Hypertension (HTN)
Conditions
Keywords
radomized, two arm, parallel, torsemide, finerenone, spironolactone, fixed-dose combination, extended-release
Brief 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).
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
Sponsors
Sarfez Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Randomized, prospective, open label, blinded endpoints
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 representative (LAR); 8. Willing to use effective methods of contraception during sexual intercourse with an opposite sex throughout the study.
Exclusion criteria
1. Have a diagnosis of type I diabetes mellitus (T1DM); 2. Have uncontrolled hypertension (SBP \>170 mmHg); 3. Have primary aldosteronism or endocrine disorders; 4. Have serum potassium \>5.0 or \<4.5 mmol/L at screening; 5. Unable to continue on 10 mg finerenone or require daily dose of more than 80mg furosemide or equivalent doses of other loop diuretics 6. Have a recent diagnosis of acute kidney injury (≤3 months); 7. Had a cardiovascular event within 3 months prior to screening (e.g., myocardial infarction, stroke, transient ischemic attack, pulmonary embolism, elective coronary artery bypass grafting) or elective percutaneous coronary intervention within 1 month prior to screening; 8. Had hospitalized for worsening heart failure in last 30 days; 9. Have an autosomal dominant or recessive polycystic kidney disease; 10. Have an Addison's disease; 11. Have Hepatic insufficiency classified as Child-Pugh; 12. Have a diagnosis of Lupus nephritis or anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis or any other kidney diseases requiring immunosuppressive therapy; 13. Have a history of organ transplant; 14. Require treatment with potassium-sparing diuretics; 15. Have an active malignancy; 16. Currently taking potassium supplement or potassium binders; 17. Have known hypersensitivity to sulfonamides or related compounds or spironolactone or finerenone; 18. Is pregnant, breastfeeding, or planning to become pregnant during the study; 19. Have participated in another clinical study involving any investigational drug within 30 days prior to Screening; 20. Is considered to be unsuitable for any other reason that may either place the patient at increased risk during participation or interfere with the interpretation of the study outcomes by the Investigator, after reviewing medical and psychiatric history, physical examination, and laboratory evaluation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparing Net Clinical Benefit (NBC) of the FDC to finerenone with SBP reduction | 12 weeks | SBP ≥10 mmHg reduction from baseline (binary: yes/no). |
| Comparing Net Clinical Benefit (NBC) of the FDC to finerenone with UACR reduction | 12 weeks | NCB is defined as UACR ≥30% reduction from baseline (binary: yes/no). |
| Comparing Net Clinical Benefit (NBC) of the FDC to finerenone with Serum K⁺ reduction | 12 weeks | Serum K⁺ ≤5.0 mmol/L at end of treatment (binary: y/no) |
Countries
United States
Contacts
CONTACTSalim Shah, PhD, JD
CONTACTSophia Shah, MD
STUDY_DIRECTORChris Wilcox, MD, PhD
Sarfez Pharmaceuticals, Inc.
Outcome results
None listed