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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
intravenous administration
oral administration
Pittsburgh Sleep Quality Index
Questionnaire survey
Time frame: Baseline, 4 weeks after medication
5D-itching scale
Questionnaire survey
Time frame: Baseline,2/4 weeks after medication
Skindex-10 scale
Questionnaire survey
Time frame: Baseline,1 /2 /3/ 4 weeks after medication
WI-NRS score
Questionnaire survey
Time frame: Baseline, every dialysis day during the treatment period
Kidney Disease Quality of Life instrument™ - 36 items
Questionnaire survey
Time frame: Baseline, 4 weeks after medication
Patient Global Impression of Change
Questionnaire survey
Time frame: 4 weeks after medication
Mechanical pain threshold
The electronic pressure sensor pain measurement method involves connecting a probe with a relatively thin tip to a force sensor. Based on the principle of Newton's third law, it records in real time the magnitude of the force applied by the probe to the pain measurement site. The pressure number at which the subject first feels pain is the pain threshold.
Time frame: Baseline, 4 weeks after medication
Peripheral blood metabolomics analysis
Peripheral blood samples will be analyzed using liquid chromatography/mass spectrometry.
Time frame: Baseline, 4 weeks after medication
Peripheral blood proteomics analysis
The proteins in blood will be digested with trypsin to obtain peptides. The peptides will be analyzed by liquid nanochromatography coupled to mass spectrometry. The identification of the proteins will be carried out using the UniProt Homo Sapiens database using the Proteome Discoverer software (ThermoFisher Scientific). All proteomic markers in capillary blood will be reported in arbitrary units as a relative unit of measurement.
Time frame: Baseline, 4 weeks after medication
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