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

Bayer AG0 个研究点目标入组 100 人开始时间: 2022年11月11日最近更新: 2024年7月15日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Bayer AG
入组人数: 100

研究概览入排标准研究者记录与标识符相似试验

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

性别: All

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.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 100
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 10
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

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

发起方

Bayer AG

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A study to learn more about how safe the study treatment finerenone is in long-term use when taken with an ACE inhibitor or angiotensin receptor blocker over 18 months of use in children and young adults from 1 to 18 years of age with chronic kidney disease and proteinuriaTreatment of children with chronic kidney disease and proteinuriaMedDRA version: 23.1Level: PTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 10038359 - Renal and urinary disordersMedDRA version: 20.1Level: PTClassification code 10037032Term: ProteinuriaSystem Organ Class: 10038359 - Renal and urinary disorders

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