- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02892149
Efficacy and Safety Study to Evaluate Vadadustat for the Maintenance Treatment of Anemia in Participants With Dialysis-dependent Chronic Kidney Disease (DD-CKD)
June 7, 2022 updated by: Akebia Therapeutics
Phase 3, Randomized, Open-Label, Active-Controlled Study Evaluating the Efficacy and Safety of Oral Vadadustat for the Maintenance Treatment of Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD) (INNO2VATE-CONVERSION)
A multicenter, randomized, open-label, active-controlled Phase 3 study for the maintenance treatment of anemia in participants with dialysis-dependent chronic kidney disease (DD-CKD)
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a multicenter, randomized, open-label, active-controlled Phase 3 study of the efficacy and safety of Vadadustat versus Darbepoetin alfa for the maintenance treatment of anemia in participants with DD-CKD
Study Type
Interventional
Enrollment (Actual)
3554
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Cordoba, Argentina, 5000
- Research Site
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Cordoba, Argentina, X5000EVQ
- Research Site
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Corrientes, Argentina, 3400
- Research Site
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Salta, Argentina, A4400AXO
- Research Site
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San Luis, Argentina, 5700
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Buenos Aires
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Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina, C1181ACH
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Junin, Buenos Aires, Argentina, 6000
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Pergamino, Buenos Aires, Argentina, B2700CPM
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Sarandi, Buenos Aires, Argentina, B1872EEA
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New South Wales
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Liverpool, New South Wales, Australia, 2170
- Research Site
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New Lambton Heights, New South Wales, Australia, 2305
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Wahroonga, New South Wales, Australia, 2076
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Queensland
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Cairns, Queensland, Australia, 4870
- Research Site
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Tasmania
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Launceston, Tasmania, Australia, 7250
- Research Site
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Victoria
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Box Hill, Victoria, Australia, 3128
- Research Site
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Fitzroy, Victoria, Australia, 3065
- Research Site
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Western Australia
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Nedlands, Western Australia, Australia, 6009
- Research Site
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Bahia
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Feira de Santana, Bahia, Brazil, 44001-584
- Research Site
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Itabuna, Bahia, Brazil, 45600-625
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Ceará
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Fortaleza, Ceará, Brazil, 60430-370
- Research Site
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Espírito Santo
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Vitória, Espírito Santo, Brazil, 29055-450
- Research Site
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brazil, 30130-100
- Research Site
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Belo Horizonte, Minas Gerais, Brazil, 30150-221
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Juiz de Fora, Minas Gerais, Brazil, 36025-330
- Research Site
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Juiz de Fora, Minas Gerais, Brazil, 36036-330
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Paraná
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Curitiba, Paraná, Brazil, 80010-030
- Research Site
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Maringá, Paraná, Brazil, 87060-040
- Research Site
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Rio Grande Do Sul
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Canoas, Rio Grande Do Sul, Brazil, 92425-900
- Research Site
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Passo Fundo, Rio Grande Do Sul, Brazil, 99010-080
- Research Site
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Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
- Research Site
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Porto Alegre, Rio Grande Do Sul, Brazil, 90035-074
- Research Site
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Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
- Research Site
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Porto Alegre, Rio Grande Do Sul, Brazil, 90160-093
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Santa Catarina
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Criciúma, Santa Catarina, Brazil, 88801-250
- Research Site
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Joinville, Santa Catarina, Brazil, 89202-050
- Research Site
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Sao Paulo
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Santo André, Sao Paulo, Brazil, 09080-110
- Research Site
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Santo André, Sao Paulo, Brazil, 09090-790
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São Bernardo do Campo, Sao Paulo, Brazil, 09715-090
- Research Site
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São José do Rio Preto, Sao Paulo, Brazil, 15015-200
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São Paulo, Sao Paulo, Brazil, 01232-010
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São Paulo, Sao Paulo, Brazil, 04039-000
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São Paulo, Sao Paulo, Brazil, 05403-000
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Byala, Bulgaria, 7100
- Research Site
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Cherven bryag, Bulgaria, 5980
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Dobrich, Bulgaria, 9300
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Dupnitsa, Bulgaria, 2600
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Haskovo, Bulgaria, 6300
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Plovdiv, Bulgaria, 4002
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Ruse, Bulgaria, 7002
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Shumen, Bulgaria, 9700
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Silistra, Bulgaria, 7500
- Research Site
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Sliven, Bulgaria, 8800
- Research Site
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Sofia, Bulgaria, 1407
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Sofia, Bulgaria, 1233
- Research Site
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Sofia, Bulgaria, 1750
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Varna, Bulgaria, 9002
- Research Site
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Veliko Tarnovo, Bulgaria, 5000
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Vidin, Bulgaria, 3700
- Research Site
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Vratsa, Bulgaria, 3000
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 2Y0
- Research Site
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Sydney, Nova Scotia, Canada, B1P 1P3
- Research Site
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Ontario
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Oshawa, Ontario, Canada, L1H 1B9
- Research Site
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Sudbury, Ontario, Canada, P3E 5J1
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Quebec
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Greenfield Park, Quebec, Canada, J4V 2H1
- Research Site
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Montréal, Quebec, Canada, H2X 3J4
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Paris, France, 75015
- Research Site
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Paris, France, 75020
- Research Site
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Bouches-du-Rhône
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Marseille, Bouches-du-Rhône, France, 13005
- Research Site
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Gironde
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Bordeaux, Gironde, France, 33300
- Research Site
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Loire
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Saint-Priest-En-Jarez, Loire, France, 42055
- Research Site
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Marne
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Reims, Marne, France, 51092
- Research Site
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Berlin, Germany, 10117
- Research Site
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Baden Wuerttemberg
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Villingen-Schwenningen, Baden Wuerttemberg, Germany, 78054
- Research Site
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Mecklenburg Vorpommern
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Rostock, Mecklenburg Vorpommern, Germany, 18057
- Research Site
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Nordrhein Westfalen
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Duesseldorf, Nordrhein Westfalen, Germany, 40210
- Research Site
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Ashkelon, Israel, 78278
- Research Site
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Haifa, Israel, 34362
- Research Site
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Haifa, Israel, 3109601
- Research Site
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Jerusalem, Israel, 91031
- Research Site
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Kfar- Saba, Israel, 4428164
- Research Site
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Rishon Lezion, Israel, 75141
- Research Site
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Bari, Italy, 70124
- Research Site
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Genova, Italy, 16132
- Research Site
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Lecco, Italy, 23900
- Research Site
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Pavia, Italy, 27100
- Research Site
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Roma, Italy, 168
- Research Site
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Siena, Italy, 53100
- Research Site
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Busan, Korea, Republic of, 47392
- Research Site
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Busan, Korea, Republic of, 49201
- Research Site
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Seoul, Korea, Republic of, 6351
- Research Site
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Seoul, Korea, Republic of, 3080
- Research Site
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Seoul, Korea, Republic of, 2841
- Research Site
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Seoul, Korea, Republic of, 6591
- Research Site
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Seoul, Korea, Republic of, 7345
- Research Site
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Gangwon-do
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Chuncheon, Gangwon-do, Korea, Republic of, 200-702
- Research Site
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Gyeonggi-do
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Bucheon-si, Gyeonggi-do, Korea, Republic of, 14647
- Research Site
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Goyang-si, Gyeonggi-do, Korea, Republic of, 10380
- Research Site
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Goyang-si, Gyeonggi-do, Korea, Republic of, 10444
- Research Site
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Guri, Gyeonggi-do, Korea, Republic of, 11923
- Research Site
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Seongnam-si,, Gyeonggi-do, Korea, Republic of, 13496
- Research Site
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Suwon-si, Gyeonggi-do, Korea, Republic of, 16247
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Hidalgo
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Pachuca, Hidalgo, Mexico, 42070
- Research Site
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Jalisco
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Zapopan, Jalisco, Mexico, 45030
- Research Site
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Michoacán
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Morelia, Michoacán, Mexico, 58260
- Research Site
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Sinaloa
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Culiacan, Sinaloa, Mexico, 80230
- Research Site
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Biala Podlaska, Poland, 21-500
- Research Site
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Golub Dobrzyn, Poland, 87-400
- Research Site
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Kolobrzeg, Poland, 78-100
- Research Site
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Lodz, Poland, 90-153
- Research Site
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Lodz, Poland, 93-338
- Research Site
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Lodz, Poland, 92-213
- Research Site
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Warszawa, Poland, 04-749
- Research Site
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Beja, Portugal, 7800-309
- Research Site
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Leiria, Portugal, 2400-441
- Research Site
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Loures, Portugal, 2674-514
- Research Site
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Ekaterinburg, Russian Federation, 620102
- Research Site
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Kemerovo, Russian Federation, 650066
- Research Site #2
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Moscow, Russian Federation, 123182
- Research Site
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Moscow, Russian Federation, 125466
- Research Site
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Nizhniy Novgorod, Russian Federation, 603076
- Research Site
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Nizhniy Novgorod, Russian Federation, 603001
- Research Site
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Novorossiysk, Russian Federation, 353915
- Research Site
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Saint-Petersburg, Russian Federation, 197022
- Research Site
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Saint-Petersburg, Russian Federation, 197110
- Research Site
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Saint-Petersburg, Russian Federation, 195067
- Research Site
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St. Petersburg, Russian Federation, 198205
- Research Site
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St. Petersburg, Russian Federation, 199004
- Research Site
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Belgrade, Serbia, 11000
- Research Site #1
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Belgrade, Serbia, 11000
- Research Site #2
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Belgrade, Serbia, 11000
- Research Site #3
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Belgrade, Serbia, 11000
- Research Site #4
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Kragujevac, Serbia, 34000
- Research Site
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Nis, Serbia, 18000
- Research Site
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Zajecar, Serbia, 19000
- Research Site
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Brovary, Ukraine, 7400
- Research Site
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Cherkassy, Ukraine, 18009
- Research Site #1
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Dnipro, Ukraine, 49005
- Research Site
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Ivano-Frankivsk, Ukraine, 76008
- Research Site
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Kharkiv, Ukraine, 61037
- Research Site
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Kyiv, Ukraine, 2125
- Research Site
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Mykolaiv, Ukraine, 54058
- Research Site
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Ternopil, Ukraine, 46002
- Research Site
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Uzhgorod, Ukraine, 88018
- Research Site
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Vinnytsia, Ukraine, 21018
- Research Site
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Zaporizhzhia, Ukraine, 69600
- Research Site
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Zhytomyr, Ukraine, 10002
- Research Site
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Cambridgeshire
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Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
- Research Site
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Greater London
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London, Greater London, United Kingdom, SE5 9RS
- Research Site
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Hertfordshire
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Stevenage, Hertfordshire, United Kingdom, SG1 4AB
- Research Site
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Leicestershire
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Kettering, Leicestershire, United Kingdom, NN16 8DB
- Research Site
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South Yorkshire
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Doncaster, South Yorkshire, United Kingdom, DN2 5LT
- Research Site
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Alabama
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Huntsville, Alabama, United States, 35805
- Research Site
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Arizona
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Mesa, Arizona, United States, 85210
- Research Site
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Arkansas
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Pine Bluff, Arkansas, United States, 71603
- Research Site
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California
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Anaheim, California, United States, 92801
- Research Site
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Bakersfield, California, United States, 93309
- Research Site #1
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Bakersfield, California, United States, 93309
- Research Site #2
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Canyon Country, California, United States, 91387
- Research Site
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Chula Vista, California, United States, 91910
- Research Site
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Downey, California, United States, 90240
- Research Site
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El Centro, California, United States, 92243
- Research Site
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Escondido, California, United States, 92025
- Research Site
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Fairfield, California, United States, 94534
- Research Site
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Glendale, California, United States, 91206
- Research Site
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Granada Hills, California, United States, 91344
- Research Site #1
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Granada Hills, California, United States, 91344
- Research Site #2
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La Habra, California, United States, 90631
- Research Site
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La Mesa, California, United States, 91942
- Research Site
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Lakewood, California, United States, 90712-2512
- Research Site
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Long Beach, California, United States, 90813
- Research Site
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Long Beach, California, United States, 90807
- Research Site
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Long Beach, California, United States, 92886
- Research Site
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Los Angeles, California, United States, 90022
- Research Site
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Montebello, California, United States, 90640
- Research Site #1
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Monterey Park, California, United States, 91754
- Research Site
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Newhall, California, United States, 91321
- Research Site
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Northridge, California, United States, 91324
- Research Site #1
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Northridge, California, United States, 91324
- Research Site #2
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Riverside, California, United States, 92505
- Research Site
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Riverside, California, United States, 92503
- Research Site
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Roseville, California, United States, 95661
- Research Site
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Sacramento, California, United States, 95825
- Research Site
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San Diego, California, United States, 92111
- Research Site
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San Diego, California, United States, 92115
- Research Site
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San Dimas, California, United States, 91773
