Efficacy, Safety and Tolerability of Balcinrenone/Dapagliflozin Compared to Dapagliflozin in Adults With Chronic Kidney Disease

NCT06350123
clinicaltrials.gov
Phase
Phase 2
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Recruitment status
Completed
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Participants
324
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Lead sponsor
AstraZeneca
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Start date
2024-05-01
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Number of sites
92
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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.
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Acronym
MIRO-CKD
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Short title
Efficacy, Safety and Tolerability of Balcinrenone/Dapagliflozin Compared to Dapagliflozin in Adults With Chronic Kidney Disease
clinicaltrials.gov
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
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Control arm
Active comparator
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Registry reports results
Yes
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 2
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Study type
Interventional
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Completion date
2025-05-09
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First posted
2024-04-05
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Registry last updated
2026-06-26
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Primary completion date
2025-05-09
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Start date
2024-05-01
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Actual participants
324
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Participants
324
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Participant count basis
Actual
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Protocol amendments
5
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Randomisation ratio
1:1:1
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Number of sites
92
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
AstraZeneca
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06350123
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ClinicalTrials.gov ID
NCT06350123
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Relative Change in Urine Albumin-to-Creatinine Ratio (UACR) From Baseline to Week 12

    Timeframe: Baseline (Day 1) until Week 12 (Day 85)

    Evaluating the effect of balcinrenone/dapagliflozin compared with dapagliflozin alone on Urine Albumin-to-Creatinine Ratio (UACR).

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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.
Sources for eligibility
clinicaltrials.gov

  • Research SiteSheffield, United States
  • Research SiteGlendale, United States
  • Research SiteWaterbury, United States
  • Research SiteHialeah, United States
  • Research SiteMiami Lakes, United States
  • Research SiteAnnapolis, United States
  • Research SiteNew Bern, United States
  • Research SiteEl Paso, United States
  • Research SiteHouston, United States
  • Research SiteHouston, United States
  • Research SiteSan Antonio, United States
  • Research SiteOgden, United States
  • Research SiteSalt Lake City, United States
  • Research SiteSalt Lake City, United States
  • Research SiteNorfolk, United States
  • Research SiteLinz, Austria
  • Research SiteSankt Pölten, Austria
  • Research SiteVienna, Austria
  • Research SiteVienna, Austria
  • Research SiteVienna, Austria
  • Research SiteVienna, Austria
  • Research SiteWels, Austria
  • Research SitePorto Alegre, Brazil
  • Research SiteSão Paulo, Brazil
  • Research SiteSão Paulo, Brazil

And 67 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2023
  • 2023-509709-63-00
Sources for references
clinicaltrials.gov

Related records

Drugs (3)

Lead sponsors (1)

Conditions (2)

Targets (18)