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

Study acronym: Anrikefon
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Recruitment opened Study sites: 0 to 1 · Start date changed from estimate of Jul 1, 2026 to Jun 22, 2026v4 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Jul 1, 2026 to Jun 22, 2026
  2. Start date: May 1, 2026 to Jul 1, 2026v3
  3. Start date: Feb 1, 2026 to May 1, 2026 Eligibility criteria expanded, about 53 wordsv2 Show 1 more changeShow less
    • Eligibility criteria expanded, about 53 words

    See this version in full on ClinicalTrials.gov ↗

  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07380113
Lead Sponsor Zhujiang Hospital
Conditions Pruritus Chronic, Kidney Diseases, Chronic, Renal Insufficiency, Chronic, Uremia; Chronic, Pruritus Due to Systemic Disorder (Disorder), Pruritus Due to Hemodialysis
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov