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Study to Investigate Efficacy, Safety, and Tolerability of Zibotentan/Dapagliflozin Compared to Dapagliflozin in Participants With Chronic Kidney Disease and High Proteinuria (ZENITH High Proteinuria)
Sponsor: AstraZeneca
Summary
This is a Phase III, randomised, multicentre, double-blinded study to evaluate efficacy, safety and tolerability of treatment with zibotentan/dapagliflozin and dapagliflozin alone in participants with chronic kidney disease (CKD) and high proteinuria
Official title: A Phase III, Randomised, Multicentre, Double-blind Study to Evaluate the Efficacy, Safety, and Tolerability of Zibotentan/Dapagliflozin Compared to Dapagliflozin Alone in Participants With Chronic Kidney Disease and High Proteinuria
Key Details
Gender
All
Age Range
18 Years - 95 Years
Study Type
INTERVENTIONAL
Enrollment
1835
Start Date
2023-11-07
Completion Date
2027-02-18
Last Updated
2026-03-25
Healthy Volunteers
No
Interventions
Zibotentan/Dapagliflozin
Participants will receive zibotentan/dapagliflozin in fixed-dose combination as per the arms they are randomized to
Dapagliflozin
Participants will receive dapagliflozin as per the arms they are randomized to
Locations (296)
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Huntsville, Alabama, United States
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Sun City West, Arizona, United States
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Bakersfield, California, United States
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Huntington Park, California, United States
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Los Alamitos, California, United States
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Los Angeles, California, United States
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Northridge, California, United States
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Oxnard, California, United States
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San Carlos, California, United States
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San Dimas, California, United States
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Tarzana, California, United States
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Victorville, California, United States
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Arvada, Colorado, United States
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Denver, Colorado, United States
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Boynton Beach, Florida, United States
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Hialeah, Florida, United States
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Hollywood, Florida, United States
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Jacksonville, Florida, United States
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Jensen Beach, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Fayetteville, Georgia, United States
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Champaign, Illinois, United States
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Chicago, Illinois, United States
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Hinsdale, Illinois, United States
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Island Lake, Illinois, United States
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Skokie, Illinois, United States
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Bowling Green, Kentucky, United States
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Shreveport, Louisiana, United States
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Silver Spring, Maryland, United States
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Flint, Michigan, United States
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Flint, Michigan, United States
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Troy, Michigan, United States
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City of Saint Peters, Missouri, United States
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Albany, New York, United States
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Middletown, New York, United States
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Orchard Park, New York, United States
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Greenville, North Carolina, United States
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Jacksonville, North Carolina, United States
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Kinston, North Carolina, United States
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New Bern, North Carolina, United States
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Statesville, North Carolina, United States
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Wilmington, North Carolina, United States
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Wilmington, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Maumee, Ohio, United States
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Pottstown, Pennsylvania, United States
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East Providence, Rhode Island, United States
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Kingsport, Tennessee, United States
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Arlington, Texas, United States
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Pearland, Texas, United States
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Sugar Land, Texas, United States
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Alexandria, Virginia, United States
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Newport News, Virginia, United States
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Mukilteo, Washington, United States
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Spokane, Washington, United States
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Ciudad de Buenos Aires, Argentina
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Mar del Plata, Argentina
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Mar del Plata, Argentina
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Santa Fe, Argentina
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Gosford, Australia
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Perth, Australia
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Deyang, China
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Foshan, China
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Hangzhou, China
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Hengyang, China
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Linhai, China
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Nanjing, China
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Nanjing, China
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Nanning, China
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Ningbo, China
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Pingxiang, China
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Shantou, China
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Shenzhen, China
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Wuxi, China
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Xi'an, China
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Xiamen, China
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Yantai, China
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Yibin, China
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Yinchuan, China
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Zhuzhou, China
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Zigong, China
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Aalborg, Denmark
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Herlev, Denmark
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Herning, Denmark
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Roskilde, Denmark
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La Tronche, France
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Mulhouse, France
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Nice, France
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Hanover, Germany
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Mainz, Germany
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Fukuoka, Japan
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Fukuoka, Japan
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Fukuoka, Japan
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Osaka, Japan
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Urayasu, Japan
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Alor Star, Malaysia
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Ipoh, Malaysia
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Mazatlán, Mexico
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Parow, South Africa
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Ansan-si, South Korea
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Busan, South Korea
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Daegu, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Girona, Spain
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L'Hospitalet de Llobregat, Spain
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Lugo, Spain
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Madrid, Spain
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Majadahonda, Spain
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Seville, Spain
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Valencia, Spain
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Gothenburg, Sweden
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Linköping, Sweden
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Rättvik, Sweden
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Stockholm, Sweden
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Uppsala, Sweden
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Kaohsiung City, Taiwan
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Kaohsiung City, Taiwan
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New Taipei City, Taiwan
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Taichung, Taiwan
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Tainan, Taiwan
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Taipei, Taiwan
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Taipei, Taiwan
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Taipei, Taiwan
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Taoyuan District, Taiwan
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Bangkok, Thailand
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Bangkok, Thailand
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Chaingmai, Thailand
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Hat Yai, Thailand
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Khon Kaen, Thailand
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Ratchathewi, Thailand
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Adapazarı, Turkey (Türkiye)
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Ankara, Turkey (Türkiye)
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Bursa, Turkey (Türkiye)
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Dinar, Turkey (Türkiye)
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Kahramanmaraş, Turkey (Türkiye)
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Kayseri, Turkey (Türkiye)
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Kocaeli, Turkey (Türkiye)
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Cardiff, United Kingdom
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Dundee, United Kingdom
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London, United Kingdom
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London, United Kingdom
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York, United Kingdom
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Haiphong, Vietnam
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Hanoi, Vietnam
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Ho Chi Minh City, Vietnam
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Ho Chi Minh City, Vietnam
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Ho Chi Minh City, Vietnam