Head-to-Head Study of Etelcalcetide (AMG 416) and Cinacalcet

Inclusion Criteria:

- Eligible subjects must be receiving adequate thrice weekly maintenance hemodialysis
with a dialysate calcium concentration ≥ 2.5 mEq/L for at least 3 months prior to
screening laboratory assessments

- Subjects must have SHPT as defined by one central laboratory screening predialysis
serum PTH value > 500 pg/mL, measured on separate days within 2 weeks prior to
randomization

- Subjects must have one serum cCa value ≥ 8.3 mg/dL obtained before dialysis within 2
weeks of the date of randomization

- Subjects receiving calcium supplements must have no more than a maximum dose change of
50% within 2 weeks before screening laboratory assessments are obtained, and the dose
must remain unchanged through randomization

Exclusion Criteria:

- Eligible subjects cannot have received cinacalcet during the 3 months preceding the
first screening laboratory assessment

- Other criteria may apply