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

This study adopts an open-label, randomized controlled design and enrolls patients with CKD-associated pruritus (CKD-aP) with a WI-NRS score ≥4. Participants are randomized to receive either anrikefon intravenous injection (0.3 μg/kg, three times per week) or nalfurafine orally disintegrating tablets administered orally (2.5 μg/day) for 4 weeks. The primary endpoint is the difference in sleep quality improvement assessed by the Pittsburgh Sleep Quality Index (PSQI). Secondary endpoints include Skindex-10, the 5-D Itch Scale, WI-NRS, KDQOL-36, Patient Global Impression of Change (PGIC), mechanical pain threshold, and serum proteomic analyses. Vital signs, laboratory parameters, and adverse events are monitored throughout the study to comprehensively evaluate the efficacy and safety of the two κ-opioid receptor agonist therapies.