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

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified February 2026 by Sarfez Pharmaceuticals, Inc.
Sponsor
Sarfez Pharmaceuticals, Inc.
Information Provided by (Responsible Party)
Sarfez Pharmaceuticals, Inc.
Clinicaltrials.gov Identifier
NCT07223502
Other Study ID Numbers:
SAR-ERTSP-01
First Submitted
October 28, 2025
First Posted
October 30, 2025
Last Update Posted
March 8, 2026
Last Verified
February 2026

ClinicalTrials.gov processed this data on March 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study 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).

Condition or DiseaseIntervention/Treatment
Hypertension (HTN)
Drug: Combination Product: FDC of spironolactone and ER torsemideDrug: Combination Product: Stabilized doses of loop diuretic and finerenone

Study Design

Study TypeInterventional
Actual Enrollment30 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposeTreatment
Official TitleA 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
Study Start DateNovember 30, 2025
Actual Primary Completion Date1mo 1d from now
Actual Study Completion Date4mos 1d from now

Groups and Cohorts

Group/CohortIntervention/Treatment
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
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.
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
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

Outcome Measures

Primary Outcome Measures
  1. Comparing Net Clinical Benefit (NBC) of the FDC to finerenone with SBP reduction
    SBP ≥10 mmHg reduction from baseline (binary: yes/no).
  2. 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).
  3. 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)

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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.

Contacts and Locations

Sponsors and CollaboratorsSarfez Pharmaceuticals, Inc.
Locations
Sarfez Pharmaceuticals, Inc. | Vienna Virginia, United States, 22182
Investigators
Study Director: Chris Wilcox, MD, PhD, Sarfez Pharmaceuticals, Inc.