Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Non-Dialysis (ASCEND-ND)

April 1, 2024 updated by: GlaxoSmithKline

A Phase 3 Randomized, Open-label (Sponsor-blind), Active-controlled, Parallel-group, Multi-center, Event Driven Study in Non-dialysis Subjects With Anemia Associated With Chronic Kidney Disease to Evaluate the Safety and Efficacy of Daprodustat Compared to Darbepoetin Alfa

The purpose of this multi-center event-driven study in non-dialysis (ND) participants with anemia associated with chronic kidney disease (CKD) is to evaluate the safety and efficacy of daprodustat compared to darbepoetin alfa.

Study Overview

Status

Completed

Conditions

Anaemia

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3872

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
- - Buenos Aires, Argentina, 1425
    - GSK Investigational Site
  - Buenos Aires, Argentina, C1181ACH
    - GSK Investigational Site
  - Buenos Aires, Argentina, CP1431FWO
    - GSK Investigational Site
  - Corrientes, Argentina, W3400AMZ
    - GSK Investigational Site
  - Formosa, Argentina, P3600LLD
    - GSK Investigational Site
  - La Plata, Argentina, B1902COS
    - GSK Investigational Site
  - Mendoza, Argentina, M5500AFA
    - GSK Investigational Site
  - Moron, Argentina, B1708DPO
    - GSK Investigational Site
  - San Miguel de Tucumán, Argentina, T4000AHL
    - GSK Investigational Site
- Buenos Aires
  - Ciudad Evita, Buenos Aires, Argentina, B1778IFA
    - GSK Investigational Site
  - Coronel Suarez, Buenos Aires, Argentina, 7540
    - GSK Investigational Site
  - Junín, Buenos Aires, Argentina, B6000GMA
    - GSK Investigational Site
  - Mar del Plata, Buenos Aires, Argentina, 7600
    - GSK Investigational Site
  - Pergamino, Buenos Aires, Argentina, B2700CPM
    - GSK Investigational Site
- Córdova
  - Cordoba, Córdova, Argentina, 5000
    - GSK Investigational Site
  - Córdoba, Córdova, Argentina, 5000
    - GSK Investigational Site
  - Córdoba, Córdova, Argentina, X5016KEH
    - GSK Investigational Site
Australia
- - Liverpool, Australia, 2107
    - GSK Investigational Site
- Australian Capital Territory
  - Garran, Australian Capital Territory, Australia, 2606
    - GSK Investigational Site
- New South Wales
  - Concord, New South Wales, Australia, 2139
    - GSK Investigational Site
  - Gosford, New South Wales, Australia, 2250
    - GSK Investigational Site
  - Kingswood, New South Wales, Australia, 2747
    - GSK Investigational Site
  - Kogarah, New South Wales, Australia, 2217
    - GSK Investigational Site
  - Randwick, New South Wales, Australia, 2031
    - GSK Investigational Site
  - St Leonards, New South Wales, Australia, 2065
    - GSK Investigational Site
  - Wollongong, New South Wales, Australia, 2500
    - GSK Investigational Site
- Queensland
  - Nambour, Queensland, Australia, 4560
    - GSK Investigational Site
- Victoria
  - Melbourne, Victoria, Australia, 3004
    - GSK Investigational Site
  - Reservoir, Victoria, Australia, 3073
    - GSK Investigational Site
  - St Albans, Victoria, Australia, 3021
    - GSK Investigational Site
- Western Australia
  - Nedlands, Western Australia, Australia, 6009
    - GSK Investigational Site
Belgium
- - Aalst, Belgium, 9300
    - GSK Investigational Site
  - Baudour, Belgium, 7331
    - GSK Investigational Site
  - Brugge, Belgium, 8310
    - GSK Investigational Site
  - Brussels, Belgium, 1200
    - GSK Investigational Site
  - Ieper, Belgium, 8900
    - GSK Investigational Site
  - Leuven, Belgium, 3000
    - GSK Investigational Site
  - Liège, Belgium, 4000
    - GSK Investigational Site
  - Roeselare, Belgium, 8800
    - GSK Investigational Site
  - Ronse, Belgium, 9600
    - GSK Investigational Site
  - Sint-Niklaas, Belgium, 9100
    - GSK Investigational Site
Brazil
- - Belo Horizonte, Brazil, 30150-320
    - GSK Investigational Site
  - Brasilia, Brazil, 70840-901
    - GSK Investigational Site
  - Feira de Santana, Brazil, 44001-465
    - GSK Investigational Site
  - Joinville, Brazil, 89201-010
    - GSK Investigational Site
  - Juiz De Fora, Brazil, 36036-330
    - GSK Investigational Site
  - Sao Paulo, Brazil, ?01323-001
    - GSK Investigational Site
  - São Paulo, Brazil, 01323903
    - GSK Investigational Site
  - São Paulo, Brazil, 04039-000
    - GSK Investigational Site
  - São Paulo, Brazil, ?04005-000
    - GSK Investigational Site
  - São Paulo, Brazil, ?08270-070
    - GSK Investigational Site
- Bahia
  - Salvador, Bahia, Brazil, 40415-065
    - GSK Investigational Site
- Paraná
  - Curitiba, Paraná, Brazil, 80730-150
    - GSK Investigational Site
  - Curitiba, Paraná, Brazil, 80440-020
    - GSK Investigational Site
  - Curitiba, Paraná, Brazil, CEP 80230-130
    - GSK Investigational Site
- Rio Grande Do Sul
  - Passo Fundo, Rio Grande Do Sul, Brazil, 99010-080
    - GSK Investigational Site
  - Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
    - GSK Investigational Site
  - Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
    - GSK Investigational Site
  - Porto Alegre, Rio Grande Do Sul, Brazil, 90035-074
    - GSK Investigational Site
- São Paulo
  - Sao Jose do Rio Preto, São Paulo, Brazil, 15090-000
    - GSK Investigational Site
  - Votuporanga, São Paulo, Brazil, 15500-003
    - GSK Investigational Site
Bulgaria
- - Blagoevgrad, Bulgaria, 2700
    - GSK Investigational Site
  - Burgas, Bulgaria, 8000
    - GSK Investigational Site
  - Dobrich, Bulgaria, 9300
    - GSK Investigational Site
  - Gabrovo, Bulgaria, 5300
    - GSK Investigational Site
  - Lom, Bulgaria, 3600
    - GSK Investigational Site
  - Pazardzhik, Bulgaria, 4400
    - GSK Investigational Site
  - Plovdiv, Bulgaria, 4000
    - GSK Investigational Site
  - Sliven, Bulgaria, 8800
    - GSK Investigational Site
  - Smolyan, Bulgaria, 4700
    - GSK Investigational Site
  - Sofia, Bulgaria, 1233
    - GSK Investigational Site
  - Sofia, Bulgaria, 1709
    - GSK Investigational Site
  - Stara Zagora, Bulgaria, 6000
    - GSK Investigational Site
  - Varna, Bulgaria, 9000
    - GSK Investigational Site
  - Veliko Tarnovo, Bulgaria, 5000
    - GSK Investigational Site
Canada
- - Quebec, Canada, G1R 2J6
    - GSK Investigational Site
- Alberta
  - Edmonton, Alberta, Canada, T6G 2B7
    - GSK Investigational Site
- Nova Scotia
  - Halifax, Nova Scotia, Canada, B3H 1V8
    - GSK Investigational Site
- Ontario
  - Brampton, Ontario, Canada, L6T 0G1
    - GSK Investigational Site
  - London, Ontario, Canada, N6A 5A5
    - GSK Investigational Site
  - Mississauga, Ontario, Canada, L5M 2V8
    - GSK Investigational Site
  - Mississauga, Ontario, Canada, L4V 1P1
    - GSK Investigational Site
  - Toronto, Ontario, Canada, M4C 5T2
    - GSK Investigational Site
- Quebec
  - Greenfield Park, Quebec, Canada, J4V 2H1
    - GSK Investigational Site
  - Montreal, Quebec, Canada, H3G 1A4
    - GSK Investigational Site
Colombia
- - Barranquilla, Colombia, 760002
    - GSK Investigational Site
  - Bogotá, Colombia, 111711
    - GSK Investigational Site
  - Cali, Colombia, 760007
    - GSK Investigational Site
  - Floridablanca, Colombia, 681001
    - GSK Investigational Site
  - Medellin, Colombia, 050012
    - GSK Investigational Site
Czechia
- - Beroun, Czechia, 26601
    - GSK Investigational Site
  - Cesky Krumlov, Czechia, 38127
    - GSK Investigational Site
  - Ivancice, Czechia, 664 95
    - GSK Investigational Site
  - Jilemnice, Czechia, 514 01
    - GSK Investigational Site
  - Marianske Lazne, Czechia, 353 01
    - GSK Investigational Site
  - Novy Jicin, Czechia, 74101
    - GSK Investigational Site
  - Pardubice, Czechia, 53203
    - GSK Investigational Site
  - Praha 2, Czechia, 128 08
    - GSK Investigational Site
  - Praha 4, Czechia, 140 21
    - GSK Investigational Site
  - Sokolov, Czechia, 356 01
    - GSK Investigational Site
Denmark
- - Aalborg, Denmark, DK-9000
    - GSK Investigational Site
  - Holstebro, Denmark, 7500
    - GSK Investigational Site
  - Kolding, Denmark, 6000
    - GSK Investigational Site
  - Odense C, Denmark, 5000
    - GSK Investigational Site
Estonia
- - Jämejala Village, Estonia, 71024
    - GSK Investigational Site
  - Tallinn, Estonia, EE-13419
    - GSK Investigational Site
  - Tartu, Estonia, 50501
    - GSK Investigational Site
France
- - Annonay, France, 07103
    - GSK Investigational Site
  - Boulogne Billancourt, France, 92100
    - GSK Investigational Site
  - Caen Cedex 9, France, 14033
    - GSK Investigational Site
  - Clermont-Ferrand, France, 63000
