EUCTR2014-003563-38-CZ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
适应症
相关药物
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
- •101 Subject'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 day 1 study-specific
- •activities/procedures being initiated.
- •102 Dialysate calcium concentration = 2.5 mEq/L at day 1
- •All subjects with > 14 days between the last study visit in Study
- •20130356 or Study 20110100 and screening for Study 20140159:
- •103 Subjects on anti-convulsant medication must be on a stable dose
- •All subjects from 20130356:
- •104 Completed treatment through week 20 in the 20130356 study or on
- •study at the time of Study 20130356 termination
- •105 Dry weight = 12.5 kg at day 1 of Study 20140159
- •Subjects Randomized to the 20130356 Standard of Care Arm Only:
- •106 iPTH value = 300 pg/mL (within 7 days of day 1 in Study 20140159)
- •(week 19 in 20130356)
- •107 Corrected calcium value = 8.8 mg/dL within 7 days of day 1 in Study 20140159 (week 19 in20130356)
- •All Subjects from 20110100
- •108 Completed week 26 End of Study visit in the, 20110100 study or on
- •study at the time of Study 20110100 termination
- •109 Dry weight = 7 kg at day 1 of Study 20140159
- •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
- •Studies 20130356 or 20110100
- •201 Currently 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), other than Amgen Studies
- •20130356 or 20110100.
- •202 Other investigational procedures while participating in this study
- •are excluded.
- •203 Malignancy except non-melanoma skin cancers, cervical or breast
- •ductal carcinoma in situ within the last 5 years.
- •204 Subject has known sensitivity to any of the products to be
- •administered during dosing.
- •205 Subject 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 [ediary]) to the best of the
- •subject and investigator's knowledge
- •206 History 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.
- •207 Subject previously has entered this study.
- •208 If sexually active, subject is not willing to use acceptable
- •contraception during treatment and for at least 9 days after the end of
- •209 Subject is pregnant or breast feeding, or planning to become
- •pregnant during the study or within 9 days after the end of treatment
- •210 History of congenital long QT syndrome, second or third degree
- •heart block, ventricular tachyarrythmias, or other conditions associated
- •with prolonged QT interval
- •211 A new onset of seizures or worsening of pre-existing seizure
- •All Subjects with > 14 days between the last study visit in Study
- •20130356 or
- •Study 20110100 and the screening visit in Study 20140159
- •212 Unstable chronic heart failure defined as worsening pulmonary
- •other signs and symptoms as per investigator assessment during
- •will have the following exclusion criteria applied during screening and
- •213 Received therapy with commercial cinacalcet after the last study
- •Study 20130356 or Study 20110100 before day 1 of Study 20140159
- •214 Scheduled date for kidney transplantation from a known living donor
- •makes completion of the study unlikely
- •215 Either new or recurrent cardiac ventricular arrhythmias requiring a
- •in treatment within 10 days prior to screening visit or day 1 of Study 20140159 screening
- •216 Hepatic impairment indicated by elevated levels of hepatic
- •transaminase or
- •bilirubin (aspartate aminotransferase [AST] = 1.5 × upper limit of
- •[ULN] OR alanine aminotransferase [ALT] = 1.5 × ULN OR total
- •bilirubin = 1 × ULN per institutional laboratory range) during screening
- •217 Subject has an ongoing adverse event from Studies 20130356 or
- •20110100 that is considered related to IP and:
- •All Subjects - Day 1 Study Visit
- •Is = CTCAE (v 4.0) grade 3, and/or
- 另有 10 项未显示
研究者
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