EUCTR2014-003563-38-BE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
- •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 in 20130356)
- •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: 78
- •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 treatment
- •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 disorder
- •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 edema
- •or other signs and symptoms as per investigator assessment during screening will have the following exclusion criteria applied during screening and day 1:
- •213 Received therapy with commercial cinacalcet after the last study visit in Study 20130356 or Study 20110100 before day 1 of Study 20140159
- •214 Scheduled date for kidney transplantation from a known living donor that makes completion of the study unlikely
- •215 Either new or recurrent cardiac ventricular arrhythmias requiring a change 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 normal [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
- •Considered clinically significant in the opinion of the investigator
- •218 Central laboratory values were not obtained/are not available at day 1 in Study 20140159
- •219 Corrected QT Interval (QTc) > 500 ms, using Bazett’s formula
- •220 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
- •221 Use of grapefruit juice, herbal medications, CYP3A4 inhibitors (eg, erythromycin, clarithromycin, ketoconazole, itrac
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