    - GSK Investigational Site
  - Lyon, France, 69003
    - GSK Investigational Site
  - Montpellier, France, 34295
    - GSK Investigational Site
  - Mulhouse, France, 68100
    - GSK Investigational Site
  - Poitiers, France, 86021
    - GSK Investigational Site
  - Saint-Ouen, France, 93400
    - GSK Investigational Site
Germany
- - Koeln, Germany, 50937
    - GSK Investigational Site
  - Wiesbaden, Germany, 65191
    - GSK Investigational Site
- Baden-Wuerttemberg
  - Mannheim, Baden-Wuerttemberg, Germany, 68167
    - GSK Investigational Site
- Bayern
  - Muenchen, Bayern, Germany, 81675
    - GSK Investigational Site
- Niedersachsen
  - Cloppenburg, Niedersachsen, Germany, 49661
    - GSK Investigational Site
- Nordrhein-Westfalen
  - Duesseldorf, Nordrhein-Westfalen, Germany, 40210
    - GSK Investigational Site
  - Muenster, Nordrhein-Westfalen, Germany, 48149
    - GSK Investigational Site
- Rheinland-Pfalz
  - Kaiserslautern, Rheinland-Pfalz, Germany, 67655
    - GSK Investigational Site
- Sachsen
  - Leipzig, Sachsen, Germany, 04129
    - GSK Investigational Site
Greece
- - Alexandroupolis, Greece, 68100
    - GSK Investigational Site
  - Arta, Greece, 471 00
    - GSK Investigational Site
  - Athens, Greece, 11527
    - GSK Investigational Site
  - Athens, Greece, 115 26
    - GSK Investigational Site
  - Athens, Greece, 12462
    - GSK Investigational Site
  - Athens, Greece, 11526
    - GSK Investigational Site
  - Efkarpia, Greece, 564 29
    - GSK Investigational Site
  - Heraklion-Crete, Greece, 71110
    - GSK Investigational Site
  - Ioannina, Greece, 45001
    - GSK Investigational Site
  - Ioannina, Greece, 45500
    - GSK Investigational Site
  - Komotini, Greece, 69100
    - GSK Investigational Site
  - Larissa, Greece, 41100
    - GSK Investigational Site
  - Melissia, Greece, 15127
    - GSK Investigational Site
  - Patras, Greece, 26500
    - GSK Investigational Site
  - Thessaloniki, Greece, 57010
    - GSK Investigational Site
  - Thessaloniki, Greece, 546 42
    - GSK Investigational Site
  - Thessaloniki, Greece, 54636
    - GSK Investigational Site
  - Thessaloniki, Greece, 57001
    - GSK Investigational Site
  - Thessaloniki, Greece, 551 34
    - GSK Investigational Site
Hong Kong
- - Hong Kong, Hong Kong
    - GSK Investigational Site
  - Lai Chi kok, Hong Kong
    - GSK Investigational Site
  - New Territories, Hong Kong
    - GSK Investigational Site
  - Tsuen Wan, Hong Kong
    - GSK Investigational Site
Hungary
- - Baja, Hungary, 6500
    - GSK Investigational Site
  - Balatonfured, Hungary, 8230
    - GSK Investigational Site
  - Esztergom, Hungary, 2500
    - GSK Investigational Site
  - Kecskemét, Hungary, 6000
    - GSK Investigational Site
  - Miskolc, Hungary, 3526
    - GSK Investigational Site
  - Pecs, Hungary, 7623
    - GSK Investigational Site
  - Salgótarján, Hungary, 3100
    - GSK Investigational Site
  - Szigetvar, Hungary, 7900
    - GSK Investigational Site
India
- - Ahmedabad, India, 380059
    - GSK Investigational Site
  - Ahmedabad, India, 380054
    - GSK Investigational Site
  - Bangalore, India, 560055
    - GSK Investigational Site
  - Bangalore, India, 560054
    - GSK Investigational Site
  - Calicut, India, 673008
    - GSK Investigational Site
  - Chandigarh, India, 160012
    - GSK Investigational Site
  - Chennai, India, 600037
    - GSK Investigational Site
  - Chennai, Tamil Nadu, India, 600 006
    - GSK Investigational Site
  - Delhi, India, 110076
    - GSK Investigational Site
  - Ghaziabad, India, 201012
    - GSK Investigational Site
  - Gurgaon, India, 122001
    - GSK Investigational Site
  - Hyderabad, India, 500034
    - GSK Investigational Site
  - Hyderabad, India, 500012
    - GSK Investigational Site
  - Jaipur, India, 302004
    - GSK Investigational Site
  - Jaipur, India, 302018
    - GSK Investigational Site
  - Lucknow, India, 226014
    - GSK Investigational Site
  - Manipal, India, 576104
    - GSK Investigational Site
  - Mumbai, India, 400016
    - GSK Investigational Site
  - Mumbai, India, 400008
    - GSK Investigational Site
  - Nadiad, India, 387001
    - GSK Investigational Site
  - Nagpur, India, 440010
    - GSK Investigational Site
  - New Delhi, India, 110060
    - GSK Investigational Site
  - New Delhi, India, 110002
    - GSK Investigational Site
  - New Delhi, India, 110025
    - GSK Investigational Site
  - New Delhi, India, 110017
    - GSK Investigational Site
  - Pune, India, 411004
    - GSK Investigational Site
  - Pune, India, 411033
    - GSK Investigational Site
  - Secunderabad, India, 560020
    - GSK Investigational Site
  - Trivandrum, India, 695011
    - GSK Investigational Site
Israel
- - Ashkelon, Israel, 78278
    - GSK Investigational Site
  - Hadera, Israel, PO Box 169
    - GSK Investigational Site
  - Haifa, Israel, 31096
    - GSK Investigational Site
  - Kfar Saba, Israel, 44281
    - GSK Investigational Site
  - Nahariya, Israel, 22100
    - GSK Investigational Site
  - Nazareth, Israel, 16100
    - GSK Investigational Site
  - Poriya, Israel, 15208
    - GSK Investigational Site
  - Zerifin, Israel, 70300
    - GSK Investigational Site
Italy
- - Imola, Italy, 40026
    - GSK Investigational Site
  - Mestre, Italy, 30122
    - GSK Investigational Site
- Calabria
  - Catanzaro, Calabria, Italy, 88100
    - GSK Investigational Site
- Campania
  - Napoli, Campania, Italy, 80131
    - GSK Investigational Site
- Emilia-Romagna
  - Piacenza, Emilia-Romagna, Italy, 29100
    - GSK Investigational Site
  - Reggio Emilia, Emilia-Romagna, Italy, 42123
    - GSK Investigational Site
- Liguria
  - Genova, Liguria, Italy, 16132
    - GSK Investigational Site
- Lombardia
  - Lecco, Lombardia, Italy, 23900
    - GSK Investigational Site
  - Milano, Lombardia, Italy, 20132
    - GSK Investigational Site
  - Pavia, Lombardia, Italy, 27100
    - GSK Investigational Site
- Piemonte
  - Torino, Piemonte, Italy, 10154
    - GSK Investigational Site
- Puglia
  - Foggia, Puglia, Italy, 71100
    - GSK Investigational Site
- Sardegna
  - Cagliari, Sardegna, Italy, ?09100
    - GSK Investigational Site
Korea, Republic of
- - Anyang-Si, Gyeonggi-do, Korea, Republic of, 14068
    - GSK Investigational Site
  - Bucheon, Korea, Republic of, 420-767
    - GSK Investigational Site
  - Busan, Korea, Republic of, 48108
    - GSK Investigational Site
  - Daegu, Korea, Republic of, 41944
    - GSK Investigational Site
  - Daegu, Korea, Republic of, 41931
    - GSK Investigational Site
  - Daejeon, Korea, Republic of, 301-721
    - GSK Investigational Site
  - Goyang-si, Korea, Republic of, 10444
    - GSK Investigational Site
  - Ilsanseo-gu, Goyang-si,, Korea, Republic of, 10380
    - GSK Investigational Site
  - Incheon, Korea, Republic of, 405-760
    - GSK Investigational Site
  - Incheon, Korea, Republic of, 021431
    - GSK Investigational Site
  - Jeonju-si, Korea, Republic of, 54987
    - GSK Investigational Site
  - Seongnam, Korea, Republic of, 13620
    - GSK Investigational Site
  - Seoul, Korea, Republic of, 06973
    - GSK Investigational Site
  - Seoul, Korea, Republic of, 137-701
    - GSK Investigational Site
  - Seoul, Korea, Republic of, 08308
    - GSK Investigational Site
  - Seoul, Korea, Republic of, 07061
    - GSK Investigational Site
  - Seoul, Korea, Republic of, 135-710
    - GSK Investigational Site
  - Seoul, Korea, Republic of, 158-710
    - GSK Investigational Site
  - Seoul, Korea, Republic of, 134-727
    - GSK Investigational Site
  - Seoul, Korea, Republic of, 3080
    - GSK Investigational Site
  - Seoul, Korea, Republic of, ?02447
    - GSK Investigational Site
  - Seoul, Korea, Republic of, ?05355
    - GSK Investigational Site
  - Suwon, Korea, Republic of, 16499
    - GSK Investigational Site
  - Suwon, Korea, Republic of, 442-723
    - GSK Investigational Site
  - Uijeongbu-si, Korea, Republic of, 11765
    - GSK Investigational Site
  - Wonju-si, Korea, Republic of, 26426
    - GSK Investigational Site
Malaysia
- - Alor Setar, Malaysia, 55600
    - GSK Investigational Site
  - Ipoh, Malaysia, 30450
    - GSK Investigational Site
  - Kuala Lumpur, Malaysia, 50603
    - GSK Investigational Site
  - Kuantan, Malaysia, 25100
    - GSK Investigational Site
  - Lumut, Malaysia, 32040
    - GSK Investigational Site
  - Pahang, Malaysia, 28000
    - GSK Investigational Site
  - Penang, Malaysia, 10990
    - GSK Investigational Site
Mexico
- - Aguascalientes, Mexico, 20230
    - GSK Investigational Site
  - Chihuahua, Mexico, 31217
    - GSK Investigational Site
