Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease on Hemodialysis

Inclusion Criteria:

- Subject understands the study procedures and agrees to participate in the study by
giving written informed consent.

- Subject is 18 years of age or older.

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

- 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, or
ended treatment on another investigational device or drug study(s) within 8 weeks
prior to screening.

- Other investigational procedures while participating in this study are excluded.

- Anticipated or scheduled parathyroidectomy during the study period.

- Subject has received a parathyroidectomy within 3 months prior to dosing.

- Anticipated or scheduled kidney transplant during the study period.

- Subject has known sensitivity to any of the products or components to be administered
during dosing.

- Subject has participated in a prior clinical trial of AMG 416 (also referred to as
KAI-4169).

- Subject has received cinacalcet within the 4 weeks prior to screening labs (treatment
with cinacalcet is prohibited during the 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.

- Other Exclusion Criteria may apply