Chronic Kidney DiseasePhase 2MIRO-CKDNCT06350123
Efficacy, Safety and Tolerability of Balcinrenone/Dapagliflozin Compared to Dapagliflozin in Adults With Chronic Kidney Disease
A Phase 2 study of Chronic Kidney Disease, run by AstraZeneca at 92 sites in 15 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 324 participants
- Where
- 92 sitesin 15 countries
- Study dates
- 1 May 2024to 9 May 2025
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
92 sites in 15 countries.
92 sites in 15 countries
United States15 sites
Research Site
Annapolis, Maryland, 21401
Research Site
El Paso, Texas, 79935
Research Site
Glendale, California, 91206
Research Site
Hialeah, Florida, 33012
Research Site
Houston, Texas, 77079
Research Site
Houston, Texas, 77099
Research Site
Miami Lakes, Florida, 33014
Research Site
New Bern, North Carolina, 28562
Research Site
Norfolk, Virginia, 23504
Research Site
Ogden, Utah, 84405
Research Site
Salt Lake City, Utah, 84115
Research Site
Salt Lake City, Utah, 84124
Research Site
San Antonio, Texas, 78212
Research Site
Sheffield, Alabama, 35660
Research Site
Waterbury, Connecticut, 06708
Japan11 sites
Research Site
Ageo, 362-8588
Research Site
Fujisawa-shi, 251-0041
Research Site
Fukuoka, 810-8563
Research Site
Koga-shi, 306-0232
Research Site
Koshigaya-shi, 343-8577
Research Site
Kumamoto, 860-0008
Research Site
Nagasaki, 852-8034
Research Site
Nagoya, 451-8511
Research Site
Okinawa-shi, 904-2143
Research Site
Takamatsu, 760-0076
Research Site
Zentsuji-shi, 765-8507
Taiwan8 sites
Research Site
Kaohsiung City, 80756
Research Site
New Taipei City, 220
Research Site
Taichung, 40201
Research Site
Tainan, 710
Research Site
Taipei, 10002
Research Site
Taipei, 110
Research Site
Taipei, 11217
Research Site
Taipei, 11490
Austria7 sites
Research Site
Linz, 4021
Research Site
Sankt Pölten, 3100
Research Site
Vienna, 1030
Research Site
Vienna, 1130
Research Site
Vienna, 1190
Research Site
Vienna, A-1090
Research Site
Wels, 4600
Poland6 sites
Research Site
Bialystok, 15-481
Research Site
Grodzisk Mazowiecki, 05-825
Research Site
Leżajsk, 37-300
Research Site
Szczecin, 70-111
Research Site
Warsaw, 02-798
Research Site
Żywiec, 34-300
Brazil5 sites
Research Site
Porto Alegre, 90020-090
Research Site
São Paulo, 01228-000
Research Site
São Paulo, 04012-909
Research Site
São Paulo, 04038-031
Research Site
São Paulo, 05403-9000
Bulgaria5 sites
Research Site
Burgas, 8018
Research Site
Dobrich, 9300
Research Site
Pleven, 5800
Research Site
Plovdiv, 4000
Research Site
Sofia, 1680
China5 sites
Research Site
Changchun, 130021
Research Site
Changzhou, 213004
Research Site
Shanghai, 200032
Research Site
Shanghai, 200050
Research Site
Tianjin, 300050
Malaysia5 sites
Research Site
Ipoh, 30990
Research Site
Johor Bahru, 80100
Research Site
Kajang, 43000
Research Site
Kota Bharu, 15586
Research Site
Kuala Terengganu, 20400
Spain5 sites
Research Site
Barcelona, 08035
Research Site
Barcelona, 08036
Research Site
Córdoba, 14004
Research Site
Palma de Mallorca, 07010
Research Site
Valencia, 46026
Turkey (Türkiye)5 sites
Research Site
Ankara, 06340
Research Site
Gaziantep, 27310
Research Site
Kahramanmaraş, 46100
Research Site
Kayseri, 38039
Research Site
Kocaeli, 41380
Canada4 sites
Research Site
London, Ontario, N6A 5A5
Research Site
Montreal, Quebec, H4J 1C5
Research Site
Québec, Quebec, G1R 2J6
Research Site
Waterloo, Ontario, N2T 0C1
Italy4 sites
Research Site
Bari, 70124
Research Site
Bologna, 40138
Research Site
Genoa, 16132
Research Site
Pavia, 27100
United Kingdom4 sites
Research Site
Dundee, DDS 1SY
Research Site
London, N18 1QX
Research Site
Newquay, TR7 1RU
Research Site
Nottingham, NG9 6DX
Vietnam3 sites
Research Site
Haiphong, 180000
Research Site
Ho Chi Minh City, 700000
Research Site
Hochiminh City, 700000
About this study
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
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.
Read the detailed description
This is a Phase IIb, multicentre, randomised, double-blind, dose-finding, parallel group, double-dummy study aiming to determine the effect on albuminuria, as well as safety and tolerability, of balcinrenone/dapagliflozin compared with dapagliflozin, when given once daily on top of other Standard of Care (SoC) to patients with CKD and albuminuria.
