NCT07380113

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

An Exploratory Study Comparing Anrikefon With Nalfurafine in Improving Sleep Quality Among CKD-aP Patients Undergoing Hemodialysis: An Open-Label Randomized Controlled Clinical Trial

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Zhujiang Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Pruritus Chronic
• Kidney Diseases, Chronic
• Renal Insufficiency, Chronic
• Uremia; Chronic
• Pruritus Due to Systemic Disorder (Disorder)
• Pruritus Due to Hemodialysis

Interventions

Type	Name	Description
DRUG	Anrikefon	intravenous administration
DRUG	Nalfurafine	oral administration

Timeline

• Start date: 2026-02-01
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2026-02-02
• Last updated: 2026-02-02