  - Chihuahua, Mexico, 31203
    - GSK Investigational Site
  - Ciudad De México, Mexico, 06100
    - GSK Investigational Site
  - Ciudad De México, Mexico, ?03800
    - GSK Investigational Site
  - Culiacan, Mexico, 80030
    - GSK Investigational Site
  - Tlalnepantla De Baz, Mexico, 54055
    - GSK Investigational Site
  - Veracruz, Mexico, 91020
    - GSK Investigational Site
  - Zapopan, Jalisco, Mexico, 45030
    - GSK Investigational Site
- Coahuila
  - Saltillo, Coahuila, Mexico, CP 25230
    - GSK Investigational Site
  - Torreon, Coahuila, Mexico, 27000
    - GSK Investigational Site
- Durango
  - Durango., Durango, Mexico, 34000
    - GSK Investigational Site
- Estado De México
  - Ciudad De Mexico, Estado De México, Mexico, 14080
    - GSK Investigational Site
- Guanajuato
  - Leon, Guanajuato, Mexico, 37530
    - GSK Investigational Site
  - León, Guanajuato, Mexico, 37000
    - GSK Investigational Site
- Jalisco
  - Guadalajara, Jalisco, Mexico, 44620
    - GSK Investigational Site
  - Guadalajara., Jalisco, Mexico, 44600
    - GSK Investigational Site
- Morelos
  - Cuernavaca, Morelos, Mexico, 62448
    - GSK Investigational Site
- Nuevo León
  - Monterrey, Nuevo León, Mexico, 64000
    - GSK Investigational Site
- Querétaro
  - Queretaro, Querétaro, Mexico, 76000
    - GSK Investigational Site
- Sinaloa
  - Culiacan, Sinaloa, Mexico, 80200
    - GSK Investigational Site
  - Culiacan, Sinaloa, Mexico, 80230
    - GSK Investigational Site
  - Mazatlán, Sinaloa, Mexico, 82020
    - GSK Investigational Site
- Yucatán
  - Merida, Yucatán, Mexico, CP 97070
    - GSK Investigational Site
  - Merida, Yucatán, Mexico, 97133
    - GSK Investigational Site
Netherlands
- - Amsterdam, Netherlands, 1081 HV
    - GSK Investigational Site
  - Deventer, Netherlands, 7416 SE
    - GSK Investigational Site
  - Rotterdam, Netherlands, 3079 DZ
    - GSK Investigational Site
New Zealand
- - Dunedin, New Zealand, 9016
    - GSK Investigational Site
  - Hamilton, New Zealand, 2001
    - GSK Investigational Site
  - Hastings, New Zealand, 4156
    - GSK Investigational Site
  - Otahuhu, New Zealand, 1640
    - GSK Investigational Site
  - Takapuna, Auckland, New Zealand, ?0740
    - GSK Investigational Site
Philippines
- - Baguio City, Benguet, Philippines, 2600
    - GSK Investigational Site
  - Cebu City, Philippines, 6000
    - GSK Investigational Site
  - Dasmarinas, Philippines, 4114
    - GSK Investigational Site
  - Iloilo City, Philippines, 5000
    - GSK Investigational Site
  - Manila, Philippines, 1000
    - GSK Investigational Site
  - Pasig, Philippines, 1605
    - GSK Investigational Site
  - Quezon City, Philippines, 1100
    - GSK Investigational Site
  - San Juan, Philippines, 1500
    - GSK Investigational Site
  - Sto Tomas, Philippines, 4234
    - GSK Investigational Site
Poland
- - Bialystok, Poland, 15-540
    - GSK Investigational Site
  - Brzeg, Poland, 49301
    - GSK Investigational Site
  - Gdansk, Poland, 80-952
    - GSK Investigational Site
  - Katowice, Poland, 40-027
    - GSK Investigational Site
  - Kielce, Poland, 25-736
    - GSK Investigational Site
  - Kolobrzeg, Poland, 78-100
    - GSK Investigational Site
  - Lodz, Poland, 92-213
    - GSK Investigational Site
  - Radom, Poland, 26-610
    - GSK Investigational Site
  - Szczecin, Poland, 70-111
    - GSK Investigational Site
  - Zyrardow, Poland, 96-300
    - GSK Investigational Site
Portugal
- - Amadora, Portugal, 2720-276
    - GSK Investigational Site
  - Aveiro, Portugal, 3814-501
    - GSK Investigational Site
  - Covilhã, Portugal, 6200-000
    - GSK Investigational Site
  - Lisboa, Portugal, 1069-166
    - GSK Investigational Site
  - Lisboa, Portugal, 1400-195
    - GSK Investigational Site
  - Lisboa, Portugal, 1250-189
    - GSK Investigational Site
  - Torres Novas, Portugal, 2350-754
    - GSK Investigational Site
Romania
- - Bucharest, Romania, 022328
    - GSK Investigational Site
  - Bucharest, Romania, ?022328
    - GSK Investigational Site
  - Bucharest, Romania, ?042122
    - GSK Investigational Site
  - Bucuresti, Romania, 022328
    - GSK Investigational Site
  - Constanta, Romania, 900591
    - GSK Investigational Site
  - Oradea, Romania, 410469
    - GSK Investigational Site
  - Timisoara, Romania, 300723
    - GSK Investigational Site
Russian Federation
- - Irkutsk, Russian Federation, 664049
    - GSK Investigational Site
  - Kemerovo, Russian Federation, 650060
    - GSK Investigational Site
  - Krasnodar, Russian Federation, 350029
    - GSK Investigational Site
  - Moscow, Russian Federation, 119121
    - GSK Investigational Site
  - Mytischi, Russian Federation, 141009
    - GSK Investigational Site
  - Omsk, Russian Federation, 644112
    - GSK Investigational Site
  - Podolsk, Russian Federation, 142110
    - GSK Investigational Site
  - Ryazan, Russian Federation, 390026
    - GSK Investigational Site
  - Smolensk, Russian Federation, 214006
    - GSK Investigational Site
  - St. Petersburg, Russian Federation, 196247
    - GSK Investigational Site
  - St. Petersburg, Russian Federation, 194104
    - GSK Investigational Site
  - Ulyanovsk, Russian Federation, 432063
    - GSK Investigational Site
  - Volzhsky, Russian Federation, 404120
    - GSK Investigational Site
  - Yaroslavl, Russian Federation, 150062
    - GSK Investigational Site
Singapore
- - Singapore, Singapore, 119074
    - GSK Investigational Site
  - Singapore, Singapore, 169608
    - GSK Investigational Site
  - Singapore, Singapore, 308433
    - GSK Investigational Site
  - Singapore, Singapore, 768828
    - GSK Investigational Site
South Africa
- - Cape Town, South Africa, 7500
    - GSK Investigational Site
  - Cape Town., South Africa, 7925
    - GSK Investigational Site
  - Somerset West, South Africa, 7130
    - GSK Investigational Site
- Eastern Cape
  - Port Elizabeth, Eastern Cape, South Africa, 6001
    - GSK Investigational Site
Spain
- - Badalona, Spain, 08916
    - GSK Investigational Site
  - Barcelona, Spain, 08025
    - GSK Investigational Site
  - Barcelona, Spain, 08035
    - GSK Investigational Site
  - Barcelona, Spain, 08003
    - GSK Investigational Site
  - Barcelona, Spain, 08011
    - GSK Investigational Site
  - Burela, Spain, 27880
    - GSK Investigational Site
  - Caceres, Spain, 10003
    - GSK Investigational Site
  - Ciudad Real, Spain, 13002
    - GSK Investigational Site
  - Girona, Spain, 17007
    - GSK Investigational Site
  - Guadalajara, Spain, 19002
    - GSK Investigational Site
  - L'Hospitalet de Llobregat, Spain, 08907
    - GSK Investigational Site
  - Mollet del Valles, Spain, ?08100
    - GSK Investigational Site
  - Santiago de Compostela, Spain, 15706
    - GSK Investigational Site
  - Sevilla, Spain, 41071
    - GSK Investigational Site
- Madrid
  - Majadahonda, Madrid, Spain, 28222
    - GSK Investigational Site
Sweden
- - Stockholm, Sweden, SE-141 86
    - GSK Investigational Site
  - Uppsala, Sweden, SE-75185
    - GSK Investigational Site
  - Örebro, Sweden, SE-701 85
    - GSK Investigational Site
Taiwan
- - Kaohsiung, Taiwan, 833
    - GSK Investigational Site
  - Kaohsiung, Taiwan, 807
    - GSK Investigational Site
  - Keelung, Taiwan, 204
    - GSK Investigational Site
  - New Taipei, Taiwan, 220
    - GSK Investigational Site
  - Tainan, Taiwan, 704
    - GSK Investigational Site
  - Taipei, Taiwan, 104
    - GSK Investigational Site
  - Taipei, Taiwan, 112
    - GSK Investigational Site
  - Taipei, Taiwan, 10002
    - GSK Investigational Site
  - Taipei, Taiwan, 116
    - GSK Investigational Site
  - Taoyuan Hsien, Taiwan, 333
    - GSK Investigational Site
Thailand
- - Bangkok, Thailand, 10400
    - GSK Investigational Site
  - Bangkok, Thailand, 10330
    - GSK Investigational Site
  - Bangkok, Thailand, 11000
    - GSK Investigational Site
  - Bangkoknoi, Thailand, 10700
    - GSK Investigational Site
  - Chiang Mai, Thailand, 50200
    - GSK Investigational Site
  - Khon Kaen, Thailand, 40002
    - GSK Investigational Site
  - Pathumthani, Thailand, 12120
    - GSK Investigational Site
Turkey
- - Adana, Turkey, ?01330
    - GSK Investigational Site
  - Ankara, Turkey, ?06100
    - GSK Investigational Site
  - Antalya, Turkey, ?07059
    - GSK Investigational Site
  - Edirne, Turkey, 22030
    - GSK Investigational Site
  - Eskisehir, Turkey, 26480
    - GSK Investigational Site
  - Istanbul, Turkey, 34899
    - GSK Investigational Site
  - Istanbul, Turkey, 34130
    - GSK Investigational Site
  - Istanbul, Turkey, 34381
