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

November 5, 2021 updated by: GlaxoSmithKline

A Phase 3 Randomized, Open-label (Sponsor-blind), Active-controlled, Parallel-group, Multi-center, Event Driven Study in Dialysis Subjects With Anemia Associated With Chronic Kidney Disease to Evaluate the Safety and Efficacy of Daprodustat Compared to Recombinant Human Erythropoietin, Following a Switch From Erythropoietin-stimulating Agents

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2964

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
  - Formosa, Argentina, P3600LLD
    - 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
  - Burzaco, Buenos Aires, Argentina, B1852FZD
    - GSK Investigational Site
  - Ciudad Evita, Buenos Aires, Argentina, B1778IFA
    - GSK Investigational Site
  - Pergamino, Buenos Aires, Argentina, B2700CPM
    - GSK Investigational Site
  - Pilar, Buenos Aires, Argentina, 1629
    - GSK Investigational Site
- Córdova
  - Córdoba, Córdova, Argentina, X5016KEH
    - GSK Investigational Site
Australia
- - Murdoch, Australia, 6150
    - GSK Investigational Site
- New South Wales
  - Concord, New South Wales, Australia, 2139
    - GSK Investigational Site
  - Kingswood, New South Wales, Australia, 2750
    - GSK Investigational Site
  - Kogarah, New South Wales, Australia, 2217
    - GSK Investigational Site
  - Liverpool, New South Wales, Australia, 2170
    - GSK Investigational Site
  - St Leonards, New South Wales, Australia, 2065
    - GSK Investigational Site
  - Westmead, New South Wales, Australia, 2145
    - GSK Investigational Site
  - Wollongong, New South Wales, Australia, 2500
    - GSK Investigational Site
- Queensland
  - Birtinya, Queensland, Australia, 4575
    - GSK Investigational Site
  - Herston, Queensland, Australia, 4006
    - GSK Investigational Site
  - Woolloongabba, Queensland, Australia, 4102
    - GSK Investigational Site
- South Australia
  - Adelaide, South Australia, Australia, 5000
    - GSK Investigational Site
- Victoria
  - Clayton, Victoria, Australia, 3168
    - GSK Investigational Site
  - Melbourne, Victoria, Australia, 3004
    - GSK Investigational Site
  - St Albans, Victoria, Australia, 3021
    - GSK Investigational Site
- Western Australia
  - Nedlands, Western Australia, Australia, 6009
    - GSK Investigational Site
Austria
- - Graz, Austria, 8036
    - GSK Investigational Site
  - St. Pölten, Austria, 3100
    - GSK Investigational Site
  - Wien, Austria, 1030
    - GSK Investigational Site
  - Wien, Austria, A-1130
    - GSK Investigational Site
Belgium
- - Baudour, Belgium, 7331
    - GSK Investigational Site
  - Brugge, Belgium, 8310
    - GSK Investigational Site
  - Brussels, Belgium, 1200
    - GSK Investigational Site
  - Bruxelles, Belgium, 1020
    - GSK Investigational Site
  - Hasselt, Belgium, 3500
    - 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
Brazil
- - Belo Horizonte, Minas Gerais, Brazil, 30150-221
    - GSK Investigational Site
  - Feira de Santana, Brazil, 44001-584
    - GSK Investigational Site
  - Porto Alegre, Brazil, 90035-070
    - GSK Investigational Site
  - Porto Alegre, Brazil, 90035-903
    - GSK Investigational Site
  - Sao Paulo, Brazil, 01323-001
    - GSK Investigational Site
  - São Paulo, Brazil, 01323903
    - GSK Investigational Site
  - São Paulo, Brazil, 04005-000
    - GSK Investigational Site
  - São Paulo, Brazil, 04039-000
    - GSK Investigational Site
  - São Paulo, Brazil, 08270-070
    - GSK Investigational Site
- Bahia
  - Salvador, Bahia, Brazil, 40415-065
    - GSK Investigational Site
- Paraná
  - Curitiba, Paraná, Brazil, 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, 90610-000
    - GSK Investigational Site
- Santa Catarina
  - Joinville, Santa Catarina, Brazil, 89227-680
    - GSK Investigational Site
- São Paulo
  - Sao Jose do Rio Preto, São Paulo, Brazil, 15090-000
    - GSK Investigational Site
