Randomized Phase 3 Study Comparing Finerenone to a Fixed-Dose Combination of Extended-Release Torsemide and Spironolactone in Adults with Hypertension and Chronic Kidney Disease

What this Trial Is About

This clinical trial is investigating the net clinical benefit of finerenone compared to a fixed-dose combination of extended-release torsemide and spironolactone in adult patients with hypertension and proteinuric chronic kidney disease. It is a randomized, parallel, two-arm study designed to evaluate these treatments specifically in patients who have certain kidney function and blood pressure measures. The study is sponsored by Sarfez Pharmaceuticals, Inc. and focuses on improving clinical outcomes in this population. Participants will be randomly assigned to one of two groups one group will receive a once-daily fixed-dose combination tablet containing 24 mg of extended-release torsemide and 30 mg of spironolactone, while the other group will continue stabilized doses of loop diuretics up to 80 mg furosemide or equivalent combined with 10 mg daily of finerenone. The treatment phase will last at least 12 weeks, during which blood pressure, urinary albumin-to-creatinine ratio, and serum potassium levels will be closely monitored to compare the treatments clinical benefits. Throughout the study, participants will undergo regular assessments including blood pressure measurements, laboratory tests for kidney function and potassium levels, and monitoring for any adverse events. The primary outcomes focus on reductions in systolic blood pressure, urinary albumin-to-creatinine ratio, and serum potassium after 12 weeks of treatment. Participants will be followed until the studys completion in 2026, with safety and adherence carefully tracked to ensure accurate evaluation of the treatment effects.

A Study Comparing the Clinical Benefit of Finerenone Versus a Fixed Dose Combination (FDC) of Extended-Release Torsemide and Spironolactone in Patients With Hypertension and Chronic Kidney Disease