Balcinrenone + Dapagliflozin for Chronic Kidney Disease

(MIRO-CKD Trial)

This trial tests a new combination of medications, balcinrenone (an experimental treatment) and dapagliflozin, to determine if they work better together than dapagliflozin alone for individuals with chronic kidney disease (CKD) and high levels of protein in their urine. Researchers aim to identify the optimal dose for future studies. The trial seeks participants with CKD who struggle to maintain stable kidney function, particularly those who have experienced these symptoms for an extended period. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

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.

Research shows that balcinrenone, when combined with dapagliflozin, is being tested for safety and effectiveness in treating chronic kidney disease (CKD). Previous studies have found that patients generally tolerate this combination well.

Dapagliflozin, already approved by the FDA for other uses, has a strong safety record. It is widely used and known for having a low risk of serious side effects.

Most treatments for chronic kidney disease focus on managing symptoms and slowing progression, mainly using drugs like ACE inhibitors and angiotensin II receptor blockers. But balcinrenone/dapagliflozin is unique because it combines two active ingredients: balcinrenone, a new mineralocorticoid receptor antagonist, and dapagliflozin, a well-known SGLT2 inhibitor. This combination targets the disease from two angles, aiming to provide better kidney protection and potentially improve heart health. Researchers are excited about this treatment because it could offer a more comprehensive approach to managing chronic kidney disease, potentially leading to better outcomes for patients.

Research has shown that using balcinrenone with dapagliflozin may be more effective than dapagliflozin alone for treating chronic kidney disease (CKD). In this trial, participants will receive either the combination of balcinrenone and dapagliflozin or dapagliflozin alone. One study found that this combination significantly reduces albuminuria, a condition where excess protein leaks into the urine, commonly seen in CKD. Lowering albuminuria can help protect the kidneys over time. Patients who have used this combination demonstrated promising results with fewer kidney problems. The trial aims to determine the optimal dose of this combination to maximize its benefits for CKD patients.¹²³⁴⁶