2023-504884-17-00招募中3 期
(19920) A 6-month multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety and PK/PD of an age-and body weightadjusted 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
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Bayer AG
- 入组人数
- 222
- 试验地点
- 63
- 主要终点
- Mean reduction from baseline to Month 6 in Urinary Protein-toCreatinine Ratio (Percent change from baseline to day 180±7 in UPCR)
研究概览
简要总结
The primary objective is to demonstrate that finerenone in addition to an ACEI or ARB is superior to placebo in reducing urine protein excretion
研究设计
- 分配方式
- Randomized
- 主要目的
- Overall
- 盲法
- Double (Investigator, Analyst, Carer, Monitor, Subject)
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Participants must be 6 months to <18 years old at the time when the informed consent/assent is signed
- •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 and 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
- •Participants must have stable kidney function between screening and D0 defined as: a. For participants with a creatinine of > 0.8 mg/dL at screening: no increase or decrease in eGFR by ≥ 20% at D0 b. For participants with a creatinine of ≤ 0.8 mg/dL at screening: no increase or decrease in creatinine ≥ 0.15 mg/dL at D
- •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
- •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
排除标准
- •Planned urological surgery expected to influence renal function
- •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)
- •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 (low-dose glucocorticoids or a short course of glucocorticoids for, e.g., treatment of an asthma exacerbation are allowed)
- •Children with hemolytic uremic syndrome (HUS) diagnosed ≤6 months prior to screening
- •Patients with nephrotic syndrome receiving albumin infusions within the last 6 months prior to screening
- •Patients who are candidates for renal transplantation, i.e., a kidney transplantation scheduled within the study time frame
- •Renal allograft in place
- •Bilateral renal artery stenosis
- •Acute kidney injury requiring dialysis within 6 months prior to screening
- •Systemic hypertension stage 2 in children ≥1 year of age defined according to guidelines on blood pressure management at screening or randomization
- •Systolic blood pressure (SBP) above 110 mmHg in infants 6 months to <1 year of age at screening or randomization
结局指标
主要结局
Mean reduction from baseline to Month 6 in Urinary Protein-toCreatinine Ratio (Percent change from baseline to day 180±7 in UPCR)
Mean reduction from baseline to Month 6 in Urinary Protein-toCreatinine Ratio (Percent change from baseline to day 180±7 in UPCR)
次要结局
- Change in UACR from baseline to day 180±7
- PK (finerenone Cmax,md, AUCτ,md) based on total concentrations in plasma
- Taste and texture of the pediatric formulation
- Number of participants with a. AEs b. Serious TEAEs c. TEAEs and serious TEAEs leading to discontinuation of treatment d. Study drug related TEAEs and serious TEAEs e. TEAEs categorized by severity f. TEAEs by maximum intensity g. No. of participants hospitalized with hyperkalemia h. No. of participants discontinuing due to hyperkalemia i. No. of participants hospitalization for worsening of renal function j. No. of participants discontinuing due to worsening of renal function
- Change in serum potassium levels, serum creatinine, eGFR and systolic blood pressure from baseline to day 180±7
- Urinary Protein-to-Creatinine Ratio (UPCR) reduction of at least 30% from baseline to day 180±7 (Proportion of responders at the day 180±7 time point, where a responder is defined as a >=30% reduction in UPCR compared to baseline
研究者
Therapeutic Area Head
Scientific
Bayer AG
研究点 (63)
Loading locations...
相似试验
已完成
3 期
Study to Evaluate the Efficacy (Effect on Disease) and Safety of Finerenone in Participants With Heart Failure and Left Ventricular Ejection Fraction (Proportion of Blood Expelled Per Heart Stroke) Greater or Equal to 40%Heart FailureNCT04435626Bayer6,016
已完成
3 期
Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney DiseaseDiabetic Kidney DiseaseNCT02545049Bayer7,352
Unknown
3 期
A Study to Evaluate Finerenone on Clinical Efficacy and Safety in Patients with Heart Failure Who Are Intolerant or Not Eligible for Treatment with Steroidal Mineralocorticoid Receptor Antagonists.2023-508875-35-00Colorado Prevention Center70
已完成
2 期
IMAAGEN: Impact of Abiraterone Acetate in Prostate-Specific AntigenProstatic NeoplasmProstate CancerNCT01314118Janssen Biotech, Inc.131
招募中
4 期
Efficacy and Safety of Finerenone in Patients With Primary Membranous NephropathyPrimary Membranous NephropathyNCT06573411First Affiliated Hospital, Sun Yat-Sen University116