- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02680574
Efficacy and Safety Study to Evaluate Vadadustat for the Maintenance Treatment of Anemia in Participants With Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD)
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 Maintenance Treatment of Anemia in Subjects With Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD) (PRO2TECT-CONVERSION)
A multicenter, randomized, open-label, active-controlled Phase 3 study for the maintenance treatment of anemia in participants with Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD)
Study Overview
Status
Completed
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 maintenance treatment of anemia in participants with NDD-CKD
Study Type
Interventional
Enrollment (Actual)
1725
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
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Ciudad Autonoma Buenos Aires, Argentina, C1093AAS
- Research Site
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Ciudad Autonoma Buenos Aires, Argentina, C1430CKE
- Research Site
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Cordoba, Argentina, 5000
- Research Site
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Cordoba, Argentina, X5000EVQ
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Cordoba, Argentina, X5000AAW
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Cordoba, Argentina, X5020AAA
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Corrientes, Argentina, 3400
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Salta, Argentina, 4406
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San Luis, Argentina, 5700
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Buenos Aires
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Bahia Blanca, Buenos Aires, Argentina, B8001HXM
- Research Site
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Junin, Buenos Aires, Argentina, 6000
- Research Site
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Junin, Buenos Aires, Argentina, B6000BHA
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Mar del Plata, Buenos Aires, Argentina, B7600FZ
- Research Site
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Mar del Plata, Buenos Aires, Argentina, B7600FYK
- Research Site
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Mar del Plata, Buenos Aires, Argentina, B7602DCK
- Research Site
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Pergamino, Buenos Aires, Argentina, B2700CPM
- Research Site
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Ramos Mejia, Buenos Aires, Argentina, B1704ETD
- Research Site
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San Miguel, Buenos Aires, Argentina, B1663CNJ
- Research Site
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San Nicolas, Buenos Aires, Argentina, B2900DMH
- Research Site
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Sarandi, Buenos Aires, Argentina, B1872EEA
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Temperley, Buenos Aires, Argentina, 1834
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Mendoza
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Godoy Cruz, Mendoza, Argentina, 5501
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Santa Fe
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Rosario, Santa Fe, Argentina, S2000DIF
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Rosario, Santa Fe, Argentina, S2000DNM
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Tucuman
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San Miguel de Tucuman, Tucuman, Argentina, 4000
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San Miguel de Tucuman, Tucuman, Argentina, T4000AXL
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San Miguel de Tucuman, Tucuman, Argentina, T4000ICL
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San Miguel de Tucuman, Tucuman, Argentina, T4000
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New South Wales
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Camperdown, New South Wales, Australia, 2050
- Research Site
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Liverpool, New South Wales, Australia, 2170
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Westmead, New South Wales, Australia, 2145
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Queensland
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Cairns, Queensland, Australia, 4870
- Research Site
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Gold Coast, Queensland, Australia, 9726
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South Australia
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Adelaide, South Australia, Australia, 5000
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Tasmania
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Launceston, Tasmania, Australia, 7250
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Victoria
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Bentleigh East, Victoria, Australia, 3165
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Box Hill, Victoria, Australia, 3128
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Fitzroy, Victoria, Australia, 3065
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Western Australia
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Nedlands, Western Australia, Australia, 6009
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Perth, Western Australia, Australia, 6000
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St. Pölten, Austria, 3100
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Wien, Austria, 1220
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Wien, Austria, 1030
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Bahia
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Feira de Santana, Bahia, Brazil, 44001-584
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Itabuna, Bahia, Brazil, 45600-625
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Salvador, Bahia, Brazil, 40451-065
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Ceará
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Fortaleza, Ceará, Brazil, 60430-370
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Fortaleza, Ceará, Brazil, 60115-282
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Espírito Santo
