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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
30
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.
Treatment will be up to 80 mg furosemide or equivalent doses of other loop diuretics and 10 mg finerenone
Sarfez Pharmaceuticals, Inc.
Vienna, Virginia, United States
RECRUITINGComparing Net Clinical Benefit (NBC) of the FDC to finerenone with SBP reduction
SBP ≥10 mmHg reduction from baseline (binary: yes/no).
Time frame: 12 weeks
Comparing Net Clinical Benefit (NBC) of the FDC to finerenone with UACR reduction
NCB is defined as UACR ≥30% reduction from baseline (binary: yes/no).
Time frame: 12 weeks
Comparing Net Clinical Benefit (NBC) of the FDC to finerenone with Serum K⁺ reduction
Serum K⁺ ≤5.0 mmol/L at end of treatment (binary: y/no)
Time frame: 12 weeks
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