Investigational Agent Shows Promise for SHPT in Hemodialysis Patients
In a phase 2 trial, etelcalcitide, a novel peptide agonist of the calcium-sensing receptor, significantly reduced parathyroid hormone levels.
AMG416 (etelcalcitide), an investigational agent, is well tolerated and appears to be an effective treatment for secondary hyperparathyroidism (SHPT) in patients on hemodialysis (HD), according to results from a phase 2 study.
The study, led by David A. Bushinsky, MD, of the University of Rochester School of Medicine in Rochester, N.Y., included 37 adult HD patients with SHPT who received etelcalcitide intravenously thrice weekly starting at 5 mg per session and titrated based on each patient's parathyroid hormone (PTH) and albumin-corrected calcium level to target a PTH level of 150–300 pg/mL. Etelcalcitide is a novel peptide agonist of the calcium-sensing receptor.
At baseline, patients had a mean PTH level of 853 pg/mL. From baseline to the efficacy assessment period (EAP), patients had a mean 53.6% decrease in PTH level, the researchers reported in the American Journal of Nephrology (2015;42:379-388). The proportion of patients with a 30% or greater reduction in PTH from baseline to the EAP was 89%. At the EAP, 56% of patients had achieved a PTH level of 300 pg/mL or less.
The researchers also compared patients with PTH values of 700 pg/mL or less and those with values above 700 pg/mL and found comparable results.
Adverse events were mild to moderate in severity, according to the researchers.
"AMG416 appears to be a promising agent to effectively manage SHPT in subjects treated with hemodialysis and potentially offers substantial advantages over currently available treatments," the authors concluded.