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.