RecruitingPhase 3NCT07223502

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

A Randomized, Parallel, Two Arm Study Comparing the Net Clinical Benefit of Finerenone Versus a Fixed Dose Combination of Extended-Release Torsemide and Spironolactone in Patients With Hypertension and PRoteinuric ChrOnic KidNey Disease


Sponsor

Sarfez Pharmaceuticals, Inc.

Enrollment

30 participants

Start Date

Dec 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two treatments for adults with chronic kidney disease (CKD) and high blood pressure: finerenone (an existing kidney-protecting drug) versus a fixed-dose combination pill containing extended-release torsemide and spironolactone. The goal is to see which approach better reduces protein in the urine and protects kidney function. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with chronic kidney disease with moderately reduced kidney function (eGFR between 25 and 60) - You have a significant amount of protein in your urine and mildly elevated potassium - Your blood pressure is elevated (systolic between 130 and 170 mmHg) - You are currently on a low dose of finerenone (10 mg/day) and a loop diuretic (such as furosemide) **You may NOT be eligible if...** - You have Type 1 diabetes - Your blood pressure is very high (above 170 mmHg systolic) - You have very high or very low potassium levels outside the specified range - You have had a recent heart attack, stroke, or acute kidney injury in the past 3 months - You have adrenal insufficiency or primary aldosteronism Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCombination Product: FDC of spironolactone and ER torsemide

The usual starting torsemide daily dose ranges from 5-10 mg (for hypertension) to 10-20 mg (for heart failure). The initial dose for treatment of heart failure or hypertension is 25 mg daily.

DRUGCombination Product: Stabilized doses of loop diuretic and finerenone

Treatment will be up to 80 mg furosemide or equivalent doses of other loop diuretics and 10 mg finerenone


Locations(1)

Sarfez Pharmaceuticals, Inc.

Vienna, Virginia, United States

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NCT07223502


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