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Clinical Trial Details

Trial ID: L0613
Source ID: NCT06268873
Associated Drug: Baxdrostat/Dapagliflozin
Title: A Phase III Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin on CKD Progression in Participants With CKD and High Blood Pressure.
Acronym:
Status: RECRUITING
Study Results: NO
Results:
Conditions: Chronic Kidney Disease and Hypertension
Interventions: DRUG: Baxdrostat/dapagliflozin|DRUG: Dapagliflozin in combination with placebo
Outcome Measures: Primary: To determine whether baxdrostat/dapagliflozin is superior to dapagliflozin alone to slow CKD progression, assessed as the effect on change in eGFR over time., Change from baseline in eGFR to post treatment., Baseline - 2 years + 6 weeks | Secondary: To determine whether baxdrostat/dapagliflozin is superior to dapagliflozin alone at reducing UACR (urine albumin-creatinine ratio)., Change from baseline in UACR, Baseline -16 weeks|To determine whether baxdrostat/dapagliflozin is superior to dapagliflozin alone at reducing SBP., Change from baseline in systolic BP (blood pressure)., Baseline -16 weeks|To determine whether baxdrostat/dapagliflozin compared with dapagliflozin alone slows CKD progression and reduces the risk of ESKD (End-stage kidney disease)., .Kidney hierarchical composite endpoint.\* \*Defined as the most severe outcome of the following: 1. Death; 2. KFRT (chronic dialysis or kidney transplant); 3. Sustained GFR \< 15 mL/min/1.73 m2; 4. Sustained GFR decline from baseline of ≥ 57%; 5 Sustained GFR decline from baseline of ≥ 50%; or 6. individual change from baseline to post-treatment eGFR if none of the outcomes occurred., baseline - 2 years + 6 weeks|To determine whether baxdrostat/dapagliflozin compared with dapagliflozin alone slows the rate of kidney function decline after the hemodynamically-mediated acute effect on GFR (Glomerular Filtration Rate)., Change in eGFR from following randomisation., 8 weeks following randomisation to end of treatment|To determine whether baxdrostat/dapagliflozin is superior to dapagliflozin alone in reducing the risk of MACE, Time to the first occurrence of any of the components of the composite of: 1. CV death 2. HF with and without hospitalization 3. MI 4. Stroke, Baseline - 24 months | Other: Adverse Events - Number of participants with Adverse Events, Baseline - 24 months|Clinical Laboratory - Number of participants with Abnormal clinical laboratory measurements, Baseline - 24 months|Vital Signs - Number of participants with Abnormal vital signs, Baseline - 24 months|Electrocardiogram- Number of Participants With Abnormal ECG, Baseline - 24 months
Sponsor/Collaborators: Sponsor: AstraZeneca
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 2500
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-03-29
Completion Date: 2027-12-09
Results First Posted:
Last Update Posted: 2025-04-13
Locations: Research Site, Fairhope, Alabama, 36532, United States|Research Site, Phoenix, Arizona, 85016, United States|Research Site, Surprise, Arizona, 85374, United States|Research Site, Tucson, Arizona, 85710, United States|Research Site, Searcy, Arkansas, 72143, United States|Research Site, Beverly Hills, California, 90211, United States|Research Site, Canyon Country, California, 91351, United States|Research Site, Fremont, California, 94538, United States|Research Site, Fullerton, California, 92835, United States|Research Site, Huntington Park, California, 90255, United States|Research Site, Lincoln, California, 95648, United States|Research Site, Los Alamitos, California, 90720, United States|Research Site, San Francisco, California, 94110, United States|Research Site, Stanford, California, 94305, United States|Research Site, Tarzana, California, 