EUCTR2012-002808-41-BE进行中（未招募）1 期
A Multicenter Single-arm Extension Study to Describe the Long-term Efficacy and Safety of AMG 416 in the Treatment of SecondaryHyperparathyroidism in Subjects With Chronic Kidney Disease on Hemodialysis
KAI Pharmaceuticals, Inc. (a subsidiary of Amgen, Inc.)0 个研究点目标入组 1,120 人开始时间: 2012年11月27日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,120
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
- •Subject understands the study procedures and agrees to participate in the study by giving written informed consent.
- •Subject must complete the treatment and follow-up period, or have been discontinued for rising iPTH, from an AMG 416 phase 3 parent study prior to the start of dosing in this study.
- •Subject agrees to not participate in another study of an investigational agent during the study.
- •Dialysis prescription dialysate calcium concentration must be = 2.25 mEq/L.
- •Female subject who is post menopausal (post menopausal is defined as no menses for the previous 1 year and over the age of 50 years), surgically sterilized, has a medical condition that prevents pregnancy, remains abstinent, or is willing to use highly effective contraception during the study and for 3 months after the last dose. Women of child-bearing potential must have a negative serum pregnancy test within 2 weeks prior to the first dose of AMG 416.
- •Male subject is willing to use highly effective contraception when sexually active and will not donate sperm during the treatment phase.
- •Subject’s legally acceptable representative has provided informed consent when the subject has any kind of condition that, in the opinion of the Investigator, may compromise the ability of the subject to give written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 700
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 300
排除标准
- •Currently receiving treatment in another investigational device or drug study.
- •Currently receiving other investigational procedures while participating in this study.
- •Subject has known sensitivity to any of the products or components to be administered during dosing.
- •Subject has received cinacalcet between the last dose of investigational product in the parent study (20120229 or 20120230 or 20120359) and the start of dosing with AMG 416 in the current study.
- •Subject has an unstable medical condition based on medical history, physical examination, and routine laboratory tests, or is otherwise unstable in the judgment of the Investigator.
- •Subject has a history of any illness that, in the opinion of the Investigator, might confound the results of the study or pose additional risk to the subject.
- •Subject has a serious concurrent medical condition (eg, malignancy) likely to result in death during the next 12 months.
- •Subject is pregnant or nursing.
- •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.
研究者
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