EUCTR2021-002905-89-HU进行中（未招募）1 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
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Bayer AG
- 入组人数
- 100
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 using rituximab, cyclophosphamide, abatacept, or intravenous glucocorticoids
- •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. 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
- •14. Pregnant or breastfeeding or intention to become pregnant during the study
研究者
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