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SGLT2 Inhibitor

Balcinrenone + Dapagliflozin for Chronic Kidney Disease (MIRO-CKD Trial)

Phase 2
Recruiting
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (day 1) until week 12 (day 85)

Summary

This trial will test a new drug combination, balcinrenone/dapagliflozin, to see if it is more effective, safe, and tolerable than using dapaglif

Who is the study for?
This trial is for adults with chronic kidney disease, specifically those who have protein in their urine (albuminuria). Participants should not be currently treated with Balcinrenone or Dapagliflozin. The study aims to find the best dose of a new combination drug.
What is being tested?
The study tests the effectiveness and safety of combining two drugs: Balcinrenone and Dapagliflozin, against using just Dapagliflozin. It's looking at how well this combo reduces protein levels in urine compared to the single drug.
What are the potential side effects?
Possible side effects include blood pressure changes, dehydration risks due to increased urination, potential for low blood sugar levels, and possible allergic reactions. Kidney function may also be affected.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day 1) until week 12 (day 85)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day 1) until week 12 (day 85) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Relative change in UACR from baseline to Week 12

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Balcinrenone/dapagliflozin 40 mg/10 mgExperimental Treatment1 Intervention
Patients will be randomized 1:1:1 to either balcinrenone/dapagliflozin and matching placebo for dapagliflozin or dapagliflozin and matching placebo for balcinrenone/dapagliflozin
Group II: Balcinrenone/dapagliflozin 15 mg/10 mgExperimental Treatment1 Intervention
Patients will be randomized 1:1:1 to either balcinrenone/dapagliflozin and matching placebo for dapagliflozin or dapagliflozin and matching placebo for balcinrenone/dapagliflozin
Group III: Dapagliflozin 10 mgActive Control1 Intervention
Patients will be randomized 1:1:1 to either balcinrenone/dapagliflozin and matching placebo for dapagliflozin or dapagliflozin and matching placebo for balcinrenone/dapagliflozin

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,384 Previous Clinical Trials
289,110,122 Total Patients Enrolled
~200 spots leftby Jan 2026
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