    - GSK Investigational Site
  - Kayseri, Turkey, 38039
    - GSK Investigational Site
Ukraine
- - Cherkasy, Ukraine, 18009
    - GSK Investigational Site
  - Chernihiv, Ukraine, 14029
    - GSK Investigational Site
  - Chernivtsi, Ukraine, 58005
    - GSK Investigational Site
  - Ivano-Frankivsk, Ukraine, 76008
    - GSK Investigational Site
  - Kharkiv, Ukraine, 61039
    - GSK Investigational Site
  - Kherson, Ukraine, 73039
    - GSK Investigational Site
  - Kiev, Ukraine, ?04107
    - GSK Investigational Site
  - Kyiv, Ukraine, 04112
    - GSK Investigational Site
  - Kyiv, Ukraine, 01014
    - GSK Investigational Site
  - Kyiv, Ukraine, ?01023
    - GSK Investigational Site
  - Kyiv, Ukraine, ?04050
    - GSK Investigational Site
  - Lutsk, Ukraine, 43000
    - GSK Investigational Site
  - Mykolaiv, Ukraine, 54058
    - GSK Investigational Site
  - Poltava, Ukraine, 36011
    - GSK Investigational Site
  - Ternopil, Ukraine, 46002
    - GSK Investigational Site
  - Zaporizhzhia, Ukraine, 69001
    - GSK Investigational Site
  - Zaporizhzhia, Ukraine, 69600
    - GSK Investigational Site
  - Zhytomyr, Ukraine, 10002
    - GSK Investigational Site
United Kingdom
- - Birmingham, United Kingdom, B9 5SS
    - GSK Investigational Site
  - Bristol, United Kingdom, BS10 5NB
    - GSK Investigational Site
  - Cambridge, United Kingdom, CB2 0QQ
    - GSK Investigational Site
  - Cardiff, United Kingdom, CF14 4XW
    - GSK Investigational Site
  - Derby, United Kingdom, DE22 3NE
    - GSK Investigational Site
  - Doncaster, United Kingdom, DN2 5LT
    - GSK Investigational Site
  - Fife, United Kingdom, KY2 5AH
    - GSK Investigational Site
  - Glasgow., United Kingdom, G51 4TF
    - GSK Investigational Site
  - Hull, United Kingdom, HU3 2JZ
    - GSK Investigational Site
  - Leeds, United Kingdom, LS9 7TF
    - GSK Investigational Site
  - London, United Kingdom, E1 1BB
    - GSK Investigational Site
  - London, United Kingdom, SE5 9RS
    - GSK Investigational Site
  - Manchester, United Kingdom, M13 9WL
    - GSK Investigational Site
  - Middlesbrough, United Kingdom, TS4 3BW
    - GSK Investigational Site
  - Oxford, United Kingdom, OX3 7LE
    - GSK Investigational Site
  - Salford, United Kingdom, M6 8HD
    - GSK Investigational Site
  - York, United Kingdom, YO31 8HE
    - GSK Investigational Site
- Hertfordshire
  - Stevenage, Hertfordshire, United Kingdom, SG1 4AB
    - GSK Investigational Site
- Lancashire
  - Preston, Lancashire, United Kingdom, PR2 9HT
    - GSK Investigational Site
- London
  - Hampstead, London, United Kingdom, NW3 2QG
    - GSK Investigational Site
- Merseyside
  - Liverpool, Merseyside, United Kingdom, L7 8XP
    - GSK Investigational Site
- West Midlands
  - Wolverhampton, West Midlands, United Kingdom, WV10 0QP
    - GSK Investigational Site
United States
- Alabama
  - Andalusia, Alabama, United States, 36420
    - GSK Investigational Site
  - Birmingham, Alabama, United States, 35249
    - GSK Investigational Site
  - Huntsville, Alabama, United States, 35805
    - GSK Investigational Site
- Arizona
  - Glendale, Arizona, United States, 85305
    - GSK Investigational Site
  - Mesa, Arizona, United States, 85202
    - GSK Investigational Site
  - Phoenix, Arizona, United States, 85016
    - GSK Investigational Site
  - Phoenix, Arizona, United States, 85027
    - GSK Investigational Site
  - Scottsdale, Arizona, United States, 48201
    - GSK Investigational Site
  - Tucson, Arizona, United States, 85745
    - GSK Investigational Site
- California
  - Azusa, California, United States, 91702
    - GSK Investigational Site
  - Bakersfield, California, United States, 93308
    - GSK Investigational Site
  - Bakersfield, California, United States, 93309
    - GSK Investigational Site
  - Chula Vista, California, United States, 91910
    - GSK Investigational Site
  - Cudahy, California, United States, 90201
    - GSK Investigational Site
  - El Centro, California, United States, 92243
    - GSK Investigational Site
  - Escondido, California, United States, 92025
    - GSK Investigational Site
  - Glendale, California, United States, 91204
    - GSK Investigational Site
  - Granada Hills, California, United States, 91344
    - GSK Investigational Site
  - La Mesa, California, United States, 91942
    - GSK Investigational Site
  - La Palma, California, United States, 90623
    - GSK Investigational Site
  - Long Beach, California, United States, 90806
    - GSK Investigational Site
  - Los Angeles, California, United States, 90095
    - GSK Investigational Site
  - Los Angeles, California, United States, 90022
    - GSK Investigational Site
  - Montebello, California, United States, 90640
    - GSK Investigational Site
  - National City, California, United States, 91950
    - GSK Investigational Site
  - Riverside, California, United States, 92505
    - GSK Investigational Site
  - San Diego, California, United States, 92103
    - GSK Investigational Site
  - San Diego, California, United States, 92111
    - GSK Investigational Site
  - San Luis Obispo, California, United States, 93405
    - GSK Investigational Site
  - Simi Valley, California, United States, 93065
    - GSK Investigational Site
  - Tarzana, California, United States, 91356
    - GSK Investigational Site
  - Whittier, California, United States, 90602
    - GSK Investigational Site
- Connecticut
  - Middlebury, Connecticut, United States, 06762
    - GSK Investigational Site
- District of Columbia
  - Washington, District of Columbia, United States, 20037
    - GSK Investigational Site
- Florida
  - Aventura, Florida, United States, 33180
    - GSK Investigational Site
  - Boca Raton, Florida, United States, 33431
    - GSK Investigational Site
  - Coral Gables, Florida, United States, 33134
    - GSK Investigational Site
  - Cutler Bay, Florida, United States, 33189
    - GSK Investigational Site
  - Doral, Florida, United States, 33122
    - GSK Investigational Site
  - Fort Lauderdale, Florida, United States, 33308
    - GSK Investigational Site
  - Homestead, Florida, United States, 33033
    - GSK Investigational Site
  - Hudson, Florida, United States, 34667
    - GSK Investigational Site
  - Jacksonville, Florida, United States, 32224
    - GSK Investigational Site
  - Jacksonville, Florida, United States, 32256
    - GSK Investigational Site
  - Lauderdale Lakes, Florida, United States, 33313
    - GSK Investigational Site
  - Miami, Florida, United States, 33143
    - GSK Investigational Site
  - Miami, Florida, United States, 33156
    - GSK Investigational Site
  - Miami, Florida, United States, 33173
    - GSK Investigational Site
  - Miami, Florida, United States, 33126
    - GSK Investigational Site
  - Miami, Florida, United States, 33169
    - GSK Investigational Site
  - Miami, Florida, United States, 33165
    - GSK Investigational Site
  - Miami, Florida, United States, 33150
    - GSK Investigational Site
  - Miami, Florida, United States, 33155
    - GSK Investigational Site
  - Miami, Florida, United States, 33145
    - GSK Investigational Site
  - Miami, Florida, United States, 33147
    - GSK Investigational Site
  - Miami Gardens, Florida, United States, 33169
    - GSK Investigational Site
  - Miami Lakes, Florida, United States, 33014
    - GSK Investigational Site
  - Ocala, Florida, United States, 34471
    - GSK Investigational Site
  - Orlando, Florida, United States, 32810
    - GSK Investigational Site
  - Pembroke Pines, Florida, United States, 33028
    - GSK Investigational Site
  - Port Charlotte, Florida, United States, 33952
    - GSK Investigational Site
  - South Miami, Florida, United States, 33143
    - GSK Investigational Site
  - Tampa, Florida, United States, 33612
    - GSK Investigational Site
  - Temple Terrace, Florida, United States, 33637
    - GSK Investigational Site
- Georgia
  - Atlanta, Georgia, United States, 30342
    - GSK Investigational Site
  - Augusta, Georgia, United States, 30909
    - GSK Investigational Site
  - Augusta, Georgia, United States, 30912
    - GSK Investigational Site
  - Augusta, Georgia, United States, 30904
    - GSK Investigational Site
  - Columbus, Georgia, United States, 31904
    - GSK Investigational Site
- Idaho
  - Nampa, Idaho, United States, 83687
    - GSK Investigational Site
- Illinois
  - Chicago, Illinois, United States, 60611
    - GSK Investigational Site
  - Chicago, Illinois, United States, 60643
    - GSK Investigational Site
  - Crystal Lake, Illinois, United States, 60014