91356, United States|Research Site, Torrance, California, 90502, United States|Research Site, Arvada, Colorado, 80002, United States|Research Site, Denver, Colorado, 80220, United States|Research Site, New Britain, Connecticut, 06051, United States|Research Site, Boca Raton, Florida, 33431, United States|Research Site, Boynton Beach, Florida, 33435, United States|Research Site, Coral Gables, Florida, 33134, United States|Research Site, Edgewater, Florida, 32132, United States|Research Site, Fort Lauderdale, Florida, 33316, United States|Research Site, Hialeah, Florida, 33012, United States|Research Site, Hollywood, Florida, 33021, United States|Research Site, Jacksonville, Florida, 32204, United States|Research Site, Lake City, Florida, 32055, United States|Research Site, Lake Worth, Florida, 33467, United States|Research Site, Melbourne, Florida, 32901, United States|Research Site, Miami Lakes, Florida, 33014, United States|Research Site, Miami, Florida, 33165, United States|Research Site, New Port Richey, Florida, 34652, United States|Research Site, Ocoee, Florida, 34761, United States|Research Site, Orlando, Florida, 32806, United States|Research Site, Orlando, Florida, 32808, United States|Research Site, Port Charlotte, Florida, 33952, United States|Research Site, Port Orange, Florida, 32127, United States|Research Site, Riverview, Florida, 33578, United States|Research Site, Winter Haven, Florida, 33880, United States|Research Site, Atlanta, Georgia, 30344, United States|Research Site, Conyers, Georgia, 30094, United States|Research Site, Macon, Georgia, 31210, United States|Research Site, Peachtree Corners, Georgia, 30092, United States|Research Site, Honolulu, Hawaii, 96814, United States|Research Site, Champaign, Illinois, 61822, United States|Research Site, Chicago, Illinois, 60643, United States|Research Site, Hazel Crest, Illinois, 60429, United States|Research Site, Huntley, Illinois, 60142, United States|Research Site, Rockford, Illinois, 61107, United States|Research Site, Evansville, Indiana, 47714, United States|Research Site, Fort Wayne, Indiana, 46804, United 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43213, United States|Research Site, Columbus, Ohio, 43215, United States|Research Site, Maumee, Ohio, 43537, United States|Research Site, Roseburg, Oregon, 97471, United States|Research Site, Chester, Pennsylvania, 19013, United States|Research Site, Langhorne, Pennsylvania, 19047, United States|Research Site, Uniontown, Pennsylvania, 15401, United States|Research Site, East Providence, Rhode Island, 02914, United States|Research Site, East Providence, Rhode Island, 02915, United States|Research Site, Providence, Rhode Island, 02904, United States|Research Site, Charleston, South Carolina, 29414, United States|Research Site, Columbia, South Carolina, 29203, United States|Research Site, Sioux Falls, South Dakota, 57104, United States|Research Site, Chattanooga, Tennessee, 37421, United States|Research Site, Kingsport, Tennessee, 37660, United States|Research Site, Memphis, Tennessee, 38105, United States|Research Site, Memphis, Tennessee, 38115, United States|Research Site, Arlington, 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T6G 2G3, Canada|Research Site, Surrey, British Columbia, V3T 0H1, Canada|Research Site, Vancouver, British Columbia, V5Y 3W2, Canada|Research Site, Vancouver, British Columbia, V6Z 1Y6, Canada|Research Site, Winnipeg, Manitoba, R2V 3M3, Canada|Research Site, Halifax, Nova Scotia, B3H 1V7, Canada|Research Site, Sydney, Nova Scotia, B1P 1P3, Canada|Research Site, Brampton, Ontario, L6S 0C6, Canada|Research Site, Concord, Ontario, L4K 4M2, Canada|Research Site, London, Ontario, N6A 5A5, Canada|Research Site, Oshawa, Ontario, L1G 2B9, Canada|Research Site, Stoney