An Open-label, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Etelcalcetide (AMG 416) in Paediatric Subjects Aged 2 to Less Than 18 Years With Secondary Hyperparathyroidism (sHPT) Receiving Maintenance Haemodialysis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Change From Baseline in Intact Parathyroid Hormone (iPTH) Levels Over Time
研究概览
简要总结
This is a study to evaluate the safety and pharmacokinetics in pediatric patients with secondary hyperparathyroidism receiving a single dose of etelcalcetide at the end of hemodialysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject's parent has provided informed consent and subject has provided assent
- •Children Age 2 to less than 18 years
- •Diagnosed with chronic kidney disease
- •Diagnosed with secondary hyperparathyroidism receiving hemodialysis,
- •Weighing at least 7 kg
- •Laboratory results within specified range.
排除标准
- •Currently receiving treatment in another investigation device or drug study
- •Subject has received cinacalcet therapy within 30 days
- •History of prolongation QT interval
- •Subject is taking any medications that are on the QT prolongation medication list
- •Electrocardiograph (ECG) measurements within specified range.
研究组 & 干预措施
Etelcalcetide
Participants received a single, intravenous (IV) bolus administration of 0.035 mg/kg etelcalcetide at the end of hemodialysis on study day 1.
干预措施: Etelcalcetide (Drug)
结局指标
主要结局
Change From Baseline in Intact Parathyroid Hormone (iPTH) Levels Over Time
时间窗: Baseline and day 1, 4 hours postdose, day 3, day 8, day 10, and day 30 (end of study)
Change From Baseline in Serum Potassium Concentration at End of Study
时间窗: Baseline and day 30 (end of study)
Change From Baseline in Blood Pressure at End of Study
时间窗: Baseline and day 30 (end of study)
Change From Baseline in PR Interval at End of Study
时间窗: Baseline and day 30 (end of study)
Change From Baseline in QRS Interval at End of Study
时间窗: Baseline and day 30 (end of study)
Common Treatment-emergent Adverse Events
时间窗: 30 days
A treatment-emergent adverse event is any adverse event (AE) that begins or worsens after the initial dose of study drug (etelcalcetide) and up to 30 days after the last dose. Common adverse events were defined as adverse events occurring in at least 2 participants. The Medical Dictionary for Regulatory Activities (MedDRA) version 21.0 was used for coding all adverse events.
Change From Baseline in Heart Rate at End of Study
时间窗: Baseline and day 30 (end of study)
Change From Baseline in QT Interval at End of Study
时间窗: Baseline and day 30 (end of study)
Change From Baseline in Serum Corrected Calcium Concentration Over Time
时间窗: Baseline and Day 1, 4 hours postdose, day 3, day 8, day 10, and day 30 (end of study)
When albumin was less than 4.0 mg/dL, the calcium concentration was corrected according to the formula: cCa (mmol/L) = measured total serum calcium (mmol/L) + 0.02 (40 - serum albumin \[g/L\]).
Change From Baseline in Temperature at End of Study
时间窗: Baseline and day 30 (end of study)
Change From Baseline in Serum Phosphorus Concentration at End of Study
时间窗: Baseline and day 30 (end of study)
Change From Baseline in Corrected (Bazett) QT Interval at End of Study
时间窗: Baseline and day 30 (end of study)
Change From Baseline in Corrected (Fridericia) QT Interval at End of Study
时间窗: Baseline and day 30 (end of study)
次要结局
- Change From Baseline in Serum Ionized Calcium Concentration(Baseline and Day 1, 4 hours postdose, day 3, day 8, day 10, and day 30 (end of study))
- Change From Baseline in Serum Total Calcium Concentration(Baseline and Day 1, 4 hours postdose, day 3, day 8, day 10, and day 30 (end of study))
- Maximum Observed Plasma Concentration (Cmax) of Etelcalcetide(10 minutes, 4 hours, and 3, 5, 8, 10, and 30 days postdose)
- Terminal Half-life (T1/2,z) of Etelcalcetide(10 minutes, 4 hours, and 3, 5, 8, 10, and 30 days postdose)
- Number of Participants Who Developed Anti-etelcalcetide Binding Antibodies(Baseline and day 30)
- Time to Maximum Concentration (Tmax) of Etelcalcetide(10 minutes, 4 hours, and 3, 5, 8, 10, and 30 days postdose)
- Area Under the Plasma Etelcalcetide Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast)(10 minutes, 4 hours, and 3, 5, 8, 10, and 30 days postdose)
- Number of Participants With Treatment-emergent Adverse Events(30 days)
- Area Under the Plasma Etelcalcetide Concentration-Time Curve From Time Zero Infinity (AUCinf)(10 minutes, 4 hours, and 3, 5, 8, 10, and 30 days postdose)