A Study Comparing the Clinical Benefit of Finerenone Versus a Fixed Dose Combination (FDC) of Ext… (NCT07223502) | Clinical Trial Compass
RecruitingPhase 3
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
United States30 participantsStarted 2025-12-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Adult male and female patients aged ≥18 years;
✓. Are diagnosed with a CKD;
✓. Have an eGFR of ≥25 and ≤60 mL/min/1.72 m2;
✓. Have an UACR 150-3500 mg/g and Sk 4.5 to 5.0 mmol/L;
✓. Have an observed clinic seated systolic blood pressure (SBP) of ≥130 and ≤170 mmHg;
✓. Are receiving up to an 80 mg daily dose of furosemide or an equivalent dose of other loop diuretics and and 10 mg daily dose of finerenone for 30 days;
✓. Willing and able to comply with all aspects of the protocol and to provide written informed consent from the patient or patient's legally acceptable representative (LAR);
✓. Willing to use effective methods of contraception during sexual intercourse with an opposite sex throughout the study.
Exclusion criteria
✕. Have a diagnosis of type I diabetes mellitus (T1DM);
✕. Have uncontrolled hypertension (SBP \>170 mmHg);
✕. Have primary aldosteronism or endocrine disorders;
✕. Have serum potassium \>5.0 or \<4.5 mmol/L at screening;
✕. Unable to continue on 10 mg finerenone or require daily dose of more than 80mg furosemide or equivalent doses of other loop diuretics
What they're measuring
1
Comparing Net Clinical Benefit (NBC) of the FDC to finerenone with SBP reduction
Timeframe: 12 weeks
2
Comparing Net Clinical Benefit (NBC) of the FDC to finerenone with UACR reduction
Timeframe: 12 weeks
3
Comparing Net Clinical Benefit (NBC) of the FDC to finerenone with Serum K⁺ reduction