Moderate to severe pruritus significantly impairs the quality of life in peritoneal dialysis patients, and effective treatment options remain limited. κ-opioid receptor agonists may alleviate itching by modulating neural signaling pathways. This study is a multicenter, prospective, single-arm clinical trial, planning to enroll 93 patients. It aims to test the hypothesis that nalfurafine hydrochloride orally disintegrating tablets compared to baseline, with acceptable safety.
Aged 18-85 years (inclusive), regardless of gender.
Chronic renal failure patients on regular peritoneal dialysis for ≥3 months, with no anticipated major treatment changes or rapid disease progression during the trial.
Able to understand and comply with study procedures, voluntarily participate, and provide written informed consent.
During the baseline period, ≥5 days with both morning and evening VAS scores recorded, and the average of the higher VAS values (morning/evening) ≥50 mm.
Poor dialysis compliance, deemed by the investigator to affect efficacy/safety assessments.
Poor dialysis compliance, deemed by the investigator to affect efficacy/safety assessments.
Peritoneal dialysis regimen adjusted within 2 weeks prior to screening.
Currently on or planning hemodialysis within 2 months.
Single group
Remitch
DrugNalfurafine 2.5μg daily for 2 weeks. Afterwards, the dose can be increased to 5μg daily if necessary (maximum dose not exceeding 5μg daily), continued for another 2 weeks.
Change in Visual Analog Scale (VAS) score for Itch from baseline to Week4 of treatment period
Calculation: Change = (Average of daily maximum VAS scores during baseline period) - (Average of daily maximum VAS scores during the 4th week of treatment period). Only dates with both daytime and nighttime VAS recordings were included in the assessment. Daily maximum VAS score: Defined as the higher value between the VAS measured at waking and bedtime each day. VAS scores range from 0 to 10 points.0 = "No itch" ,10 = "Worst itch". Higher scores indicate worse itch severity.
Change in Visual Analog Scale(VAS) for Itch scores at Weeks 1, 2, 4 of treatment and follow-up period
Change from baseline in daily maximum Visual Analog Scale for Itch (VAS) scores at each assessment time point (Weeks 1, 2, 4 of treatment and follow-up period).VAS scores range from 0 to 10 points.0 = "No itch" ,10 = "Worst itch". Higher scores indicate worse itch severity.
Change in Xie-Kawashima Itch Scale scores
Change from baseline in daily maximum Xie-Kawashima Itch Scale scores at each assessment time point (Weeks 1, 2, 4 of treatment and follow-up period). Xie-Kawashima Itch Scale scores range from 0 to 4 points.0 = "No itch" ,4 = "Worst itch". Higher scores indicate worse itch severity.
The degree of change in Visual Analog Scale (VAS) scores from Baseline to Week 2,4 of treatment period
Change of itch intensity,assessed by the Visual Analog Scale for Itch from baseline to Week 2,4 of treatment period. Calculated as: average of baseline VAS score minus average of VAS score during Week 2,4 of treatment period. Response Criteria: Clinically Significant Improvement:Mean VAS score \< 20 mm during treatment period OR reduction ≥40 mm from baseline Improvement:Reduction ≥20 mm but \<40 mm from baseline (excluding Clinically Significant Improvement) No Clinically Meaningful Improvement:Neither Category 1 nor Category 2 criteria met.
Change in Health-Related Quality of Life Scores
Kidney Disease Quality of Life-36 (KDQOL-36) Scale score Range: 36-185 points.Higher scores indicate better quality of life. Skindex-16 Dermatology Life Quality Index Scale score Range: 0-96 points.Higher scores indicate worse quality of life.
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