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WithdrawnNCT07223502NEPHRONUpdated Sep 22, 2026

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 interventional study of Combination Product: FDC of spironolactone and ER torsemide and Combination Product: Stabilized doses of loop diuretic and finerenone in Hypertension (HTN), sponsored by Sarfez Pharmaceuticals, Inc.. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.

Sponsored by Sarfez Pharmaceuticals, Inc. · Phase 3, Interventional, and Treatment

Why this study was withdrawn
No recruitment

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled May 2025, registered Oct 2025).
Phase
Phase 3
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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).

02

Conditions studied

  • Hypertension (HTN)

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Keywords

  • radomized
  • two arm
  • parallel
  • torsemide
  • finerenone
  • spironolactone
  • fixed-dose combination
  • extended-release
03

In context

Hypertension

6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.

Browse Hypertension studies →

Lead sponsor

Sarfez Pharmaceuticals, Inc. is the lead sponsor of 11 studies on the registry; none are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Adult male and female patients aged ≥18 years;
  2. Are diagnosed with a CKD;
  3. Have an 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 from the patient or patient's legally acceptable representative (LAR);
  8. Willing to use effective methods of during sexual intercourse with an opposite sex throughout the study.

Exclusion criteria

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, , 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 ;
  12. Have a diagnosis of Lupus nephritis or anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis or any other kidney diseases requiring therapy;
  13. Have a history of organ transplant;
  14. Require treatment with potassium-sparing diuretics;
  15. Have an active ;
  16. Currently taking potassium supplement or potassium binders;
  17. Have known 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 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.
Terms in these criteria, in plain language(9)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

Child-Pugh class

A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Active comparator
    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

  • Active comparator
    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

Interventions

  • DrugCombination 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.

  • DrugCombination 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

06

What researchers measure

Primary outcomes

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

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

    Time frame: 12 weeks

  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).

    Time frame: 12 weeks

  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)

    Time frame: 12 weeks

07

Study locations

1 site
  • Sarfez Pharmaceuticals, Inc.
    Vienna, Virginia 22182, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07223502
Lead sponsor
Sarfez Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
Oct 31, 2025
Start date
May 1, 2025
Primary completion
Sep 17, 2026
Completion
Sep 17, 2026
Last update
Sep 22, 2026

Study contacts

Chris Wilcox, MD, PhD
study director · Sarfez Pharmaceuticals, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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