- Research Site #1
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San Dimas, California, United States, 91773
- Research Site #2
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Simi Valley, California, United States, 93065
- Research Site
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Tarzana, California, United States, 91356
- Research Site
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Whittier, California, United States, 90603
- Research Site
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Whittier, California, United States, 90606
- Research Site
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Colorado
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Arvada, Colorado, United States, 80002
- Research Site
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Denver, Colorado, United States, 80230
- Research Site
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Westminster, Colorado, United States, 80031
- Research Site
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Connecticut
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Stamford, Connecticut, United States, 06902
- Research Site
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Florida
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Bradenton, Florida, United States, 34209
- Research Site
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Coral Gables, Florida, United States, 33134
- Research Site
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Coral Springs, Florida, United States, 33065
- Research Site
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Coral Springs, Florida, United States, 33071
- Research Site
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Hollywood, Florida, United States, 33024
- Research Site
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Lauderdale Lakes, Florida, United States, 33313
- Research Site #1
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Miami, Florida, United States, 33173
- Research Site
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Miami, Florida, United States, 33150
- Research Site
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Miami, Florida, United States, 33145
- AMPM Research Clinic
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Miami, Florida, United States, 33125
- Research Site
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Miami Beach, Florida, United States, 33140
- Research Site
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Ocala, Florida, United States, 34471
- Research Site
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Pembroke Pines, Florida, United States, 33026
- Research Site
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Tampa, Florida, United States, 33614
- Research Site
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Winter Park, Florida, United States, 32789
- Research Site
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Georgia
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Augusta, Georgia, United States, 30904
- Research Site
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Columbus, Georgia, United States, 31904
- Research Site #1
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Columbus, Georgia, United States, 31904
- Research Site #2
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Lawrenceville, Georgia, United States, 30046
- Research Site #1
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Lawrenceville, Georgia, United States, 30046
- Research Site #2
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Roswell, Georgia, United States, 30076
- Research Site
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Statesboro, Georgia, United States, 30458
- Research Site
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Idaho
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Meridian, Idaho, United States, 83642
- Research Site
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Indiana
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Fort Wayne, Indiana, United States, 46804
- Research Site
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Merrillville, Indiana, United States, 46410
- Research Site
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Louisiana
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Monroe, Louisiana, United States, 71201
- Research Site
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Shreveport, Louisiana, United States, 71101
- Research Site
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Maryland
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Takoma Park, Maryland, United States, 20912
- Research Site
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Massachusetts
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Springfield, Massachusetts, United States, 01107
- Research Site
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Michigan
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Detroit, Michigan, United States, 48202
- Research Site
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Pontiac, Michigan, United States, 48341
- Research Site
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Port Huron, Michigan, United States, 91344
- Research Site
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Roseville, Michigan, United States, 48066
- Research Site
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Mississippi
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Columbus, Mississippi, United States, 39705
- Research Site
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Missouri
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Kansas City, Missouri, United States, 64111
- Research Site
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Saint Louis, Missouri, United States, 63136
- Research Site
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New Mexico
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Albuquerque, New Mexico, United States, 87109
- Research Site
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Gallup, New Mexico, United States, 87301
- Research Site
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Santa Fe, New Mexico, United States, 87505
- Research Site
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New York
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Astoria, New York, United States, 11102
- Research Site
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Bronx, New York, United States, 10461
- Research Site
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Flushing, New York, United States, 11355
- Research Site
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Great Neck, New York, United States, 11021
- Research Site
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New York, New York, United States, 10016
- Research Site
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New York, New York, United States, 10010
- Research Site
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Yonkers, New York, United States, 10710
- Research Site
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North Carolina
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Asheville, North Carolina, United States, 28801
- Research Site
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Charlotte, North Carolina, United States, 28204
- Research Site #1
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Charlotte, North Carolina, United States, 28204
