Head-to-Head Study of Etelcalcetide and Cinacalcet in Asian Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT)

Inclusion Criteria:

• Subject has provided informed consent prior to performing any study-relatedactivities/procedures.
• Male or female subjects ≥ 18 years of age or older at the time of signing informedconsent.
• Subject must be receiving maintenance hemodialysis 3 times weekly for at least 3months, with adequate hemodialysis based on a delivered measure of dialysis adequacy (Kt/V) ≥ 1.2 or urea reduction ratio ≥ 65% within 4 weeks prior to screeninglaboratory assessments. The Kt/V formula used for a subject must be the formula usedduring routine care prior to screening.
• Dialysate calcium concentration must be ≥ 2.5 mEq/L (1.25 mmol/L) and stable for atleast 4 weeks prior to screening laboratory assessments, and must remain ≥ 2.5 mEq/L (1.25 mmol/L) for the duration of the study.
• Subject must have SHPT as defined by one central laboratory screening predialysisserum PTH value > 500 pg/mL, within 2 weeks prior to randomization.
• Subject currently receiving vitamin D sterols must have had no more than a maximumdose change of 50% within the 4 weeks prior to screening laboratory assessments,remain stable through randomization, and be expected to maintain stable doses for theduration of the study, except for adjustments allowed per protocol or for safetyreasons.
• Subject must have 1 screening predialysis serum cCa laboratory value ≥ 8.3 mg/dLmeasured within 2 weeks prior to randomization.
• A subject receiving calcium supplements must have had no more than a maximum dosechange of 50% within 2 weeks prior to screening laboratory assessments and remainstable through randomization.
• A subject receiving phosphate binders must have had no more than a maximum dose changeof 50% within the 2 weeks prior to screening laboratory assessments, remain stablethrough randomization, and be expected to maintain stable dose for the duration of thestudy, except for adjustments allowed per protocol or for safety reasons.

Exclusion Criteria:

• Currently receiving treatment in another investigational device or drug study, or ≤ 30days since ending treatment on another investigational device or drug study(s). Otherinvestigational procedures while participating in this study are excluded.
• Subject has received etelcalcetide in a prior clinical trial of etelcalcetide.
• Subject has received cinacalcet during the 3 months prior to the first screeninglaboratory assessments.
• Subject has known sensitivity to any of the products or components of eithercinacalcet or etelcalcetide to be administered during dosing.
• Subject has previously been randomized in this study.
• Anticipated or scheduled parathyroidectomy during the study period.
• Subject has received a parathyroidectomy within 6 months prior to dosing.
• Anticipated or scheduled kidney transplant during the study period.
• Subject has an unstable medical condition based on medical history, physicalexamination, and routine laboratory tests, or is otherwise unstable in the judgment ofthe Investigator.
• Malignancy within the last 5 years of screening (except non-melanoma skin cancers orcervical carcinoma in situ).
• Grapefruit juice is prohibited.
• Subject is pregnant or nursing, or planning to become pregnant or nurse duringtreatment or within 3 months after the last dose of etelcalcetide or 30 days after thelast dose of cinacalcet
• Female subject of childbearing potential who is unwilling to use an acceptable methodof effective contraception during treatment with investigational product (IP) through 3 months after the last dose of IP.
• Subject has a history of symptomatic ventricular dysrhythmias or Torsades de Pointes.
• Subject has a history of myocardial infarction, coronary angioplasty, or coronaryarterial bypass grafting within the past 6 months prior to screening.
• Subject has clinically significant abnormalities on prestudy clinical examination orabnormalities on the most recent central laboratory tests during the screening periodprior to randomization according to the Investigator including but not limited to thefollowing:
• serum albumin < 3.0 g/dL
• serum magnesium < 1.5 mg/dL
• serum transaminase (alanine transaminase [ALT] or serum glutamic pyruvictransaminase [SGPT], aspartate aminotransferase [AST] or serum glutamicoxaloacetic transaminase [SGOT]) > 3 times the upper limit of normal (ULN) atscreening.
• Subject likely not available to complete all protocol-required study visits orprocedures, and/or to comply with all required study procedures to the best of thesubject and Investigator's knowledge.
• History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the Investigatoror Amgen physician, if consulted, would pose a risk to subject safety or interferewith the study evaluation, procedures or completion.