医学
继发性甲状旁腺功能亢进
安慰剂
内科学
血液透析
拟钙质
胃肠病学
甲状旁腺激素
西那卡塞特
甲状旁腺功能亢进
恶心
内分泌学
不利影响
泌尿科
维生素D与神经学
呕吐
钙
病理
替代医学
作者
Takashi Shigematsu,Fumihiko Koiwa,Yoshitaka Isaka,Masafumi Fukagawa,Keiko Hagita,Yukihisa S. Watanabe,Daisuke Honda,Tadao Akizawa
出处
期刊:Clinical Journal of The American Society of Nephrology
[American Society of Nephrology]
日期:2023-09-11
卷期号:18 (10): 1300-1309
被引量:9
标识
DOI:10.2215/cjn.0000000000000253
摘要
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 hyperparathyroidism receiving HD. Methods In this phase 3, double-blind, placebo-controlled study, we randomized Japanese patients undergoing 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. Clinical Trial Registry Name and Registration Number Phase 3 Study of SK-1403, NCT03801980.
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