protocolSection identificationModule nctId: NCT06350123, orgStudyIdInfo id: D6405C00002, briefTitle: Efficacy, Safety and Tolerability of Balcinrenone/Dapagliflozin Compared to Dapagliflozin in Adults With Chronic Kidney Disease., acronym: MIRO-CKD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-06, primaryCompletionDateStruct date: 2026-01-13, completionDateStruct date: 2026-01-13, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: AstraZeneca, class: INDUSTRY, descriptionModule 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., conditionsModule conditions: Chronic Kidney Disease, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Multicentre, randomised, double-blind, dose-finding, parallel group, double-dummy, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg, interventions name: Balcinrenone/dapagliflozin 40 mg/10 mg and matching placebo for dapagliflozin 10 mg, interventions name: Dapagliflozin 10 mg and matching placebo for balcinrenone/dapa gliflozin, outcomesModule primaryOutcomes measure: Relative change in UACR from baseline to Week 12, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Research Site, city: San Carlos, state: California, zip: 94070, country: United States, geoPoint lat: 37.50716, lon: -122.26052, locations facility: Research Site, city: Waterbury, state: Connecticut, zip: 06708, country: United States, geoPoint lat: 41.55815, lon: -73.0515, locations facility: Research Site, city: Hialeah, state: Florida, zip: 33012, country: United States, geoPoint lat: 25.8576, lon: -80.27811, locations facility: Research Site, city: Salt Lake City, state: Utah, zip: 84124, country: United States, geoPoint lat: 40.76078, lon: -111.89105, locations facility: Research Site, city: Norfolk, state: Virginia, zip: 23504, country: United States, geoPoint lat: 36.84681, lon: -76.28522, locations facility: Research Site, city: Linz, zip: 4021, country: Austria, geoPoint lat: 48.30639, 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Taiwan, geoPoint lat: 22.99083, lon: 120.21333, locations facility: Research Site, city: Taipei City, zip: 110, country: Taiwan, geoPoint lat: 25.04776, lon: 121.53185, locations facility: Research Site, city: Taipei City, zip: 11217, country: Taiwan, geoPoint lat: 25.04776, lon: 121.53185, locations facility: Research Site, city: Taipei, zip: 10002, country: Taiwan, geoPoint lat: 25.04776, lon: 121.53185, locations facility: Research Site, city: Taipei, zip: 11490, country: Taiwan, geoPoint lat: 25.04776, lon: 121.53185, hasResults: False