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

Официальное название

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

Обзор

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.

Подробное описание

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).

Вмешательства

• Препарат 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.
• Препарат 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

Первичные конечные точки

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Sarfez Pharmaceuticals, Inc. — Vienna

Идентификаторы

NCT: NCT07223502 · SAR-ERTSP-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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