Both studies were 26-week, randomized, double-blind, placebo-controlled studies that evaluated the efficacy and safety of AMG 416 for the treatment of SHPT in a total of 1,023 patients with CKD receiving hemodialysis. Patients received AMG 416 or placebo three times per week by intravenous injection at the end of each hemodialysis treatment. The primary endpoint of both studies was the proportion of patients achieving >30% reduction in parathyroid hormone (PTH) during the Efficacy Assessment Phase, defined as weeks 20 through 27.
The studies met the primary endpoint, with 74.7% of patients in the AMG 416 group, achieving a >30% reduction from baseline in PTH compared with 8.9% in the placebo arm. Furthermore, a statistically significant proportion of patients (51.5%) randomized to receive AMG 416 achieved ≤300pg/mL, compared with 5.9% in the placebo-controlled group, despite similar baseline mean PTH values of 724pg/mL and 716pg/mL, respectively.
AMG 416 is a novel calcimimetic agent that binds to and activates the calcium-sensing receptor on the parathyroid gland, thereby decreasing PTH levels.
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