Study to Assess the Impact on Calcium Levels When Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT) Switch From Cinacalcet to Etelcalcetide

Inclusion Criteria

- Subject is 18 years of age or older at the time of informed consent.

- Subject must be receiving maintenance hemodialysis 3 times weekly for at least 8
weeks.

- Subject must have SHPT as defined by having a mean of 3 consecutive central laboratory
screening predialysis serum parathyroid hormone (PTH) values ≥ 200 pg/mL, with
measurements obtained from 3 different calendar weeks in the 4-week screening period
while receiving cinacalcet.

- Subject must have a mean of 3 consecutive central laboratory screening predialysis
serum corrected calcium (cCa) values ≥ 7.5 mg/dL, with measurements obtained from 3
different calendar weeks in the 4-week screening period while receiving cinacalcet.

- Subject must be on a stable dose of cinacalcet before screening (defined as no dose
change within the 4 weeks prior to screening).

- Other Inclusion Criteria may apply.

Exclusion Criteria

- Currently receiving treatment in another investigational device or drug study, or less
than 30 days since ending treatment on another investigational device or drug
study(s).

- Subject has received AMG 416 in a prior clinical trial of AMG 416 (also known as
KAI-4169).

- Subject has known sensitivity to any of the products or components of AMG 416 to be
administered during dosing.

- Subject is unwilling to use effective contraception during the study, and for women,
up to a period of up to 3 months after the last dose of AMG 416.

- Subject is pregnant or nursing.

- Anticipated or scheduled parathyroidectomy during the study period.

- Subject has received a parathyroidectomy within 6 months prior to dosing.

- Other Exclusion Criteria may apply.