Efficacy, Safety and Tolerability of Balcinrenone/Dapagliflozin Compared to Dapagliflozin in Adults With Chronic Kidney Disease (MIRO-CKD)

May 15, 2025 updated by: AstraZeneca

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
324

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Austria
      • Linz, Austria, 4021
        • Research Site
      • St. Pölten, Austria, 3100
        • Research Site
      • Vienna, Austria, A-1090
        • Research Site
      • Wels, Austria, 4600
        • Research Site
      • Wien, Austria, 1130
        • Research Site
      • Wien, Austria, 1030
        • Research Site
      • Wien, Austria, 1190
        • Research Site
  • Brazil
      • Porto Alegre, Brazil, 90020-090
        • Research Site
      • Sao Paulo, Brazil, 05403-9000
        • Research Site
      • Sao Paulo, Brazil, 01228-000
        • Research Site
      • São Paulo, Brazil, 04012-909
        • Research Site
      • São Paulo, Brazil, 04038-031
        • Research Site
  • Bulgaria
      • Burgas, Bulgaria, 8018
        • Research Site
      • Dobrich, Bulgaria, 9300
        • Research Site
      • Pleven, Bulgaria, 5800
        • Research Site
      • Plovdiv, Bulgaria, 4000
        • Research Site
      • Sofia, Bulgaria, 1680
        • Research Site
  • Canada
      • Quebec, Canada, G1R 2J6
        • Research Site
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • Research Site
      • Waterloo, Ontario, Canada, N2T 0C1
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada, H4J 1C5
        • Research Site
  • China
      • Changchun, China, 130021
        • Research Site
      • Changzhou, China, 213004
        • Research Site
      • Shanghai, China, 200032
        • Research Site
      • Shanghai, China, 200050
        • Research Site
      • Tianjin, China, 300050
        • Research Site
  • Italy
      • Bari, Italy, 70124
        • Research Site
      • Bologna, Italy, 40138
        • Research Site
      • Genoa, Italy, 16132
        • Research Site
      • Novara, Italy, 28100
        • Research Site
      • Pavia, Italy, 27100
        • Research Site
  • Japan
      • Ageo, Japan, 362-8588
        • Research Site
      • Fujisawa-shi, Japan, 251-0041
        • Research Site
      • Fukuoka-shi, Japan, 810-8563
        • Research Site
      • Koga-shi, Japan, 306-0232
        • Research Site
      • Koshigaya-shi, Japan, 343-8577
        • Research Site
      • Kumamoto-shi, Japan, 860-0008
        • Research Site
      • Nagasaki-shi, Japan, 852-8034
        • Research Site
      • Nagoya, Japan, 451-8511
        • Research Site
      • Okinawa-shi, Japan, 904-2143
        • Research Site
      • Takamatsu-shi, Japan, 760-0076
        • Research Site
      • Zentsuji-shi, Japan, 765-8507
        • Research Site
  • Malaysia
      • Ipoh, Malaysia, 30990
        • Research Site
      • Johor Bahru, Malaysia, 80100
        • Research Site
      • Kajang, Malaysia, 43000
        • Research Site
      • Kota Bharu, Malaysia, 15586
        • Research Site
      • Kuala Terengganu, Malaysia, 20400
        • Research Site
  • Poland
      • Białystok, Poland, 15-481
        • Research Site
      • Grodzisk Mazowiecki, Poland, 05-825
        • Research Site
      • Leżajsk, Poland, 37-300
        • Research Site
      • Szczecin, Poland, 70-111
        • Research Site
      • Warszawa, Poland, 02-798
        • Research Site
      • Żywiec, Poland, 34-300
        • Research Site
  • Spain
      • Barcelona, Spain, 08035
        • Research Site
      • Barcelona, Spain, 08036
        • Research Site
      • Córdoba, Spain, 14004
        • Research Site
      • Palma de Mallorca, Spain, 07010
        • Research Site
      • Valencia, Spain, 46026
        • Research Site
  • Taiwan
      • Kaohsiung, Taiwan, 80756
        • Research Site
      • New Taipei City, Taiwan, 220
        • Research Site
      • Taichung, Taiwan, 40201
        • Research Site
      • Tainan, Taiwan, 710
        • Research Site
      • Taipei, Taiwan, 10002
        • Research Site
      • Taipei, Taiwan, 11490
        • Research Site
      • Taipei City, Taiwan, 110
        • Research Site
      • Taipei City, Taiwan, 11217
