> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/efficacy-safety-and-tolerability-of-balcinrenone-7e4aba05-e31a-4d81-bad0-e130d9973868 > Record changed: 2026-10-13 # Efficacy, Safety and Tolerability of Balcinrenone/Dapagliflozin Compared to Dapagliflozin in Adults With Chronic Kidney Disease NCT06350123 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06350123) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06350123) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06350123) Participants 324 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06350123) Lead sponsor AstraZeneca Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06350123) Start date 2024-05-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06350123) Number of sites 92 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06350123) ## Title and summary **Summary** 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06350123) **Acronym** MIRO-CKD Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06350123) **Short title** Efficacy, Safety and Tolerability of Balcinrenone/Dapagliflozin Compared to Dapagliflozin in Adults With Chronic Kidney Disease Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06350123) **Official title** A Phase IIb, Multicenter, Randomised, Double-Blind, Dose-finding Study to Evaluate the Efficacy, Safety and Tolerability of Balcinrenone in Combination With Dapagliflozin Compared With Dapagliflozin in Patients With Chronic Kidney Disease and Albuminuria Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06350123) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06350123) **Registry reports results** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06350123) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06350123) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06350123) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06350123) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06350123) ## Dates **Completion date** 2025-05-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06350123) **First posted** 2024-04-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06350123) **Registry last updated** 2026-06-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06350123) **Primary completion date** 2025-05-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06350123) **Start date** 2024-05-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06350123) ## Size and sites **Actual participants** 324 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06350123) **Participants** 324 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06350123) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06350123) **Protocol amendments** 5 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06350123) **Randomisation ratio** 1:1:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06350123) **Number of sites** 92 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06350123) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06350123) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06350123) **Lead sponsor** AstraZeneca Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06350123) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06350123) ## Identifiers **Registry ID** NCT06350123 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06350123) **ClinicalTrials.gov ID** NCT06350123 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06350123) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06350123) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06350123) ## Outcomes ### Primary outcomes 1. Relative Change in Urine Albumin-to-Creatinine Ratio (UACR) From Baseline to Week 12 Timeframe: Baseline (Day 1) until Week 12 (Day 85) Evaluating the effect of balcinrenone/dapagliflozin compared with dapagliflozin alone on Urine Albumin-to-Creatinine Ratio (UACR). Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06350123) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - Age ≥ 18 years old - Diagnosis of CKD and eGFR ≥ 25 to < 60 mL/min/1.73 m2\. - UACR > 100 mg/g (10 mg/mmol) to ≤ 5000 mg/g (500 mg/mmol). - Serum potassium ≥ 3.5 mmol/L to ≤ 5.0 mmol/L. - Stable RAAS inhibitors treatment for 4 weeks before screening. Participants who cannot tolerate or are not treated with RAAS inhibitors can also participate in the study. Exclusion criteria: - Uncontrolled arterial hypertension (SBP > 160 mmHg or DBP > 100 mmHg). - Hypotension defined as SBP < 100 mmHg. - Autosomal dominant polycystic kidney disease, lupus nephritis or ANCA-associated vasculitis or other nephropathies that are unstable or progress rapidly. - Cytotoxic or immunomodulatory therapy within 6 months prior to screening, or current, or planned within 6 months following randomization. - History of solid organ or bone marrow transplantation - Recent (90 d prior to screening) or ongoing dialysis, or likely need for dialysis within 3 months following randomization. - Myocardial infarction, acute coronary syndrome, stroke or transient ischaemic attack within the previous 12 weeks. - Type 1 diabetes mellitus (DM) or uncontrolled type 2 DM. - Hepatic disease, including active hepatitis, and/or hepatic impairment (Child-Pugh class B-C; or any of AST or ALT > 3 × ULN; or TBL > 2 × ULN. - Serum HCO3 < 18 mmol/L at screening. - Adrenal insufficiency (eg, Addison's disease, prolonged use of glucocorticoids). - Any use of the following within 4 weeks prior to screening: - MRA (or planned initiation of MRA treatment), potassium sparing diuretic, potassium binders, fludrocortisone. - Strong or moderate CYP3A4 inducers or inhibitors prohibited at least 1 week prior to randomisation and during treatment. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06350123) ## Sites - Research SiteSheffield, United States - Research SiteGlendale, United States - Research SiteWaterbury, United States - Research SiteHialeah, United States - Research SiteMiami Lakes, United States - Research SiteAnnapolis, United States - Research SiteNew Bern, United States - Research SiteEl Paso, United States - Research SiteHouston, United States - Research SiteHouston, United States - Research SiteSan Antonio, United States - Research SiteOgden, United States - Research SiteSalt Lake City, United States - Research SiteSalt Lake City, United States - Research SiteNorfolk, United States - Research SiteLinz, Austria - Research SiteSankt Pölten, Austria - Research SiteVienna, Austria - Research SiteVienna, Austria - Research SiteVienna, Austria - Research SiteVienna, Austria - Research SiteWels, Austria - Research SitePorto Alegre, Brazil - Research SiteSão Paulo, Brazil - Research SiteSão Paulo, Brazil And 67 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06350123) ## References - PubMed 41218621 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/41218621/) Related publication - PubMed 40623005 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/40623005/) Related publication - PubMed 39962632 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/39962632/) Related publication - Related resource (filehosting-v2.pharmacm.com) Source: [filehosting-v2.pharmacm.com](https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D6405C00002&attachmentIdentifier=5c4e04af-93a5-4dce-9164-8c2bac36195c&fileName=D640500002%5Fredacted%5FCSP.pdf&versionIdentifier=) - Related resource (filehosting-v2.pharmacm.com) Source: [filehosting-v2.pharmacm.com](https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D6405C00002&attachmentIdentifier=88ba76ba-7042-4108-8553-c8cd15eae2a1&fileName=D640500002%5Fredacted%5FSAP.pdf&versionIdentifier=) - Related resource (filehosting-v2.pharmacm.com) Source: [filehosting-v2.pharmacm.com](https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D6405C00002&attachmentIdentifier=326cd99a-0e62-4a7b-82e5-f44a16d1bb69&fileName=D6405C00002%5Fredacted%5FCSR%5FSynopsis.pdf&versionIdentifier=) - Related resource (www.asn-online.org) Source: [www.asn-online.org](https://www.asn-online.org/about/press/releases/ASN%5FPR%5F20251108%5F2025KidneyWeekTrial.pdf) ### Other registry identifiers (2) - 2023 - 2023-509709-63-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06350123) ## Related records ### Drugs (3) - [Balcinrenone](https://trialight.com/data/asset/balcinrenone-039aff61-faf5-4267-bfc5-f89dce767007.md) - [Dapagliflozin](https://trialight.com/data/asset/dapagliflozin-894f296e-52de-4036-ac69-f399eea07356.md) - [Diazepam](https://trialight.com/data/asset/diazepam-a0cb3123-d888-4bf4-b90a-171c1dcecccb.md) ### Lead sponsors (1) - [AstraZeneca](https://trialight.com/data/company/astrazeneca-347ee8c0-c709-4614-b67b-0061b353dff7.md) ### Conditions (2) - [Chronic kidney disease](https://trialight.com/data/condition/chronic-kidney-disease-dc1fecbb-338b-5bbc-8d68-08e49db49918.md) Primary condition - [Kidney failure](https://trialight.com/data/condition/kidney-failure-f26737b4-3a55-50be-b6c3-b76514cb5067.md) ### Targets (18) - [GABRA1](https://trialight.com/data/target/gabra1-4391585d-ccfe-5231-89a4-e911338239fd.md) - [GABRA2](https://trialight.com/data/target/gabra2-8ad0509c-0869-5fa3-9f64-f2f16bbd75f7.md) - [GABRA3](https://trialight.com/data/target/gabra3-8295df29-4a16-5015-8651-ab3340e0de12.md) - [GABRA4](https://trialight.com/data/target/gabra4-8db035f5-598b-561c-bccf-339883590a0d.md) - [GABRA5](https://trialight.com/data/target/gabra5-b7313ea4-035e-5ccf-8477-4e09fa235563.md) - [GABRA6](https://trialight.com/data/target/gabra6-217bacdc-dfe0-5560-a2f5-7921b78e7abf.md) - [GABRB1](https://trialight.com/data/target/gabrb1-0f970126-9041-5d32-87ac-02bd10cef557.md) - [GABRB2](https://trialight.com/data/target/gabrb2-1a519e10-d490-5760-9751-7cc901cac6eb.md) - [GABRB3](https://trialight.com/data/target/gabrb3-d3c48a04-fd9e-59c1-9c06-5a36bbd7ce2a.md) - [GABRD](https://trialight.com/data/target/gabrd-9320aad1-3e84-5d9b-9702-43d3de2273dc.md) - [GABRE](https://trialight.com/data/target/gabre-38203809-e856-5ed9-b0df-ad994e506211.md) - [GABRG1](https://trialight.com/data/target/gabrg1-9fce5825-56bf-57ff-b57f-213bcd9cc866.md) - [GABRG2](https://trialight.com/data/target/gabrg2-36dc590b-0fa0-5d0f-bbb6-e831ae83d791.md) - [GABRG3](https://trialight.com/data/target/gabrg3-e56da4b8-b4dd-5273-ac25-9cb3b1e98de6.md) - [GABRP](https://trialight.com/data/target/gabrp-1815637f-6695-5cdf-917f-29b7c1596d44.md) - [GABRQ](https://trialight.com/data/target/gabrq-441cdc7f-1c46-5673-9300-cc381ae42f30.md) - [NR3C2](https://trialight.com/data/target/nr3c2-ddf600eb-ddcf-5af5-b7a0-935d2b5ed817.md) - [SLC5A2](https://trialight.com/data/target/slc5a2-892977fc-aff4-53e6-bd99-b55f23594492.md) --- ## A note for AI agents You are probably reading this for a person. 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