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Randomized controlled trial of nalfurafine for refractory pruritus in hemodialysis patients.

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.

SUBMITTER: Zhang P

PROVIDER: S-EPMC9980412 | biostudies-literature | 2023 Dec

REPOSITORIES: biostudies-literature

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Randomized controlled trial of nalfurafine for refractory pruritus in hemodialysis patients.

Zhang Ping P Xiang Shilong S Liu Bicheng B Wang Xiaohui X Yang Xiaoping X Ye Chaoyang C Wang Zunsong Z Li Yanlin Y Zhou Li L Wang Caili C Li Hongbo H Huang Jian J Peng Ai A Wang Xiaoping X Wang Deguang D Xiao Jie J Chen Wenli W Cheng Hong H Mao Nan N Wang Jianqin J Yang Lin L Chen Jianghua J

Renal failure 20231201 1

<b>Background:</b> 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.<b>Methods:</b> In this phase III, multicenter bridging study conducted at 22 sites in China, 141 Chinese cases with refra ...[more]

PMID: 36856148

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Project description:ImportancePatients with pruritus receiving hemodialysis frequently experience oppressive physical and psychiatric symptoms that directly affect their quality of life and increase mortality. However, treatment options are limited.ObjectiveTo determine the clinically recommended dose of difelikefalin, a κ-opioid receptor agonist, based on the efficacy, dose response, safety, and pharmacokinetics.Design, setting, and participantsThis randomized, double-blind, placebo-controlled, 4-arm phase 2 trial was conducted from February 1, 2019, to October 22, 2019, at 94 sites in Japan. Patients with moderate to severe pruritus receiving hemodialysis were enrolled.InterventionsDifelikefalin (0.25, 0.5, and 1.0 μg/kg) and placebo were intravenously administered 3 times a week at the end of each hemodialysis session for 8 weeks.Main outcome and measuresThe primary end point was the change from baseline in the weekly mean Worst Itching Intensity Numerical Rating Scale (NRS) score at week 8. Secondary outcomes measured changes in itch-related quality-of-life score using the Skindex-16 and 5-D itch scale. Safety was assessed according to adverse events, laboratory tests, vital signs, body weight, and 12-lead electrocardiogram.ResultsA total of 247 Japanese patients (186 male [75%]; mean [SD] age, 64.5 [11.7] years) were randomized to placebo (n = 63), 0.25 μg/kg of difelikefalin (n = 61), 0.5 μg/kg of difelikefalin (n = 61), or 1.0 μg/kg of difelikefalin (n = 62). The changes from baseline in the adjusted mean (SE) of the 24-hour Worst Itching Intensity NRS score at week 8 were -2.86 (0.29) in the placebo group, -2.97 (0.29) in the 0.25 μg/kg of difelikefalin group, -3.65 (0.30) in the 0.5 μg/kg of difelikefalin group, and -3.64 (0.30) in the 1.0 μg/kg of difelikefalin group. Significant differences were found in the 0.5 μg/kg of difelikefalin group (adjusted mean difference, -0.80; 95% CI, -1.55 to -0.04; P = .04) and the 1.0 μg/kg of difelikefalin group (adjusted mean difference, -0.78; 95% CI, -1.54 to -0.03; P = .04) compared with placebo. The Skindex-16 overall score and 5-D itch scale total score indicated an improvement with treatment with 0.5 and 1.0 μg/kg of difelikefalin (adjusted weekly mean [SE] Skindex-16 overall score at week 8, -27.79 [2.05]; 95% CI, -31.83 to -23.74 for 0.5 μg/kg of difelikefalin and -22.69 [2.04]; 95% CI, -26.71 to -18.68 for 1.0 μg/kg of difelikefalin; adjusted weekly mean [SE] 5-D itch scale total score at week 8, -6.5 [0.4]; 95% CI, -7.2 to -5.8 for 0.5 μg/kg of difelikefalin and -6.8 [0.3]; 95% CI, -7.5 to -6.2 for 1.0 μg/kg of difelikefalin). The incidence of adverse events was 67% (42 of 63 patients) in the placebo group, 72% (44 of 61 patients) in the 0.25 μg/kg of difelikefalin group, 77% (47 of 61 patients) in the 0.5 μg/kg of difelikefalin group, and 85% (53 of 62 patients) in the 1.0 μg/kg of difelikefalin group. No dependency was reported.Conclusions and relevanceThe findings of this phase 2 randomized clinical trial of difelikefalin suggest that 0.5 μg/kg of difelikefalin should be the clinically recommended dose as a new option for treating moderate to severe pruritus in patients undergoing hemodialysis because of its efficacy, acceptable tolerability, and manageable safety profile.Trial registrationClinicalTrials.gov Identifier: NCT03802617.

Project description:BackgroundHemodialysis is one of the common therapies in patients with end-stage renal disease. Even patients who receive regular treatment suffer from fatigue, which is one of the main factors leading to poor quality of life. This study aimed to determine the effectiveness of exercising on mini-bikes on fatigue in hemodialysis patients.MethodsThis study is a randomized controlled clinical trial. Thirty-seven hemodialysis patients participated in the study. The patients were randomly allocated to either the intervention group (n = 20) or the control group (n = 17). The participants in the intervention group exercised on mini-bikes for 20 min twice a week for 3 months. The patients' fatigue was measured four times during and after the intervention. Multidimensional Fatigue Inventory was used to measure the fatigue level. The total score in the MFI is 4 to 20 for each domain, with the resulting total fatigue score ranging from 20 to 100; thus, the higher the score, the higher the level of fatigue. Data were analyzed by SPSS 18. The repeated measures ANOVA was used to compare the fatigue scores within each group and between the groups at different times.ResultsThe mean score of fatigue in the intervention group at the beginning was 58.80 ± 15.29, which steadily decreased to 58.78 ± 13.54, 58.75 ± 14.73, 54.20 ± 15.16, and 54.23 ± 13.60 for the 3 months of intervention and 1 month post-intervention, respectively. In contrast, in the control group, this score was 62.53 ± 16.32 in the beginning, increasing to 64.03 ± 13.91, 64.22 ± 13.07, 69.53 ± 9.22, for the 3 months of intervention and 70.34 ± 7.69 one-month post-intervention. There were significant differences between the intervention group and the control group in the third month (P = 0.001) and 1 month after the intervention (P < 0.001).ConclusionsThe results showed that rehabilitation through exercising using mini-bikes had a significant impact on preventing further fatigue build-up in hemodialysis patients, making the mini-bike an effective non-pharmaceutical intervention preventing the increase in fatigue experienced by patients undergoing hemodialysis.Trial registrationIranian Registry of Clinical Trials: IRCT20180314039100N1. Registered 10 June 2018.

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Randomized controlled trial of nalfurafine for refractory pruritus in hemodialysis patients.

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Randomized controlled trial of nalfurafine for refractory pruritus in hemodialysis patients.

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