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Vitória, Espírito Santo, Brazil, 29055-450
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brazil, 30150-320
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Juiz de Fora, Minas Gerais, Brazil, 36036-330
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Paraná
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Curitiba, Paraná, Brazil, 80230-130
- Research Site
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Curitiba, Paraná, Brazil, 80810-040
- Research Site #1
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Curitiba, Paraná, Brazil, 80810-040
- Research Site #2
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Maringá, Paraná, Brazil, 87060-040
- Research Site
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Rio Do Janeiro
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Rio de Janeiro, Rio Do Janeiro, Brazil, 20551-030
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Rio Grande Do Sul
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Caxias do Sul, Rio Grande Do Sul, Brazil, 95010-005
- Research Site
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Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
- Research Site
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Porto Alegre, Rio Grande Do Sul, Brazil, 90035-074
- Research Site
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Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
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Porto Alegre, Rio Grande Do Sul, Brazil, 90160-093
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Santa Catarina
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Criciúma, Santa Catarina, Brazil, 88801-250
- Research Site
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Joinville, Santa Catarina, Brazil, 89202-050
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Sao Paulo
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Botucatu, Sao Paulo, Brazil, 18618-970
- Research Site
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Campinas, Sao Paulo, Brazil, 13087-567
- Research Site
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Santo André, Sao Paulo, Brazil, 09080-110
- Research Site
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Santo André, Sao Paulo, Brazil, 09090-790
- Research Site
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São Bernardo do Campo, Sao Paulo, Brazil, 09715-090
- Research Site
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São Paulo, Sao Paulo, Brazil, 05403-000
- Research Site
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São Paulo, Sao Paulo, Brazil, 01141-020
- Research Site
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São Paulo, Sao Paulo, Brazil, 01406-200
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São Paulo, Sao Paulo, Brazil, 04025-011
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Byala, Bulgaria, 7100
- Research Site
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Cherven bryag, Bulgaria, 5980
- Research Site
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Lom, Bulgaria, 3600
- Research Site
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Silistra, Bulgaria, 7500
- Research Site
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Sliven, Bulgaria, 8800
- Research Site
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Smolyan, Bulgaria, 4700
- Research Site
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Sofia, Bulgaria, 1784
- Research Site
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Sofia, Bulgaria, 1407
- Research Site
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Sofia, Bulgaria, 1233
- Research Site
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Sofia, Bulgaria, 1606
- Research Site
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Sofia, Bulgaria, 1431
- Research Site #1
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Sofia, Bulgaria, 1431
- Research Site #2
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Stara Zagora, Bulgaria, 6000
- Research Site
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Varna, Bulgaria, 9000
- Research Site
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Varna, Bulgaria, 9002
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Veliko Tarnovo, Bulgaria, 5000
- Research Site
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Vratsa, Bulgaria, 3000
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Ontario
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Scarborough, Ontario, Canada, M1H 3G4
- Research Site
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Concepción, Chile, 4030000
- Research Site
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Puerto Varas, Chile, 5550170
- Research Site
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Santiago, Chile, 8431657
- Research Site
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Temuco, Chile, 4780000
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Barranquilla, Colombia, 080020
- Research Site
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Bogota, Colombia, 110221
- Research Site
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Espinal, Colombia, 00000
- Research Site
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Manizales, Colombia, 170004
- Research Site
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Medellin, Colombia, 050021
- Research Site #1
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Medellin, Colombia, 050021
- Research Site #2
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Medellín, Colombia, 500515
- Research Site
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Ceske Budejovice, Czechia, 370 01
- Research Site
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Hradec Kralove, Czechia, 50333
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Praha 2, Czechia, 128 08
- Research Site
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Praha 4, Czechia, 140 21
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Paris, France, 75015
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Paris, France, 75020
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Alpes De Haute Provence
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Lille, Alpes De Haute Provence, France, 59000
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Loire