Bulgaria
- - Blagoevgrad, Bulgaria, 2700
    - GSK Investigational Site
  - Dobrich, Bulgaria, 9300
    - GSK Investigational Site
  - Gabrovo, Bulgaria, 5300
    - GSK Investigational Site
  - Lom, Bulgaria, 3600
    - GSK Investigational Site
  - Lovech, Bulgaria, 5500
    - GSK Investigational Site
  - Montana, Bulgaria, 3400
    - GSK Investigational Site
  - Pazardzhik, Bulgaria, 4400
    - GSK Investigational Site
  - Plovdiv, Bulgaria, 4000
    - GSK Investigational Site
  - Plovdiv, Bulgaria, 4003
    - GSK Investigational Site
  - Ruse, Bulgaria, 7002
    - GSK Investigational Site
  - Smolyan, Bulgaria, 4700
    - GSK Investigational Site
  - Sofia, Bulgaria, 1233
    - GSK Investigational Site
  - Sofia, Bulgaria, 1709
    - GSK Investigational Site
  - Sofia, Bulgaria, 1309
    - GSK Investigational Site
  - Varna, Bulgaria, 9000
    - GSK Investigational Site
  - Veliko Tarnovo, Bulgaria, 5000
    - GSK Investigational Site
Canada
- Alberta
  - Edmonton, Alberta, Canada, T6G 2B7
    - GSK Investigational Site
- Ontario
  - London, Ontario, Canada, N6A 5A5
    - GSK Investigational Site
  - Toronto, Ontario, Canada, M3M 0B2
    - GSK Investigational Site
Czechia
- - Beroun, Czechia, 26601
    - GSK Investigational Site
  - Frýdek-mistek, Czechia, 738 18
    - 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
  - Pardubice, Czechia, 53203
    - GSK Investigational Site
  - Praha 2, Czechia, 128 08
    - GSK Investigational Site
  - Praha 4, Czechia, 14021
    - GSK Investigational Site
  - Praha 4, Czechia, 142 00
    - 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
  - Svendborg, Denmark, 5700
    - GSK Investigational Site
Estonia
- - Parnu, Estonia, 80011
    - GSK Investigational Site
  - Tallinn, Estonia, EE-13419
    - GSK Investigational Site
  - Tartu, Estonia, 50501
    - GSK Investigational Site
France
- - Annonay, France, 07103
    - GSK Investigational Site
  - Bois-Guillaume, France, 76230
    - GSK Investigational Site
  - Bordeaux, France, 33076
    - GSK Investigational Site
  - Boulogne Billancourt, France, 92100
    - GSK Investigational Site
  - Caen Cedex 9, France, 14033
    - GSK Investigational Site
  - Mulhouse, France, 68100
    - GSK Investigational Site
  - Poitiers, France, 86021
    - GSK Investigational Site
  - Reims, France, 51092
    - GSK Investigational Site
  - Tours cedex 9, France, 37044
    - GSK Investigational Site
Germany
- - Dieburg, Germany, 64807
    - GSK Investigational Site
  - Freiburg, Germany, 79110
    - GSK Investigational Site
  - Minden, Germany, 32429
    - GSK Investigational Site
- Baden-Wuerttemberg
  - Mannheim, Baden-Wuerttemberg, Germany, 68167
    - GSK Investigational Site
- Hessen
  - Bad Koenig, Hessen, Germany, 64732
    - GSK Investigational Site
  - Wiesbaden, Hessen, Germany, 65191
    - GSK Investigational Site
- Mecklenburg-Vorpommern
  - Rostock, Mecklenburg-Vorpommern, Germany, 18059
    - GSK Investigational Site
- Niedersachsen
  - Cloppenburg, Niedersachsen, Germany, 49661
    - GSK Investigational Site
- Nordrhein-Westfalen
  - Duesseldorf, Nordrhein-Westfalen, Germany, 40210
    - GSK Investigational Site
- Rheinland-Pfalz
  - Kaiserslautern, Rheinland-Pfalz, Germany, 67655
    - GSK Investigational Site
- Schleswig-Holstein
  - Kiel, Schleswig-Holstein, Germany, 24105
    - GSK Investigational Site
Greece
- - Alexandroupolis, Greece, 68100
    - GSK Investigational Site
  - Arta, Greece, 471 00
    - GSK Investigational Site
  - Athens, Greece, 11527
    - 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, 41110
    - GSK Investigational Site
  - Patras, Greece, 26500
    - GSK Investigational Site
  - Thessaloniki, Greece, 546 42
    - GSK Investigational Site
  - Thessaloniki, Greece, 54636
    - GSK Investigational Site
  - Thessaloniki, Greece, 56403
    - GSK Investigational Site
  - Thessaloniki, Greece, 57001
    - GSK Investigational Site
