to an acute care facility requiring an overnight hospitalization (change in calendar day) with an exacerbation of heart failure requiring treatment. EAC confirmed thromboembolic events for this secondary outcome measure included arterial thrombosis, deep vein thrombosis, and pulmonary embolism. PROTECT MACE results and analysis, by design, was performed on pooled data from studies AKB-6548-CI-0014 (NCT02648347) and AKB-6548-CI-0015 (NCT02680574). Results and statistical analysis from study AKB-6548-CI-0014 has been reported in below table and under section "Statistical Analysis 1". Results and statistical analysis of the pooled data from studies AKB-6548-CI-0014 and AKB-6548-CI-0015 has been reported under section "Statistical Analysis 2" of this outcome measure.	Up to Week 208
Median Time to First Cardiovascular MACE Time Frame: Up to Week 208	MACE was defined as all-cause mortality, non-fatal MI, or non-fatal stroke. Cardiovascular MACE analysis differed from the primary MACE endpoint as it included only deaths adjudicated by the EAC as cardiovascular deaths (i.e, only EAC-confirmed cardiovascular deaths) in addition to first events of non-fatal MI or non-fatal stroke. PROTECT MACE results and analysis, by design, was performed on pooled data from studies AKB-6548-CI-0014 (NCT02648347) and AKB-6548-CI-0015 (NCT02680574). Results and statistical analysis from study AKB-6548-CI-0014 has been reported in below table and under section "Statistical Analysis 1". Results and statistical analysis of the pooled data from studies AKB-6548-CI-0014 and AKB-6548-CI-0015 has been reported under section "Statistical Analysis 2" of this outcome measure.	Up to Week 208
Median Time to First Cardiovascular Death Time Frame: Up to Week 208	Cardiovascular death included EAC adjudicated fatal MI, pump failure, sudden death, presumed sudden death, fatal stroke, fatal pulmonary embolism, cardiovascular procedure-related death, other cardiovascular death, and presumed cardiovascular death. PROTECT MACE results and analysis, by design, was performed on pooled data from studies AKB-6548-CI-0014 (NCT02648347) and AKB-6548-CI-0015 (NCT02680574). Results and statistical analysis from study AKB-6548-CI-0014 has been reported in below table and under section "Statistical Analysis 1". Results and statistical analysis of the pooled data from studies AKB-6548-CI-0014 and AKB-6548-CI-0015 has been reported under section "Statistical Analysis 2" of this outcome measure.	Up to Week 208
Median Time to First All-cause Mortality Time Frame: Up to Week 208	Only events that were positively adjudicated and confirmed by the EAC were included in the MACE analyses. PROTECT MACE results and analysis, by design, was performed on pooled data from studies AKB-6548-CI-0014 (NCT02648347) and AKB-6548-CI-0015 (NCT02680574). Results and statistical analysis from study AKB-6548-CI-0014 has been reported in below table and under section "Statistical Analysis 1". Results and statistical analysis of the pooled data from studies AKB-6548-CI-0014 and AKB-6548-CI-0015 has been reported under section "Statistical Analysis 2" of this outcome measure.	Up to Week 208

Other Outcome Measures

Outcome Measure	Time Frame
Exploratory - Proportion of Participants With Hb Values Within the Target Range During the Primary Evaluation Period (Weeks 24 to 36) Time Frame: Weeks 24 to 36	Weeks 24 to 36
Exploratory - Proportion of Time With Hb Values Within the Target Range During the Primary Evaluation Period (Weeks 24 to 36) Time Frame: Weeks 24 to 36	Weeks 24 to 36
Exploratory - Proportion of Time With Hb Values Within the Target Range During the Secondary Evaluation Period (Weeks 40 to 52) Time Frame: Weeks 40 to 52	Weeks 40 to 52
Exploratory - Proportion of Participants With Hb Values Within the Target Range During the Secondary Evaluation Period (Weeks 40 to 52) Time Frame: Weeks 40 to 52	Weeks 40 to 52
Exploratory - Proportion of Participants With an Hb Increase of >1.0 g/dL From Baseline Visit Time Frame: Baseline; up to Week 52	Baseline; up to Week 52
Exploratory - Time to Achieve Hb Increase of >1.0 g/dL From Baseline Visit Time Frame: Baseline; up to Week 52	Baseline; up to Week 52
Exploratory - Mean Change in Hb Between Baseline (Mean Pretreatment Hb) and the Primary Evaluation Period (Mean Hb From Weeks 24 to 36) Stratified by Pre-baseline Erythropoiesis-stimulating Agent (ESA) Exposure Time Frame: Baseline; Weeks 24 to 36	Baseline; Weeks 24 to 36
Exploratory - Mean Monthly Dose of Intravenous (IV) Elemental Iron Administered in Participants Who Have Received IV Iron Time Frame: Up to Week 52	Up to Week 52
Exploratory - Proportion of Participants Receiving IV Iron Therapy Time Frame: Up to Week 52	Up to Week 52
Exploratory - Proportion of Participants Receiving Red Blood Cells (RBCs) Transfusion(s) Time Frame: Up to Week 52	Up to Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Akebia Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2015

Primary Completion (ACTUAL)

June 4, 2020

Study Completion (ACTUAL)

July 31, 2020

Study Registration Dates

First Submitted

January 4, 2016

First Submitted That Met QC Criteria

January 6, 2016

First Posted (ESTIMATE)

January 7, 2016

Study Record Updates

Last Update Posted (ACTUAL)

June 27, 2022

Last Update Submitted That Met QC Criteria

June 7, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

AKB-6548-CI-0014
2015-004265-81 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Other Outcome Measures

Outcome Measure

Time Frame

Collaborators and Investigators

Sponsor

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start (ACTUAL)

Primary Completion (ACTUAL)

Study Completion (ACTUAL)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (ESTIMATE)

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Clinical Trials on Anemia

Clinical Trials on Vadadustat

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ecuador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations