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Clinical Trial Details

Trial ID: L0801
Source ID: NCT06087835
Associated Drug: Zibotentan/Dapagliflozin
Title: 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)
Acronym:
Status: ACTIVE_NOT_RECRUITING
Study Results: NO
Results:
Conditions: Chronic Kidney Disease With High Proteinuria
Interventions: DRUG: Zibotentan/Dapagliflozin|DRUG: Dapagliflozin
Outcome Measures: Primary: Change in eGFR from baseline, To determine whether zibotentan and dapagliflozin in fixed dose combination is superior to dapagliflozin alone to slow decline in kidney function, At month 24 | Secondary: Change in Urine Protein to Creatinine Ratio (UPCR) from baseline to each participant's mean level, To determine whether zibotentan and dapagliflozin in fixed dose combination is superior to dapagliflozin alone in reducing proteinuria, Across the visits from Day 15 up to Month 24|Change in UACR from baseline to each participant's mean level, To determine whether zibotentan and dapagliflozin in fixed dose combination is superior to dapagliflozin alone in reducing albuminuria, Across the visits from Day 15 up to Month 24|Time to the first occurrence of any of the components of the renal composite endpoint of 40% sustained decline in eGFR or ESKD or renal death, To determine whether zibotentan and dapagliflozin in fixed dose combination is superior to dapagliflozin alone in reducing the incidence of the renal composite endpoint of 40% sustained decline in eGFR or ESKD or renal death, Through study completion, approximately 43 months|Change in systolic blood pressure from baseline to each participant's mean level, To determine whether zibotentan and dapagliflozin in fixed dose combination is superior to dapagliflozin alone in reducing systolic blood pressure, Across the visits from Day 15 up to Month 24|Proportion of participants achieving Urine Protein to Creatinine Ratio (UPCR) < 1000 mg/g and > 30% reduction from baseline for each participant's mean level, To determine whether zibotentan and dapagliflozin in fixed dose combination is superior to dapagliflozin alone, in reducing proteinuria, as measured by the proportion of participants achieving Urine Protein to Creatinine Ratio (UPCR) \< 1000 mg/g and \> 30% reduction from baseline, Across the visits from Day 15 up to Month 24
Sponsor/Collaborators: Sponsor: AstraZeneca
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 1835
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-11-07
Completion Date: 2027-01-22
Results First Posted:
Last Update Posted: 2025-02-25
Locations: Research Site, Huntsville, Alabama, 35805, United States|Research Site, Sun City West, Arizona, 85375, United States|Research Site, Bakersfield, California, 93309, United States|Research Site, Huntington Park, California, 90255, United States|Research Site, Los Alamitos, California, 90720, United States|Research Site, Los Angeles, California, 90010, United States|Research Site, Northridge, California, 91324, United States|Research Site, Oxnard, California, 93036, United States|Research Site, San Carlos, California, 94070, United States|Research Site, San Dimas, California, 91773, United States|Research Site, Tarzana, California, 91356, United States|Research Site, Victorville, California, 92392, United States|Research Site, Arvada, Colorado, 80002, United States|Research Site, Denver, Colorado, 80230, United States|Research Site, Boynton Beach, Florida, 33435, United States|Research Site, Hialeah, Florida, 33016, United States|Research Site, Hollywood, Florida, 33024, United States|Research Site, Jacksonville, Florida, 32204, United States|Research Site, Jensen Beach, Florida, 34957, United States|Research Site, Miami, Florida, 33126, United States|Research Site, Miami, Florida, 33165, United States|Research Site, Orlando, Florida, 32806, United States|Research Site, Fayetteville, Georgia, 30214, United States|Research Site, Champaign, Illinois, 61822, United States|Research