A Multicenter single-arm Extension Study to Describe the Long-term Safety of AMG 416 in the Treatment of Secondary Hyperparathyroidism in Subjects With Chronic Kidney Disease on Hemodialysis. - AMG 416 in the Treatment of SHTP in Subj. With Chronic Kidney Disease on HD

Amgen0 个研究点目标入组 4 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

暂无简介。

•-Subject has provided informed consent prior to initiation of any study-specific
•activities/procedures.
•-Subject has completed treatment in Study 20120231 (also known as
•KAI-4169-008) or Study 20120360, or has participated in Study 20120334 (also
•known as KAI-4169-005-01).
•-Female subjects who are:
•* post menopausal (post menopausal is defined as no menses for the previous
•1 year and over the age of 50 years)
•* surgically sterilized
•* have a medical condition that prevents pregnancy
•* remain abstinent
•* or are willing to use an acceptable method of effective contraception during
•the study and for 3 months after the last dose
•Women of child-bearing potential (WOCBP) must have a negative serum
•pregnancy test within 2 weeks prior to the first dose of AMG 416 in the current
•-Subject must be receiving hemodialysis 3 or 4 times weekly for at least 3 months.

•-Currently receiving treatment in another investigational device or drug study
•(other than in one of the designated parent studies).
•-Other investigational procedures while participating in this study are excluded.
•-Subject has known sensitivity to any of the products or components to be
•administered during dosing.
•-Subject has been prescribed cinacalcet by the primary nephrologist between the
•conclusion of the parent study and the start of dosing with AMG 416 in the
•current study.
•-Subject has any illness that, in the judgment of the Investigator, might confound
•the results of the study or pose additional risk to the subject.
•-Subject is receiving dialysis prescription dialysate calcium concentration
•< 2.25 mEq/L
•-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 judgment of the Investigator would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.

发起方