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Saint-Priest-En-Jarez, Loire, France, 42055
- Research Site
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Marne
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Reims Cedex, Marne, France, 51090
- Research Site
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Val De Marne
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Créteil Cedex, Val De Marne, France, 94010
- Research Site
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Val d'Oise
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Pontoise, Val d'Oise, France, 95300
- Research Site
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Berlin, Germany, 10117
- Research Site
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Berlin, Germany, 12627
- Research Site
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Hamburg, Germany, 22297
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Baden Wuerttemberg
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Villingen-Schwenningen, Baden Wuerttemberg, Germany, 78052
- Research Site
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Mecklenburg Vorpommern
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Rostock, Mecklenburg Vorpommern, Germany, 18057
- Research Site
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Nordrhein Westfalen
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Duesseldorf, Nordrhein Westfalen, Germany, 40210
- Research Site
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Baja, Hungary, 6500
- Research Site #1
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Baja, Hungary, 6500
- Research Site #2
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Balatonfured, Hungary, 8230
- Research Site
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Budapest, Hungary, 1145
- Research Site
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Budapest, Hungary, 1076
- Research Site
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Debrecen, Hungary, 4032
- Research Site
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Esztergom, Hungary, 2500
- Research Site
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Hodmezovasarhely, Hungary, 6800
- Research Site
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Kalocsa, Hungary, 6300
- Research Site
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Kaposvar, Hungary, 7400
- Research Site
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Kecskemet, Hungary, 6000
- Research Site
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Kistarcsa, Hungary, 2143
- Research Site
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Pecs, Hungary, 7623
- Research Site
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Szeged, Hungary, 6720
- Research Site
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Szigetvar, Hungary, 7900
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Ashkelon, Israel, 78278
- Research Site
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Haifa, Israel, 3109601
- Research Site
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Nahariya, Israel, 2210001
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Ramat Gan, Israel, 52363
- Research Site
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Rishon Lezion, Israel, 75141
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Bari, Italy, 70124
- Research Site
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Lecco, Italy, 23900
- Research Site
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Milano, Italy, 20162
- Research Site
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Milano, Italy, 20142
- Research Site
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Napoli, Italy, 80138
- Research Site #1
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Napoli, Italy, 80138
- Research Site #2
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Parma, Italy, 43100
- Research Site
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Pavia, Italy, 27100
- Research Site
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Roma, Italy, 00168
- Research Site
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Siena, Italy, 53100
- Research Site
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Caserta
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Piedimonte Matese, Caserta, Italy, 81016
- Research Site
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Foggia
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San Giovanni Rotondo, Foggia, Italy, 71013
- Research Site
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Busan, Korea, Republic of, 47392
- Research Site
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Busan, Korea, Republic of, 49201
- Research Site
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Daegu, Korea, Republic of, 41944
- Research Site
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Seoul, Korea, Republic of, 03080
- Research Site
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Seoul, Korea, Republic of, 135-710
- Research Site
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Seoul, Korea, Republic of, 02841
- Research Site
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Seoul, Korea, Republic of, 06591
- Research Site
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Seoul, Korea, Republic of, 07345
- Research Site
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Gyeonggi-do
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Bucheon-si, Gyeonggi-do, Korea, Republic of, 14647
- Research Site
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Goyang-si, Gyeonggi-do, Korea, Republic of, 10380
- Research Site
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Guri-si, Gyeonggi-do, Korea, Republic of, 11923
- Research Site
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Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
- Research Site
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Kuala Lumpur, Malaysia, 59100
- Research Site
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Kuala Lumpur, Malaysia, 56000
- Research Site
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Pulau Pinang, Malaysia, 10990
- Research Site
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Kedah
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Alor Setar, Kedah, Malaysia, 05460
- Research Site
