NL-OMON56223尚未招募3 期
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 - FIONA OLE
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- Bayer
- 入组人数
- 2
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 17（—）
入选标准
- •1. Participants must be >=1 year to 18 years of age, at the time of signing the
- •informed consent/assent. 2. 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. 3. Participants must have a clinical diagnosis
- •of chronic kidney disease (CKD) at Visit 1 which is defined as - CKD stages 1-3
- •(estimated glomerular filtration rate [eGFR] >=30 mL/min/1.73m^2) for children
- •>=1 year to <19 years of age at FIONA EoT and at Visit 1 4. 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 1. 5. K+ <=5.0 mmol/L
- •for children >=2 years of age at both FIONA EoT and Visit 1, and <=5.3 mmol/L for
- •children <2 years of age at both FIONA EoT and Visit 1 6. 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
- •1. Planned urological surgery expected to influence renal function 2. Patients
- •who are candidates for renal transplantation, i.e., a kidney transplantation
- •scheduled within the study time frame 3. Systemic hypertension Stage 2 defined
- •according to institutional guidelines on BP management at Visit 1. 4. Systemic
- •hypotension defined as symptomatic hypotension or a mean systolic BP below the
- •5th percentile for age, sex and height but no lower than 80 mmHg for
- •participants <18 years and symptomatic hypotension or a mean systolic blood
- •pressure (SBP) <90 mmHg in participants >=18 years at Visit 1. 5. Known
- •hypersensitivity to the study treatment (active substance or excipients) 6.
- •Severe hepatic insufficiency defined by e.g. Child-Pugh C or analogous scores.
- •7. Participants with immune-mediated CKD using rituximab, cyclophosphamide,
- •abatacept, or prolonged high-dose glucocorticoids (defined as >= 0.5 mg/kg/day
- •of prednisolone or equivalent) for more than 7 days. 8. 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) 9. Concomitant therapy with both ACEI and ARBs
- •together 10. Concomitant therapy with strong cytochrome P450 isoenzyme 3A4
- •(CYP3A4) inhibitors, moderate or strong CYP3A4 inducers 11. Previous assignment
- •to treatment during this study 12. Simultaneous participation in another
- •interventional clinical study (e.g., Phase 1 to 4 clinical studies). 13. Any
- •suspected (S)AE related to the study intervention which led to permanent
- •discontinuation of study intervention during the FIONA study 14. Pregnant or
- •breastfeeding or intention to become pregnant during the study
研究者
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