Amgen announced positive Phase 3 results for AMG 416 (formerly known as velcalcetide) for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD), receiving hemodialysis.
The study was a 26-week, randomized, double-blind, placebo-controlled study (Study #20120230) evaluating the efficacy and safety of AMG 416 for the treatment of SHPT in 515 patients with CKD receiving hemodialysis. Patients received AMG 416 or placebo three times per week by IV injection with each hemodialysis treatment along with any standard of care, including calcium supplements, vitamin D sterols and phosphate binders, if prescribed.
The study met its primary endpoint, which was defined as the proportion of patients with >30% reduction from baseline in parathyroid hormone (PTH) levels during an Efficacy Assessment Phase (EAP) defined as the period between weeks 20 and 27. In the AMG 416 group, 75.3% of patients achieved a >30% reduction from baseline in PTH compared with 9.6% in the placebo arm, a statistically significant result.
AMG 416 is a novel calcimimetic agent that binds to and activates the calcium-sensing receptor on the parathyroid gland, thereby decreasing PTH.
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