20120231: Single-arm Extension Study of AMG 416 in the Treatment of SHPT in CKD Subjects on HD



Status:Completed
Conditions:Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease, Endocrine
Therapuetic Areas:Endocrinology, Nephrology / Urology
Healthy:No
Age Range:18 - 100
Updated:4/21/2016
Start Date:July 2013
End Date:July 2015

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A Multicenter Single-arm Extension Study to Describe the Long-term Efficacy and Safety of AMG 416 in the Treatment of Secondary Hyperparathyroidism in Subjects With Chronic Kidney Disease on Hemodialysis

This study is designed to describe the long-term safety and efficacy of IV administration of
AMG 416 for the treatment of SHPT in subjects with CKD on hemodialysis.


Inclusion Criteria:

- 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.

- Other Inclusion Criteria may apply

Exclusion Criteria:

- 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 an unstable medical condition based on medical history, physical
examination, and routine laboratory tests, or is otherwise unstable in the judgment
of the Investigator.

Other Exclusion Criteria may apply
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