- Research Site #2
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Durham, North Carolina, United States, 27704
- Research Site
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Greenville, North Carolina, United States, 27834
- Research Site
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New Bern, North Carolina, United States, 28562
- Research Site #1
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New Bern, North Carolina, United States, 28562
- Research Site #2
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Winston-Salem, North Carolina, United States, 27103
- Research Site
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19106
- Research Site
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Rhode Island
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Providence, Rhode Island, United States, 02903
- Research Site
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Tennessee
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Chattanooga, Tennessee, United States, 37408
- Research Site #1
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Chattanooga, Tennessee, United States, 37408
- Research Site #2
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Knoxville, Tennessee, United States, 37923
- Research Site
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Nashville, Tennessee, United States, 37205
- Research Site
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Texas
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Arlington, Texas, United States, 76015
- Research Site
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Austin, Texas, United States, 78705
- Research Site
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Austin, Texas, United States, 78758
- Research Site
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Austin, Texas, United States, 78751
- Research Site
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Dallas, Texas, United States, 75231
- Research Site
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Dallas, Texas, United States, 75235
- Research Site
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Duncanville, Texas, United States, 75137
- Research Site
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El Paso, Texas, United States, 77429
- Research Site
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Greenville, Texas, United States, 75402
- Research Site
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Houston, Texas, United States, 77030
- Research Site
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Houston, Texas, United States, 77054
- Research Site
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Houston, Texas, United States, 77099
- Research Site
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McAllen, Texas, United States, 78503
- Research Site
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San Antonio, Texas, United States, 78251
- Research Site
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San Antonio, Texas, United States, 78207
- Research Site
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San Antonio, Texas, United States, 78202
- Research Site
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San Antonio, Texas, United States, 78212-4740
- Research Site
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San Antonio, Texas, United States, 78221
- Research Site
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San Antonio, Texas, United States, 78229
- Research Site #2
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Utah
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Saint George, Utah, United States, 84790
- Research Site
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Vermont
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South Burlington, Vermont, United States, 05403
- Research Site
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Virginia
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Hampton, Virginia, United States, 23666
- Research Site
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Manassas, Virginia, United States, 20110
- Research Site
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Norfolk, Virginia, United States, 23502
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- ≥18 years of age
- Receiving chronic maintenance dialysis (either peritoneal or hemodialysis) for end-stage kidney disease for at least 12 weeks prior to Screening
- Currently maintained on erythropoiesis-stimulating agent therapy, with a dose received within 6 weeks prior to or during Screening
- Mean Screening hemoglobin between 8.0 and 11.0 grams per deciliter (g/dL) (inclusive) in the US and between 9.0 and 12.0 g/dL (inclusive) outside of the US
- Serum ferritin ≥100 nanograms per milliliter (ng/mL) and transferrin saturation (TSAT) ≥20% during Screening
Exclusion Criteria:
- Anemia due to a cause other than chronic kidney disease or participants with active bleeding or recent blood loss
- Uncontrolled hypertension
- Red blood cell transfusion within 8 weeks prior to randomization
- Anticipated to recover adequate kidney function to no longer require dialysis
- Severe heart failure at Screening (New York Heart Association Class IV)
- Acute coronary syndrome (hospitalization for unstable angina or myocardial infarction), surgical or percutaneous intervention for coronary, cerebrovascular or peripheral artery disease (aortic or lower extremity), surgical or percutaneous valvular replacement or repair, sustained ventricular tachycardia, hospitalization for heart failure, or stroke within 12 weeks prior to or during Screening
- Hypersensitivity to Vadadustat, Darbepoetin alfa, or any of their excipients
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Vadadustat
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Oral dose administered once daily for ≥36 weeks.
Dose adjustment based on hemoglobin level as defined in the protocol.
Other Names:
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Active Comparator: Darbepoetin alfa
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Subcutaneous or intravenous dose administered for ≥36 weeks.
Initial dose based on the current package insert for investigational sites in the United States (US), and the Summary of Product Characteristics for all other investigational sites (non-US) for adult participants with chronic kidney disease not on dialysis.
For participants already on Darbepoetin alfa, the initial dosing regimen in the study was based on the prior dosing regimen.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Hemoglobin (Hb) to the Average Over the Primary Efficacy Period (Weeks 24 to 36)
Time Frame: Baseline; Weeks 24 to 36
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The Baseline average was calculated as the average of the Hb values obtained at the screening visit closest to the date of randomization and the randomization visit.
The average for the Primary Efficacy Period was calculated as the average Hb value over Weeks 24 to 36.
Analysis was conducted using an analysis of covariance (ANCOVA) model with multiple imputation for missing data with Baseline hemoglobin concentration (<10.0 versus ≥10.0 g/dL), geographic region (United States [US] versus European Union [EU] versus Rest of World [ROW]), and New York Heart Association congestive heart failure (NYHA CHF) class (Class 0 [no CHF] or I versus II or III) as covariates.