Site, Chicago, Illinois, 60616, United States|Research Site, Hinsdale, Illinois, 60521, United States|Research Site, Island Lake, Illinois, 60042, United States|Research Site, Skokie, Illinois, 60077, United States|Research Site, Bowling Green, Kentucky, 42101, United States|Research Site, Shreveport, Louisiana, 71101, United States|Research Site, Silver Spring, Maryland, 20901, United States|Research Site, Flint, Michigan, 48504, United States|Research Site, Flint, Michigan, 48532, United States|Research Site, Troy, Michigan, 48098, United States|Research Site, Saint Peters, Missouri, 63376, United States|Research Site, Albany, New York, 12205, United States|Research Site, Middletown, New York, 10940, United States|Research Site, Orchard Park, New York, 14127, United States|Research Site, Greenville, North Carolina, 27834, United States|Research Site, Jacksonville, North Carolina, 28546, United States|Research Site, Kinston, North Carolina, 28504, United States|Research Site, New Bern, North Carolina, 28562, United States|Research Site, Statesville, North Carolina, 28625, United States|Research Site, Wilmington, North Carolina, 28401, United States|Research Site, Wilmington, North Carolina, 28412, United States|Research Site, Winston-Salem, North Carolina, 27103, United States|Research Site, Maumee, Ohio, 43537, United States|Research Site, Pottstown, Pennsylvania, 19464, United States|Research Site, East Providence, Rhode Island, 02915, United States|Research Site, Kingsport, Tennessee, 37660, United States|Research Site, Arlington, Texas, 76015, United States|Research Site, Austin, Texas, 78726, United States|Research Site, Houston, Texas, 77004, United States|Research Site, Houston, Texas, 77099, United States|Research Site, Missouri City, Texas, 77459, United States|Research Site, Pearland, Texas, 77584, United States|Research Site, San Antonio, Texas, 78204, United States|Research Site, San Antonio, Texas, 78207, United States|Research Site, San Antonio, Texas, 78212, United States|Research Site, Salt Lake City, Utah, 84115, United States|Research Site, Alexandria, Virginia, 22311, United States|Research Site, Newport News, Virginia, 23606, United States|Research Site, Mukilteo, Washington, 98275, United States|Research Site, Spokane, Washington, 99202, United States|Research Site, Buenos Aires, C1425AGC, Argentina|Research Site, Ciudad de Buenos Aires, 1280, Argentina|Research Site, Mar del Plata, 7600, Argentina|Research Site, Mar del Plata, B7600, Argentina|Research Site, Santa Fe, S3000, Argentina|Research Site, Gosford, 2250, Australia|Research Site, Meadowbrook, 4131, Australia|Research Site, Perth, 6000, Australia|Research Site, Reservoir, 3021, Australia|Research Site, Reservoir, 3073, Australia|Research Site, Southport, 4222, Australia|Research Site, Feldkirch, 6800, Austria|Research Site, Wien, 1130, Austria|Research Site, Belem, 66073-005, Brazil|Research Site, Botucatu, 18618-687, Brazil|Research Site, Joinville, 89227-680, Brazil|Research Site, Sao Jose Do Rio Preto, 15090-000, Brazil|Research Site, São Paulo, 01228-200, Brazil|Research Site, São Paulo, 04012-909, Brazil|Research Site, São Paulo, 04038-031, Brazil|Research Site, Dobrich, 9300, Bulgaria|Research Site, Pleven, 5800, Bulgaria|Research Site, Plovdiv, 4000, Bulgaria|Research Site, Plovdiv, 4001, Bulgaria|Research Site, Sofia, 1680, Bulgaria|Research Site, Stara Zagora, 6000, Bulgaria|Research Site, London, Ontario, N6A 5A5, Canada|Research Site, Waterloo, Ontario, N2T 0C1, Canada|Research Site, Greenfield Park, Quebec, J4V 2H1, Canada|Research Site, Montreal, Quebec, H4J 1C5, Canada|Research Site, Baotou, 014010, China|Research Site, Beijing, 100029, China|Research Site, Beijing, 102218, China|Research Site, Changsha, 410013, China|Research Site, Chengdu, 610000, China|Research Site, Chengdu, 610072, China|Research Site, Chongqing, 400010, China|Research Site, Deyang, 618000, China|Research Site, Foshan, 528000, China|Research Site, Guangzhou, 510120, China|Research