EUCTR2021-002071-19-FI进行中（未招募）1 期
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
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
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 old at the time when the informed consent/assent is signed
- •2. Participants must have a clinical diagnosis of chronic kidney disease (CKD) at screening which is defined as
- •a. CKD stages 1-3 (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. Urinary protein-to-creatinine ratio (UPCR) of = 0.50 g/g in participants = 2 years with CKD stage 2 and 3 or
- •ii. UPCR = 1.0 g/g for patients < 2 years of age or = 2 years of age and with CKD stage 1
- •3. Participants must have stable kidney function between screening and D0 defined as:
- •a. no increase or decrease in eGFR = 15% for children =1 year or
- •b. no increase or decrease in creatinine = 0.10 mg/dL for children <1 year
- •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 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
- •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 (HUS) diagnosed =6 months prior to screening
- •3. Patients with nephrotic syndrome receiving albumin infusions within the last 6 months prior to screening
- •4. Patients who are candidates for renal transplantation, i.e., a kidney transplantation scheduled within the study time frame
- •5. Renal allograft in place
- •6. Bilateral renal artery stenosis
- •7. Acute kidney injury requiring dialysis within 6 months prior to screening
- •8. Systemic hypertension stage 2 in children =1 year of age defined according to guidelines on blood pressure management at screening or randomization
- •9. Systolic blood pressure (SBP) above 110 mmHg in infants 6 months to <1 year of age at screening or randomization
- •10. 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)
- •11. Participants with immune-mediated CKD using rituximab, cyclophosphamide, abatacept, or high-dose glucocorticoids (e.g., prednisolone =0.5 mg/kg/d), within <6 months prior to screening (lowdose glucocorticoids or a short course of glucocorticoids for, e.g., treatment of an asthma exacerbation are allowed
研究者
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