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SGLT2 Inhibitor

Balcinrenone/dapagliflozin 15 mg/10 mg for Chronic Kidney Disease (MIRO-CKD Trial)

Phase 2

Waitlist Available

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)

Awards & highlights

MIRO-CKD Trial 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.Check my eligibility

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.See study design

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.

MIRO-CKD Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Relative change in UACR from baseline to Week 12

MIRO-CKD 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor

4,274 Previous Clinical Trials

288,613,121 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In how many distinct settings is this medical study being conducted?

"Patient enrollment for this research study is ongoing at 47 different sites, with centers situated in Montreal, Vienna, Bologna, and various other locations. Opting for the closest site to your residence can help reduce travel obligations if you decide to participate."

Answered by AI

Are there any ongoing efforts to enlist participants for this medical study?

"As per clinicaltrials.gov, this specific medical study is not actively seeking volunteers. Despite being initially listed on May 6, 2024, and last updated on April 2, 2024, it is no longer accepting participants. Nonetheless, there are currently 536 alternative trials open for enrollment."

Answered by AI

What is the safety profile of Balcinrenone/dapagliflozin 15 mg/10 mg for individuals?

"Based on our evaluation at Power, the safety rating for Balcinrenone/dapagliflozin 15 mg/10 mg is a 2. This assessment aligns with it being a Phase 2 trial where some data exists supporting its safety profile but not yet confirming efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Efficacy, Safety and Tolerability of Balcinrenone/Dapagliflozin Compared to Dapagliflozin in Adults With Chronic Kidney Disease.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06350123.

All > Chronic Kidney Disease