To Assess the Long-term Safety of AMG 416 in the Treatment of SHPT in Subjects With CKD on Hemodialysis



Status:Completed
Conditions:Renal Impairment / Chronic Kidney Disease, Endocrine
Therapuetic Areas:Endocrinology, Nephrology / Urology
Healthy:No
Age Range:18 - 110
Updated:10/21/2017
Start Date:March 25, 2014
End Date:June 26, 2017

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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

This is a multicenter, single-arm, extension study to characterize the long-term safety and
tolerability of AMG 416 in the treatment of SHPT in subjects with CKD on hemodialysis.

This is a multicenter, single-arm, extension study in which subjects with secondary
hyperparathyroidism currently receiving hemodialysis previously treated in AMG 20120231,
20120334, or 20120360 will continue to be treated with AMG 416. The study will assess the
long-term safety and tolerability of AMG 416 as well as measuring the intact parathyroid
hormone (iPTH), total serum albumin, corrected calcium (cCa), and serum phosphorous (P)
values in these subjects during the course of their treatment.

Inclusion Criteria:

- 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 study

- Subject must be receiving hemodialysis 3 or 4 times weekly for at least 3 months

Exclusion Criteria:

- Currently receiving treatment in another investigational device or drug study (other
than in one of the designated parent studies)

- 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 is receiving dialysis prescription dialysate calcium concentration < 2.25
mEq/L

- Subject is pregnant or nursing
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