Efficacy of Nalfurafine for Chronic Kidney Disease-Associated Pruritus in Twice-Weekly Hemodialysis Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 36
- 主要终点
- Change from baseline in Visual Analog Scale (VAS) score for pruritus
研究概览
简要总结
This study evaluates the efficacy and safety of nalfurafine as a treatment for chronic kidney disease-associated pruritus (CKD-aP) in patients undergoing maintenance hemodialysis twice weekly.
Pruritus (severe itching) is a common and distressing symptom in patients with end-stage renal disease receiving hemodialysis, significantly impairing their quality of life. Nalfurafine is a selective kappa-opioid receptor agonist designed to reduce itching.
The main objective of this clinical trial is to evaluate whether nalfurafine effectively reduces itch intensity and improves symptom control compared to control, while monitoring for any adverse effects.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with chronic kidney disease-associated pruritus (CKD-aP) undergoing maintenance hemodialysis twice weekly for more than 6 months and in a hemodynamically stable condition.
- •Aged 18 to 65 years old and willing to participate in the study.
- •Received standard therapy for at least 2 weeks and met the moderate to severe pruritus criteria based on Visual Analog Scale (VAS) score and 5-D Pruritus Scale.
- •Able to understand and comply with the study instructions/protocol.
排除标准
- •Patients with active malignancy or active infection.
- •Patients with primary skin diseases, such as allergic dermatitis, irritant contact dermatitis, neurodermatitis, or psoriasis.
- •Patients with chronic liver disease or cholestatic disease.
- •Received phototherapy or acupuncture therapy within the last 1 week prior to study enrollment.
研究组 & 干预措施
Control Group
Patients in this arm receive matching placebo (or standard care) alongside standard hemodialysis care.
干预措施: plasebo (Drug)
Nalfurafine Group
Patients in this arm receive Nalfurafine therapy alongside standard hemodialysis care.
干预措施: Nalfurafine Hydrochloride (Drug)
结局指标
主要结局
Change from baseline in Visual Analog Scale (VAS) score for pruritus
时间窗: Baseline, Week 1, Week 2, Week 3, and Week 4
Pruritus intensity measured using a Visual Analog Scale (VAS) ranging from 0 to 10 (or 0 to 100 mm), where 0 represents no itch and 10 (or 100) represents the worst imaginable itch. Lower scores indicate reduction in itch severity.
次要结局
未报告次要终点
研究者
Ayu Cahya Andhayani
Internist
Indonesia University