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Chihuahua, Mexico, 31217
- Research Site
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Chihuahua, Mexico, 31203
- Research Site
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Durango, Mexico, 34000
- Research Site
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Veracruz, Mexico, 91900
- Research Site
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Coahuila
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Torreon, Coahuila, Mexico, 27000
- Research Site
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Distrito Federal
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Mexico, Distrito Federal, Mexico, 06100
- Research Site
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Mexico, Distrito Federal, Mexico, 06700
- Research Site
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Guerrero
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Acapulco de Juarez, Guerrero, Mexico, 39670
- Research Site
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Hidalgo
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Pachuca, Hidalgo, Mexico, 42070
- Research Site #1
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Pachuca, Hidalgo, Mexico, 42070
- Research Site #2
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Jalisco
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Guadalajara, Jalisco, Mexico, 44130
- Research Site
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Zapopan, Jalisco, Mexico, 45030
- Research Site
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Zapopan, Jalisco, Mexico, 45200
- Research Site
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Zapopan, Jalisco, Mexico, 45116
- Research Site
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Michoacán
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Morelia, Michoacán, Mexico, 58260
- Research Site
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Nuevo León
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Monterrey, Nuevo León, Mexico, 64710
- Research Site
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Monterrey, Nuevo León, Mexico, 64620
- Research Site
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Queretaro
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San Juan del Rio, Queretaro, Mexico, 76800
- Research Site
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Sinaloa
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Culiacan, Sinaloa, Mexico, 80230
- Research Site
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Culiacan, Sinaloa, Mexico, 80200
- Research Site
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Culiacán, Sinaloa, Mexico, 80030
- Research Site
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Mazatlan, Sinaloa, Mexico, 82110
- Research Site
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Hamilton, New Zealand, 3200
- Research Site
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New Plymouth, New Zealand, 4342
- Research Site
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Nowa Sol, Poland, 67-100
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Caguas, Puerto Rico, 00725
- Research Site
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Bucuresti, Romania, 042122
- Research Site
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Bucuresti, Romania, 011794
- Research Site
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Bucuresti, Romania, 010719
- Research Site
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Bucuresti, Romania, 022328
- Research Site #1
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Bucuresti, Romania, 022328
- Research Site #2
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Oradea, Romania, 410469
- Research Site
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Timisoara, Romania, 300182
- Research Site
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Kazan, Russian Federation, 420012
- Research Site
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Kemerovo, Russian Federation, 650066
- Research Site
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Krasnoyarsk, Russian Federation, 660062
- Research Site
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Nizhniy Novgorod, Russian Federation, 603076
- Research Site
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Novosibirsk, Russian Federation, 630054
- Research Site
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Novosibirsk, Russian Federation, 630091
- Research Site
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Petrozavodsk, Russian Federation, 185019
- Research Site
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Pushkin, Russian Federation, 196603
- Research Site
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Saint-Petersburg, Russian Federation, 197022
- Research Site
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Saint-Petersburg, Russian Federation, 195271
- Research Site
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Yaroslavl, Russian Federation, 150062
- Research Site
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Belgrade, Serbia, 11000
- Research Site #1
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Belgrade, Serbia, 11000
- Research Site #2
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Belgrade, Serbia, 11000
- Research Site #3
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Kragujevac, Serbia, 34000
- Research Site
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Lazarevac, Serbia, 11000
- Research Site
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Nis, Serbia, 18000
- Research Site
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Zajecar, Serbia, 19000
- Research Site
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Bardejov, Slovakia, 08501
- Research Site
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Bratislava, Slovakia, 83103
- Research Site
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Galanta, Slovakia, 924 22
- Research Site
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Svidnik, Slovakia, 08901
- Research Site
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Trstena, Slovakia, 02801
- Research Site
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Free State
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Bloemfontein, Free State, South Africa, 9301
- Research Site
