Abstract: FR-OR104
Efficacy and Safety of HSK21542 for Moderate-to-Severe CKD-Associated Pruritus: A Phase 3 Trial in Hemodialysis Patients
Session Information
- High-Impact Clinical Trials - 1
October 25, 2024 | Location: Hall D, Convention Center
Abstract Time: 11:45 AM - 12:00 PM
Category: Dialysis
- 801 Dialysis: Hemodialysis and Frequent Dialysis
Authors
- Liu, Bi-Cheng, Zhongda Hospital Southeast University, Nanjing, China
- Chen, Jianghua, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China
- Zhong, Aimin, Jiangxi Provincial People's Hospital, Nanchang, China
- Bai, Yaling, The Fourth Hospital of Hebei Medical University and Hebei Tumor Hospital, Shijiangzhuang, China
- Xu, Yan, The Affiliated Hospital of Qingdao University, Qingdao, Shandong, China
- Gao, Bi hu, The Affiliated Zhong-Shan Hospital of DaLian University, Dalian, China
- Li, Yanlin, Zhongshan hospital of Traditional Chinese Medicine, Zhongshan, China
- Wang, Yu, The First Affiliated Hospital of Nanchang University, Nanchang, China
Background
Chronic kidney disease-associated pruritus (CKD-aP) is a common and distressing condition that often presents in patients on hemodialysis(HD),which reduced quality of life and an increased risk of death.HSK21542 is a peripherally restricted and selective agonist of kappa opioid receptors that are considered to be important in treating CKD-aP. Here we reported the results from the phase 3 trial of HSK21542 in HD pts with CKD-aP (21542-302; NCT05135390).
Methods
In this double-blind, placebo-controlled, phase 3 trial, we randomly assigned patients undergoing hemodialysis who had moderate-to-severe pruritus to receive either intravenous HSK21542 (at a dose of 0.3 μg per kilogram of body weight) or placebo three times per week for 12 weeks. The primary outcome was the percentage of patients with an improvement (decrease) of at least 4 points from baseline at week 12 in the weekly mean score on the 24-hour Worst Itching Intensity Numerical Rating Scale (WI-NRS). The secondary outcomes included the percentage of patients with an improvement of at least 3 points in the WI-NRS score at week 12,the change from baseline in itch-related quality-of-life measures, and safety.
Results
A total of 545 patients underwent randomization. The percentage of patients with a decrease of at least 4 points in the WI-NRS score at week 12 was significantly greater in the HSK21542 group than in the placebo group (37.2% vs. 15.0%, P<0.001).The imputed percentage of patients with a decrease of at least 3 points in the WI-NRS score was 51.0% in the HSK21542 group, as compared with 24.2% in the placebo group (P<0.001). HSK21542 also resulted in a significant improvement from baseline to week 12 in itch-related quality of life as measured by the 5-D itch scale and the Skindex-10 scale. HSK21542 was generally safe and well tolerated throughout. Dizziness and hypotension were more common in the HSK21542 group than in the placebo group.
Conclusion
Patients treated with HSK21542 had a significant reduction in itch intensity and improved itch-related quality of life as compared with those who received placebo.
Funding
- Commercial Support – This study was funded by Haisco Pharmaceutical Group Co., Ltd.