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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 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)
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
4,427 Previous Clinical Trials
289,164,311 Total Patients Enrolled