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
NCT ID: NCT07223502
Last Updated: 2025-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
30 participants
INTERVENTIONAL
2025-12-01
2026-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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
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.
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
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
Interventions
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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.
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
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Sarfez Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Chris Wilcox, MD, PhD
Role: STUDY_DIRECTOR
Sarfez Pharmaceuticals, Inc.
Locations
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Sarfez Pharmaceuticals, Inc.
Vienna, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Salim Shah, PhD, JD
Role: primary
Sophia Shah, MD
Role: backup
Other Identifiers
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SAR-ERTSP-01
Identifier Type: -
Identifier Source: org_study_id