Balcinrenone + Dapagliflozin for Renal Failure

This trial tests the safety and tolerability of a new treatment for individuals with kidney failure undergoing regular hemodialysis (a process that cleans the blood when kidneys cannot). The treatment combines two drugs, balcinrenone (a potential new drug) and dapagliflozin, to examine how the body processes them. Participants will receive the treatment at different times relative to their dialysis sessions to determine if timing affects the results. This trial may suit individuals who have experienced kidney failure and have been stable on dialysis for at least three months. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Research has shown that using balcinrenone and dapagliflozin together is generally safe for people with chronic kidney disease and heart failure. Studies have found that most people tolerate this treatment well. For instance, one study with varying dose levels reported unwanted effects in about 27.3% to 52.9% of participants, depending on the dose, indicating that most did not experience serious side effects.

Researchers are excited about balcinrenone combined with dapagliflozin for treating renal failure because it offers a new approach compared to standard treatments like ACE inhibitors, ARBs, and SGLT2 inhibitors alone. This combination leverages dapagliflozin's ability to reduce blood sugar and protect kidney function, while balcinrenone, a new active ingredient, works as a non-steroidal mineralocorticoid receptor antagonist to reduce inflammation and fibrosis in the kidneys. By targeting different pathways, this combination has the potential to enhance kidney protection more effectively than current options.

This trial will evaluate the combination of balcinrenone and dapagliflozin for treating kidney problems. Research has shown that using these drugs together may lower protein levels in urine, indicating healthier kidneys. It also reduces the risk of kidney failure and heart issues in people with chronic kidney disease (CKD). The treatment is generally well-tolerated, with only minor effects on potassium levels, and previous patients have not reported any unexpected safety concerns. Overall, this combination is effective and safe for improving kidney health. Participants in this trial will receive the combination in different sequences relative to their hemodialysis sessions to assess its effectiveness and safety.¹²³⁴⁶