    - GSK Investigational Site
  - Mount Prospect, Illinois, United States, 60056
    - GSK Investigational Site
  - Quincy, Illinois, United States, 62301
    - GSK Investigational Site
  - Springfield, Illinois, United States, 62702
    - GSK Investigational Site
- Indiana
  - Fort Wayne, Indiana, United States, 46845
    - GSK Investigational Site
  - Jeffersonville, Indiana, United States, 47130
    - GSK Investigational Site
  - Michigan City, Indiana, United States, 46360
    - GSK Investigational Site
- Iowa
  - Des Moines, Iowa, United States, 50309
    - GSK Investigational Site
  - Iowa City, Iowa, United States, 52242
    - GSK Investigational Site
- Kansas
  - Hutchinson, Kansas, United States, 67502
    - GSK Investigational Site
  - Wichita, Kansas, United States, 67214
    - GSK Investigational Site
- Kentucky
  - Louisville, Kentucky, United States, 40202
    - GSK Investigational Site
- Louisiana
  - Baton Rouge, Louisiana, United States, 70808
    - GSK Investigational Site
  - Baton Rouge, Louisiana, United States, 70836
    - GSK Investigational Site
  - Metairie, Louisiana, United States, 70006
    - GSK Investigational Site
- Maryland
  - Baltimore, Maryland, United States, 21287
    - GSK Investigational Site
  - Potomac, Maryland, United States, 20854
    - GSK Investigational Site
  - Takoma Park, Maryland, United States, 20912-6385
    - GSK Investigational Site
- Massachusetts
  - Boston, Massachusetts, United States, 02114
    - GSK Investigational Site
- Michigan
  - Detroit, Michigan, United States, 48202
    - GSK Investigational Site
  - Kalamazoo, Michigan, United States, 49007
    - GSK Investigational Site
  - Pontiac, Michigan, United States, 48341
    - GSK Investigational Site
- Minnesota
  - Minneapolis, Minnesota, United States, 55414
    - GSK Investigational Site
- Mississippi
  - Jackson, Mississippi, United States, 39216
    - GSK Investigational Site
  - Tupelo, Mississippi, United States, 38801
    - GSK Investigational Site
- Missouri
  - Saint Louis, Missouri, United States, 63110
    - GSK Investigational Site
  - Saint Louis, Missouri, United States, 63106
    - GSK Investigational Site
- Nebraska
  - North Platte, Nebraska, United States, 69101
    - GSK Investigational Site
- Nevada
  - Las Vegas, Nevada, United States, 89106
    - GSK Investigational Site
- New York
  - Bronx, New York, United States, 10461
    - GSK Investigational Site
  - Bronx, New York, United States, 10467
    - GSK Investigational Site
  - Brooklyn, New York, United States, 11203
    - GSK Investigational Site
  - Buffalo, New York, United States, 14215
    - GSK Investigational Site
  - Flushing, New York, United States, 11355
    - GSK Investigational Site
  - Laurelton, New York, United States, 11413
    - GSK Investigational Site
  - New York, New York, United States, 10021
    - GSK Investigational Site
  - New York, New York, United States, 10029
    - GSK Investigational Site
  - Ridgewood, New York, United States, 11385
    - GSK Investigational Site
  - Yonkers, New York, United States, 10704
    - GSK Investigational Site
- North Carolina
  - Charlotte, North Carolina, United States, 28204
    - GSK Investigational Site
  - Raleigh, North Carolina, United States, 27609
    - GSK Investigational Site
  - Rocky Mount, North Carolina, United States, 27804
    - GSK Investigational Site
  - Wilmington, North Carolina, United States, 28401
    - GSK Investigational Site
  - Winston-Salem, North Carolina, United States, 27103
    - GSK Investigational Site
- North Dakota
  - Grand Forks, North Dakota, United States, 58201
    - GSK Investigational Site
- Ohio
  - Canton, Ohio, United States, 15212
    - GSK Investigational Site
  - Cincinnati, Ohio, United States, 45206
    - GSK Investigational Site
  - Cincinnati, Ohio, United States, 45220
    - GSK Investigational Site
  - Mentor, Ohio, United States, 44060
    - GSK Investigational Site
- Oklahoma
  - Lawton, Oklahoma, United States, 73505
    - GSK Investigational Site
- Oregon
  - Portland, Oregon, United States, 97210
    - GSK Investigational Site
  - Roseburg, Oregon, United States, 97471
    - GSK Investigational Site
- Pennsylvania
  - Bethlehem, Pennsylvania, United States, 18017
    - GSK Investigational Site
  - Doylestown, Pennsylvania, United States, 18901
    - GSK Investigational Site
  - Lancaster, Pennsylvania, United States, 17601
    - GSK Investigational Site
  - Upland, Pennsylvania, United States, 19013
    - GSK Investigational Site
  - Wyomissing, Pennsylvania, United States, 19610
    - GSK Investigational Site
- South Carolina
  - Anderson, South Carolina, United States, 29621
    - GSK Investigational Site
  - Charleston, South Carolina, United States, 29425
    - GSK Investigational Site
  - Columbia, South Carolina, United States, 29209
    - GSK Investigational Site
  - Sumter, South Carolina, United States, 29150
    - GSK Investigational Site
- Tennessee
  - Cordova, Tennessee, United States, 38018
    - GSK Investigational Site
  - Knoxville, Tennessee, United States, 37923
    - GSK Investigational Site
  - Memphis, Tennessee, United States, 38163
    - GSK Investigational Site
  - Nashville, Tennessee, United States, 37205
    - GSK Investigational Site
- Texas
  - Arlington, Texas, United States, 76002
    - GSK Investigational Site
  - Austin, Texas, United States, 78751
    - GSK Investigational Site
  - Austin, Texas, United States, 78758
    - GSK Investigational Site
  - Corpus Christi, Texas, United States, 78404
    - GSK Investigational Site
  - Corsicana, Texas, United States, 75110
    - GSK Investigational Site
  - Dallas, Texas, United States, 75246
    - GSK Investigational Site
  - Dallas, Texas, United States, 75237
    - GSK Investigational Site
  - Houston, Texas, United States, 77099
    - GSK Investigational Site
  - Houston, Texas, United States, 77004
    - GSK Investigational Site
  - Houston, Texas, United States, 77084
    - GSK Investigational Site
  - Houston, Texas, United States, 77043
    - GSK Investigational Site
  - Lufkin, Texas, United States, 75904
    - GSK Investigational Site
  - McAllen, Texas, United States, 78503
    - GSK Investigational Site
  - San Antonio, Texas, United States, 78229
    - GSK Investigational Site
  - San Antonio, Texas, United States, 78258
    - GSK Investigational Site
  - San Antonio, Texas, United States, 78212
    - GSK Investigational Site
  - San Antonio, Texas, United States, 78202
    - GSK Investigational Site
  - Temple, Texas, United States, 76508
    - GSK Investigational Site
  - Waxahachie, Texas, United States, 75165
    - GSK Investigational Site
- Virginia
  - Alexandria, Virginia, United States, 22304
    - GSK Investigational Site
  - Fairfax, Virginia, United States, 22033
    - GSK Investigational Site
  - Hampton, Virginia, United States, 23666
    - GSK Investigational Site
  - Salem, Virginia, United States, 24153
    - GSK Investigational Site
- West Virginia
  - Bluefield, West Virginia, United States, 24701
    - GSK Investigational Site
Vietnam
- - Ha Noi, Vietnam, 10000
    - GSK Investigational Site
  - Ha Noi City, Vietnam, 10000
    - GSK Investigational Site
  - Hai Phong, Vietnam, 180000
    - GSK Investigational Site
  - Hanoi, Vietnam, 11000
    - GSK Investigational Site
  - Ho Chi Minh, Vietnam, 700000
    - GSK Investigational Site
  - Ho Chi Minh City, Vietnam, 700000
    - GSK Investigational 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 to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Age: 18 to 99 years of age (inclusive)
CKD stage: Kidney Disease Outcomes Quality Initiative (KDOQI) CKD stages 3, 4, or 5 defined by electronic eGFR using the CKD Epidemiology Collaboration (CKD-EPI) formula.
Erythropoietin-stimulating agents (ESAs)/Hgb: Group 1 (not using ESAs): No ESA use within the 6 weeks prior to screening and no ESA use between screening and randomization (Day 1). Group 2 (ESA users): Use of any approved ESA for the 6 weeks prior to screening and continuing between screening and randomization.
For Group 1 (not using ESAs), Hgb concentration at Week -8 and Week 1 should be 8 to 10 gram per deciliter (g/dL). For Group 2 (ESA users), Hgb concentration at Week -8 should be 8 to 12 g/dL and at Week 1 should be 8 to 11 g/dL.
>=80% and <=120% compliance with placebo during run-in period.
Informed consent (screening only): capable of giving signed informed consent which includes compliance with the requirements and restrictions.

