EUCTR2014-003563-38-SK进行中（未招募）1 期
A Multicenter Single-arm Extension Study to Characterize the Long-termSafety of Cinacalcet Hydrochloride in the Treatment of SecondaryHyperparathyroidism in Pediatric Subjects With Chronic Kidney Disease onDialysis
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Amgen, Inc.
- 入组人数
- 48
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
- •101Subject’s legally acceptable representative has provided informed consent when the subject is legally too young to provide informed consent and the subject has provided written assent based on local regulations and/or guidelines prior to any study-specific activities/procedures being initiated.
- •102Subject must complete treatment through Week 20 in parent study 20130356
- •103Dry weight > 12.5 kg at Day 1
- •104The mean iPTH value (Week19 in 20130356) = 300 pg/mL (Standard of Care arm)
- •105Corrected calcium value (Week 19 in 2010356) = 8.8 mg/dL (Standard of Care arm)
- •106Dialysate calcium concentration = 2.5 mEq/L at day 1
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 48
- •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
- •201Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(s).
- •202Other investigational procedures while participating in this study are excluded.
- •203Malignancy except non-melanoma skin cancers, cervical or breast ductal carcinoma in situ within the last 5 years.
- •204Subject has known sensitivity to any of the products to be administered during dosing
- •205Subject likely to not be available to complete all protocol required study visits or procedures, and/or to comply with all required study procedures (eg, electronic patient diary) to the best of the subject and investigator’s knowledge
- •206History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
- •207Subject previously has entered this study.
- •208If sexually active, subject is not willing to use highly effective contraception during treatment and for at least 9 days after the end of treatment
- •209Subject is pregnant or breast feeding, or planning to become pregnant during the study or within 9 days after the end of treatment
- •210History of congenital long QT syndrome, second or third degree heart block, ventricular tachyarrythmias or other conditions associated with prolonged QT interval
- •At Day 1 Study Visit
- •211Subject has a clinically significant (in the opinion of the investigator) or severe (grade = 3 CTCAE v 4.0) ongoing adverse event related to IP from Study 20130356
- •212Corrected QT Interval (QTc) > 500 ms, using Bazett’s formula
- •213QTc = 450 to = 500 ms, using Bazett’s formula, unless written permission to enroll is provided by the investigator after consultation with a pediatric cardiologist
- •214Use of grapefruit juice, herbal medications or CYP3A4 inhibitors (eg, erythromycin, clarithromycin, ketoconazole, itraconazole) or CYP2D6 substrates (eg,flecainide, propafenone, metoprolol, desipramine, nortriptyline, clomipramine)
- •215Use of concomitant medications that may prolong the corrected QT interval (eg, ondansetron, albuterol)
研究者
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