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

Part of paid clinical trials in Vienna, Virginia.

Sponsor
Sarfez Pharmaceuticals, Inc.
Study ID
NCT07223502
Phase
PHASE3
Status
Withdrawn

Conditions

  • Hypertension (HTN)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Combination Product: FDC of spironolactone and ER torsemide — DRUG
    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.
  • Combination Product: Stabilized doses of loop diuretic and finerenone — DRUG
    Treatment will be up to 80 mg furosemide or equivalent doses of other loop diuretics and 10 mg finerenone

Study Details

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.

Key Dates

First listed
Oct 31, 2025
Start date
May 1, 2025
Status verified
Sep 2026
Primary completion
Sep 17, 2026
Completion
Sep 17, 2026

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Active Comparator: Fixed-dose combination (FDC) of ER Torsemide and Spironolactone tablet
    Once daily fixed-dose combination of extended release Torsemide 24 mg and Spironolactone 30 mg
  • Active Comparator: Active Comparator: Continued on stabilized doses of loop diuretic and finerenone
    Oral dose of once daily up to 80 mg furosemide or equivalent doses of other loop diuretics and 10 mg finerenone

Primary Outcome Measure

Comparing Net Clinical Benefit (NBC) of the FDC to finerenone with SBP reduction [ Time Frame: 12 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Sarfez Pharmaceuticals, Inc.ViennaVirginia22182-

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