        • Research Site
  • Turkey
      • Ankara, Turkey, 06340
        • Research Site
      • Gaziantep, Turkey, 27310
        • Research Site
      • Kahramanmaras, Turkey, 46100
        • Research Site
      • Kayseri, Turkey, 38039
        • Research Site
      • Kocaeli, Turkey, 41380
        • Research Site
  • United Kingdom
      • Dundee, United Kingdom, DDS 1SY
        • Research Site
      • London, United Kingdom, N18 1QX
        • Research Site
      • Newquay, United Kingdom, TR7 1RU
        • Research Site
      • Nottingham, United Kingdom, NG9 6DX
        • Research Site
  • United States
    • Alabama
      • Sheffield, Alabama, United States, 35660
        • Research Site
    • California
      • Glendale, California, United States, 91206
        • Research Site
    • Connecticut
      • Waterbury, Connecticut, United States, 06708
        • Research Site
    • Florida
      • Hialeah, Florida, United States, 33012
        • Research Site
      • Miami Lakes, Florida, United States, 33014
        • Research Site
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Research Site
    • North Carolina
      • New Bern, North Carolina, United States, 28562
        • Research Site
    • Texas
      • El Paso, Texas, United States, 79935
        • Research Site
      • Houston, Texas, United States, 77099
        • Research Site
      • Houston, Texas, United States, 77079
        • Research Site
      • San Antonio, Texas, United States, 78212
        • Research Site
    • Utah
      • Ogden, Utah, United States, 84405
        • Research Site
      • Salt Lake City, Utah, United States, 84124
        • Research Site
      • Salt Lake City, Utah, United States, 84115
        • Research Site
    • Virginia
      • Norfolk, Virginia, United States, 23504
        • Research Site
  • Vietnam
      • Hai Phong, Vietnam, 180000
        • Research Site
      • Ho Chi Minh, Vietnam, 700000
        • Research Site
      • Hochiminh city, Vietnam, 700000
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Balcinrenone/dapagliflozin 15 mg/10 mg
Patients will be randomized 1:1:1 to either balcinrenone/dapagliflozin and matching placebo for dapagliflozin or dapagliflozin and matching placebo for balcinrenone/dapagliflozin
Drug: Balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg
1 capsule of balcinrenone/dapagliflozin 15 mg/10 mg and 1 tablet of matching placebo for dapagliflozin 10 mg once daily, oral use
Experimental: Balcinrenone/dapagliflozin 40 mg/10 mg
Patients will be randomized 1:1:1 to either balcinrenone/dapagliflozin and matching placebo for dapagliflozin or dapagliflozin and matching placebo for balcinrenone/dapagliflozin
Drug: Balcinrenone/dapagliflozin 40 mg/10 mg and matching placebo for dapagliflozin 10 mg
1 capsule of balcinrenone/dapagliflozin 40 mg/10 mg and 1 tablet of matching placebo for dapagliflozin 10 mg once daily, oral use
Active Comparator: Dapagliflozin 10 mg
Patients will be randomized 1:1:1 to either balcinrenone/dapagliflozin and matching placebo for dapagliflozin or dapagliflozin and matching placebo for balcinrenone/dapagliflozin
Drug: Dapagliflozin 10 mg and matching placebo for balcinrenone/dapa gliflozin
1 tablet of dapagliflozin 10 mg and 1 capsule of matching placebo for balcinrenone/dapagliflozin once daily, oral use

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Relative change in UACR from baseline to Week 12
Time Frame: Baseline (Day 1) until Week 12 (Day 85)
Evaluating the effect of balcinrenone/dapagliflozin compared with dapagliflozin alone on UACR.
Baseline (Day 1) until Week 12 (Day 85)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 9, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 9, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 2, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 5, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 16, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D6405C00002
  • 2023-509709-63-00 (Registry Identifier: EU CT number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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Dietary Supplements

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