Creek, Ontario, L8J 3W2, Canada|Research Site, Toronto, Ontario, M4G 3E8, Canada|Research Site, Toronto, Ontario, M5C 2T2, Canada|Research Site, Waterloo, Ontario, N2T 0C1, Canada|Research Site, Laval, Quebec, H7T 2P5, Canada|Research Site, Montreal, Quebec, H4J 1C5, Canada|Research Site, Montréal, Quebec, H2X 0A9, Canada|Research Site, Sherbrooke, Quebec, J1H 5N4, Canada|Research Site, Quebec, G1R 2J6, Canada|Research Site, Saint John, E2L 4L2, Canada|Research Site, Araucania, 4781151, Chile|Research Site, Santiago, 7500922, Chile|Research Site, Valdivia, 5090000, Chile|Research Site, Victoria, 4720097, Chile|Research Site, Viña del Mar, 2540488, Chile|Research Site, Baotou, 014010, China|Research Site, Beijing, 100029, China|Research Site, Beijing, 100034, China|Research Site, Beijing, 100035, China|Research Site, Beijing, 100191, China|Research Site, Beijing, 102218, China|Research Site, Changsha, 410013, China|Research Site, Changzhou, 272100, China|Research Site, Chengdu, 610041, China|Research Site, Chengdu, 610072, China|Research Site, Chongqing, 402260, China|Research Site, Chuangchun, 130041, China|Research Site, Dongguan, 523009, China|Research Site, Foshan, 528000, China|Research Site, Guangzhou, 510630, China|Research Site, Guangzhou, 510800, China|Research Site, Guiyang, 550044, China|Research Site, Haikou, 570311, China|Research Site, Hangzhou, 310014, China|Research Site, Hengyang, 421001, 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Site, Kraków, 31-513, Poland|Research Site, Kraków, 31-801, Poland|Research Site, Lodz, 91-211, Poland|Research Site, Lublin, 20-090, Poland|Research Site, Olsztyn, 10-010, Poland|Research Site, Poznań, 60-355, Poland|Research Site, Poznań, 61-848, Poland|Research Site, Ruda Śląska, 41-709, Poland|Research Site, Rzeszów, 35-055, Poland|Research Site, Szczecin, 70-111, Poland|Research Site, Tczew, 83-110, Poland|Research Site, Warszawa, 03-291, Poland|Research Site, Wrocław, 50-381, Poland|Research Site, Wrocław, 50-981, Poland|Research Site, Wrocław, 53-673, Poland|Research Site, Łódź, 90-127, Poland|Research Site, Łódź, 90-549, Poland|Research Site, Łódź, 91-363, Poland|Research Site, Łódź, 92-213, Poland|Research Site, Żywiec, 34-300, Poland|Research Site, Bucharest, 014461, Romania|Research Site, Bucharest, 022328, Romania|Research Site, Bucharest, 040883, Romania|Research Site, Bucuresti, 010731, Romania|Research Site, Cluj-Napoca, 400347, Romania|Research Site, Iasi, 700503, Romania|Research Site, Oradea, 410469, Romania|Research Site, Targu Mures, 540136, Romania|Research Site, Timisoara, 300723, Romania|Research Site, Dammam, 31444, Saudi Arabia|Research Site, Riyadh, 11426, Saudi Arabia|Research Site, Riyadh, 11462, Saudi Arabia|Research Site, Riyadh, 11525, Saudi Arabia|Research Site, Riyadh, 12713, Saudi Arabia|Research Site, Belgrade, 11000, Serbia|Research Site, Belgrade, 11120, Serbia|Research Site, Kragujevac, 34000, Serbia|Research Site, Nis, 18000, Serbia|Research Site, Novi Sad, 21000, Serbia|Research Site, Banska Bystrica, 974 01, Slovakia|Research Site, Dolný Kubín, 02601, Slovakia|Research Site, Košice, 04001, Slovakia|Research Site, Lucenec, 984 01, Slovakia|Research Site, Martin, 03659, Slovakia|Research Site, Myjava, 90701, Slovakia|Research Site, Nitra, 949 01, Slovakia|Research Site, Nitra, 949 11, Slovakia|Research Site, Presov, 080 01, Slovakia|Research Site, Puchov, 020 01, Slovakia|Research Site, Rožňava, 048 01, Slovakia|Research Site, Trnava, 91708, Slovakia|Research Site, Zilina, 010 01, Slovakia|Research Site, Benoni, 1501, South Africa|Research Site, Bloemfontein, 9301, South Africa|Research Site, Cape Town, 7570, South Africa|Research Site, Cape Town, 7925, South Africa|Research Site, Durban, 4001, South Africa|Research