Hungary
- - Budapest, Hungary, 1077
    - GSK Investigational Site
  - Egri, Hungary, 3300
    - GSK Investigational Site
  - Esztergom, Hungary, 2500
    - GSK Investigational Site
  - Kecskemet, Hungary, 6001
    - GSK Investigational Site
  - Miskolc, Hungary, 3526
    - GSK Investigational Site
  - Pécs, Hungary, 7624
    - GSK Investigational Site
  - Pécs, Hungary, 7633
    - GSK Investigational Site
  - Szigetvar, Hungary, 7900
    - GSK Investigational Site
India
- - Ahmedabad, India, 380059
    - GSK Investigational Site
  - Bangalore, India, 560055
    - GSK Investigational Site
  - Bangalore, India, 560054
    - GSK Investigational Site
  - Calicut, India, 673008
    - GSK Investigational Site
  - Chennai, India, 600 034
    - GSK Investigational Site
  - Chennai, Tamil Nadu, India, 600 006
    - GSK Investigational Site
  - Delhi, India, 110076
    - GSK Investigational Site
  - Gurgaon, India, 122001
    - GSK Investigational Site
  - Hyderabad, India, 500034
    - GSK Investigational Site
  - Jaipur, India, 302004
    - GSK Investigational Site
  - Mumbai, India, 400016
    - 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, 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
Italy
- - Imola, Italy, 40026
    - GSK Investigational Site
  - Mestre, Italy, 30122
    - GSK Investigational Site
- Calabria
  - Catanzaro, Calabria, Italy, 88100
    - GSK Investigational Site
  - Reggio Calabria, Calabria, Italy, 89124
    - GSK Investigational Site
- Campania
  - Napoli, Campania, Italy, 80131
    - GSK Investigational Site
- Emilia-Romagna
  - Piacenza, Emilia-Romagna, Italy, 29100
    - GSK Investigational Site
- Liguria
  - Genova, Liguria, Italy, 16132
    - GSK Investigational Site
- Lombardia
  - Bergamo, Lombardia, Italy, 24127
    - GSK Investigational Site
  - Lecco, Lombardia, Italy, 23900
    - GSK Investigational Site
  - Milano, Lombardia, Italy, 20153
    - GSK Investigational Site
  - Monza, Lombardia, Italy, 20900
    - GSK Investigational Site
  - Pavia, Lombardia, Italy, 27100
    - GSK Investigational Site
  - Seriate, Lombardia, Italy, 24068
    - 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-si,, Korea, Republic of, 14647
    - GSK Investigational Site
  - Busan, Korea, Republic of, 48108
    - GSK Investigational Site
  - Daegu-si, Korea, Republic of, 42601
    - GSK Investigational Site
  - Daejeon, Korea, Republic of, 35233
    - GSK Investigational Site
  - Goyang-si, Korea, Republic of, 10475
    - GSK Investigational Site
  - Goyang-si, Korea, Republic of, 410-719
    - GSK Investigational Site
  - Goyang-si, Gyeonggi-do, Korea, Republic of, 411706
    - GSK Investigational Site
  - Gyeonggi-do, Korea, Republic of, 463-707
    - GSK Investigational Site
  - Incheon, Korea, Republic of, 405-760
    - GSK Investigational Site
  - Seoul, Korea, Republic of, 135-720
    - GSK Investigational Site
  - Seoul, Korea, Republic of, 05030
    - GSK Investigational Site
  - Seoul, Korea, Republic of, 07061
    - GSK Investigational Site
  - Seoul, Korea, Republic of, 158-710
    - GSK Investigational Site
  - Seoul, Korea, Republic of, 05355
    - GSK Investigational Site
  - Seoul, Korea, Republic of, 07441
    - GSK Investigational Site
  - Seoul, Korea, Republic of, 134-727
    - GSK Investigational Site
  - Seoul, Korea, Republic of, 150-713
    - 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
- - Batu Caves, Malaysia, 68100
    - GSK Investigational Site
  - Ipoh, Malaysia, 30990
    - GSK Investigational Site
  - Johor Bahru, Malaysia, 80100
    - GSK Investigational Site
  - Kuala Lumpur, Malaysia, 50603
    - 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
  - México, D.F., Mexico, 14080
    - GSK Investigational Site
  - Zapopan, Jalisco, Mexico, 45030
    - GSK Investigational Site
- Coahuila
  - Saltillo, Coahuila, Mexico, CP 25230
    - GSK Investigational Site
- Durango
