nctId: NCT06350123 id: D6405C00002 briefTitle: Efficacy, Safety and Tolerability of Balcinrenone/Dapagliflozin Compared to Dapagliflozin in Adults With Chronic Kidney Disease. acronym: MIRO-CKD overallStatus: NOT_YET_RECRUITING date: 2024-05-06 date: 2026-01-13 date: 2026-01-13 date: 2024-04-05 date: 2024-04-05 name: AstraZeneca class: INDUSTRY briefSummary: The purpose of the study is to evaluate the efficacy, safety and tolerability of balcinrenone/dapagliflozin compared with dapagliflozin alone on patients with chronic kidney disease (CKD) and albuminuria. This study will evaluate the effect of the balcinrenone/dapagliflozin on urinary albumin-to-creatinine ratio (UACR), compared with dapagliflozin in patients with CKD. This is a dose-finding study aiming to identify an optimal dose of balcinrenone/dapagliflozin for a future Phase III study in patients with CKD. conditions: Chronic Kidney Disease studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Multicentre, randomised, double-blind, dose-finding, parallel group, double-dummy primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 300 type: ESTIMATED name: Balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg name: Balcinrenone/dapagliflozin 40 mg/10 mg and matching placebo for dapagliflozin 10 mg name: Dapagliflozin 10 mg and matching placebo for balcinrenone/dapa gliflozin measure: Relative change in UACR from baseline to Week 12 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Research Site city: San Carlos state: California zip: 94070 country: United States lat: 37.50716 lon: -122.26052 facility: Research Site city: Waterbury state: Connecticut zip: 06708 country: United States lat: 41.55815 lon: -73.0515 facility: Research Site city: Hialeah state: Florida zip: 33012 country: United States lat: 25.8576 lon: -80.27811 facility: Research Site city: Salt Lake City state: Utah zip: 84124 country: United States lat: 40.76078 lon: -111.89105 facility: Research Site city: Norfolk state: Virginia zip: 23504 country: United States lat: 36.84681 lon: -76.28522 facility: Research Site city: Linz zip: 4021 country: Austria lat: 48.30639 lon: 14.28611 facility: Research Site city: St. Pölten zip: 3100 country: Austria lat: 48.2 lon: 15.63333 facility: Research Site city: Vienna zip: A-1090 country: Austria lat: 48.20849 lon: 16.37208 facility: Research Site city: Wels zip: 4600 country: Austria lat: 48.16667 lon: 14.03333 facility: Research Site city: Wien zip: 1030 country: Austria lat: 48.20849 lon: 16.37208 facility: Research Site city: Wien zip: 1130 country: Austria lat: 48.20849 lon: 16.37208 facility: Research Site city: Wien zip: 1190 country: Austria lat: 48.20849 lon: 16.37208 facility: Research Site city: Burgas zip: 8018 country: Bulgaria lat: 42.50606 lon: 27.46781 facility: Research Site city: Dobrich zip: 9300 country: Bulgaria lat: 43.56667 lon: 27.83333 facility: Research Site city: Pleven zip: 5800 country: Bulgaria lat: 43.41667 lon: 24.61667 facility: Research Site city: Plovdiv zip: 4000 country: Bulgaria lat: 42.15 lon: 24.75 facility: Research Site city: Sofia zip: 1680 country: Bulgaria lat: 42.69751 lon: 23.32415 facility: Research Site city: London state: Ontario zip: N6A 5A5 country: Canada lat: 42.98339 lon: -81.23304 facility: Research Site city: Waterloo state: Ontario zip: N2T 0C1 country: Canada lat: 43.4668 lon: -80.51639 facility: Research Site city: Montreal state: Quebec zip: H4J 1C5 country: Canada lat: 45.50884 lon: -73.58781 facility: Research Site city: Quebec zip: G1R 2J6 country: Canada lat: 46.81228 lon: -71.21454 facility: Research Site city: Bari zip: 70124 country: Italy lat: 41.11148 lon: 16.8554 facility: Research Site city: Bologna zip: 40138 country: Italy lat: 44.49381 lon: 11.33875 facility: Research Site city: Genoa zip: 16132 country: Italy lat: 44.40478 lon: 8.94438 facility: Research Site city: Parma zip: 43126 country: Italy lat: 44.79935 lon: 10.32618 facility: Research Site city: Pavia zip: 27100 country: Italy lat: 45.19205 lon: 9.15917 facility: Research Site city: Ipoh zip: 30990 country: Malaysia lat: 4.5841 lon: 101.0829 facility: Research Site city: Kota Bahru zip: 15586 country: Malaysia lat: 6.13328 lon: 102.2386 facility: Research Site city: Kuala Lumpur zip: 59100 country: Malaysia lat: 3.1412 lon: 101.68653 facility: Research Site city: Białystok zip: 15-481 country: Poland lat: 53.13333 lon: 23.16433 facility: Research Site city: Gdańsk zip: 80-546 country: Poland lat: 54.35205 lon: 18.64637 facility: Research Site city: Grodzisk Mazowiecki zip: 05-825 country: Poland lat: 52.10387 lon: 20.6337 facility: Research Site city: Leżajsk zip: 37-300 country: Poland lat: 50.26257 lon: 22.41932 facility: Research Site city: Ruda Śląska zip: 41-709 country: Poland lat: 50.2584 lon: 18.85632 facility: Research Site city: Szczecin zip: 70-111 country: Poland lat: 53.42894 lon: 14.55302 facility: Research Site city: Warszawa zip: 02-798 country: Poland lat: 52.22977 lon: 21.01178 facility: Research Site city: Łódź zip: 92-213 country: Poland lat: 51.75 lon: 19.46667 facility: Research Site city: Żywiec zip: 34-300 country: Poland lat: 49.68529 lon: 19.19243 facility: Research Site city: Barcelona zip: 08036 country: Spain lat: 41.38879 lon: 2.15899 facility: Research Site city: Barcelona zip: 8035 country: Spain lat: 41.38879 lon: 2.15899 facility: Research Site city: Cordoba zip: 14004 country: Spain lat: 37.89155 lon: -4.77275 facility: Research Site city: Palma de Mallorca zip: 07010 country: Spain lat: 39.56939 lon: 2.65024 facility: Research Site city: Sevilla zip: 41013 country: Spain lat: 37.38283 lon: -5.97317 facility: Research Site city: Valencia zip: 46026 country: Spain lat: 39.46975 lon: -0.37739 facility: Research Site city: Kaohsiung zip: 80756 country: Taiwan lat: 22.61626 lon: 120.31333 facility: Research Site city: New Taipei City zip: 220 country: Taiwan lat: 25.01111 lon: 121.44583 facility: Research Site city: Taichung zip: 40201 country: Taiwan lat: 24.1469 lon: 120.6839 facility: Research Site city: Tainan zip: 710 country: Taiwan lat: 22.99083 lon: 120.21333 facility: Research Site city: Taipei City zip: 110 country: Taiwan lat: 25.04776 lon: 121.53185 facility: Research Site city: Taipei City zip: 11217 country: Taiwan lat: 25.04776 lon: 121.53185 facility: Research Site city: Taipei zip: 10002 country: Taiwan lat: 25.04776 lon: 121.53185 facility: Research Site city: Taipei zip: 11490 country: Taiwan lat: 25.04776 lon: 121.53185 hasResults: False