Site, Guangzhou, 510515, China|Research Site, Hangzhou, 310014, China|Research Site, Hengyang, 50012, China|Research Site, Linhai, 318000, China|Research Site, Nanjing, 210009, China|Research Site, Nanjing, 210011, China|Research Site, Nanning, 530022, China|Research Site, Ningbo, 315010, China|Research Site, Pingxiang, 337055, China|Research Site, Shanghai, 200240, China|Research Site, Shantou, 515041, China|Research Site, Shenzhen, 518039, China|Research Site, Shenzhen, 518053, China|Research Site, Wenzhou, 325000, China|Research Site, Wuhan, 430010, China|Research Site, Wuxi, 214000, China|Research Site, XI 'an, 710077, China|Research Site, Xiamen, 361101, China|Research Site, Yantai, 264000, China|Research Site, Yibin, 610500, China|Research Site, Yinchuan, 750004, China|Research Site, Zhuzhou, 412007, China|Research Site, Zigong, 643000, China|Research Site, Aalborg, 9100, Denmark|Research Site, Aarhus, 8200, Denmark|Research Site, Herlev, 2730, Denmark|Research Site, Herning, 7400, Denmark|Research Site, Roskilde, 4000, Denmark|Research Site, La Tronche, 38700, France|Research Site, Mulhouse, 68100, France|Research Site, Nice, 06000, France|Research Site, Nimes, 30000, France|Research Site, Rouen, 76031, France|Research Site, St-Priest-en-Jarez, 42270, France|Research Site, Strasbourg, 67090, France|Research Site, Tours, 37000, France|Research Site, Aachen, 52074, Germany|Research Site, Bad Oeynhausen, 32545, Germany|Research Site, Berlin, 10117, Germany|Research Site, Dresden, 01279, Germany|Research Site, Hannover, 30625, Germany|Research Site, Mainz, 55131, Germany|Research Site, München, 80336, Germany|Research Site, Bangalore, 560060, India|Research Site, Belagavi, 590010, India|Research Site, Delhi, 110029, India|Research Site, Nadiad, 387001, India|Research Site, New Delhi, 110017, India|Research Site, Ashkelon, 78278, Israel|Research Site, Haifa, 3109601, Israel|Research Site, Jerusalem, 9372212, Israel|Research Site, Kfar-Saba, 44281, Israel|Research Site, Nahariya, 22100, Israel|Research Site, Petah Tikva, 49372, Israel|Research Site, Ramat Gan, 52621, Israel|Research Site, Rehovot, 76100, Israel|Research Site, Bergamo, 24127, Italy|Research Site, Bologna, 40138, Italy|Research Site, Foggia, 71100, Italy|Research Site, Genoa, 16132, Italy|Research Site, Napoli, 80138, Italy|Research Site, Pisa, 56124, Italy|Research Site, Roma, 161, Italy|Research Site, Torino, 10126, Italy|Research Site, Chuo-ku, 103-0027, Japan|Research Site, Fujisawa-shi, 251-0041, Japan|Research Site, Fukui-shi, 910-8526, Japan|Research Site, Fukuoka-shi, 810-0001, Japan|Research Site, Fukuoka-shi, 810-8563, Japan|Research Site, Fukuoka-shi, 819-0168, Japan|Research Site, Hashima-gun, 501-6061, Japan|Research Site, Kamakura-shi, 247-0056, Japan|Research Site, Kasuga-shi, 816-0864, Japan|Research Site, Kawaguchi-shi, 332-0012, Japan|Research Site, Kitakyushu-shi, 802-8555, Japan|Research Site, Kitakyusyu-shi, 806-8501, Japan|Research Site, Kofu-shi, 400-8506, Japan|Research Site, Kurume-shi, 830-0011, Japan|Research Site, Kurume-shi, 830-8543, Japan|Research Site, Kusatsu-shi, 525-8585, Japan|Research Site, Kyoto-shi, 607-8062, Japan|Research Site, Matsumoto-shi, 390-8510, Japan|Research Site, Meguro-ku, 153-0061, Japan|Research Site, Minato-ku, 108-0073, Japan|Research Site, Minokamo shi, 505-8510, Japan|Research Site, Nishinomiya-Shi, 662-0918, Japan|Research Site, Nishinomiya-shi, 662-0971, Japan|Research Site, Okawa-shi, 831-0016, Japan|Research Site, Osaka-shi, 550-0006, Japan|Research Site, Osaka-shi, 559-0012, Japan|Research Site, Oyama-shi, 323-0022, Japan|Research Site, Saku-shi, 385-8558, Japan|Research Site, Sapporo-shi, 003-0026, Japan|Research Site, Sapporo-shi, 062-0931, Japan|Research Site, Sendai-shi, 980-8574, Japan|Research Site, Soka-shi, 340-0015, Japan|Research Site, Takamatsu-shi, 760-0076, Japan|Research Site, Takasago-shi, 676-0812, Japan|Research Site, Tondabayashi-shi, 584-0082, Japan|Research Site, Toride-shi, 