Safety and Efficacy Study of AMG 073 in Hemodialysis Subjects

A Phase 3 Study to Assess the Efficacy and Safety of an Oral Calcimimetic Agent (AMG 073) in Secondary Hyperparathyroidism of End Stage Renal Disease Treated With Hemodialysis

Subjects on Hemodialysis will be randomized to AMG 073 or placebo. The screening period is a maximum of 30 days followed by a 26-week treatment period. Lab assessments will be completed throughout the study along with PRO assessments.

Inclusion Criteria:

• Men and Women greater than or equal to 18 years of age
• Using effective contraceptive measures
• Mean iPTH during screening of greater than or equal to 300 pg/mL
• Mean calcium during screening of greater than or equal to 8.4 mg/dL
• Stable on hemodialysis

Exclusion Criteria:

• Unstable medical conditions
• Parathyroidectomy within 3 months
• Change in Vitamin D therapy
• Receiving antidepressants
• Experienced an MI within 3 months
• Inability to swallow tablets
• Previously received AMG 073