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Brandfort, Free State, South Africa, 9400
- Research Site
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Gauteng
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Pretoria, Gauteng, South Africa, 0002
- Research Site
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Pretoria, Gauteng, South Africa, 1692
- Research Site
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Vereeniging, Gauteng, South Africa, 1935
- Research Site
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KwaZulu-Natal
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Durban, KwaZulu-Natal, South Africa, 4001
- Research Site #1
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Durban, KwaZulu-Natal, South Africa, 4001
- Research Site #2
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Durban, KwaZulu-Natal, South Africa, 4092
- Research Site
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Durban, KwaZulu-Natal, South Africa, 4320
- Research Site
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Tongaat, KwaZulu-Natal, South Africa, 4399
- Research Site
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Western Cape
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Worcester, Western Cape, South Africa, 6850
- Research Site
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Almeria, Spain, 04007
- Research Site
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Almeria, Spain, 04009
- Research Site
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Badajoz, Spain, 06006
- Research Site
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Barcelona, Spain, 08035
- Research Site
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Barcelona, Spain, 08003
- Research Site
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Barcelona, Spain, 08025
- Research Site
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Madrid, Spain, 28041
- Research Site
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Madrid, Spain, 28040
- Research Site
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Madrid, Spain, 28007
- Research Site
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Pamplona, Spain, 31001
- Research Site
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Sevilla, Spain, 41013
- Research Site
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Sevilla, Spain, 41071
- Research Site
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Valencia, Spain, 46026
- Research Site
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Valencia, Spain, 46014
- Research Site
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Alicante
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Elche, Alicante, Spain, 03293
- Research Site
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Torrevieja, Alicante, Spain, 03186
- Research Site
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Baleares
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Palma de Mallorca, Baleares, Spain, 07120
- Research Site
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Barcelona
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L'Hospitalet de Llobregat, Barcelona, Spain, 08907
- Research Site
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Málaga
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Malaga, Málaga, Spain, 29010
- Research Site
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Ankara, Turkey, 06100
- Research Site
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Erciyes, Turkey, 38039
- Research Site
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Istanbul, Turkey, 34098
- Research Site
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Istanbul, Turkey, 34722
- Research Site
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Kocaeli, Turkey, 41380
- Research Site
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Dnipro, Ukraine, 49005
- Research Site
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Ivano-Frankivsk, Ukraine, 76018
- Research Site
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Ivano-Frankivsk, Ukraine, 76008
- Research Site
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Kharkiv, Ukraine, 61039
- Research Site
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Kharkiv, Ukraine, 61103
- Research Site
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Kharkiv, Ukraine, 61037
- Research Site
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Kharkiv, Ukraine, 61157
- Research Site
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Kropyvnytskyi, Ukraine, 25006
- Research Site
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Kyiv, Ukraine, 02125
- Research Site
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Kyiv, Ukraine, 04050
- Research Site
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Lutsk, Ukraine, 43005
- Research Site
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Lviv, Ukraine, 79013
- Research Site
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Mykolaiv, Ukraine, 54058
- Research Site
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Odesa, Ukraine, 65025
- Research Site
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Vinnytsia, Ukraine, 21018
- Research Site
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Vinnytsia, Ukraine, 21001
- Research Site
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Vinnytsia, Ukraine, 21005
- Research Site
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Zaporizhzhia, Ukraine, 69118
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Swansea, United Kingdom, SA6 6NL
- Research Site
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Devon
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Exeter, Devon, United Kingdom, EX2 5DW
- Research Site
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Greater London
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London, Greater London, United Kingdom, E1 1BB
- Research Site
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London, Greater London, United Kingdom, SE5 9RS
- Research Site
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Greater Manchester
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Salford, Greater Manchester, United Kingdom, M6 8HD
- Research Site
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Hertfordshire