302-0022, Japan|Research Site, Urayasu, 279-0001, Japan|Research Site, Utsunomiya-shi, 320-8580, Japan|Research Site, Ansan-si, 15355, Korea, Republic of|Research Site, Busan, 49241, Korea, Republic of|Research Site, Cheonan-si, 31151, Korea, Republic of|Research Site, Daegu, 41944, Korea, Republic of|Research Site, Goyang-si, 10380, Korea, Republic of|Research Site, Seoul, 06591, Korea, Republic of|Research Site, Seoul, 120-752, Korea, Republic of|Research Site, Seoul, 156-707, Korea, Republic of|Research Site, Alor Setar, 5460, Malaysia|Research Site, Ipoh, 30990, Malaysia|Research Site, Kota Kinabalu, 88200, Malaysia|Research Site, Kuala Lumpur, 59100, Malaysia|Research Site, Seremban, 70300, Malaysia|Research Site, Seri Manjung, 32040, Malaysia|Research Site, Mazatlán, 82110, Mexico|Research Site, Amersfoort, 3813 TZ, Netherlands|Research Site, Breda, 4818 CK, Netherlands|Research Site, Dordrecht, 3318 AT, Netherlands|Research Site, Bodø, 8073, Norway|Research Site, Lørenskog, 1478, Norway|Research Site, Oslo, 0450, Norway|Research Site, Stavanger, 4011, Norway|Research Site, Tromsø, 9019, Norway|Research Site, Chrzanów, 32-500, Poland|Research Site, Krakow, 31-501, Poland|Research Site, Kraków, 31-156, Poland|Research Site, Poznań, 60-354, Poland|Research Site, Radom, 26-600, Poland|Research Site, Rzeszów, 35-055, Poland|Research Site, Szczecin, 70-111, Poland|Research Site, Warszawa, 03-291, Poland|Research Site, Łódź, 92-213, Poland|Research Site, Lucenec, 984 01, Slovakia|Research Site, Presov, 080 01, Slovakia|Research Site, Puchov, 020 01, Slovakia|Research Site, Roznava, 048 01, Slovakia|Research Site, Trebišov, 07501, Slovakia|Research Site, Benoni, 1501, South Africa|Research Site, Cape Town, 7925, South Africa|Research Site, Chatsworth, 4092, South Africa|Research Site, Durban, 4450, South Africa|Research Site, Lenasia, 1827, South Africa|Research Site, Midrand, 1685, South Africa|Research Site, Parow, 7505, South Africa|Research Site, Girona, 17007, Spain|Research Site, L'Hospitalet de Llobregat, 08907, Spain|Research Site, Lugo, 27004, Spain|Research Site, Madrid, 28041, Spain|Research Site, Majadahonda, 28222, Spain|Research Site, Sevilla, 41071, Spain|Research Site, Valencia, 46010, Spain|Research Site, Göteborg, 413 46, Sweden|Research Site, Linköping, 581 85, Sweden|Research Site, Rättvik, 79530, Sweden|Research Site, Stockholm, 141 86, Sweden|Research Site, Uppsala, 751 85, Sweden|Research Site, Kaohsiung city, 833, Taiwan|Research Site, Kaohsiung, 807, Taiwan|Research Site, New Taipei, 220, Taiwan|Research Site, Taichung, 40705, Taiwan|Research Site, Tainan, 710, Taiwan|Research Site, Taipei City, 110, Taiwan|Research Site, Taipei, 10002, Taiwan|Research Site, Taipei, 11490, Taiwan|Research Site, Taoyuan, 333, Taiwan|Research Site, Bangkok, 10330, Thailand|Research Site, Bangkok, 10700, Thailand|Research Site, Chaingmai, 50200, Thailand|Research Site, Hat Yai, 90110, Thailand|Research Site, Khon Kaen, 40002, Thailand|Research Site, Ratchathewi, 10400, Thailand|Research Site, Adapazarı, 54100, Turkey|Research Site, Ankara, 06230, Turkey|Research Site, Bursa, 16059, Turkey|Research Site, Dinar, 03400, Turkey|Research Site, Kahramanmaras, 46040, Turkey|Research Site, Kayseri, 38039, Turkey|Research Site, Kocaeli, 41380, Turkey|Research Site, Cardiff, CF14 4XW, United Kingdom|Research Site, Dundee, DD1 9SY, United Kingdom|Research Site, Glasgow, G51 4TF, United Kingdom|Research Site, London, EC1A 2BE, United Kingdom|Research Site, London, NW3 2QG, United Kingdom|Research Site, London, SE5 9RJ, United Kingdom|Research Site, York, YO21 8HE, United Kingdom|Research Site, Hai Phong, 180000, Vietnam|Research Site, Hanoi, 10000, Vietnam|Research Site, Ho Chi Minh City, 70000, Vietnam|Research Site, Ho Chi Minh City, Vietnam|Research Site, Ho Chi Minh, 700000, Vietnam
URL: https://clinicaltrials.gov/show/NCT06087835

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D445 Dapagliflozin small molecule DB06292 Details