Clinical Trial

Efficacy and Safety of Nalfurafine Hydrochloride ODT for Moderate-to-Severe Pruritus in Patients on Peritoneal Dialysis

Study acronym: KARE-PD
Recruiting
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Record status
This record was last updated September 3, 2025 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.
Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-07-25.
Status change: Not Yet Recruiting → Recruiting 2025-08-26
Trial Details
NCT Number NCT07098351
Lead Sponsor Guangdong Provincial People's Hospital
Conditions Adverse Event, Peritoneal Dialysis, Moderate-to-severe Pruritus, Chronic Kidney Disease-associated Itch
Enrollment 93 participants
Start Date 2025-08-07
Primary Completion 2026-06-30 (estimated)
Study Completion 2026-06-30 (estimated)
Updated on ClinicalTrials.gov 2025-09-03