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Stevenage, Hertfordshire, United Kingdom, SG1 4AB
- Research Site
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Leicestershire
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Leicester, Leicestershire, United Kingdom, LE5 4PW
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Norfolk
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King's Lynn, Norfolk, United Kingdom, PE30 4ET
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South Yorkshire
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Doncaster, South Yorkshire, United Kingdom, DN2 5LT
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Alabama
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Birmingham, Alabama, United States, 35211
- Research Site
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Huntsville, Alabama, United States, 35805
- Research Site
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Tuscumbia, Alabama, United States, 35674
- Research Site
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Arizona
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Glendale, Arizona, United States, 85306
- Research Site
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Mesa, Arizona, United States, 85210
- Research Site
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Phoenix, Arizona, United States, 85027
- Research Site
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Tucson, Arizona, United States, 85724
- Research Site
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Tucson, Arizona, United States, 85718
- Research Site
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California
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Anaheim, California, United States, 92801
- Research Site
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Bakersfield, California, United States, 93309
- Research Site
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Chula Vista, California, United States, 91910
- Research Site #1
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Chula Vista, California, United States, 91910
- Research Site #2
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El Centro, California, United States, 92243
- Research Site
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Fountain Valley, California, United States, 92708
- Research Site
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Glendale, California, United States, 91206
- Research Site
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Granada Hills, California, United States, 91344
- Research Site
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La Mesa, California, United States, 91942
- Research Site
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Laguna Hills, California, United States, 92653
- Research Site
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Long Beach, California, United States, 90807
- Research Site
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Long Beach, California, United States, 92886
- Research Site
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Los Angeles, California, United States, 90048
- Research Site
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Lynwood, California, United States, 90260
- Research Site
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Northridge, California, United States, 91324
- Research Site #1
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Northridge, California, United States, 91324
- Research Site #2
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Riverside, California, United States, 92505
- Research Site
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Roseville, California, United States, 95661
- Research Site
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Salinas, California, United States, 93901
- Research Site
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San Diego, California, United States, 92103-6204
- Research Site
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San Dimas, California, United States, 91773
- Research Site #1
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San Dimas, California, United States, 91773
- Research Site #2
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Santa Ana, California, United States, 92704
- Research Site
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Santa Monica, California, United States, 90404
- Research Site
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Sherman Oaks, California, United States, 91403
- Research Site
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Thousand Oaks, California, United States, 91360
- Research Site
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Whittier, California, United States, 90603
- Research Site
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Whittier, California, United States, 99999
- Research Site
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Colorado
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Arvada, Colorado, United States, 80002
- Research Site
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Denver, Colorado, United States, 80230
- Research Site
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Westminster, Colorado, United States, 80031
- Research Site
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Connecticut
-
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
-
Edgewater, Florida, United States, 32132
- 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, 33173
- 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, 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, Florida, United States, 33144
- Research Site #1
-
Miami, Florida, United States, 33144
- 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 #1
-
Miami Lakes, Florida, United States, 33016
- Research Site #2
-
Pembroke Pines, Florida, United States, 33026
- Research Site
-
Pompano Beach, Florida, United States, 33060
- Research Site
-
Port Charlotte, Florida, United States, 33952
- 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
-
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
-
Elk Grove Village, Illinois, United States, 60007
- 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
-
Muncie, Indiana, United States, 47304
- 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
-
-
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
-
