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

NCT07380113 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-08-25

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Anrikefon

intravenous administration

DRUG

Nalfurafine

oral administration

Sponsors & Collaborators

  • Zhujiang Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-22
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07380113 on ClinicalTrials.gov