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Clinical Trial Details

Trial ID: L0155
Source ID: NCT06350123
Associated Drug: Balcinrenone/Dapagliflozin 15 Mg/10 Mg And Matching Placebo For Dapagliflozin 10 Mg
Title: Efficacy, Safety and Tolerability of Balcinrenone/Dapagliflozin Compared to Dapagliflozin in Adults With Chronic Kidney Disease
Acronym: MIRO-CKD
Status: ACTIVE_NOT_RECRUITING
Study Results: NO
Results:
Conditions: Chronic Kidney Disease
Interventions: DRUG: Balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg|DRUG: Balcinrenone/dapagliflozin 40 mg/10 mg and matching placebo for dapagliflozin 10 mg|DRUG: Dapagliflozin 10 mg and matching placebo for balcinrenone/dapa gliflozin
Outcome Measures: Primary: Relative change in UACR from baseline to Week 12, Evaluating the effect of balcinrenone/dapagliflozin compared with dapagliflozin alone on UACR., Baseline (Day 1) until Week 12 (Day 85) |
Sponsor/Collaborators: Sponsor: AstraZeneca
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 324
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-05-01
Completion Date: 2025-05-12
Results First Posted:
Last Update Posted: 2025-04-06
Locations: Research Site, Sheffield, Alabama, 35660, United States|Research Site, Glendale, California, 91206, United States|Research Site, Waterbury, Connecticut, 06708, United States|Research Site, Hialeah, Florida, 33012, United States|Research Site, Miami Lakes, Florida, 33014, United States|Research Site, Annapolis, Maryland, 21401, United States|Research Site, New Bern, North Carolina, 28562, United States|Research Site, El Paso, Texas, 79935, United States|Research Site, Houston, Texas, 77079, United States|Research Site, Houston, Texas, 77099, United States|Research Site, San Antonio, Texas, 78212, United States|Research Site, Ogden, Utah, 84405, United States|Research Site, Salt Lake City, Utah, 84115, United States|Research Site, Salt Lake City, Utah, 84124, United States|Research Site, Norfolk, Virginia, 23504, United States|Research Site, Linz, 4021, Austria|Research Site, St. Pölten, 3100, Austria|Research Site, Vienna, A-1090, Austria|Research Site, Wels, 4600, Austria|Research Site, Wien, 1030, Austria|Research Site, Wien, 1130, Austria|Research Site, Wien, 1190, Austria|Research Site, Porto Alegre, 90020-090, Brazil|Research Site, Sao Paulo, 01228-000, Brazil|Research Site, Sao Paulo, 05403-9000, Brazil|Research Site, São Paulo, 04012-909, Brazil|Research Site, São Paulo, 04038-031, Brazil|Research Site, Burgas, 8018, Bulgaria|Research Site, Dobrich, 9300, Bulgaria|Research Site, Pleven, 5800, Bulgaria|Research Site, Plovdiv, 4000, Bulgaria|Research Site, Sofia, 1680, Bulgaria|Research Site, London, Ontario, N6A 5A5, Canada|Research Site, Waterloo, Ontario, N2T 0C1, Canada|Research Site, Montreal, Quebec, H4J 1C5, Canada|Research Site, Quebec, G1R 2J6, Canada|Research Site, Changchun, 130021, China|Research Site, Changzhou, 213004, China|Research Site, Shanghai, 200032, China|Research Site, Shanghai, 200050, China|Research Site, Tianjin, 300050, China|Research Site, Bari, 70124, Italy|Research Site, Bologna, 40138, Italy|Research Site, Genoa, 16132, Italy|Research Site, Novara, 28100, Italy|Research Site, Pavia, 27100, Italy|Research Site, Ageo, 362-8588, Japan|Research Site, Fujisawa-shi, 251-0041, Japan|Research Site, Fukuoka-shi, 810-8563, Japan|Research Site, Kawagoe-shi, 350-0851, Japan|Research Site, Koga-shi, 306-0232, Japan|Research Site, Koshigaya-shi, 343-8577, Japan|Research Site, Kumamoto-shi, 860-0008, Japan|Research Site, Nagasaki-shi, 852-8034, Japan|Research Site, Nagoya, 451-8511, Japan|Research Site, Okinawa-shi, 904-2143, Japan|Research Site, Takamatsu-shi, 760-0076, Japan|Research Site, Zentsuji-shi, 765-8507, Japan|Research Site, Ipoh, 30990, Malaysia|Research Site, Johor Bahru, 80100, Malaysia|Research Site, Kajang, 43000, Malaysia|Research Site, Kota Bharu, 15586, Malaysia|Research Site, Kuala Terengganu, 20400, Malaysia|Research Site, Białystok, 15-481, Poland|Research Site, Grodzisk Mazowiecki, 05-825, Poland|Research Site, Leżajsk, 37-300, Poland|Research Site, Szczecin, 70-111, Poland|Research Site, Warszawa, 02-798, Poland|Research Site, Żywiec, 34-300, Poland|Research Site, Barcelona, 08035, Spain|Research Site, Barcelona, 08036, Spain|Research Site, Córdoba, 14004, Spain|Research Site, Palma de Mallorca, 07010, Spain|Research Site, Valencia, 46026, Spain|Research Site, Kaohsiung, 80756, Taiwan|Research Site, New Taipei City, 220, Taiwan|Research Site, Taichung, 40201, Taiwan|Research Site, Tainan, 710, Taiwan|Research Site, Taipei City, 110, Taiwan|Research Site, Taipei City, 11217, Taiwan|Research Site, Taipei, 10002, Taiwan|Research Site, Taipei, 11490, Taiwan|Research Site, Ankara, 06340, Turkey|Research Site, Gaziantep, 27310, Turkey|Research Site, Kahramanmaras, 46100, Turkey|Research Site, Kayseri, 38039, Turkey|Research Site, Kocaeli, 41380, Turkey|Research Site, Dundee, DDS 1SY, United Kingdom|Research Site, London, N18 1QX, United Kingdom|Research Site, Newquay, TR7 1RU, United Kingdom|Research Site, Nottingham, NG9 6DX, United Kingdom|Research Site, Hai Phong, 180000, Vietnam|Research Site, Ho Chi Minh, 700000, Vietnam|Research Site, Hochiminh city, 700000, Vietnam
URL: https://clinicaltrials.gov/show/NCT06350123

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