324 Participants Needed

Balcinrenone + Dapagliflozin for Chronic Kidney Disease

(MIRO-CKD Trial)

Recruiting at 104 trial locations
AC
Overseen ByAstraZeneca Clinical Study Information Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

Trial Summary

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify if you must stop all current medications, but you cannot use MRAs, potassium sparing diuretics, potassium binders, fludrocortisone, or strong/moderate CYP3A4 inducers or inhibitors within 4 weeks before screening and during treatment.

What data supports the idea that Balcinrenone + Dapagliflozin for Chronic Kidney Disease is an effective drug?

The available research shows that finerenone, a drug similar to Balcinrenone, has been effective in reducing the risk of kidney failure and heart complications in patients with chronic kidney disease and type 2 diabetes. In a study, finerenone reduced the occurrence of kidney failure and other serious kidney issues from 21.1% to 17.8%. It also showed a significant reduction in both kidney and heart-related problems when compared to a placebo. Although the research does not directly mention Balcinrenone + Dapagliflozin, the effectiveness of similar drugs like finerenone suggests potential benefits for this combination as well.12345

What safety data exists for Balcinrenone + Dapagliflozin in treating chronic kidney disease?

The safety data for dapagliflozin, a component of the treatment, is well-documented. Dapagliflozin (Farxiga) is approved to reduce the risk of kidney function decline, kidney failure, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease. It has been studied extensively for its efficacy, safety, and tolerability in treating type 2 diabetes and heart failure with reduced ejection fraction. Dapagliflozin is generally well-tolerated, with a safety profile consistent across various indications, as observed in trials like DECLARE-TIMI 58 and DAPA-HF. However, specific safety data for the combination of Balcinrenone and Dapagliflozin is not detailed in the provided research.678910

Is the drug dapagliflozin a promising treatment for chronic kidney disease?

Yes, dapagliflozin is a promising drug for chronic kidney disease. It is approved to reduce the risk of worsening kidney function, kidney failure, heart-related death, and hospital visits for heart failure in people with chronic kidney disease, whether or not they have type 2 diabetes.2361112

What is the purpose of this trial?

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.

Eligibility Criteria

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.

Inclusion Criteria

I have chronic kidney disease with a specific kidney function level.
Serum potassium ≥ 3.5 mmol/L to ≤ 5.0 mmol/L
UACR > 100 mg/g (10 mg/mmol) to ≤ 5000 mg/g (500 mg/mmol)
See 1 more

Exclusion Criteria

I have not had a heart attack, stroke, or similar event in the last 3 months.
I haven't used specific heart or kidney medications in the last 4 weeks.
Hypotension defined as SBP < 100 mmHg
See 10 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

Up to 3 weeks

Treatment

Participants receive either balcinrenone/dapagliflozin or dapagliflozin alone to evaluate efficacy, safety, and tolerability

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

Treatment Details

Interventions

  • Balcinrenone/dapagliflozin
  • Dapagliflozin
Trial Overview 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.
Participant Groups
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 Clinic Near You

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials
4,491
Recruited
290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Findings from Research

Finerenone is a first-in-class oral medication that selectively targets mineralocorticoid receptors, approved in the USA for reducing the risk of serious complications like kidney decline and heart issues in adults with chronic kidney disease related to type 2 diabetes.
It has shown efficacy in preventing sustained declines in kidney function and reducing cardiovascular risks, and is currently being studied in a phase III trial for heart failure with preserved ejection fraction.
Finerenone: First Approval.Frampton, JE.[2022]
In the phase 3 FIDELIO-DKD trial, finerenone significantly reduced the risk of kidney failure and related outcomes in patients with diabetic kidney disease, lowering the primary composite outcome from 21.1% to 17.8%.
Finerenone has a favorable safety profile and offers a different mechanism of action compared to other treatments like GLP-1 receptor agonists and SGLT-2 inhibitors, suggesting it could be an effective option for managing diabetic chronic kidney disease.
Finerenone - are we there yet with a non-steroidal mineralocorticoid receptor antagonist for the treatment of diabetic chronic kidney disease?Doggrell, SA.[2022]
In a study of 5674 patients with chronic kidney disease (CKD) and type 2 diabetes (T2D), finerenone significantly reduced urine albumin-to-creatinine ratio (UACR) regardless of whether patients were also using sodium-glucose cotransporter-2 inhibitors (SGLT-2i).
Finerenone demonstrated consistent benefits on kidney and cardiovascular outcomes compared to placebo, with improved safety profile, particularly showing fewer hyperkalemia events in patients using SGLT-2i.
Finerenone in Predominantly Advanced CKD and Type 2 Diabetes With or Without Sodium-Glucose Cotransporter-2 Inhibitor Therapy.Rossing, P., Filippatos, G., Agarwal, R., et al.[2023]

References

Finerenone: First Approval. [2022]
Finerenone - are we there yet with a non-steroidal mineralocorticoid receptor antagonist for the treatment of diabetic chronic kidney disease? [2022]
Finerenone in Predominantly Advanced CKD and Type 2 Diabetes With or Without Sodium-Glucose Cotransporter-2 Inhibitor Therapy. [2023]
[Finerenone (Kerendia®), a new weapon against the chronic kidney disease of a patient with type 2 diabetes]. [2023]
Finerenone: a new mineralocorticoid receptor antagonist to beat chronic kidney disease. [2023]
Antidiabetic Drug Approved to Reduce Risk of Kidney Disease. [2023]
Dapagliflozin: A Sodium Glucose Cotransporter 2 Inhibitor for the Treatment of Diabetes Mellitus. [2021]
Dapagliflozin/Saxagliptin Fixed-Dose Tablets: A New Sodium-Glucose Cotransporter 2 and Dipeptidyl Peptidase 4 Combination for the Treatment of Type 2 Diabetes. [2022]
Dapagliflozin: A Review in Symptomatic Heart Failure with Reduced Ejection Fraction. [2022]
Pharmacokinetics, pharmacodynamics and clinical efficacy of dapagliflozin for the treatment of type 2 diabetes. [2021]
Dapagliflozin in people with chronic kidney disease. [2023]
12.United Statespubmed.ncbi.nlm.nih.gov
In CKD, dapagliflozin reduced a composite of eGFR decline, end-stage kidney disease, or CV or renal mortality. [2021]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security