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: 2013年2月26日最近更新: 2016年5月30日

适应症

试验速览

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•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.
•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

•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, 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.

发起方

KAI Pharmaceuticals, Inc. (a subsidiary of Amgen, Inc.)