Study Comparing Vicadrostat Plus Empagliflozin Versus Spironolactone Plus Empagliflozin on Kidney Function and Protein Changes in Chronic Kidney Disease Patients With Heart or Cardiovascular Disease

What this Trial Is About

Researchers are investigating the effects of two different drug combinations on kidney function and protein profiles in blood and urine in patients with chronic kidney disease CKD who also have cardiovascular disease or heart failure. The study compares vicadrostat, an aldosterone synthase inhibitor, combined with empagliflozin, against spironolactone, a mineralocorticoid receptor antagonist, combined with empagliflozin. The goal is to understand how these drugs differ in their impact on kidney and heart function due to their different mechanisms of action. Participants will be randomly assigned to one of two groups. Group 1 will take one tablet of vicadrostat 10 mg and one tablet of empagliflozin 10 mg daily for 26 weeks. Group 2 will take one tablet of spironolactone 25 mg and one tablet of empagliflozin 10 mg daily for the first four weeks, then two tablets of spironolactone 50 mg and one tablet of empagliflozin 10 mg daily for the remaining 22 weeks, with possible dose adjustments based on blood tests. The study is open-label with blinded endpoint assessment. During the study, kidney function will be measured at the start, at 4 weeks, and at 26 weeks. In about half of participants, detailed kidney blood flow measurements will also be taken at these times. Researchers will also examine changes in protein profiles and concentration markers in blood and urine. The study will monitor treatment effects and safety over the 26-week period, with patient visits and assessments scheduled accordingly.

Comparative Study on the Mode of Action of Vicadrostat and Spironolactone on Protein Profiles and Renal Hemodynamic Effects (COMPARE-VS)