2024-519830-22-00招募中3 期
(21467) A Phase 3, single-arm, open-label extension study to evaluate the safety of finerenone in addition to standard of care, in pediatric heart failure patients, from birth to 18 years of age, with left ventricular systolic dysfunction (LVSD)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Bayer AG
- 入组人数
- 11
- 试验地点
- 6
- 主要终点
- Number of participants with treatment emergent adverse events (TEAEs)
研究概览
简要总结
To demonstrate that finerenone in addition to standard of care (SoC) is safe when given long-term in pediatric left ventricular systolic dysfunction (LVSD) patients
入排标准
- 年龄范围
- 0 years 至 64 years（0-17 Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •For participants rolling over from randomized controlled trial (RCT): Prior participation in the finerenone Phase 3 study FIORE (21466) and not permanently discontinued from the study intervention prior to the end of treatment (EoT) visit in FIORE
- •For newly enrolled infants <6 months of age: LV systolic dysfunction (LVSD) with left ventricular ejection fraction (LVEF) ≤ 50% at screening assessed by echocardiography
- •For newly enrolled infants <6 months of age: Elevated NT-pro BNP levels (> 500 mg/L) at screening
- •For newly enrolled infants <6 months of age: Heart failure etiologies include congenital heart defects (CHD) with biventricular physiology and systemic LV; idiopathic cardiomyopathy (CM); familial/inherited and/or genetic CM; history of myocarditis (diagnosis of an acute episode at least 3 months prior to treatment assignment); neuromuscular disorder; inborn error of metabolism; mitochondrial disorder; acquired (chemotherapy, iatrogenic, infection, rheumatic, or nutritional); ischemic (e.g., Kawasaki disease and postoperative HF); LV noncompaction
- •For newly enrolled infants <6 months of age: Receiving standard of care (SoC) treatment for heart failure according to local guidelines or investigator´s discretion (on a stable regimen for 30 days before baseline).
- •Newly enrolled newborns and infants < 6 months of age must have a body weight of ≥3 kg at Visit 1.
排除标准
- •For participants rolling over from RCT: To roll-over to FIORELLO, all participants: Potassium (K+) >5.5 mmol/L After unblinding: • For participants who received finerenone in FIORE: K+ >5.5 mmol/ L • For participants who received placebo in FIORE: K+ >5.0 mmol/L for children ≥2 years of age, and >5.3 mmol/L for children <2 years of age (if eGFR is <60 mL/min/1.73m² for participants <2 years of age, the serum potassium threshold of >5.0 mmol/L will be used for exclusion).
- •For newly enrolled newborns and infants < 6 months of age: Potassium ≥ 5.3 mmol/l (if eGFR is <60 mL/min/1.73m², the serum potassium threshold of >5.0 mmol/L will be used for exclusion)
- •For participants rolling over from RCT: Severe renal dysfunction with estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m2 at FIORE EoT or Visit
- •For newly enrolled infants < 6 months of age: Severe renal dysfunction with eGFR < 30 ml/min/1.73m2 at screening or Visit
- •Treatment with a mineralocorticoid receptor antagonist, other than the study intervention, (e.g., spironolactone, eplerenone) within 30 days of Visit
- •Requirement of any intravenous (IV) vasoactive agents; mechanical ventilation; mechanical circulatory support; sustained or symptomatic arrhythmias not controlled by drug or device therapy within 30 days prior to study treatment.
结局指标
主要结局
Number of participants with treatment emergent adverse events (TEAEs)
Number of participants with treatment emergent adverse events (TEAEs)
Change in serum potassium levels from baseline to Day 270± 7 (Visit 6, EoT)
Change in serum potassium levels from baseline to Day 270± 7 (Visit 6, EoT)
Change in systolic blood pressure (SBP) from baseline to Day 270± 7 (Visit 6, EoT)
Change in systolic blood pressure (SBP) from baseline to Day 270± 7 (Visit 6, EoT)
Change in estimated glomerular filtration rate (eGFR) from baseline to Day 270± 7 (Visit 6, EoT)
Change in estimated glomerular filtration rate (eGFR) from baseline to Day 270± 7 (Visit 6, EoT)
次要结局
- Change in NT-proBNP from baseline to Day 270± 7 (Visit 6, EoT)
- Change in key echocardiographic parameters of left ventricular systolic function from baseline to Day 270± 7 (Visit 6, EoT)
- Maximum observed finerenone concentration in plasma after multiple doses (Cmax, md)
- Area under the curve for finerenone concentration in plasma after multiple doses (AUCτ,md)
- Taste and texture questionnaire of the pediatric formulation
研究者
Therapeutic Area Head
Scientific
Bayer AG
研究点 (6)
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