A calcimimetic agent administered intravenously, AMG 416 binds to and activates the calcium-sensing receptor on the parathyroid gland, thereby reducing serum intact PTH levels.
The randomized, active-controlled, double-blind, double-dummy study compared the efficacy and safety of AMG 416 with cinacalcet in 683 patients over 26 weeks.
The study’s primary endpoint was non-inferiority of AMG 416 compared to cinacalcet, while the secondary endpoint was statistically significantly superior to cinacalcet.
Amgen Research and Development executive vice-president Dr Sean E. Harper said: "These findings, combined with results from two positive placebo-controlled studies of more than 1,000 patients, add to the growing body of evidence that reinforce the promise of AMG 416 for hemodialysis patients with secondary hyperparathyroidism.
"The management of this disease in patients with chronic kidney disease is a complex process, and at Amgen, we are committed to building upon our leadership in nephrology to provide patients with an innovative therapy that can be administered intravenously along with hemodialysis."