  - Durango., Durango, Mexico, 34000
    - GSK Investigational Site
- Estado De México
  - Ciudad De México, Estado De México, Mexico, 14000
    - GSK Investigational Site
  - Cuautitlan Izcalli, Estado De México, Mexico, 54769
    - GSK Investigational Site
- Jalisco
  - Guadalajara, Jalisco, Mexico, 44650
    - GSK Investigational Site
  - Guadalajara, Jalisco, Mexico, 44620
    - GSK Investigational Site
- Querétaro
  - Queretaro, Querétaro, Mexico, 76000
    - GSK Investigational Site
- Yucatán
  - Merida, Yucatán, Mexico, 97070
    - 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
- - Hamilton, New Zealand, 2001
    - GSK Investigational Site
  - Hastings, New Zealand, 4156
    - GSK Investigational Site
  - Otahuhu, New Zealand, 1640
    - GSK Investigational Site
Norway
- - Oslo, Norway, 0405
    - GSK Investigational Site
  - Stavanger, Norway, 4011
    - GSK Investigational Site
Poland
- - Biala Podlaska, Poland, 21-500
    - GSK Investigational Site
  - Gdansk, Poland, 80-462
    - GSK Investigational Site
  - Grojec, Poland, 05-600
    - GSK Investigational Site
  - Kielce, Poland, 25-736
    - GSK Investigational Site
  - Kolo, Poland, 62-600
    - GSK Investigational Site
  - Kolobrzeg, Poland, 78-100
    - GSK Investigational Site
  - Lodz, Poland, 92-213
    - GSK Investigational Site
  - Lodz, Poland, 90-262
    - GSK Investigational Site
  - Olkusz, Poland, 32-300
    - GSK Investigational Site
  - Pruszkow, Poland, 05-800
    - GSK Investigational Site
  - Tomaszow Mazowiecki, Poland, 97-200
    - GSK Investigational Site
  - Warszawa, Poland, 02-758
    - GSK Investigational Site
  - Zary, Poland, 68-200
    - GSK Investigational Site
Portugal
- - Amadora, Portugal, 2700-391
    - GSK Investigational Site
  - Corroios., Portugal, 2855227
    - GSK Investigational Site
  - Covilhã, Portugal, 6200-000
    - GSK Investigational Site
  - Forte Da Casa, Portugal, 2625-437
    - GSK Investigational Site
  - Lisboa, Portugal, 1069-166
    - GSK Investigational Site
  - Lisboa, Portugal, 1250-203
    - GSK Investigational Site
  - Lisboa, Portugal, 1400-195
    - GSK Investigational Site
  - Lisboa, Portugal, 1750-130
    - GSK Investigational Site
  - Mirandela, Portugal, 5370-530
    - GSK Investigational Site
  - Portimão, Portugal, 8500-311
    - GSK Investigational Site
  - Vila Franca de Xira, Portugal, 2600-076
    - GSK Investigational Site
  - Vila Real (Lordelo), Portugal, 5000-668
    - GSK Investigational Site
Romania
- - Arad, Romania, 310141
    - GSK Investigational Site
  - Bucharest, Romania, 022328
    - GSK Investigational Site
  - Resita, Romania, 320166
    - GSK Investigational Site
  - Targu-Jiu, Romania, 210146
    - GSK Investigational Site
Russian Federation
- - Irkutsk, Russian Federation, 664049
    - GSK Investigational Site
  - Krasnodar, Russian Federation, 350029
    - GSK Investigational Site
  - Mytischi, Russian Federation, 141009
    - GSK Investigational Site
  - Nizhniy Novgorod, Russian Federation, 603126
    - GSK Investigational Site
  - Novosibirsk, Russian Federation, 630087
    - GSK Investigational Site
  - Omsk, Russian Federation, 644112
    - GSK Investigational Site
  - Orenburg, Russian Federation, 460040
    - GSK Investigational Site
  - Penza, Russian Federation, 440034
    - GSK Investigational Site
  - St-Petersburg, Russian Federation, 197110
    - GSK Investigational Site
  - St. Petersburg, Russian Federation, 196247
    - GSK Investigational Site
  - St. Petersburg, Russian Federation, 191104
    - GSK Investigational Site
  - St. Petersburg, Russian Federation, 194354
    - 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
South Africa
- - Cape Town, South Africa, 7500
    - GSK Investigational Site
  - Cape Town., South Africa, 7925
    - GSK Investigational Site
Spain
- - Alcala de Henares, Spain, 28805
    - GSK Investigational Site
  - Aranda de Duero, Spain, 09400
