EUCTR2011-004618-40-HU进行中（未招募）1 期
An Open-label, Single-arm Study to Assess the Safety and Tolerability of Cinacalcet 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: 2012年5月4日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 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 at enrollment
- •Diagnosed with 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
- •Screening corrected calcium from the central laboratory:
- •- 9.4 mg/dL (2.35 mmol/L) for subjects aged 28 days to < 2 years
- •- 8.8 ( 2.2 mmol/L) for subjects aged 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 year to < 6 years
- •SHPT not due to vitamin D deficiency, per investigator assessment
- •Dialysate calcium level = 2.5 mEq/L during screening
- •Subjects on anti-convulsant medication must be on a stable dose and have a therapeutic blood level of the anti-convulsant at time of screening
- •Subject or subject's legally acceptable representative has provided informed consent, and subject has provided assent when required by institutional guidelines
- •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
- •A new onset of seizure or worsening of a pre-existing seizure disorder within 2 months prior to first dose of IP
- •Received therapy with cinacalcet within 30 days prior to enrollment
- •Scheduled date for kidney transplantation from a known living donor that makes completion of the study unlikely
- •Anemia which in the judgment of the investigator makes it inadvisable to undergo sequential blood draws
- •Subjects aged 28 days to 6 months of age who were born prematurely at < 36 weeks gestational age
- •Unstable chronic heart failure (CHF) defined as worsening pulmonary edema or other signs and symptoms as per investigator assessment during screening
- •History of congenital long QT interval, second or third degree heart block, ventricular tachyarrythmias or other conditions which prolong the QT interval
- •Corrected QT Interval (QTc) > 500 ms, using Bazett’s formula, during screening
- •QTc > 450 to = 500 ms, using Bazett’s formula, during screening, unless written permission to enroll is provided by the investigator after consultation with a pediatric cardiologist
- •Any evidence of active malignancy
- •Either new or recurrent cardiac ventricular arrhythmias requiring a change in treatment within 10 days prior to screening or enrollment
- •Any unstable medical condition or unacceptable physical findings which in the judgment of the investigator precludes enrollment in this study
- •Hepatic impairment indicated by elevated levels of hepatic transaminase or bilirubin (aspartate aminotransferase (AST) = 1.5 x upper limit of normal (ULN) OR alanine aminotransferase (ALT) = 1.5 x ULN OR total bilirubin = 1 x ULN per institutional laboratory range) at screening or Day 1
- •Known hypersensitivity to cinacalcet or any of the excipients in cinacalcet
- •Use of grapefruit juice, herbal medications or potent CYP 3A4 inhibitors (eg, erythromycin, clarithromycin, ketoconazole, itraconazole) or, CYP2D6 substrates (e.g., flecainide, propafenone, metoprolol, desipramine, nortriptyline, clomipramine) within the 14 days prior to enrollment and during the study
- •Use of concomitant medications that may prolong the corrected QT interval (eg, ondansetron, albuterol), during screening
- •Currently enrolled in another investigational device or drug study, or less than 30 days since ending another investigational device or drug study(s), or receiving other investigational agent(s)
- •Subject has previously been enrolled in this study
- •Subject will not be available for protocol required study visits or procedures, to the best of the subject and investigator's knowledge
- •Subject or subject's guardian has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject or guardian to give written informed consent and/or to comply with all required study procedures
研究者
相似试验
进行中（未招募）
不适用
Safety and Tolerability of Cinacalcet in Pediatric Subjects With Chronic Kidney Disease and Secondary HyperparathyroidismSecondary hyperparathyroidism in pediatric subjects with chronic kidney disease receiving hemodialysis or peritoneal dialysisMedDRA version: 16.0Level: PTClassification code 10020708Term: Hyperparathyroidism secondarySystem Organ Class: 10014698 - Endocrine disordersEUCTR2011-004618-40-DEAmgen Inc.20
进行中（未招募）
不适用
Safety and Tolerability of Cinacalcet in Pediatric Subjects With ChronicKidney Disease and Secondary HyperparathyroidismSecondary hyperparathyroidism in pediatric subjects with chronic kidney disease receiving hemodialysis or peritoneal dialysisMedDRA version: 18.0Level: PTClassification code 10020708Term: Hyperparathyroidism secondarySystem Organ Class: 10014698 - Endocrine disordersEUCTR2011-004618-40-Outside-EU/EEAAmgen Inc.30
进行中（未招募）
1 期
Safety and Tolerability of Cinacalcet in Pediatric Subjects With Chronic Kidney Disease and Secondary HyperparathyroidismSecondary hyperparathyroidism in pediatric subjects with chronic kidney disease receiving hemodialysis or peritoneal dialysisMedDRA version: 17.0Level: PTClassification code 10020708Term: Hyperparathyroidism secondarySystem Organ Class: 10014698 - Endocrine disordersEUCTR2011-004618-40-ITAmgen Inc.30
进行中（未招募）
1 期
An Open-label, Single-arm Study to Assess the Safety, Pharmacokinetics, and Efficacy of Adjunctive Cannabidiol Oral Solution (GWP42003-P) in Participants with Tuberous Sclerosis Complex (Age 1 Month to < 2 Years of Age), Dravet Syndrome (1 Year to < 2 Years of Age), or Lennox-Gastaut Syndrome (1 Year to < 2 Years of Age) who Experience Inadequately-controlled SeizuresDravet Syndrome, Tuberous sclerosis complex, Lennox-Gastaut SyndromeMedDRA version: 20.0Level: LLTClassification code: 10073682Term: Dravet syndrome Class: 10010331MedDRA version: 21.0Level: PTClassification code: 10080584Term: Tuberous sclerosis complex Class: 100000004850MedDRA version: 20.1Level: PTClassification code: 10048816Term: Lennox-Gastaut syndrome Class: 100000004852CTIS2023-505851-33-00Gw Research Limited27
进行中（未招募）
1 期
Safety and Tolerability of Cinacalcet in Pediatric Subjects With Chronic Kidney Disease and Secondary HyperparathyroidismSecondary hyperparathyroidism in pediatric subjects with chronic kidney disease receiving hemodialysis or peritoneal dialysisMedDRA version: 18.1Level: PTClassification code 10020708Term: Hyperparathyroidism secondarySystem Organ Class: 10014698 - Endocrine disordersEUCTR2011-004618-40-BEAmgen Inc.30