EUCTR2011-004618-40-Outside-EU/EEA进行中（未招募）不适用
An Open-label, Single-arm Study to Assess the Safety and Tolerability ofCinacalcet HCl in Addition to Standard of Care in Pediatric Subjects Age 28 Days to < 6 Years With Chronic Kidney Disease and Secondary Hyperparathyroidism Receiving Dialysis
Amgen Inc.0 个研究点目标入组 30 人开始时间: 2015年7月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
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
- •Subjects between the ages of 28 days to < 6 years of age, who have CKD and SHPT undergoing either HD or PD at the time of screening (subjects 6 months or older should have been receiving dialysis for = 1 month).
- •- Screening plasma iPTH level > 300 pg/mL (31.8 pmol/L) from the central laboratory, and not have received any cinacalcet therapy for at least 30 days prior to start of dosing
- •- Screening corrected total serum calcium from the central laboratory:
- •- = 9.4 mg/dL (2.35 mmol/L) if age 28 days to < 2 years
- •- = 8.8 mg/dL (2.2 mmol/L) if age = 2 to < 6 years
- •- Serum phosphorus from the central laboratory:
- •- = 5.0 mg/dL (1.25 mmol/L) if age 28 days to < 1 year
- •- = 4.5 mg/dL (1.13 mmol/L) if age = 1 to < 6 years
- •- SHPT not due to vitamin D deficiency, per investigator assessment
- •- Dry weight = 7 kg at the time of screening
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 30
- •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
- •- History of congenital long QT syndrome, second or third degree heart block, ventricular tachyarrhythmias or other conditions associated with prolonged QT interval
- •- Corrected QT interval (QTc) > 500 ms, using Bazett’s formula
- •- QTc =450 to = 500 ms, using Bazett’s formula, unless written permission to enroll is provided by the investigator after consultation with a pediatric cardiologist
- •- Use of grapefruit juice, herbal medications, CYP3A4 inhibitors (eg, erythromycin, clarithromycin, ketoconazole, itraconazole), or CYP2D6 substrates (eg, flecainide, propafenone, metoprolol, desipramine, nortriptyline, clomipramine)
- •- Use of concomitant medications that may prolong the QTc interval (eg, ondansetron, albuterol)
研究者
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