NCT07650851尚未招募不适用
Clinical Study on the Efficacy and Safety of Nalfurafine Hydrochloride Orally Disintegrating Tablets in Treating Pruritus in Patients Undergoing Maintenance Hemodialysis
Chinese PLA General Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2026年7月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change in Visual Analogue Scale (VAS) from baseline
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •The number of days during which VAS values are measured at both wake-up and bedtime in the baseline period must be no less than 5 days, and the average value of the larger VAS values in morning and evening measurements must not be less than 50 mm.
- •The number of days evaluated for the severity of itching in Xie Chuandao during the baseline period must be no less than 5 days at both wake-up and bedtime.
排除标准
- •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.
- •Severe cardiovascular disease patients: those who have been screened for NYHA class III or IV, acute myocardial infarction, unstable angina, large pericardial effusion, severe arrhythmia, or abnormal electrocardiogram within the previous 6 months and are deemed unsuitable for inclusion by the researchers.
- •Screening for individuals who have been in the active stage of malignant tumors within the previous 12 months, or have received radiotherapy, chemotherapy, targeted therapy, and immunotherapy during this period.
- •There are uncontrollable or drug-induced fungal, bacterial, viral, or other infections, including tuberculosis patients undergoing anti tuberculosis treatment, patients known to be infected with human immunodeficiency virus (HIV), etc.
- •Hypertensive patients who cannot achieve good control with drug therapy: systolic blood pressure ≥ 180mmHg, or diastolic blood pressure ≥ 110mmHg.
- •Patients who are currently using glucocorticoids and immunosuppressants.
- •Patients with mental illness or cognitive impairment who are unable to correctly understand VAS scores and describe their own feelings.
- •Received or adjusted antihistamines, systemic or local corticosteroids (excluding ear or eye preparations), calcineurin inhibitors, gabapentin, pregabalin, and other restricted combination drugs within 7 days prior to screening, or expected to change their treatment regimen during the study period.
- •Started receiving or adjusting drugs that may affect the assessment of itch relief efficacy within 2 weeks prior to screening, including but not limited to antipsychotics, sedatives, selective serotonin reuptake inhibitors (SSRIs), anxiolytics, or tricyclic antidepressants, or expected to change their treatment regimen during the study period.
- •Individuals with a history of drug abuse, drug dependence, or alcohol abuse within the past 12 months prior to screening.
- •Select patients who have received phototherapy for pruritus within the previous month.
- •Individuals who have used opioid receptor agonists or antagonists within the past 2 weeks prior to screening.
- •Individuals with a known history of allergy to opioid drugs, or those who are allergic to test drug excipients.
- •Individuals who have participated in other clinical studies and used the investigational drug or medical device within the 28 days prior to screening, or whose investigational drug is within 5 half lives prior to screening.
- •Pregnant women, breastfeeding women, patients with positive pregnancy tests, or those who do not agree to use contraception during the study period.
- •Other patients deemed unsuitable by researchers to participate in this clinical study.
研究组 & 干预措施
Basic treatment
Other
干预措施: Basic treatment (Other)
Nalfurafine
Experimental
The experimental group took nalfurafine hydrochloride orally disintegrating tablets at a dose of 2.5μg (1 tablet) once daily for 12 consecutive weeks.
干预措施: Nalfurafine Hydrochloride (Drug)
结局指标
主要结局
Change in Visual Analogue Scale (VAS) from baseline
时间窗: Change from baseline at 12 weeks
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
次要结局
- Change in average VAS value from baseline across each evaluation period(Changes from baseline at weeks 1, 2, 4, 8, 12 of drug administration and during the follow-up period (1 week after the end of drug administration))
- Change in itch score based on the Xie-Kawashima Itch Severity Assessment compared to baseline(Change from baseline at 12 weeks)
- The change in itch score from baseline for the Xie-Kawashima Itch Severity Assessment during each evaluation period(Changes from baseline at weeks 1, 2, 4, 8, 12 of drug administration and during the follow-up period (1 week after the end of drug administration))
- Improvement degree of VAS(Change from baseline at 12 weeks)
- Skin Disease Quality of Life Scale (Skindrex-16)(Change from baseline at 12 weeks)
- Improved sleep quality(Change from baseline at 12 weeks)
- Serum endorphin levels(Change from baseline at day 29, day 57, and day 85.)
- Serum dynorphin levels(Change from baseline at day 29, day 57, and day 85.)
- Kidney Disease Quality of Life Scale (KDQOL-36)(Change from baseline at 12 weeks)
研究者
Chen Xiangmei
Principal Investigator
Chinese PLA General Hospital
研究点 (1)
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