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Baseline; Weeks 24 to 36
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Median Time to First Major Adverse Cardiovascular Event (MACE)
Time Frame: Up to 170 weeks
|
MACE was defined as all-cause mortality, non-fatal myocardial infarction (MI), or non-fatal stroke.
The primary safety outcome was positively adjudicated first MACE, which was defined as any death, Endpoint Adjudication Committee (EAC)-confirmed non-fatal MI, or EAC-confirmed non-fatal stroke occurring between the first dose date and each participant's last participation date.
INNOVATE MACE results and analysis, by design, was performed on pooled data from studies AKB-6548-CI-0016 (NCT02865850) and AKB-6548-CI-0017 (NCT02892149).
Results and statistical analysis from study AKB-6548-CI-0017 has been reported in below table and under section "Statistical Analysis 1".
Results and statistical analysis of the pooled data from studies AKB-6548-CI-0016 and AKB-6548-CI-0017 has been reported under section "Statistical Analysis 2" of this outcome measure.
|
Up to 170 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Hb to the Average Over the Secondary Efficacy Period (Weeks 40 to 52)
Time Frame: Baseline; Weeks 40 to 52
|
The Baseline average was calculated as the average of the Hb values obtained at the screening visit closest to the date of randomization and the randomization visit.
The average for the Secondary Efficacy Period was calculated as the average Hb value over Weeks 40 to 52.
Analysis was conducted using an ANCOVA model with multiple imputation for missing data with Baseline hemoglobin concentration (<10.0 versus ≥10.0 g/dL), geographic region (US versus EU versus ROW), and NYHA CHF class (Class 0 [no CHF] or I versus II or III) as covariates.
|
Baseline; Weeks 40 to 52
|
Median Time to First MACE Plus Hospitalization for Heart Failure or Thromboembolic Event Excluding Vascular Access Thrombosis
Time Frame: Up to 170 weeks
|
MACE was defined as all-cause mortality, non-fatal MI, or non-fatal stroke.
Hospitalization for EAC adjudicated heart failure included presentation of participants to an acute care facility requiring an overnight hospitalization (change in calendar day) with an exacerbation of heart failure requiring treatment.
EAC confirmed thromboembolic events for this secondary outcome measure included arterial thrombosis, deep vein thrombosis, and pulmonary embolism.
INNOVATE MACE results and analysis, by design, was performed on pooled data from studies AKB-6548-CI-0016 (NCT02865850) and AKB-6548-CI-0017 (NCT02892149).
Results and statistical analysis from study AKB-6548-CI-0017 has been reported in below table and under section "Statistical Analysis 1".
Results and statistical analysis of the pooled data from studies AKB-6548-CI-0016 and AKB-6548-CI-0017 has been reported under section "Statistical Analysis 2" of this outcome measure.
|
Up to 170 weeks
|
Median Time to First Cardiovascular MACE
Time Frame: Up to 170 weeks
|
MACE was defined as all-cause mortality, non-fatal MI, or non-fatal stroke.
Cardiovascular MACE analysis differed from the primary MACE endpoint as it included only deaths adjudicated by the EAC as cardiovascular deaths (i.e,
only EAC-confirmed cardiovascular deaths) in addition to first events of non-fatal MI or non-fatal stroke.
INNOVATE MACE results and analysis, by design, was performed on pooled data from studies AKB-6548-CI-0016 (NCT02865850) and AKB-6548-CI-0017 (NCT02892149).
Results and statistical analysis from study AKB-6548-CI-0017 has been reported in below table and under section "Statistical Analysis 1".
Results and statistical analysis of the pooled data from studies AKB-6548-CI-0016 and AKB-6548-CI-0017 has been reported under section "Statistical Analysis 2" of this outcome measure.
|
Up to 170 weeks
|
Median Time to First Cardiovascular Death
Time Frame: Up to 170 weeks
|
Cardiovascular death included EAC adjudicated fatal MI, pump failure, sudden death, presumed sudden death, fatal stroke, fatal pulmonary embolism, cardiovascular procedure-related death, other cardiovascular death, and presumed cardiovascular death.
INNOVATE MACE results and analysis, by design, was performed on pooled data from studies AKB-6548-CI-0016 (NCT02865850) and AKB-6548-CI-0017 (NCT02892149).
