Finerenone versus a combined pill of extended‑release torsemide plus spironolactone for hypertension with proteinuric chronic kidney disease

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

This tests whether finerenone or a single pill that combines extended‑release torsemide and spironolactone works better for adults with hypertension and proteinuric chronic kidney disease.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Sarfez Pharmaceuticals, Inc. (Industry-sponsored)
• Locations: 1 site (Vienna, Virginia)
• Trial ID: NCT07223502 on ClinicalTrials.gov

What this trial studies

This is a randomized, parallel, two‑arm Phase 3 trial comparing net clinical benefit of finerenone (with stabilized loop diuretic use) to a fixed‑dose combination pill of extended‑release torsemide plus spironolactone in adults with hypertension and proteinuric chronic kidney disease. Eligible participants have eGFR between 25 and 60 mL/min/1.73 m2, UACR 150–3500 mg/g, clinic seated systolic BP 130–170 mmHg, and a screening serum potassium between 4.5 and 5.0 mmol/L. Participants must be on stable loop diuretic therapy (up to furosemide 80 mg daily or equivalent) and meet other protocol requirements before randomization. The trial is conducted at a single sponsor site and compares clinical outcomes between the two treatment strategies over the protocol follow‑up period.

Who should consider this trial

Good fit: Adults aged 18 or older with proteinuric chronic kidney disease and hypertension who have eGFR 25–60 mL/min/1.73 m2, UACR 150–3500 mg/g, clinic SBP 130–170 mmHg, stable loop diuretic use (≤80 mg furosemide daily or equivalent), and screening serum potassium 4.5–5.0 mmol/L are ideal candidates.

Not a fit: Patients with type 1 diabetes, uncontrolled hypertension (SBP >170 mmHg), primary aldosteronism or other endocrine disorders, or abnormal potassium outside the specified screening range are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the comparison could identify a more effective or safer approach to lower blood pressure and reduce kidney damage in patients with proteinuric CKD, and may offer a simpler fixed‑dose option.

How similar studies have performed: Mineralocorticoid receptor antagonists like finerenone and spironolactone have shown kidney and cardiovascular benefits in related CKD populations, but head‑to‑head comparisons against a fixed torsemide+spironolactone FDC are limited.

Eligibility criteria

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.

Where this trial is running

Vienna, Virginia

• Sarfez Pharmaceuticals, Inc. — Vienna, Virginia, United States (Recruiting)

Study contacts

• Study coordinator: Salim Shah, PhD, JD

Conditions Hypertension; radomized; two arm; parallel; torsemide; finerenone; spironolactone; fixed-dose combination