Balcinrenone + Dapagliflozin for Chronic Kidney Disease
(MIRO-CKD Trial)
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?
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either balcinrenone/dapagliflozin or dapagliflozin alone to evaluate efficacy, safety, and tolerability
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Balcinrenone/dapagliflozin
- Dapagliflozin
Find a Clinic Near You
Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
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