Springfield, Massachusetts, United States, 01107
- Research Site
-
-
Michigan
-
Detroit, Michigan, United States, 48202
- Research Site
-
Pontiac, Michigan, United States, 48341
- Research Site
-
Port Huron, Michigan, United States, 91344
- Research Site
-
Roseville, Michigan, United States, 48066
- Research Site
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55404
- Research Site
-
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, 64111
- Research Site
-
Kansas City, Missouri, United States, 64128
- 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
-
Mineola, New York, United States, 11501
- 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
-
Jacksonville, North Carolina, United States, 28546
- Research Site
-
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
-
Wilmington, North Carolina, United States, 28401
- Research Site
-
Winston-Salem, North Carolina, United States, 27103
- Research Site
-
-
Ohio
-
Akron, Ohio, United States, 44302
- Research Site
-
Columbus, Ohio, United States, 43203
- 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
-
Doylestown, Pennsylvania, United States, 18901
- Research Site
-
Jersey Shore, Pennsylvania, United States, 17740
- Research Site
-
Philadelphia, Pennsylvania, United States, 19140
- Research Site
-
-
Rhode Island
-
East Providence, Rhode Island, United States, 02915
- Research Site
-
Providence, Rhode Island, United States, 02908
- Research Site
-
-
South Carolina
-
Anderson, South Carolina, United States, 29625
- Research Site
-
Columbia, South Carolina, United States, 29203
- Research Site
-
Orangeburg, South Carolina, United States, 29118
- Research Site
-
Sumter, South Carolina, United States, 29150-1900
- 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, 75390
- Research Site
-
Dallas, Texas, United States, 75220
- 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, 77054
- Research Site
-
Houston, Texas, United States, 77004
- Research Site #1
-
Houston, Texas, United States, 77004
- Research Site #2
-
Houston, Texas, United States, 33143
- 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, 75024-5327
- 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
-
Saint George, Utah, United States, 84790
- Research Site
-
Salt Lake City, Utah, United States, 84115
- Research Site
-
-
Vermont
-
Burlington, Vermont, United States, 05401
- 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
-
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
No
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
- Currently maintained on erythropoiesis-stimulating agents therapy, with a dose received within 6 weeks prior to or during Screening
- Mean Screening hemoglobin between 8.0 and 11.0 grams per deciliter (g/dL) (inclusive) in the United States (US) and between 9.0 and 12.0 g/dL (inclusive) outside of the US
- 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 participant with active bleeding or recent blood loss
- Red blood cell transfusion 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
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: 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.
Other Names:
|
EXPERIMENTAL: Vadadustat
|
Oral dose administered once daily for ≥36 weeks.
Dose adjustment based on hemoglobin level as defined in the protocol.
Other Names:
|
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 hemoglobin concentration (<10.0 versus ≥10.0 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-0015 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 hemoglobin concentration (<10.0 versus ≥10.0 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-0015 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-0015 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-0015 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-0015 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
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
- Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.
- Chertow GM, Pergola PE, Farag YMK, Agarwal R, Arnold S, Bako G, Block GA, Burke S, Castillo FP, Jardine AG, Khawaja Z, Koury MJ, Lewis EF, Lin T, Luo W, Maroni BJ, Matsushita K, McCullough PA, Parfrey PS, Roy-Chaudhury P, Sarnak MJ, Sharma A, Spinowitz B, Tseng C, Tumlin J, Vargo DL, Walters KA, Winkelmayer WC, Wittes J, Eckardt KU; PRO2TECT Study Group. Vadadustat in Patients with Anemia and Non-Dialysis-Dependent CKD. N Engl J Med. 2021 Apr 29;384(17):1589-1600. doi: 10.1056/NEJMoa2035938.
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)
February 1, 2016
Primary Completion (ACTUAL)
June 18, 2020
Study Completion (ACTUAL)
July 31, 2020
Study Registration Dates
First Submitted
February 9, 2016
First Submitted That Met QC Criteria
February 9, 2016
First Posted (ESTIMATE)
February 11, 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-0015
- 2015-004774-14 (EUDRACT_NUMBER)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
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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Akebia TherapeuticsSuspendedAnemia of Chronic Kidney DiseaseUnited States
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The University of Texas Health Science Center,...United States Department of Defense; Akebia Therapeutics Inc.CompletedCoronavirus Infection | Acute Respiratory Distress SyndromeUnited States
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Akebia TherapeuticsCompletedAnemia | Dialysis Dependent Chronic Kidney DiseaseJapan
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Akebia TherapeuticsCompletedAnemia | Non-dialysis Dependent Chronic Kidney DiseaseJapan
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Akebia TherapeuticsCompletedAnemia Associated With Chronic Kidney Disease (CKD)United States
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Akebia TherapeuticsSuspendedAnemia of Chronic Kidney DiseaseUnited States
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Akebia TherapeuticsCompletedChronic Kidney DiseaseUnited States
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Akebia TherapeuticsCompletedHepatic ImpairmentUnited States
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Akebia TherapeuticsCompleted
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Mitsubishi Tanabe Pharma CorporationCompletedAnemia; Hemodialysis Dependent Chronic Kidney DiseaseJapan