Results and statistical analysis from study AKB-6548-CI-0017 has been reported in below table and under section "Statistical Analysis 1".
Results and statistical analysis of the pooled data from studies AKB-6548-CI-0016 and AKB-6548-CI-0017 has been reported under section "Statistical Analysis 2" of this outcome measure.
|
Up to 170 weeks
|
Median Time to First All-cause Mortality
Time Frame: Up to 170 weeks
|
Only events that were positively adjudicated and confirmed by the EAC were included in the MACE analyses.
INNOVATE MACE results and analysis, by design, was performed on pooled data from studies AKB-6548-CI-0016 (NCT02865850) and AKB-6548-CI-0017 (NCT02892149).
Results and statistical analysis from study AKB-6548-CI-0017 has been reported in below table and under section "Statistical Analysis 1".
Results and statistical analysis of the pooled data from studies AKB-6548-CI-0016 and AKB-6548-CI-0017 has been reported under section "Statistical Analysis 2" of this outcome measure.
|
Up to 170 weeks
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Exploratory - Proportion of Participants With Hb Values Within the Target Range During the Primary Evaluation Period (Weeks 24 to 36)
Time Frame: Weeks 24 to 36
|
Weeks 24 to 36
|
Exploratory - Proportion of Time With Hb Values Within the Target Range During the Primary Evaluation Period (Weeks 24 to 36)
Time Frame: Weeks 24 to 36
|
Weeks 24 to 36
|
Exploratory - Proportion of Time With Hb Values Within the Target Range During the Secondary Evaluation Period (Weeks 40 to 52)
Time Frame: Weeks 40 to 52
|
Weeks 40 to 52
|
Exploratory - Proportion of Participants With Hb Values Within the Target Range During the Secondary Evaluation Period (Weeks 40 to 52)
Time Frame: Weeks 40 to 52
|
Weeks 40 to 52
|
Exploratory - Proportion of Participants With an Hb Increase of >1.0 g/dL From Baseline Visit
Time Frame: Baseline; up to Week 52
|
Baseline; up to Week 52
|
Exploratory - Time to Achieve Hb Increase of >1.0 g/dL From Baseline Visit
Time Frame: Baseline; up to Week 52
|
Baseline; up to Week 52
|
Exploratory - Mean Change in Hb Between Baseline (Mean Pretreatment Hb) and the Primary Evaluation Period (Mean Hb From Weeks 24 to 36) Stratified by Pre-baseline Erythropoiesis-stimulating Agent (ESA) Exposure
Time Frame: Baseline; Weeks 24 to 36
|
Baseline; Weeks 24 to 36
|
Exploratory - Mean Monthly Dose of Intravenous (IV) Elemental Iron Administered in Participants Who Have Received IV Iron
Time Frame: Up to Week 52
|
Up to Week 52
|
Exploratory - Proportion of Participants Receiving IV Iron Therapy
Time Frame: Up to Week 52
|
Up to Week 52
|
Exploratory - Proportion of Participants Receiving Red Blood Cells (RBCs) Transfusion(s)
Time Frame: Up to Week 52
|
Up to Week 52
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.
- Eckardt KU, Agarwal R, Aswad A, Awad A, Block GA, Bacci MR, Farag YMK, Fishbane S, Hubert H, Jardine A, Khawaja Z, Koury MJ, Maroni BJ, Matsushita K, McCullough PA, Lewis EF, Luo W, Parfrey PS, Pergola P, Sarnak MJ, Spinowitz B, Tumlin J, Vargo DL, Walters KA, Winkelmayer WC, Wittes J, Zwiech R, Chertow GM. Safety and Efficacy of Vadadustat for Anemia in Patients Undergoing Dialysis. N Engl J Med. 2021 Apr 29;384(17):1601-1612. doi: 10.1056/NEJMoa2025956.
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)
August 1, 2016
Primary Completion (Actual)
January 16, 2020
Study Completion (Actual)
March 30, 2020
Study Registration Dates
First Submitted
September 2, 2016
First Submitted That Met QC Criteria
September 2, 2016
First Posted (Estimate)
September 8, 2016
Study Record Updates
Last Update Posted (Actual)
June 28, 2022
Last Update Submitted That Met QC Criteria
June 7, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AKB-6548-CI-0017
- 2016-001360-11 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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