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
Sarfez Pharmaceuticals, Inc.
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.
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).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Adult male and female patients aged ≥18 years; 2. Are diagnosed with a CKD; 3. Have an eGFR of ≥25 and ≤60 mL/min/1.72 m2; 4. Have an UACR 150-3500 mg/g and Sk 4.5 to 5.0 mmol/L; 5. Have an observed clinic seated systolic blood pressure (SBP) of ≥130 and ≤170 mmHg; 6. 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; 7. 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 rep…
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
Location
- Sarfez Pharmaceuticals, Inc.Vienna, Virginia