Positive Results for AMG 416 in Secondary Hyperparathyroidism Trial
Amgen announced results from its Phase 3 study evaluating AMG 416 for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease (CKD) receiving hemodialysis. AMG 416 is a novel calcimimetic agent that is administered intravenously. AMG 416 binds to and activates the calcium-sensing receptor on the parathyroid gland, thereby causing decreases in parathyroid hormone (PTH).
The study was a 26-week, randomized, double-blind, placebo-controlled study (Study #20120229) that evaluated the efficacy and safety of AMG 416 in 508 patients with CKD receiving hemodialysis. Patients received AMG 416 or placebo three times per week by intravenous injection with each hemodialysis treatment. Doses ranged from a minimum of 2.5mg to a maximum of 15mg. Patients also received standard of care which could include calcium supplements, vitamin D sterols, and phosphate binders, if prescribed by the individual physician. The primary endpoint was the proportion of patients with >30% reduction from baseline in PTH levels during an Efficacy Assessment Phase (EAP) defined as the period between weeks 20 and 27.
The primary endpoint of this study was met. In the AMG 416 group, 74% of patients achieved a >30% reduction from baseline in PTH compared with 8.3% in the placebo arm, a statistically significant result.
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