Safety, Tolerability and Pharmacokinetics of Etelcalcetide in Hemodialysis Patients With Secondary Hyperparathyroidism

Inclusion Criteria:

- Subjects provides written informed consent.

- Intact parathyroid hormone (iPTH) ≥ 400 pg/mL (≥ 300 and < 1200 pg/ml for Cohorts
1-3).

- Serum corrected calcium ≥ 9.0 mg/dL

- Receiving hemodialysis three times per week for at least 3 months and had adequate
hemodialysis with a delivered Kt/V (dialyzer clearance of urea * dialysis time/ volume
of distribution of urea) ≥ 1.2 or urea reduction ratio (URR)

≥ 65%.

- Excepting chronic renal failure, subject is judged to be in stable medical condition
based on medical history, physical examination, and routine laboratory tests

Exclusion Criteria:

- History or symptomatic ventricular dysrhythmias

- History of angina pectoris or congestive heart failure

- History of myocardial infarction, coronary angioplasty, or coronary artery bypass
grafting within the past 6 months

- History of or treatment for seizure disorder

- Recent (3 months) parathyroidectomy