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NCT06350123: MIRO-CKD
Efficacy, Safety and Tolerability of Balcinrenone/Dapagliflozin Compared to Dapagliflozin in Adults With Chronic Kidney Disease
Phase 2 trial testing Balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg in Chronic Kidney Disease in 324 participants. Completed in 9 May 2025.
9 May 2025
Quick facts
| Lead sponsor | AstraZeneca |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 324 |
| Start date | 1 May 2024 |
| Primary completion | 9 May 2025 |
| Estimated completion | 9 May 2025 |
| Sites | 93 locations across Italy, Japan, Malaysia, Austria, Taiwan, United Kingdom, Vietnam, Poland |
Drugs / interventions tested
- Balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg — full drug profile →
- Balcinrenone/dapagliflozin 40 mg/10 mg and matching placebo for dapagliflozin 10 mg — full drug profile →
- Dapagliflozin 10 mg and matching placebo for balcinrenone/dapa gliflozin — full drug profile →
Conditions studied
- Chronic Kidney Disease — all drugs for Chronic Kidney Disease →
Sponsor
AstraZeneca — full company profile →
Who can join
18 and older, any sex, with Chronic Kidney Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Balcinrenone in combination with dapagliflozin compared with dapagliflozin alone in patients with chronic kidney disease and albuminuria: a randomised, active-controlled double-blind, phase 2b clinical trial.
Heerspink HJL, Cardona JF, Jolly S, Pergola PE, et al · · 2025 · cited 10× · PMID 41218621 · DOI 10.1016/s0140-6736(25)02014-8 -
Developments in albuminuria testing: A key biomarker for detection, prognosis and surveillance of kidney and cardiovascular disease-A practical update for clinicians.
Beernink JM, van Mil D, Laverman GD, Heerspink HJL, et al · · 2025 · cited 10× · PMID 40143452 · DOI 10.1111/dom.16359 -
Advancing Cardiovascular, Kidney, and Metabolic Medicine: A Narrative Review of Insights and Innovations for the Future.
Fernando K, Connolly D, Darcy E, Evans M, et al · · 2025 · cited 8× · PMID 40272772 · DOI 10.1007/s13300-025-01738-3 -
New pharmacological agents and novel cardiovascular pharmacotherapy strategies in 2024.
Tamargo J, Agewall S, Ambrosio G, Borghi C, et al · · 2025 · cited 6× · PMID 40058879 · DOI 10.1093/ehjcvp/pvaf012 -
Efficacy and safety of balcinrenone and dapagliflozin for CKD: design and baseline characteristics of the MIRO-CKD trial.
Mark PB, De Sousa-Amorim E, Eriksson AL, Leonsson-Zachrisson M, et al · · 2025 · cited 4× · PMID 40623005 · DOI 10.1093/ndt/gfaf119 -
SGLT2 inhibitor with and without ALDosterone AntagonIst for heart failure with preserved ejection fraction: Design paper.
Ferreira JP, Vasques-Nóvoa F, Saraiva F, Oliveira AC, et al · · 2025 · cited 3× · PMID 40388563 · DOI 10.1002/ehf2.15294 -
The effect of severe renal impairment on the pharmacokinetics, safety and tolerability of balcinrenone.
Bhattacharya CS, Ericsson H, Johansson S, Parkinson J, et al · · 2025 · cited 3× · PMID 39962632 · DOI 10.1002/bcp.70017 -
Sodium-Glucose Cotransporter 2 Inhibitors in Lupus Nephritis and ANCA-Associated Vasculitis: Unmet Needs to be Addressed.
Vajgel G, Säemann MD, Kronbichler A. · · 2026 · PMID 42182829 · DOI 10.1159/000551255
Verify or expand the search:
- PubMed search for NCT06350123
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06350123 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by AstraZeneca
- Last refreshed: 16 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06350123.
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