Anrikefon vs Nalfurafine for Sleep Quality in Hemodialysis Patients With CKD-aP

Summary

The goal of this clinical trial is to compare a new intravenous drug, Anruikefen, with a traditional oral medication, nalfurafine orally disintegrating tablets, in improving sleep quality in patients with chronic kidney disease-associated pruritus. Sleep quality will be primarily assessed using the Pittsburgh Sleep Quality Index (PSQI). The study will also evaluate the safety of Anruikefen. The main questions it aims to answer are: * Does Anruikefen injection improve sleep quality better than oral nalfurafine? * Does Anruikefen injection improve patients' quality of life more than oral nalfurafine? Researchers will compare Anruikefen with nalfurafine (an active control drug) to evaluate differences in their effects on sleep quality in patients with chronic kidney disease-associated pruritus. Participants will: * Receive either Anruikefen injection (0.3 μg/kg, three times per week) or nalfurafine hydrochloride orally disintegrating tablets (2.5 μg once daily). * Continue treatment for 4 weeks, followed by a 1-week safety follow-up. * Complete the Pittsburgh Sleep Quality Index and other quality-of-life questionnaires after one month.

Timeline

Start

2026-07-01

Primary completion

2027-12-31

Completion

2027-12-31

Drugs

Indications