Analysis of the efficacy and safety of nalfurafine hydrochloride for treating chronic kidney disease-associated pruritus in hemodialysis patients

 

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https://storage.unitedwebnetwork.com/files/1099/45facb92cb8b7145312a3d41042815a6.pdf
Analysis of the efficacy and safety of nalfurafine hydrochloride for treating chronic kidney disease-associated pruritus in hemodialysis patients

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Nan
Zhu
Nan Zhu 527564010@qq.com The First Affiliated Hospital of Zhengzhou University Blood Purification Center Zhengzhou China *
Xianhui Liang fccliangxh@zzu.edu.cn The First Affiliated Hospital of Zhengzhou University Blood Purification Center Zhengzhou China -
Xin Wang zzzzzxsw@163.com The First Affiliated Hospital of Zhengzhou University Blood Purification Center Zhengzhou China -
Lili Yang 912145844@qq.com The First Affiliated Hospital of Zhengzhou University Blood Purification Center Zhengzhou China -
Fangxing Zhang zfx52165656@163.com The First Affiliated Hospital of Zhengzhou University Blood Purification Center Zhengzhou China -
Dengke Jiang 18039673216@163.com The First Affiliated Hospital of Zhengzhou University Blood Purification Center Zhengzhou China -
Pei Wang wangpei146@hotmail.com The First Affiliated Hospital of Zhengzhou University Blood Purification Center Zhengzhou China -
 
 
 
 
 
 
 
 

To analyze the efficacy and safety of nalfurafine hydrochloride in treating chronic kidney disease-associated pruritus (CKD-aP) in hemodialysis (HD) patients. 

This study adopted a multicenter, single-arm, self-controlled before-after design. Patients with CKD-aP undergoing HD at 13 blood purification centers, including The First Affiliated Hospital of Zhengzhou University, from December 2024 to May 2025 were enrolled. All subjects received nalfurafine hydrochloride orally disintegrating tablets (2.5 μg qd) for 14 days, followed by a 14-day follow-up without the medication. The severity of pruritus was assessed daily using the visual analogue scale (VAS), and the treatment efficacy was also evaluated by the VAS scores. Adverse events were closely monitored. Paired t-tests were performed to compare the daily VAS scores during treatment with baseline, and Kaplan–Meier analysis was used to assess the time to onset of efficacy. Furthermore, univariate and multivariate ordered logistic regression were used to explore factors associated with therapeutic efficacy. 

A total of 61 HD patients were enrolled in this study, including 38 males (62.30%), aged 62.07±12.29 years, with a dialysis vintage of 64.18±40.31 months. At baseline, 14 patients (22.95%) had moderate, 22 patients (36.07%) had severe, and 25 patients (40.98%) had extremely severe pruritus. During treatment, the VAS scores decreased most significantly in the first week (64.90±14.43mm vs 83.72±13.98mm, P <0.001). Although slight fluctuations occurred in the second week, VAS scores remained significantly lower than baseline (55.88±16.64 vs 83.72±13.98mm, P<0.001). The overall response rate reached 68.33% after 14 days of treatment, and the median time to onset of effect was 4 days. The incidence of adverse events was 9.84%. Multivariate ordered logistic regression analysis indicated that the frequency of hemodiafiltration was an independent factor associated with the antipruritic efficacy of nalfurafine hydrochloride(OR=0.24, 95%CI 0.06~0.90, P=0.035). Figure 1. Daily Visual Analogue Scale (VAS) scores (mean ± SEM) of patients during baseline and treatment periods with nalfurafine hydrochloride.Figure 2: Daily VAS Improvement Degree of Patients During Nalfurafine Hydrochloride TreatmentFigure 3: Distribution of Efficacy by Pruritus Severity

Nalfurafine hydrochloride effectively relieves pruritus symptoms in HD patients and has a good safety profile.

Kewords