An 18-month, open-label, single-arm safety extension study of an age-and bodyweight adjusted oral finerenone regimen, in addition to an ACEI or ARB, for the treatment of children and young adults from 1 to 18 years of age with chronic kidney disease and proteinuria.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- • Change in serum potassium levels from baseline to Day 540 plus or minus 7 days
研究概览
简要总结
Finerenone has been demonstrated to be safe and efficacious in reducing proteinuria and decreasing the risk for renal events like kidney failure, a sustained decrease in estimated glomerular filtration rate (eGFR) of 40% or more from baseline, or renal death, as well as cardiovascular (CV) events in a high risk population of adults with Chronic Kidney Disease (CKD) and type 2 Diabetes (T2D).
FIONA-OLE Study (20186) is part of an agreed Pediatric Investigation Plan (PIP) in the condition “treatment of CKD”. Finerenone is currently being studied in pediatric patients with CKD and severely increased proteinuria despite optimized treatment with an ACEI or ARB in the 6-month double-blind, placebo-controlled FIONA study (19920). The primary aim of this study is to provide data on the long-term safety of Finerenone in the treatment of pediatric and young adult patients with CKD. In addition, further study goals are to collect data on the long-term efficacy and to offer access to Finerenone to all participants previously treated in FIONA study (19920).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 1.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants must be greater than or equal to 1 year to 18 years of age, at the time of signing the informed consent/assent.
- •Prior participation in the Finerenone Phase 3 study FIONA (19920) and not permanently discontinued from treatment by the end of treatment (EoT) visit in FIONA.
- •Participants must have a clinical diagnosis of Chronic Kidney Disease (CKD) at Visit
- •Treated with an angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) at optimized doses defined as maximally tolerable doses within the recommended dose range according to guidelines on blood pressure (BP) management, unchanged for at least 30 days prior to Visit
- •K+ less than or equal to 5.0 mmol/L for children greater than or equal to 2 years of age at both FIONA EoT and Visit 1, and less than or equal to 5.3 mmol/L for children less then 2 years of age at both FIONA EoT and Visit
- •Participant is able to receive enteral feeding (solid food, bottle or cup fed, feeding through nasogastric or gastric feeding tubes) with or without breastfeeding.
排除标准
- •Planned urological surgery expected to influence renal function.
- •Patients who are candidates for renal transplantation, i.e., a kidney transplantation scheduled within the study time frame.
- •Systemic hypertension Stage 2 at Visit
- •Systemic hypotension at Visit
- •Known hypersensitivity to the study treatment (active substance or excipients).
- •Severe hepatic insufficiency.
- •Participants using rituximab, cyclophosphamide, abatacept, or intravenous glucocorticoids.
- •Concomitant therapy with a mineralocorticoid receptor antagonist (MRA) (eplerenone, spironolactone, esaxerenone, canrenone), any renin inhibitor (aliskiren, enalkiren, remikiren), any sodium-glucose co-transporter-2 (SGLT2) inhibitor (SGLT2i), sacubitril/valsartan combination (ARNI), or potassium-sparing diuretic (amiloride, triamterene).
- •Concomitant therapy with both ACEI and ARBs together.
- •Concomitant therapy with strong cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors, moderate or strong CYP3A4 inducers.
- •Previous assignment to treatment during this study.
- •Simultaneous participation in another interventional clinical study (e.g., Phase 1 to 4 clinical studies).
- •Experienced a drug-related serious adverse event (SAE) or an adverse event (AE) which led to permanent discontinuation of study intervention during the FIONA study.
结局指标
主要结局
• Change in serum potassium levels from baseline to Day 540 plus or minus 7 days
时间窗: • Change in serum potassium levels from baseline to Day 540 plus or minus 7 days | • Change in systolic blood pressure from baseline to Day 540 plus or minus 7 days | • Number of participants with TEAEs
• Change in systolic blood pressure from baseline to Day 540 plus or minus 7 days
时间窗: • Change in serum potassium levels from baseline to Day 540 plus or minus 7 days | • Change in systolic blood pressure from baseline to Day 540 plus or minus 7 days | • Number of participants with TEAEs
• Number of participants with TEAEs
时间窗: • Change in serum potassium levels from baseline to Day 540 plus or minus 7 days | • Change in systolic blood pressure from baseline to Day 540 plus or minus 7 days | • Number of participants with TEAEs
次要结局
- Change in Urinary Protein-to-Creatinine Ratio (UPCR) and Urinary Albumin-to-Creatinine Ratio (UACR) from baseline to Day 540 plus or minus 7 days.(From baseline to Day 540 plus or minus 7 days.)
- Change in estimated Glomerular Filtration Rate (eGFR) from baseline to Day 540 plus or minus 7 days.(From baseline to Day 540 plus or minus 7 days)
研究者
Sudiksha Phadnis
Bayer Pharmaceuticals Private Limited