Study population will include participants with CKD (eGFR ≥ 25 to < 60 mL/min/1.73 m2) and UACR > 100 mg/g to ≤ 5000 mg/g. Participants with or without a diagnosis of T2DM and with or without an SGLT2 inhibitor treatment at screening are eligible for the study.
The study will be conducted at approximately 110 sites in approximately 16 countries globally.
At least 300 participants will be randomised in order to have 300 evaluable participants.
Participants will be randomised to one of 3 treatment arms in a 1:1:1 ratio:
- Balcinrenone/dapagliflozin 15 mg/10 mg
- Balcinrenone/dapagliflozin 40 mg/10 mg
- Dapagliflozin 10 mg
For each participant, the total duration of participation will be approximately 23 weeks: an up to 3-week screening period followed by a 12-week treatment period, and an 8-week follow-up period after end of investigational medicinal product (IMP) treatment.
- Conditions
- Chronic Kidney Disease
- Being tested
- Balcinrenone/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
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mgDrug
1 capsule of balcinrenone/dapagliflozin 15 mg/10 mg and 1 tablet of matching placebo for dapagliflozin 10 mg once daily, oral use
Balcinrenone/dapagliflozin 40 mg/10 mg and matching placebo for dapagliflozin 10 mgDrug
1 capsule of balcinrenone/dapagliflozin 40 mg/10 mg and 1 tablet of matching placebo for dapagliflozin 10 mg once daily, oral use
Dapagliflozin 10 mg and matching placebo for balcinrenone/dapa gliflozinDrug
1 tablet of dapagliflozin 10 mg and 1 capsule of matching placebo for balcinrenone/dapagliflozin once daily, oral use
| Study group | Role | What they receive |
|---|---|---|
| Balcinrenone/dapagliflozin 15 mg/10 mg | Experimental | Patients will be randomized 1:1:1 to either balcinrenone/dapagliflozin and matching placebo for dapagliflozin or dapagliflozin and matching placebo for balcinrenone/dapagliflozin Receives: Drug: Balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg |
| Balcinrenone/dapagliflozin 40 mg/10 mg | Experimental | Patients will be randomized 1:1:1 to either balcinrenone/dapagliflozin and matching placebo for dapagliflozin or dapagliflozin and matching placebo for balcinrenone/dapagliflozin Receives: Drug: Balcinrenone/dapagliflozin 40 mg/10 mg and matching placebo for dapagliflozin 10 mg |
| Dapagliflozin 10 mg | Active comparator | Patients will be randomized 1:1:1 to either balcinrenone/dapagliflozin and matching placebo for dapagliflozin or dapagliflozin and matching placebo for balcinrenone/dapagliflozin Receives: Drug: Dapagliflozin 10 mg and matching placebo for balcinrenone/dapa gliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative Change in Urine Albumin-to-Creatinine Ratio (UACR) From Baseline to Week 12
Evaluating the effect of balcinrenone/dapagliflozin compared with dapagliflozin alone on Urine Albumin-to-Creatinine Ratio (UACR).
Measured: Baseline (Day 1) until Week 12 (Day 85)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start1 May 2024
- Primary completion9 May 2025
- Study completion9 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicentre, randomised, double-blind, dose-finding, parallel group, double-dummy
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 324 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06350123
- Sponsor's protocol ID
- D6405C00002
- Other IDs
- 2023-509709-63-00, 2023
- Acronym
- MIRO-CKD
- Status last verified
- Jun 2026
- First submitted
- 2 Apr 2024
- Last updated
- 26 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
Publications
Heerspink HJL, Cardona JF, Jolly S, Pergola PE, de Sousa-Amorim E, Eriksson AL, Fredholm M, Gasparyan SB, Guzman NJ, Hartleib-Geschwindner J, Jiang Y, Leonsson-Zachrisson M, Mark PB; MIRO-CKD study investigators. 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. Lancet. 2025 Nov 22;406(10518):2449-2460. doi: 10.1016/S0140-6736(25)02014-8. Epub 2025 Nov 8.
PubMed 41218621Mark PB, De Sousa-Amorim E, Eriksson AL, Leonsson-Zachrisson M, Guzman NJ, Miller MT, Jiang Y, Heerspink HJL. Efficacy and safety of balcinrenone and dapagliflozin for CKD: design and baseline characteristics of the MIRO-CKD trial. Nephrol Dial Transplant. 2025 Nov 26;40(12):2280-2288. doi: 10.1093/ndt/gfaf119.
PubMed 40623005Bhattacharya CS, Ericsson H, Johansson S, Parkinson J, Boca SM, Yang Y, Heijer M, Housler G, Leonsson-Zachrisson M, Hartleib-Geschwindner J, Pizzato PE. The effect of severe renal impairment on the pharmacokinetics, safety and tolerability of balcinrenone. Br J Clin Pharmacol. 2025 Jul;91(7):1937-1946. doi: 10.1002/bcp.70017. Epub 2025 Feb 17.
PubMed 39962632