Lorundrostat + Dapagliflozin for Kidney Disease

This trial tests a new combination treatment for individuals with chronic kidney disease (CKD) who also have high blood pressure and protein in their urine. The study examines how lorundrostat, a drug that blocks a hormone known to raise blood pressure, works with dapagliflozin, a medication used to lower blood sugar and blood pressure, to safely reduce blood pressure. It targets those who have maintained a stable regimen, including an ACE inhibitor or ARB, for at least two months. Participants should have CKD with protein in their urine and manage high blood pressure between 135-180 mmHg. This trial may suit those who haven't found relief from current treatments and experience these specific symptoms. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering a chance to benefit from innovative therapies.

The trial requires you to stay on a stable treatment with an ACE inhibitor or an Angiotensin receptor blocker for at least 2 months before screening. You cannot use epithelial sodium channel inhibitors or mineralocorticoid receptor antagonists from 4 weeks before screening and during the study.

Research has shown that lorundrostat, a medication that blocks a hormone involved in blood pressure regulation, is generally well-tolerated. In studies, individuals with high blood pressure experienced significant reductions without major safety issues. Most side effects were mild, such as dizziness and tiredness.

Studies have also shown that dapagliflozin, a medication that helps the kidneys remove sugar from the body, is safe for people with chronic kidney disease (CKD). It has a good safety record, with no serious side effects like diabetic ketoacidosis (a dangerous condition where acids build up in the blood) reported in patients, whether or not they have type 2 diabetes.

Unlike the standard treatments for kidney disease, which often include blood pressure medications and diuretics, Lorundrostat offers a new approach by targeting the aldosterone pathway. This pathway is crucial because aldosterone can contribute to kidney damage by causing inflammation and fibrosis. Researchers are excited about Lorundrostat because it may protect the kidneys more effectively by directly reducing aldosterone production, potentially slowing down the progression of kidney disease. This mechanism of action is different from current options and could offer a new hope for patients with kidney disease.

This trial will evaluate the effects of Lorundrostat and Dapagliflozin on kidney disease. Research has shown that Lorundrostat, which participants in this trial may receive, can lower blood pressure and reduce protein in the urine for people with chronic kidney disease (CKD) and high blood pressure. In one study, patients taking Lorundrostat experienced a 9.3 mmHg drop in systolic blood pressure. Another study found that it lowered both blood pressure and the urine albumin-to-creatinine ratio, a key marker of kidney health.