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

NCT07223502 | Recruiting Phase 3 FDA Drug

• 1 other identifier: SAR-ERTSP-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension (HTN)

Keywords

radomized; two arm; parallel; torsemide; finerenone; spironolactone; fixed-dose combination; extended-release

Outcome Measures

Primary Outcomes (3)

• Comparing Net Clinical Benefit (NBC) of the FDC to finerenone with SBP reduction

  SBP ≥10 mmHg reduction from baseline (binary: yes/no).

  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).

  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)

  12 weeks

Study Arms (2)

Active Comparator: Fixed-dose combination (FDC) of ER Torsemide and Spironolactone tablet

ACTIVE COMPARATOR

Once daily fixed-dose combination of extended release Torsemide 24 mg and Spironolactone 30 mg

Drug: Combination Product: FDC of spironolactone and ER torsemide

Active Comparator: Continued on stabilized doses of loop diuretic and finerenone

ACTIVE COMPARATOR

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

Interventions

Combination Product: FDC of spironolactone and ER torsemide DRUG

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: Fixed-dose combination (FDC) of ER Torsemide and Spironolactone tablet

Combination Product: Stabilized doses of loop diuretic and finerenone DRUG

Treatment will be up to 80 mg furosemide or equivalent doses of other loop diuretics and 10 mg finerenone

Active Comparator: Continued on stabilized doses of loop diuretic and finerenone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult male and female patients aged ≥18 years;
• Are diagnosed with a CKD;
• Have an eGFR of ≥25 and ≤60 mL/min/1.72 m2;
• Have an UACR 150-3500 mg/g and Sk 4.5 to 5.0 mmol/L;
• Have an observed clinic seated systolic blood pressure (SBP) of ≥130 and ≤170 mmHg;
• 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;
• 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);
• Willing to use effective methods of contraception during sexual intercourse with an opposite sex throughout the study.

You may not qualify if:

• Have a diagnosis of type I diabetes mellitus (T1DM);
• Have uncontrolled hypertension (SBP \>170 mmHg);
• Have primary aldosteronism or endocrine disorders;
• Have serum potassium \>5.0 or \<4.5 mmol/L at screening;
• Unable to continue on 10 mg finerenone or require daily dose of more than 80mg furosemide or equivalent doses of other loop diuretics
• Have a recent diagnosis of acute kidney injury (≤3 months);
• 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;
• Had hospitalized for worsening heart failure in last 30 days;
• Have an autosomal dominant or recessive polycystic kidney disease;
• Have an Addison's disease;
• Have Hepatic insufficiency classified as Child-Pugh;
• Have a diagnosis of Lupus nephritis or anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis or any other kidney diseases requiring immunosuppressive therapy;
• Have a history of organ transplant;
• Require treatment with potassium-sparing diuretics;
• Have an active malignancy;

Sponsors & Collaborators

• Sarfez Pharmaceuticals, Inc.: lead

Study Sites (1)

Sarfez Pharmaceuticals, Inc.

Vienna, Virginia, 22182, United States

RECRUITING

MeSH Terms

Conditions

Hypertension

Interventions

finerenone

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Chris Wilcox, MD, PhD

  Sarfez Pharmaceuticals, Inc.

  STUDY DIRECTOR

Central Study Contacts

Salim Shah, PhD, JD

CONTACT

877-872-7339; info@sarfez.com

Sophia Shah, MD

CONTACT

877-872-7339; Sophia.Shah@sarfez.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, prospective, open label, blinded endpoints

Study Record Dates

• First Submitted: October 29, 2025
• First Posted: October 31, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-03

Locations

US (1)