Efficacy and Safety of Upacicalcet in Hemodialysis Patients with Secondary Hyperparathyroidism A Randomized Placebo-Controlled Trial

Background Secondary hyperparathyroidism is a major complication of patients undergoing hemodialysis (HD). Upacicalcet, a new injectable calcimimetic, acts on calcium-sensing receptors to suppress parathyroid hormone (PTH) secretion. We examined the efficacy and safety of upacicalcet in patients with secondary hyperpara-thyroidism receiving HD.Methods In this phase 3, double-blind, placebo-controlled study, we randomized Japanese patients undergo-ing HD with serum intact PTH (iPTH) concentrations .240 pg/ml and corrected calcium concentrations $8.4 mg/dl. Either upacicalcet or placebo was administered after each HD session for 24 weeks. The primary outcome was the percentage of participants achieving the target mean serum iPTH concentration (60-240 pg/ml) at weeks 22-24.Results A total of 103 participants received upacicalcet, and 50 participants received the placebo. The percentage of participants achieving mean serum iPTH concentrations of 60-240 pg/ml during the evaluation period was 67% (69/103) in the upacicalcet group and 8% (4/50) in the placebo group. The difference between the two groups was 59% (95% confidence interval, 48% to 71%). Upacicalcet also decreased serum fibroblast growth factor-23, bone-specific alkaline phosphatase, total type 1 procollagen-N-propeptide, and tartrate-resistant acid phosphatase-5b concentrations. Adverse events were reported in 85% (88/103) and 72% (36/50) participants in the upacicalcet and placebo groups, respectively. The incidence of upper gastrointestinal adverse events, such as nausea and vomiting, was similar between the two groups. Serum corrected calcium concentrations ,7.5 mg/dl were observed in 2% of participants in the upacicalcet group and no participants in the placebo group.Conclusions Upacicalcet, a novel injectable calcimimetic, is effective and safe for secondary hyperparathyroidism patients receiving HD.

Automated summary

Upacicalcet, a novel injectable calcimimetic, is effective and safe for patients with secondary hyperparathyroidism receiving hemodialysis.