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Recruiting NCT07223502

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

Phase III Interventional Hypertension (HTN)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Combination Product: FDC of spironolactone and ER torsemide, Combination Product: Stabilized doses of loop diuretic and finerenone.
Who it may be relevant to
Registry conditions: Hypertension (HTN). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

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).

Interventions

  • 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.
  • 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

Primary outcome measures

  • Comparing Net Clinical Benefit (NBC) of the FDC to finerenone with SBP reduction [Time frame: 12 weeks]
  • Comparing Net Clinical Benefit (NBC) of the FDC to finerenone with UACR reduction [Time frame: 12 weeks]
  • Comparing Net Clinical Benefit (NBC) of the FDC to finerenone with Serum K⁺ reduction [Time frame: 12 weeks]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Sarfez Pharmaceuticals, Inc. — Vienna

Identifiers

NCT: NCT07223502 · SAR-ERTSP-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