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