    - GSK Investigational Site
  - Badalona, Spain, 08916
    - GSK Investigational Site
  - Badalona, Spain, 08036
    - GSK Investigational Site
  - Barcelona, Spain, 08025
    - GSK Investigational Site
  - Barcelona, Spain, 08003
    - GSK Investigational Site
  - Ciudad Real, Spain, 13005
    - GSK Investigational Site
  - Girona, Spain, 17007
    - GSK Investigational Site
  - Guadalajara, Spain, 19002
    - GSK Investigational Site
  - Madrid, Spain, 28007
    - GSK Investigational Site
  - Madrid, Spain, 28040
    - GSK Investigational Site
  - Madrid, Spain, 28020
    - GSK Investigational Site
  - Manises (Valencia), Spain, 46940
    - GSK Investigational Site
  - Mollet del Valles, Spain, 08100
    - GSK Investigational Site
  - Málaga, Spain, 29530
    - GSK Investigational Site
  - Palma de Mallorca, Spain, 07120
    - GSK Investigational Site
  - Sabadell, Spain, 08208
    - GSK Investigational Site
  - Santiago de Compostela, Spain, 15706
    - GSK Investigational Site
  - Sevilla, Spain, 41071
    - GSK Investigational Site
  - Valladolid, Spain, 47005
    - GSK Investigational Site
- Madrid
  - Majadahonda, Madrid, Spain, 28222
    - GSK Investigational Site
Sweden
- - Stockholm, Sweden, SE-182 88
    - GSK Investigational Site
  - Stockholm, Sweden, SE-141 86
    - GSK Investigational Site
  - Uppsala, Sweden, 756 55
    - GSK Investigational Site
  - Örebro, Sweden, SE-701 85
    - GSK Investigational Site
Taiwan
- - Kaohsiung, Taiwan, 83301
    - GSK Investigational Site
  - Kaohsiung, Taiwan, 807
    - GSK Investigational Site
  - Keelung, Taiwan, 204
    - GSK Investigational Site
  - New Taipei, Taiwan, 220
    - GSK Investigational Site
  - New Taipei City, Taiwan, 23561
    - GSK Investigational Site
  - New Taipei City, Taiwan, 237
    - GSK Investigational Site
  - Tainan, Taiwan, 704
    - GSK Investigational Site
  - Taipei, Taiwan, 112
    - GSK Investigational Site
  - Taipei, Taiwan, 116
    - GSK Investigational Site
  - Taoyuan Hsien, Taiwan, 333
    - GSK Investigational Site
  - Zhongzheng Dist., Taipei, Taiwan, 10002
    - 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
  - Kayseri, Turkey, 38039
    - GSK Investigational Site
Ukraine
- - Chernihiv, Ukraine, 14029
    - GSK Investigational Site
  - Chernivtsi, Ukraine, 58005
    - GSK Investigational Site
  - Ivano-Frankivsk, Ukraine, 76008
    - GSK Investigational Site
  - Kherson, Ukraine, 73039
    - GSK Investigational Site
  - Kiev, Ukraine, 04107
    - GSK Investigational Site
  - Kyiv, Ukraine, 01023
    - GSK Investigational Site
  - Kyiv, Ukraine, 04050
    - GSK Investigational Site
  - Kyiv, Ukraine, 04112
    - GSK Investigational Site
  - Mykolaiv, Ukraine, 54058
    - 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
  - Derby, United Kingdom, DE22 3NE
    - GSK Investigational Site
  - Doncaster, United Kingdom, DN2 5LT
    - GSK Investigational Site
  - Dundee, United Kingdom, DD1 9SY
    - 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
  - London, United Kingdom, E1 1BB
    - GSK Investigational Site
  - London, United Kingdom, SE5 9RS
    - GSK Investigational Site
  - Oxford, United Kingdom, OX3 7LE
    - GSK Investigational Site
  - Salford, United Kingdom, M6 8HD
    - GSK Investigational Site
- Hertfordshire
  - Stevenage, Hertfordshire, United Kingdom, SG1 4AB
    - GSK Investigational Site
- Lancashire
  - Preston, Lancashire, United Kingdom, PR2 9HT
    - GSK Investigational Site
- West Midlands
  - Wolverhampton, West Midlands, United Kingdom, WV10 0QP
    - GSK Investigational Site
United States
- Alabama
  - Huntsville, Alabama, United States, 35805
    - GSK Investigational Site
- Arkansas
  - Pine Bluff, Arkansas, United States, 71603
    - GSK Investigational Site
- California
  - Anaheim, California, United States, 92801
    - GSK Investigational Site
  - Bakersfield, California, United States, 93308
    - GSK Investigational Site
