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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (day 1) until week 12 (day 85)

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

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