Fukagawa M, et al. - A novel intravenous calcimimetic viz. etelcalcetide (ONO-5163/AMG 416) was tested for efficacy and safety in Japanese haemodialysis patients with secondary hyperparathyroidism (SHPT). As per findings, etelcalcetide was effective and safe and, is likely to provide a new treatment option for SHPT in haemodialysis patients.

Methods

• A phase 3, multicentre, randomized, double-blind, placebo-controlled, parallel-group study was performed, wherein, researchers administered etelcalcetide three times per week at an initial dose of 5 mg, subsequently adjusted to doses between 2.5 and 15 mg at 4-week intervals for 12 weeks.
• They assigned a total of 155 SHPT patients with serum intact parathyroid hormone (iPTH) levels ≥300 pg/mL to receive etelcalcetide (n = 78) or placebo (n = 77).
• The primary endpoint was the proportion of patients with decreased serum iPTH to the target range proposed by the Japanese Society for Dialysis Therapy (60–240 pg/mL).
• The major secondary endpoint was the proportion of patients with ≥30% reductions in serum iPTH from baseline.

Results

• Findings revealed that the proportion of patients meeting the primary endpoint was significantly higher for etelcalcetide (59.0%) versus placebo (1.3%).
• Similarly, It was observed that the proportion of patients meeting the major secondary endpoint was significantly higher for etelcalcetide (76.9%) versus placebo (5.2%).
• Researchers also noted that the serum albumin-corrected calcium, phosphorus and intact fibroblast growth factor-23 levels were decreased in the etelcalcetide group.
• Data showed that nausea, vomiting and symptomatic hypocalcaemia were mild with etelcalcetide.
• In addition, researchers did not report serious adverse events related to etelcalcetide.