  - Bakersfield, California, United States, 93309
    - GSK Investigational Site
  - Beverly Hills, California, United States, 90211
    - GSK Investigational Site
  - Cerritos, California, United States, 90703
    - GSK Investigational Site
  - Chula Vista, California, United States, 91910
    - GSK Investigational Site
  - El Centro, California, United States, 92243
    - GSK Investigational Site
  - Escondido, California, United States, 92025
    - GSK Investigational Site
  - Fairfield, California, United States, 94534
    - GSK Investigational Site
  - Fountain Valley, California, United States, 92708
    - GSK Investigational Site
  - Glendale, California, United States, 91205
    - GSK Investigational Site
  - Granada Hills, California, United States, 91344
    - GSK Investigational Site
  - Hacienda Heights, California, United States, 91745
    - GSK Investigational Site
  - La Mesa, California, United States, 91942
    - GSK Investigational Site
  - La Palma, California, United States, 90623
    - GSK Investigational Site
  - Lakewood, California, United States, 90712
    - GSK Investigational Site
  - Long Beach, California, United States, 90806
    - GSK Investigational Site
  - Long Beach, California, United States, 90813
    - GSK Investigational Site
  - Long Beach, California, United States, 90807
    - GSK Investigational Site
  - Los Angeles, California, United States, 90095
    - GSK Investigational Site
  - Los Angeles, California, United States, 90022
    - GSK Investigational Site
  - Lynwood, California, United States, 60262
    - GSK Investigational Site
  - Montebello, California, United States, 90640
    - GSK Investigational Site
  - Monterey Park, California, United States, 91754
    - GSK Investigational Site
  - Moreno Valley, California, United States, 92553
    - GSK Investigational Site
  - Norco, California, United States, 92860
    - GSK Investigational Site
  - Northridge, California, United States, 91324
    - GSK Investigational Site
  - Ontario, California, United States, 91762
    - GSK Investigational Site
  - Riverside, California, United States, 92501
    - GSK Investigational Site
  - Sacramento, California, United States, 95825
    - 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
  - Santa Clarita, California, United States, 91387
    - GSK Investigational Site
  - Simi Valley, California, United States, 93065-091
    - GSK Investigational Site
  - Tarzana, California, United States, 91356
    - GSK Investigational Site
  - Whittier, California, United States, 90602
    - GSK Investigational Site
  - Whittier, California, United States, 90603
    - GSK Investigational Site
  - Yorba Linda, California, United States, 92886
    - 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
  - Coral Gables, Florida, United States, 33134
    - GSK Investigational Site
  - Hollywood, Florida, United States, 33024
    - GSK Investigational Site
  - Jacksonville, Florida, United States, 32224
    - 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, 33126
    - GSK Investigational Site
  - Miami, Florida, United States, 33150
    - GSK Investigational Site
  - Miami Gardens, Florida, United States, 33169
    - GSK Investigational Site
  - Ocala, Florida, United States, 34471
    - GSK Investigational Site
  - Port Charlotte, Florida, United States, 33952
    - GSK Investigational Site
  - Spring Hill, Florida, United States, 34608
    - GSK Investigational Site
  - Winter Park, Florida, United States, 32789
    - GSK Investigational Site
- Georgia
  - 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
  - Meridian, Idaho, United States, 83642
    - GSK Investigational Site
- Illinois
  - Crystal Lake, Illinois, United States, 60014
    - GSK Investigational Site
- Indiana
  - Fort Wayne, Indiana, United States, 46804
    - GSK Investigational Site
  - Jeffersonville, Indiana, United States, 47130