Exclusion Criteria:

Dialysis: On dialysis or clinical evidence of impending need to initiate dialysis within 90 days after study start (Day 1).
Kidney transplant: Planned living-related or living-unrelated kidney transplant within 52 weeks after study start (Day 1).
Ferritin: <=100 nanograms (ng)/milliliter (mL) (<=100 micrograms/liter [L]) at screening.
Transferrin saturation (TSAT) (screening only): <=20%.
Aplasias: History of bone marrow aplasia or pure red cell aplasia.
Other causes of anemia: untreated pernicious anemia, thalassemia major, sickle cell disease or myelodysplastic syndrome.
Gastrointestinal (GI) bleeding: Evidence of actively bleeding gastric, duodenal, or esophageal ulcer disease or clinically significant GI bleeding <=4 weeks prior to screening through to randomization (Day 1).
MI or acute coronary syndrome: <=4 weeks prior to screening through to randomization (Day 1).
Stroke or transient ischemic attack: <=4 weeks prior to screening through to randomization (Day 1).
Heart failure (HF): Chronic Class IV HF, as defined by the New York Heart Association (NYHA) functional classification system.
Current uncontrolled hypertension: Current uncontrolled hypertension as determined by the investigator.
Bazett's corrected QT interval (QTcB) (Day 1): QTcB >500 millisecond (msec), or QTcB >530 msec in subjects with bundle branch block. There is no Q-T Interval Corrected for Heart Rate (QTc) exclusion for subjects with a predominantly ventricular paced rhythm.
Alanine transaminase (ALT): >2x upper limit of normal (ULN) at screening.
Bilirubin: >1.5xULN at screening.
Current unstable liver or biliary disease per investigator assessment, generally defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.
Malignancy: History of malignancy within the 2 years prior to screening through to randomization (Day 1) or currently receiving treatment for cancer, or complex kidney cyst (example [e.g.] Bosniak Category II F, III or IV) > 3 centimeter (cm); with the exception of localized squamous cell or basal cell carcinoma of the skin that has been definitively treated >=4 weeks prior to screening.
Severe allergic reactions: History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product, or darbepoetin alfa.
Drugs and supplements: Use of strong inhibitors of Cytochrome P4502C8 (CYP2C8) (e.g., gemfibrozil) or strong inducers of CYP2C8 (e.g., rifampin/rifampicin).
Other study participation: Use of other investigational agent or device prior to screening through to randomization (Day 1). At screening, this exclusion applies to use of the investigational agent within 30 days or within five half lives (whichever is longer).
Prior treatment with daprodustat: Any prior treatment with daprodustat for treatment duration of >30 days.
Females only: Subject is pregnant [as confirmed by a positive urine human chorionic gonadotrophin (hCG) test for females of reproductive potential (FRP) only], subject is breastfeeding, or subject is of reproductive potential and does not agree to follow one of the contraceptive options.
Other Conditions: Any other condition, clinical or laboratory abnormality, or examination finding that the investigator considers would put the subject at unacceptable risk, which may affect study compliance (e.g., intolerance to darbepoetin alfa) or prevent understanding of the aims or investigational procedures or possible consequences of the study.

