A 6-month multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety and PK/PD of an age-and body weight-adjusted oral finerenone regimen, in addition to an ACEI or ARB, for the treatment of children, 6 months to <18 years of age, with chronic kidney disease and proteinuria - FIONA

Bayer AG0 个研究点目标入组 219 人开始时间: 2021年12月13日最近更新: 2024年4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: 219

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 clinical trial of medicinal product

入排标准

性别: All

入选标准

•1. Participants must be 6 months to <18 years at the time when the informed consent/assent is signed
•2. Participants must have a clinical diagnosis of CKD at screening which is defined as
•a. CKD stages I-III (eGFR =30 mL/min/1.73m^2) for children =1 year to <18 years of age or
•b. a serum creatinine = 0.40 mg/dL for infants 6 months to < 1 year of age
•c. severely increased proteinuria as defined by
•i. UPCR of = 0.50 g/g in participants = 2 years with CKD stage II and III or
•ii. UPCR = 1.0 g/g for patients < 2 years of age or = 2 years of age and with CKD stage I
•3. Participants must have stable kidney function defined as no change in eGFR =± 15% for children =1 year to <18 years of age, or no change in serum creatinine = ±0.10 mg/dL for infants 6 months to <1 year of age between screening and D0
•4. Treated with an ACEI or ARB at optimized doses defined as maximally tolerable doses within the recommended dose range according to guidelines on blood pressure management, unchanged for at least 30 days prior to screening
•5. K+ =5.0 mmol/L for children =2 years of age at both screening and D0, and =5.3 mmol/L for children <2 years of age at both screening and D0
•6. Participants can be enrolled in the outpatient or inpatient setting
•7. Study participants must have a body weight =4kg
•8. Pregnancy testing as well as highly effective female contraception as appropriate for sexual maturity and activity and as required by local regulations are required for female participants
•9. Participant has understood the study and if applicable, has signed an informed assent. The parent(s) or guardian(s) is capable of giving signed informed consent as described which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol
•10. Participant is able to receive enteral feeding (solid food, bottle or cup fed, feeding through nasogastric or gastric feeding tubes) with or without breastfeeding
•11. A legal guardian or primary caregiver must be available to help the study-site personnel ensure follow up; accompany the participant to the study site on each assessment day (e.g., able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures); consistently and consecutively be available to provide information on the participant; accurately and reliably dispense study intervention as directed.
•12. A legal guardian or primary caregiver must be able to accurately maintain the child’s take-home record, including items of general health.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 219
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•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. Children with hemolytic uremic syndrome diagnosed =6 months prior to screening
•3. Patients with nephrotic syndrome receiving albumin infusions within the last 6 months prior to screening
•4. Scheduled renal transplant within the next 6 months
•5. Renal allograft in place
•6. Bilateral renal artery stenosis
•7. Acute kidney injury requiring dialysis within 6 months prior to screening
•8. Patients with genetically defined primary tubulopathies leading to tubular proteinuria, such as Dent´s disease
•9. Systemic hypertension stage 2 in children =1 year of age defined according to institutional guidelines on blood pressure management at screening or randomization
•10. SBP above 110 mmHg in infants 6 months to <1 year of age at screening or randomization
•11. Systemic hypotension defined as a systolic blood pressure below the 5th percentile for age, sex and height at either screening or randomization but no lower than 80 mmHg (although for some participants the 5th percentile of SBP is < 80 mmHg they must be excluded if their SBP is <80 mmHg).
•12. Known hypersensitivity to the study treatment (active substance or excipients)
•13. Addison’s disease
•14. Severe hepatic insufficiency defined by e.g. Child-Pugh C or analogous scores
•15. Participants using rituximab, cyclophosphamide, abatacept, or intravenous glucocorticoids, within <6 months prior to screening for any reason
•16. Concomitant therapy with an MRA (eplerenone, spironolactone, esaxerenone, canrenone), any renin inhibitor (aliskiren, enalkiren, remikiren), any SGLT2 inhibitor (SGLT2i), sacubitril/valsartan combination (ARNI), or potassium-sparing diuretic (amiloride, triamterene) which cannot be discontinued at least 30 days prior to the screening visit
•17. Concomitant therapy with both ACEI and ARBs in case one of those cannot be discontinued at least 30 days prior to the screening visit
•18. Concomitant therapy with potent CYP3A4 inhibitors, moderate or potent CYP3A4 inducers and/or the moderate CYP3A4 inhibitor erythromycin (to be stopped at least 7 days before randomization)
•19. Previous assignment to treatment during this study
•20. Simultaneous participation in another interventional clinical study (e.g., Phase 1-3 clinical studies) or treatment with any investigational medicinal product within 30 days prior to Run-in visit
•21. Any other condition or therapy, which would make the participant unsuitable for this study and will not allow participation for the full planned study period (e.g. active malignancy or other condition limiting life expectancy to less than 6 months)
•22. Any other history, condition, therapy, or uncontrolled intercurrent illness which could in the opinion of the investigator affect compliance with study requirements
•23. Pregnant or breast-feeding or intention to become pregnant during the study
•24. Close affiliation with the investigational site; e.g. a close relative of the investigator, dependent person (e.g. employee or student of the investigational site)

研究者

发起方

Bayer AG

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