This is a randomized, open-label, multi-center clinical study aimed at evaluating the efficacy and safety of 12 weeks of nalfurafine hydrochloride administration in the treatment of pruritus in patients undergoing maintenance hemodialysis.
Age range of 18-80 years old (including both ends), male or female not limited.
Chronic renal failure patients who undergo stable dialysis for 3 months or more, receive regular hemodialysis 3 times a week, and are expected to have no significant changes in treatment or rapid changes in their condition during the clinical trial period.
Within one year prior to signing the informed consent form, the effectiveness of itch treatment (including topical medications such as moisturizers/moisturizers, systemic medications such as antihistamines or antiepileptic drugs, and non pharmacological treatments) was not satisfactory.
Those who are able to understand and comply with the research procedures and methods, voluntarily participate in this study, and sign a written informed consent form.
Given poor compliance with dialysis treatment, researchers believe that it may affect the effectiveness and safety of clinical studies.
Patients who plan to undergo kidney transplantation or other elective surgeries during the study period.
Patients with alanine aminotransferase (ALT), aspartate aminotransferase (AST), or glutamine transferase (GGT) levels exceeding the upper limit of normal (ULN) by 2 times, or total bilirubin levels exceeding the upper limit of normal (ULN) by 2 times during the screening period.
Skin itching is not caused by chronic kidney disease, including allergic skin diseases (atopic dermatitis, urticaria, eczema, drug rash, etc.), physical skin diseases (prickly heat, solar rash, etc.), infectious skin diseases (insect bite dermatitis, chickenpox, measles, pyoderma, tinea corporis, etc.), cholestatic liver disease, etc.
Parallel
Nalfurafine Hydrochloride
DrugNalfurafine hydrochloride orally disintegrating tablets will be took at a dose of 2.5μg (1 tablet) once daily for 12 consecutive weeks.
Basic treatment
Other interventionIf any itching treatment medication is being received on the day of the screening period, the itching treatment medication (prescription drugs, over-the-counter drugs, moisturizers, etc. with itching as the indication, see the allowed medication list for details) will continue to be used as the basic treatment during the subsequent itching evaluation period. If no itching treatment medication is received by the start of the screening period, no other itching treatment medication will be used as the baseline treatment during the itch evaluation period of the study.
Change in Visual Analogue Scale (VAS) from baseline
Visual Analog Scale (VAS) is a scale that allows patients to indicate their level of itching on a 10cm scale. The larger the value, the higher the level of itching
Change in average VAS value from baseline across each evaluation period
Visual Analog Scale (VAS) is a scale that allows patients to indicate their level of itching on a 10cm scale. The larger the value, the higher the level of itching
Change in itch score based on the Xie-Kawashima Itch Severity Assessment compared to baseline
Xie-Kawashima Itch Severity Assessment evaluates the severity of itching, scratching behavior, and impact on sleep in patients during both daytime and nighttime. The total score is 0-10 points, with 0-4 points indicating "almost no itching" to "unbearable itching", 4-7 points indicating moderate itching, and 7-10 points indicating severe itching.
The change in itch score from baseline for the Xie-Kawashima Itch Severity Assessment during each evaluation period
Xie-Kawashima Itch Severity Assessment evaluates the severity of itching, scratching behavior, and impact on sleep in patients during both daytime and nighttime. The total score is 0-10 points, with 0-4 points indicating "almost no itching" to "unbearable itching", 4-7 points indicating moderate itching, and 7-10 points indicating severe itching.
Improvement degree of VAS
Visual Analog Scale (VAS) is a scale that allows patients to indicate their level of itching on a 10cm scale. The larger the value, the higher the level of itching
Adverse events and serious adverse events
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Chinese PLA General Hospital
Lead sponsor
The First Affiliated Hospital of Dalian Medical University
Collaborator
Beijing Friendship Hospital
Collaborator
The General Hospital of Northern Theater Command
Collaborator
Tianjin First Central Hospital
Collaborator
RenJi Hospital
Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Collaborator
Xiangyang Central Hospital
Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborator
Jiangsu Taizhou People's Hospital
Collaborator
Qilu Hospital of Shandong University
Collaborator
First Affiliated Hospital Xi'an Jiaotong University
Collaborator
Zigong No.1 Peoples Hospital
Collaborator
Chengdu First People's Hospital
Collaborator
The People's Hospital of Leshan
Collaborator
The Third Affiliated Hospital of Wenzhou Medical University
Collaborator
Henan Provincial People's Hospital
Collaborator
Shanghai Changzheng Hospital
Collaborator
Daping Hospital of Army Medical University
Collaborator
First Affiliated Hospital of Wannan Medical College
Collaborator
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