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Randomized Controlled Trial
. 2023 Dec;45(1):2175590.
doi: 10.1080/0886022X.2023.2175590.

Randomized controlled trial of nalfurafine for refractory pruritus in hemodialysis patients

Ping Zhang  1   2   3   4   5 , Shilong Xiang  1   2   3   4   5 , Bicheng Liu  6 , Xiaohui Wang  7 , Xiaoping Yang  8 , Chaoyang Ye  9 , Zunsong Wang  10 , Yanlin Li  11 , Li Zhou  12 , Caili Wang  13 , Hongbo Li  14 , Jian Huang  15 , Ai Peng  16 , Xiaoping Wang  17 , Deguang Wang  18 , Jie Xiao  19 , Wenli Chen  20 , Hong Cheng  21 , Nan Mao  22 , Jianqin Wang  23 , Lin Yang  24 , Jianghua Chen  1   2   3   4   5
Affiliations
Randomized Controlled Trial

Randomized controlled trial of nalfurafine for refractory pruritus in hemodialysis patients

Ping Zhang et al. Ren Fail. 2023 Dec.

Abstract

Background: Chronic kidney disease-associated pruritus (CKD-aP) is very common and sometimes refractory to treatment in hemodialysis patients. In a trial conducted in Japan, nalfurafine, effectively reduced itching of treatment-resistant CKD-aP. Our present bridging study aimed to evaluate the efficacy and safety of nalfurafine in Chinese cohort with refractory CKD-aP.Methods: In this phase III, multicenter bridging study conducted at 22 sites in China, 141 Chinese cases with refractory CKD-aP were randomly (2:2:1) assigned to receive 5 μg, 2.5 μg of nalfurafine or a placebo orally for 14 days in a double-blind manner. The primary end point was the mean decrease in the mean visual analogue scale (VAS) from baseline.Results: A total of 141 patients were included. The primary endpoint analysis based on full analysis set (FAS), the difference of mean VAS decrease between 5 μg nalfurafine and placebo group was 11.37 mm (p = .041); the difference of mean VAS decrease between 2.5 μg and placebo group was 8.81 mm, but not statistically significantly different. Both differences were greater than 4.13 mm, which met its predefined success criterion of at least 50% efficacy of the key Japanese clinical trial. The per protocol set (PPS) analysis got similar results. The incidence of adverse drug reactions (ADRs) was 49.1% in 5μg, 38.6% in 2.5 μg and 33.3% in placebo group. The most common ADR was insomnia, seen in 21 of the 114 nalfurafine patients.Conclusions: Oral nalfurafine effectively reduced itching with few significant ADRs in Chinese hemodialysis patients with refractory pruritus.

Keywords: Nalfurafine; chronic kidney disease-associated pruritus; clinical trial; hemodialysis; kappa opioid receptor agonist; refractory.

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Conflict of interest statement

No potential conflict of interest was reported by the author(s).

Figures

Figure 1.
Figure 1.
Flow diagram of the progress through the randomized trial.
Figure 2.
Figure 2.
The trend of mean larger Shiratori’s severity score during the study period.
Figure 3.
Figure 3.
The trend of mean Shiratori’s severity score in evening during the study period.
See this image and copyright information in PMC

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