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
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Comparing Net Clinical Benefit (NBC) of the FDC to finerenone with Serum K⁺ reduction
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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
干预措施: Combination Product: FDC of spironolactone and ER torsemide (Drug)
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
干预措施: Combination Product: Stabilized doses of loop diuretic and finerenone (Drug)
结局指标
主要结局
Comparing Net Clinical Benefit (NBC) of the FDC to finerenone with Serum K⁺ reduction
时间窗: 12 weeks
Serum K⁺ ≤5.0 mmol/L at end of treatment (binary: y/no)
Comparing Net Clinical Benefit (NBC) of the FDC to finerenone with SBP reduction
时间窗: 12 weeks
SBP ≥10 mmHg reduction from baseline (binary: yes/no).
Comparing Net Clinical Benefit (NBC) of the FDC to finerenone with UACR reduction
时间窗: 12 weeks
NCB is defined as UACR ≥30% reduction from baseline (binary: yes/no).
次要结局
未报告次要终点