Evidence map›Paper›PMID 40623005›Full record

ArticleNephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association2025

Efficacy and safety of balcinrenone and dapagliflozin for CKD: design and baseline characteristics of the MIRO-CKD trial.

Patrick B Mark, Erika De Sousa-Amorim, Anna L Eriksson, Maria Leonsson-Zachrisson, Nicolas J Guzman, Matthew T Miller, Yunyun Jiang, Hiddo J L Heerspink

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06350123 (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), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06350123 phase2completednot on this map

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

TypeinterventionalSponsorAstraZenecaRan2024 to 2025Enrolled324ConditionsChronic Kidney DiseaseArmsBalcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg, Balcinrenone/dapagliflozin 40 mg/10 mg and matching placebo for dapagliflozin 10 mg, Dapagliflozin 10 mg and matching placebo for balcinrenone/dapa gliflozin
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Review
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Patrick B MarkSchool of Cardiovascular and Metabolic Health, University of Glasgow, Glasgow, UK.ORCID 0000-0003-3387-2123
Erika De Sousa-AmorimLate-stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Warsaw, Poland.
Anna L ErikssonLate-stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
Maria Leonsson-ZachrissonLate-stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
Nicolas J GuzmanLate-stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.
Matthew T MillerBiometrics, Late Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.
Yunyun JiangBiometrics, Late Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.
Hiddo J L HeerspinkDepartment of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.ORCID 0000-0002-3126-3730

Funding

AstraZeneca
6 · The paper itself

Abstract

background and hypothesisDespite benefits of sodium-glucose cotransporter 2 inhibitors (SGLT2i) being recommended for treatment of chronic kidney disease (CKD), there is still an unmet need for managing renal residual risk. Based on pre-clinical data, balcinrenone is a novel mineralocorticoid receptor antagonist that maintains cardio-renal benefits without increasing hyperkalaemia risk. Use of balcinrenone and dapagliflozin is expected to provide complementary and additive kidney and cardiovascular protection. The MIRO-CKD study tests the hypothesis that balcinrenone with dapagliflozin is superior to dapagliflozin alone in reducing albuminuria in patients with CKD.

methodsMIRO-CKD is a double-blind, active-controlled, phase 2b study evaluating the efficacy and safety of balcinrenone/dapagliflozin in 300 adults (planned) with CKD, estimated glomerular filtration rate (eGFR) 25-60 mL/min/1.73 m2 and serum potassium within normal range. Participants are being randomized 1:1:1 to balcinrenone/dapagliflozin 15 mg/10 mg, 40 mg/10 mg or placebo/dapagliflozin 10 mg for 12 weeks, followed by an 8-week wash-out period to assess off-drug effects. The primary endpoint is the change in log-transformed urinary albumin-to-creatinine ratio (UACR) from baseline to Week 12. Other outcomes include pharmacokinetics, safety and tolerability.

resultsA total of 614 patients were screened and 324 were randomized across 15 countries in Asia, Europe, and North and South America. There were 56.2% of participants taking SGLT2i and 87.1% renin-angiotensin-aldosterone system inhibitors at enrolment. The patient population are at increased risk of CKD progression by having CKD stage 3/4 and albuminuria (median UACR: 365.5 mg/g; mean eGFR: 42.2 mL/min/1.73 m2). 56.5% of participants had type 2 diabetes mellitus.

conclusionsMIRO-CKD is a fully recruited global trial enrolling a contemporary CKD population at increased risk of progression and with an increased risk of hyperkalaemia based on their reduced kidney function. The study will assess the efficacy, safety and tolerability of the combination of balcinrenone and dapagliflozin to identify an optimal dose for a future phase 3 study in patients with CKD. CLINICAL TRIAL REGISTRATION NUMBER: NCT06350123.

Indexed as

AlbuminuriaBenzhydryl CompoundsGlucosidesMineralocorticoid Receptor AntagonistsRenal Insufficiency, ChronicAdultAgedClinical Trials, Phase II as TopicDouble-Blind MethodFemaleFollow-Up StudiesGlomerular Filtration RateGlycosidesHumansMaleMiddle Aged(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triolBenzhydryl CompoundsdapagliflozinGlucosidesGlycosidesMineralocorticoid Receptor AntagonistsSodium-Glucose Transporter 2 Inhibitorsbalcinrenonechronic kidney disease (CKD)dapagliflozinefficacysafety

Identifiers

PMID40623005
PMCPMC12648066

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.