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 Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Daprodustat Participants will receive oral daprodustat once daily.	Drug: Placebo Oral placebo tablets will be taken from Week -4 up to randomization (Day 1). Drug: Daprodustat The initial dose or oral daprodustat for ESA naïve subjects is based on Hgb and for ESA users is based on prior ESA dose. The dose is adjusted thereafter in order to achieve the target range. Drug: Iron Therapy Participants will receive supplemental iron therapy if ferritin is <=100 ng/mL or TSAT is <=20%. The investigator will choose the route of administration and dose of iron.
Active Comparator: Darbepoetin alfa Participants will be administered darbepoetin alfa subcutaneously (SC).	Drug: Placebo Oral placebo tablets will be taken from Week -4 up to randomization (Day 1). Drug: Iron Therapy Participants will receive supplemental iron therapy if ferritin is <=100 ng/mL or TSAT is <=20%. The investigator will choose the route of administration and dose of iron. Drug: Darbepoetin alfa The initial dose of darbepoetin alfa to be administered for SC injection for ESA naïve subjects is based in Hgb and weight, and for ESA users is based on converting the prior ESA dose to the nearest available study darbepoetin alfa dose. The dose is adjusted thereafter in order to achieve the target range. IV darbepoetin alfa can be considered for participants transitioning to hemodialysis.

