Efficacy, Safety and Tolerability of Balcinrenone/Dapagliflozin Compared to Dapagliflozin in Adults With Chronic Kidney Disease
MIRO-CKD
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
2 other identifiers
interventional
324
15 countries
93
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2024
Shorter than P25 for phase_2
93 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 2, 2024
CompletedFirst Posted
Study publicly available on registry
April 5, 2024
CompletedStudy Start
First participant enrolled
May 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 9, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 9, 2025
CompletedMay 16, 2025
May 1, 2025
1 year
April 2, 2024
May 15, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Relative change in UACR from baseline to Week 12
Evaluating the effect of balcinrenone/dapagliflozin compared with dapagliflozin alone on UACR.
Baseline (Day 1) until Week 12 (Day 85)
Study Arms (3)
Balcinrenone/dapagliflozin 15 mg/10 mg
EXPERIMENTALPatients will be randomized 1:1:1 to either balcinrenone/dapagliflozin and matching placebo for dapagliflozin or dapagliflozin and matching placebo for balcinrenone/dapagliflozin
Balcinrenone/dapagliflozin 40 mg/10 mg
EXPERIMENTALPatients will be randomized 1:1:1 to either balcinrenone/dapagliflozin and matching placebo for dapagliflozin or dapagliflozin and matching placebo for balcinrenone/dapagliflozin
Dapagliflozin 10 mg
ACTIVE COMPARATORPatients will be randomized 1:1:1 to either balcinrenone/dapagliflozin and matching placebo for dapagliflozin or dapagliflozin and matching placebo for balcinrenone/dapagliflozin
Interventions
1 capsule of balcinrenone/dapagliflozin 15 mg/10 mg and 1 tablet of matching placebo for dapagliflozin 10 mg once daily, oral use
1 capsule of balcinrenone/dapagliflozin 40 mg/10 mg and 1 tablet of matching placebo for dapagliflozin 10 mg once daily, oral use
1 tablet of dapagliflozin 10 mg and 1 capsule of matching placebo for balcinrenone/dapagliflozin once daily, oral use
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (93)
Research Site
Sheffield, Alabama, 35660, United States
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Glendale, California, 91206, United States
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Waterbury, Connecticut, 06708, United States
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Hialeah, Florida, 33012, United States
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Miami Lakes, Florida, 33014, United States
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Annapolis, Maryland, 21401, United States
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New Bern, North Carolina, 28562, United States
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El Paso, Texas, 79935, United States
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Houston, Texas, 77079, United States
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Houston, Texas, 77099, United States
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San Antonio, Texas, 78212, United States
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Ogden, Utah, 84405, United States
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Salt Lake City, Utah, 84115, United States
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Salt Lake City, Utah, 84124, United States
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Norfolk, Virginia, 23504, United States
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Linz, 4021, Austria
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Sankt Pölten, 3100, Austria
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Vienna, 1030, Austria
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Vienna, 1130, Austria
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Vienna, 1190, Austria
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Vienna, A-1090, Austria
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Wels, 4600, Austria
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Porto Alegre, 90020-090, Brazil
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São Paulo, 01228-000, Brazil
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São Paulo, 04012-909, Brazil
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São Paulo, 04038-031, Brazil
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São Paulo, 05403-9000, Brazil
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Burgas, 8018, Bulgaria
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Dobrich, 9300, Bulgaria
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Pleven, 5800, Bulgaria
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Plovdiv, 4000, Bulgaria
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Sofia, 1680, Bulgaria
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London, Ontario, N6A 5A5, Canada
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Waterloo, Ontario, N2T 0C1, Canada
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Montreal, Quebec, H4J 1C5, Canada
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Québec, Quebec, G1R 2J6, Canada
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Changchun, 130021, China
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Changzhou, 213004, China
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Shanghai, 200032, China
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Shanghai, 200050, China
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Tianjin, 300050, China
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Bari, 70124, Italy
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Bologna, 40138, Italy
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Genoa, 16132, Italy
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Novara, 28100, Italy
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Pavia, 27100, Italy
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Ageo, 362-8588, Japan
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Fujisawa-shi, 251-0041, Japan
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Fukuoka, 810-8563, Japan
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Koga-shi, 306-0232, Japan
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Koshigaya-shi, 343-8577, Japan
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Kumamoto, 860-0008, Japan
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Nagasaki, 852-8034, Japan
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Nagoya, 451-8511, Japan
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Okinawa-shi, 904-2143, Japan
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Takamatsu, 760-0076, Japan
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Zentsuji-shi, 765-8507, Japan
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Ipoh, 30990, Malaysia
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Johor Bahru, 80100, Malaysia
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Kajang, 43000, Malaysia
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Kota Bharu, 15586, Malaysia
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Kuala Terengganu, 20400, Malaysia
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Bialystok, 15-481, Poland
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Grodzisk Mazowiecki, 05-825, Poland
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Leżajsk, 37-300, Poland
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Szczecin, 70-111, Poland
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Warsaw, 02-798, Poland
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Żywiec, 34-300, Poland
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Barcelona, 08035, Spain
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Barcelona, 08036, Spain
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Córdoba, 14004, Spain
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Palma de Mallorca, 07010, Spain
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Valencia, 46026, Spain
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Kaohsiung City, 80756, Taiwan
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New Taipei City, 220, Taiwan
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Taichung, 40201, Taiwan
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Tainan, 710, Taiwan
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Taipei, 10002, Taiwan
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Taipei, 110, Taiwan
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Taipei, 11217, Taiwan
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Taipei, 11490, Taiwan
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Ankara, 06340, Turkey (Türkiye)
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Gaziantep, 27310, Turkey (Türkiye)
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Kahramanmaraş, 46100, Turkey (Türkiye)
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Kayseri, 38039, Turkey (Türkiye)
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Kocaeli, 41380, Turkey (Türkiye)
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Dundee, DDS 1SY, United Kingdom
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London, N18 1QX, United Kingdom
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Newquay, TR7 1RU, United Kingdom
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Nottingham, NG9 6DX, United Kingdom
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Haiphong, 180000, Vietnam
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Ho Chi Minh City, 700000, Vietnam
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Hochiminh City, 700000, Vietnam
Related Publications (3)
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.
PMID: 41218621DERIVEDMark 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.
PMID: 40623005DERIVEDBhattacharya 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.
PMID: 39962632DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 2, 2024
First Posted
April 5, 2024
Study Start
May 1, 2024
Primary Completion
May 9, 2025
Study Completion
May 9, 2025
Last Updated
May 16, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
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.