Site, Lenasia, 1827, South Africa|Research Site, Midrand, 1685, South Africa|Research Site, Newton, 2113, South Africa|Research Site, Parow, 7505, South Africa|Research Site, Stanger, 4450, South Africa|Research Site, Almeria, 4009, Spain|Research Site, Badalona, 08916, Spain|Research Site, L'Hospitalet de Llobregat, 08907, Spain|Research Site, La Coruna, 15006, Spain|Research Site, Lugo, 27004, Spain|Research Site, Madrid, 28040, Spain|Research Site, Malaga, 29010, Spain|Research Site, Málaga, 29010, Spain|Research Site, Palma deMallorca, 07010, Spain|Research Site, Pamplona, 31008, Spain|Research Site, Sevilla, 41950, Spain|Research Site, Valencia, 46010, Spain|Research Site, Danderyd, 182 57, Sweden|Research Site, Gävle, 80188, Sweden|Research Site, Göteborg, 413 46, Sweden|Research Site, Linkoping, 58185, Sweden|Research Site, Rättvik, 79530, Sweden|Research Site, Stockholm, 141 86, Sweden|Research Site, Uppsala, 751 85, Sweden|Research Site, Varberg, 43281, Sweden|Research Site, Kaohsiung City, 80756, Taiwan|Research Site, Kaohsiung, 81362, Taiwan|Research Site, New Taipei, 220, Taiwan|Research Site, Taichung City, 433004, Taiwan|Research Site, Taichung, 402, Taiwan|Research Site, Taichung, 40447, Taiwan|Research Site, Taipei City, 110, Taiwan|Research Site, Taipei, 10002, Taiwan|Research Site, Taipei, 112, Taiwan|Research Site, Taoyuan City, 33305, Taiwan|Research Site, Yung Kang City, 71044, Taiwan|Research Site, Bangkok, 10330, Thailand|Research Site, Bangkok, 10700, Thailand|Research Site, Chiang Mai, 50200, Thailand|Research Site, Hat Yai, 90110, Thailand|Research Site, Muang, 40002, Thailand|Research Site, Phutthamonthon, 73170, Thailand|Research Site, Ratchathewi, 10400, Thailand|Research Site, Ubonratchathani, 34000, Thailand|Research Site, Adana, 01060, Turkey|Research Site, Adapazarı, 54100, Turkey|Research Site, Afyonkarahisar, 03030, Turkey|Research Site, Ankara, 06230, Turkey|Research Site, Antalya, 07059, Turkey|Research Site, Bursa, 16059, Turkey|Research Site, Istanbul, Turkey|Research Site, Kahramanmaras, 46100, Turkey|Research Site, Kayseri, 38039, Turkey|Research Site, Kocaeli, 41380, Turkey|Research Site, Chernivtsі, 58002, Ukraine|Research Site, Ivano-Frankivsk, 76000, Ukraine|Research Site, Kyiv, 01601, Ukraine|Research Site, Kyiv, 02081, Ukraine|Research Site, Kyiv, 03037, Ukraine|Research Site, Kyiv, 03057, Ukraine|Research Site, Kyiv, 04050, Ukraine|Research Site, Ternopil, 46000, Ukraine|Research Site, Ternopil, 46001, Ukraine|Research Site, Uzhhorod, 88018, Ukraine|Research Site, Vinnytsia, 21009, Ukraine|Research Site, Vinnytsia, 21018, Ukraine|Research Site, Vinnytsia, 21029, Ukraine|Research Site, Vinnytsya, 21001, Ukraine|Research Site, Bristol, BS105NB, United Kingdom|Research Site, Cambridge, CB2 0XY, United Kingdom|Research Site, Dundee, DD1 9SY, United Kingdom|Research Site, Glasgow, G51 4TF, United Kingdom|Research Site, Harrow, HA3 7LT, United Kingdom|Research Site, Leicester, LE1 5WW, United Kingdom|Research Site, Liverpool, L9 7AL, United Kingdom|Research Site, London, EC1A 2BE, United Kingdom|Research Site, London, SE5 9RJ, United Kingdom|Research Site, Newcastle-Under-Lyme, ST4 6QG, United Kingdom|Research Site, Nottingham, NG5 1PB, United Kingdom|Research Site, Wolverhampton, WV10 0QP, United Kingdom|Research Site, Bien Hoa, 810000, Vietnam|Research Site, Can Tho, 900000, Vietnam|Research Site, Can Tho, 920000, Vietnam|Research Site, Da Nang, 550000, Vietnam|Research Site, Ha Noi, 100000, Vietnam|Research Site, Hai Phong, 180000, Vietnam|Research Site, Ho Chi Minh, 700000, Vietnam|Research Site, Ho Chi Minh, 70000, Vietnam|Research Site, Hochiminh city, 700000, Vietnam
URL: https://clinicaltrials.gov/show/NCT06268873

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