Participant Group / Arm

Intervention / Treatment

Experimental: Daprodustat

Participants will receive oral daprodustat once daily.

Drug: Placebo

Oral placebo tablets will be taken from Week -4 up to randomization (Day 1).

Drug: Daprodustat

The initial dose or oral daprodustat for ESA naïve subjects is based on Hgb and for ESA users is based on prior ESA dose. The dose is adjusted thereafter in order to achieve the target range.

Drug: Iron Therapy

Participants will receive supplemental iron therapy if ferritin is <=100 ng/mL or TSAT is <=20%. The investigator will choose the route of administration and dose of iron.

Active Comparator: Darbepoetin alfa

Participants will be administered darbepoetin alfa subcutaneously (SC).

Drug: Placebo

Oral placebo tablets will be taken from Week -4 up to randomization (Day 1).

Drug: Iron Therapy

Participants will receive supplemental iron therapy if ferritin is <=100 ng/mL or TSAT is <=20%. The investigator will choose the route of administration and dose of iron.

Drug: Darbepoetin alfa

The initial dose of darbepoetin alfa to be administered for SC injection for ESA naïve subjects is based in Hgb and weight, and for ESA users is based on converting the prior ESA dose to the nearest available study darbepoetin alfa dose. The dose is adjusted thereafter in order to achieve the target range. IV darbepoetin alfa can be considered for participants transitioning to hemodialysis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to First Occurrence of Adjudicated Major Adverse Cardiovascular Event (MACE) During Cardiovascular (CV) Events Follow-up Time Period (Non-inferiority Analysis) Time Frame: Up to 4.3 person-years for CV follow-up time period	Time to MACE defined as time to first occurrence of Clinical Events Committee (CEC) adjudicated MACE (composite of all-cause mortality, non-fatal myocardial infarction [MI] and non-fatal stroke) was analyzed using a Cox proportional hazards regression model with treatment group, current erythropoiesis-stimulating agents (ESA) use at randomization and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) plus (+) 1. The incidence rate per 100 person years calculated as (100 multiplied [*] number of participants with at least 1 event) divided by [/] first event person-years) is presented along with 95 percent (%) confidence interval (CI). First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.	Up to 4.3 person-years for CV follow-up time period
Mean Change From Baseline in Hgb Levels Over the Evaluation Period (Week 28 to Week 52) Time Frame: Baseline (Pre-dose on Day 1) and evaluation period (Week 28 to Week 52)	Blood samples were collected from participants for Hgb measurements. Hgb during the evaluation period was defined as the mean of all available post-randomization Hgb values (on and off-treatment) during the evaluation period (Week 28 to Week 52). For the primary analysis missing post-Baseline Hgb values were imputed using pre-specified multiple imputation methods. Change from Baseline was defined as post-Baseline value minus (-) Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. Analysis was performed using the Analysis of covariance (ANCOVA) model with terms for treatment, Baseline Hgb, current ESA use and region.	Baseline (Pre-dose on Day 1) and evaluation period (Week 28 to Week 52)

Secondary Outcome Measures

Collaborators and Investigators

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

Sponsor

GlaxoSmithKline

Investigators

Study Director: GSK Clinical Trials, GlaxoSmithKline

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.
Perkovic V, Blackorby A, Cizman B, Carroll K, Cobitz AR, Davies R, DiMino TL, Jha V, Johansen KL, Lopes RD, Kler L, Macdougall IC, McMurray JJV, Meadowcroft AM, Obrador GT, Solomon S, Taft L, Wanner C, Waikar SS, Wheeler DC, Wiecek A, Singh AK. The ASCEND-ND trial: study design and participant characteristics. Nephrol Dial Transplant. 2022 Oct 19;37(11):2157-2170. doi: 10.1093/ndt/gfab318.
Ajay K. Singh, Kevin Carroll, John J. V. McMurray, Scott Solomon, Vivekanand Jha, Kirsten L. Johansen, Renato D. Lopes, Iain C. Macdougall, Gregorio T. Obrador, Sushrut S. Waikar, Christoph Wanner, David C. Wheeler, Andrzej Wiecek, Allison Blackorby, Borut Cizman, Alexander R. Cobitz, Rich Davies, Tara L. DiMino, Lata Kler, Amy M. Meadowcroft, Lin Taft, Vlado Perkovic for the ASCEND-ND Study Group. DAPRODUSTAT FOR THE TREATMENT OF ANEMIA IN PATIENTS NOT UNDERGOING DIALYSIS. N Engl J Med. 2021; DOI: 10.1056/NEJMoa2113380 PMID: 34739196
Singh AK, Carroll K, McMurray JJV, Solomon S, Jha V, Johansen KL, Lopes RD, Macdougall IC, Obrador GT, Waikar SS, Wanner C, Wheeler DC, Wiecek A, Blackorby A, Cizman B, Cobitz AR, Davies R, DiMino TL, Kler L, Meadowcroft AM, Taft L, Perkovic V; ASCEND-ND Study Group. Daprodustat for the Treatment of Anemia in Patients Not Undergoing Dialysis. N Engl J Med. 2021 Dec 16;385(25):2313-2324. doi: 10.1056/NEJMoa2113380. Epub 2021 Nov 5.

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)

September 27, 2016

Primary Completion (Actual)

April 19, 2021

Study Completion (Actual)

April 19, 2021

Study Registration Dates

First Submitted

August 19, 2016

First Submitted That Met QC Criteria

August 19, 2016

First Posted (Estimated)

August 24, 2016

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

April 1, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

200808
2016-000542-65 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

IPD Sharing Time Frame

Anonymized IPD is made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.

IPD Sharing Access Criteria

Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

IPD Sharing Supporting Information Type

STUDY_PROTOCOL
SAP
ICF
CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

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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Accepts Healthy Volunteers

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Primary Outcome Measures

Outcome Measure

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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 (Estimated)

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)?

IPD Plan Description

IPD Sharing Time Frame

IPD Sharing Access Criteria

IPD Sharing Supporting Information Type

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

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