Hypertension (HTN)Phase 3NEPHRONNCT07223502

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

A Phase 3 study testing Combination Product: FDC of spironolactone and ER torsemide and Combination Product: Stabilized doses of loop diuretic and finerenone in people with Hypertension (HTN), run by Sarfez Pharmaceuticals, Inc. at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hypertension (HTN)
What is being tested?: Combination Product: FDC of spironolactone and ER torsemide and Combination Product: Stabilized doses of loop diuretic and finerenone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 1 siteUnited States
Study dates: 1 May 2025to 17 Sep 2026
Phase: Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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);

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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;
Currently taking potassium supplement or potassium binders;
Have known hypersensitivity to sulfonamides or related compounds or spironolactone or finerenone;
Is pregnant, breastfeeding, or planning to become pregnant during the study;
Have participated in another clinical study involving any investigational drug within 30 days prior to Screening;
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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Sarfez Pharmaceuticals, Inc.
Vienna, Virginia, 22182

Other trials in United States

About this study

Official title: 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

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.

Read the 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).

Conditions: Hypertension (HTN)
Being tested: Combination Product: FDC of spironolactone and ER torsemide, Combination Product: Stabilized doses of loop diuretic and finerenone
Keywords: radomized, two arm, parallel, torsemide, finerenone, spironolactone, fixed-dose combination, extended-release
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Combination Product: FDC of spironolactone and ER torsemideDrug
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 finerenoneDrug
Treatment will be up to 80 mg furosemide or equivalent doses of other loop diuretics and 10 mg finerenone

Study groups in NCT07223502
Study group	Role	What they receive
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 Receives: 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 Receives: Drug: Combination Product: Stabilized doses of loop diuretic and finerenone

What is being measured

The primary outcome is the main question the study is designed to answer.

Comparing Net Clinical Benefit (NBC) of the FDC to finerenone with SBP reduction
SBP ≥10 mmHg reduction from baseline (binary: yes/no).
Measured: 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).
Measured: 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)
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 202517 Sep 2026

First posted31 Oct 2025
Study start1 May 2025
Primary completion17 Sep 2026
Study completion17 Sep 2026

Why it stopped: No recruitment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Hypertension (HTN)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Randomized, prospective, open label, blinded endpoints
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07223502
Sponsor's protocol ID: SAR-ERTSP-01
Acronym: NEPHRON
Status last verified: Sep 2026
First submitted: 29 Oct 2025
Last updated: 22 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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