Trials / Recruiting
RecruitingNCT07223502
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
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Sarfez Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
SAR-ERTSP-01P, 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 (NEPHRON).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Combination 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. |
| DRUG | Combination 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 |
Timeline
- Start date
- 2025-12-01
- Primary completion
- 2026-07-01
- Completion
- 2026-10-01
- First posted
- 2025-10-31
- Last updated
- 2026-03-09
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07223502. Inclusion in this directory is not an endorsement.