    - GSK Investigational Site
  - Merrillville, Indiana, United States, 46410
    - GSK Investigational Site
  - Michigan City, Indiana, United States, 46360
    - GSK Investigational Site
- Iowa
  - Iowa City, Iowa, United States, 52242
    - 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
- Maryland
  - Greenbelt, Maryland, United States, 20770
    - GSK Investigational Site
  - Takoma Park, Maryland, United States, 20912-6385
    - GSK Investigational Site
- Michigan
  - Kalamazoo, Michigan, United States, 49007
    - GSK Investigational Site
  - Pontiac, Michigan, United States, 48341
    - GSK Investigational Site
  - Roseville, Michigan, United States, 48066
    - GSK Investigational Site
- Mississippi
  - Gulfport, Mississippi, United States, 39501
    - GSK Investigational Site
  - Tupelo, Mississippi, United States, 38801
    - GSK Investigational Site
- Missouri
  - Florissant, Missouri, United States, 63033
    - GSK Investigational Site
  - Kansas City, Missouri, United States, 64111
    - GSK Investigational Site
  - Saint Louis, Missouri, United States, 63110
    - GSK Investigational Site
- Nevada
  - Las Vegas, Nevada, United States, 89102
    - GSK Investigational Site
  - Las Vegas, Nevada, United States, 89107
    - GSK Investigational Site
- New Hampshire
  - Portsmouth, New Hampshire, United States, 3801
    - GSK Investigational Site
- New Mexico
  - Gallup, New Mexico, United States, 87301
    - GSK Investigational Site
- New York
  - Bronx, New York, United States, 10461
    - 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
  - Mineola, New York, United States, 11501
    - 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, 10710
    - GSK Investigational Site
- North Carolina
  - Asheville, North Carolina, United States, 28801
    - GSK Investigational Site
  - Clyde, North Carolina, United States, 28721
    - GSK Investigational Site
  - Raleigh, North Carolina, United States, 27609
    - GSK Investigational Site
  - Winston-Salem, North Carolina, United States, 27103
    - GSK Investigational Site
  - Winston-Salem, North Carolina, United States, 27517
    - GSK Investigational Site
- Ohio
  - Canton, Ohio, United States, 44718
    - GSK Investigational Site
  - Cincinnati, Ohio, United States, 45206
    - GSK Investigational Site
  - Cincinnati, Ohio, United States, 45220
    - GSK Investigational Site
- Oregon
  - Roseburg, Oregon, United States, 97471
    - GSK Investigational Site
- Pennsylvania
  - Bethlehem, Pennsylvania, United States, 18017
    - GSK Investigational Site
  - Philadelphia, Pennsylvania, United States, 19140
    - GSK Investigational Site
- Rhode Island
  - Providence, Rhode Island, United States, 02903
    - GSK Investigational Site
- South Carolina
  - Anderson, South Carolina, United States, 29621
    - GSK Investigational Site
  - Charleston, South Carolina, United States, 29425
    - 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
  - Knoxville, Tennessee, United States, 37924
    - GSK Investigational Site
  - Nashville, Tennessee, United States, 37205
    - GSK Investigational Site
- Texas
  - Beaumont, Texas, United States, 77701
    - GSK Investigational Site
  - Houston, Texas, United States, 77030
    - GSK Investigational Site
  - Houston, Texas, United States, 77099
    - GSK Investigational Site
  - Houston, Texas, United States, 77004
    - GSK Investigational Site
  - Lufkin, Texas, United States, 75904
    - GSK Investigational Site
  - San Antonio, Texas, United States, 78258
    - GSK Investigational Site
  - San Antonio, Texas, United States, 78221
    - GSK Investigational Site
  - San Antonio, Texas, United States, 78207
    - GSK Investigational Site
  - San Antonio, Texas, United States, 78251
    - 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
- Wisconsin
  - Shorewood, Wisconsin, United States, 53211
    - 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

