12-month Study of AMG 073 in Renal Osteodystrophy

A Multicenter, Randomized, Placebo-controlled, Double-blind, 12-month Study to Assess the Effects of an Oral Calcimimetic Agent (AMG 073) on Renal Osteodystrophy in Hemodialysis Patients With Secondary Hyperparathyroidism

4 doses of AMG 073 or placebo over 52 weeks after a 30-day screening period. Throughout the study, labs will be drawn to measure analytes such as iPTH and corrected calcium. In addition, a bone biopsy will be performed at screening and at the end of study.

Inclusion Criteria:

• 18 years of age of greater
• Using effective contraceptive measures
• iPTH greater than or equal to 300 pg/mL
• Serum Calcium greater than or equal to 8.4 mg/dL; Hemoglobin greater than 9
• Stable hemodialysis for 1 month prior to day 1

Exclusion Criteria:

• Any unstable medical condition
• Pregnant or nursing women Recent parathyroidectomy
• Change in Vitamin D therapy
• Recent MI, Seizure, Malignancy, GI Disorder
• Inability to swallow tablets