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
Recruiting
Apply to this trial

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

Start date
Dec 1, 2025
Status verified
Mar 2026
Primary completion
Jul 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
30 participants (estimated)
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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Sarfez Pharmaceuticals, Inc.ViennaVirginia22182
Salim Shah, PhD, JD
[email protected]
877-872-7339
Sophia Shah, MD
[email protected]
877-872-7339
Sophia Shah, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Vienna, VA

By research site
Sarfez Pharmaceuticals, Inc.· Vienna, VA

Related Studies