Genders Eligible for Study

All

Description

Inclusion Criteria:

Age: 18 to 99 years of age (inclusive).
Erythropoietin-stimulating agents (ESAs): Use of any approved ESA for at least the 6 weeks prior to screening and between screening and randomization.
Hgb concentration: On Week -8: Hgb 8 to 12 grams per deciliter (g/dL). On randomization (Day 1): Hgb 8 to 11 g/dL and receiving at least the minimum ESA dose. Hgb >11 g/dL to 11.5 g/dL and receiving greater than the minimum ESA dose.
Dialysis: On dialysis >90 days prior to screening and continuing on the same mode of dialysis from screening (Week -8) through to randomization (Day 1).
Frequency of Dialysis: Hemodialysis (HD) >=2 times/week and peritoneal dialysis (PD) >=5 times/week. Home hemodialysis >=2 times/week.
Compliance with placebo [randomization (Day 1) only]: >=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 listed in the consent form and in this protocol.

Exclusion Criteria:

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 that would contraindicate the use of recombinant human erythropoietin (rhEPO).
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 QT 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 epoetin alfa 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).
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 serum 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 listed in the List of Highly Effective Methods for Avoiding Pregnancy.
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 rhEPO) 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: Daprodustat Daprodustat dose is based on prior ESA dose, the dose is adjusted thereafter in order to achieve the target range. 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.
Active Comparator: rhEPO Participants on peritoneal dialysis (PD) will be administered darbepoetin alfa subcutaneously (SC) and participants on hemodialysis (HD) will be administered epoetin alfa intravenously (IV).	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: rhEPO The initial ESA dose is based on converting the prior ESA dose to the nearest available study rhEPO dose and is administered IV. The dose is adjusted thereafter in order to achieve the target range.

Participant Group / Arm

Intervention / Treatment

Experimental: Daprodustat

Participants will receive oral daprodustat once daily.

Drug: Daprodustat

Daprodustat dose is based on prior ESA dose, the dose is adjusted thereafter in order to achieve the target range.

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.

Active Comparator: rhEPO

Participants on peritoneal dialysis (PD) will be administered darbepoetin alfa subcutaneously (SC) and participants on hemodialysis (HD) will be administered epoetin alfa intravenously (IV).

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: rhEPO

The initial ESA dose is based on converting the prior ESA dose to the nearest available study rhEPO dose and is administered IV. The dose is adjusted thereafter in order to achieve the target range.

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 3.9 person-years for CV follow-up time period	Time to MACE defined as the 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, dialysis type 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 by [*] 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 3.9 person-years for CV follow-up time period
Mean Change From Baseline in Hemoglobin (Hgb) Levels During 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 hemoglobin measurements. Hemoglobin during the evaluation period was defined as the mean of all available post-randomization hemoglobin values (on and off-treatment) during the evaluation period (Week 28 to Week 52). For the primary analysis, missing post-Baseline hemoglobin 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.	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

Publications and helpful links

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

General Publications

Study record dates

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

Study Major Dates

Study Start (Actual)

September 28, 2016

Primary Completion (Actual)

November 9, 2020

Study Completion (Actual)

November 9, 2020

Study Registration Dates

First Submitted

August 22, 2016

First Submitted That Met QC Criteria

August 22, 2016

First Posted (Estimate)

August 25, 2016

Study Record Updates

Last Update Posted (Actual)

December 3, 2021

Last Update Submitted That Met QC Criteria

November 5, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

200807
2016-000541-31 (EudraCT Number)

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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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Anaemia

Clinical Trials on Daprodustat

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malawi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations