Efficacy and safety of anrikefon in patients with pruritus undergoing haemodialysis: multicentre, double blind, randomised placebo controlled phase 3 trial

作者：Bi‐Cheng Liu, Zuo‐Lin Li, Ping Zhang, Aimin Zhong, Yaling Bai, Yan Xu, Bihu Gao, Yanlin Li, Yu Wang, Linghui Zhou, Li Yao, Junxia Wang, Rui Yan, Liang Wang, Bing Liao, Deqiong Xie, Xie Yi, Tianjun Guan, Caili Wang, Guisen Li, Fangqiong Li, Jianghua Chen · 发表于：BMJ · 年份：2025 · DOI：10.1136/bmj-2025-085208 · 被引用次数：6 · 研究领域：Dermatology and Skin Diseases、Psoriasis: Treatment and Pathogenesis、Urinary Bladder and Prostate Research

Abstract Objective To evaluate the efficacy and safety of anrikefon (formerly known as HSK21542), a novel selective peripherally restricted kappa opioid receptor agonist, in patients with chronic kidney disease associated pruritus. Design Multicentre, double blind, randomised placebo controlled phase 3 trial. Setting 50 centres in China, June 2022 to June 2024. Participants 652 patients with moderate to severe CKD associated pruritus undergoing haemodialysis were screened: 545 were randomly assigned (1:1 ratio) to receive either anrikefon (n=275) or placebo (n=270). Interventions Intravenous anrikefon (0.3 μg/kg body weight) or placebo three times weekly for 12 weeks, followed by an optional open label extension phase with anrikefon treatment for 40 weeks. Main outcome measures The primary endpoint was the percentage of patients achieving at least a 4 point reduction in weekly mean 24 hour worst itching intensity numerical rating scale (WI-NRS) score from baseline to week 12. Secondary outcomes were the percentage of patients achieving at least a 3 point reduction in weekly mean WI-NRS score from baseline to week 12, as well as changes in itch related quality of life from baseline using the Skindex-10 and 5-D itch scales. The change in itch related quality of life from baseline to week 40 of open label treatment was also reported using the 5-D itch scale. The safety of anrikefon was evaluated throughout the trial. Results 243/275 (88%) patients in the anrikefon group and 254/...