NCT05525234Unknown4 期
A Prospective, Randomized, Double-blind, Placebo-controlled Study of Thalidomide in the Treatment of Refractory Uremic Pruritus
适应症
干预措施
试验速览
- 阶段
- 4 期
- 入组人数
- 40
- 主要终点
- Pruritus score
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of thalidomide in the treatment of refractory uremic pruritus in maintenance hemodialysis patients.
详细描述
A prospective, randomized, double-blind, placebo-controlled study was conducted to explore the efficacy and safety of thalidomide in the treatment of refractory urmia pruritus.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Maintenance hemodialysis patients (≥3 month), 3 times/week, 4 hours/session
- •spKT/V≥1.2
- •The diagnosis was refractory urmia pruritus and pruritus score ≥8 score
- •Patients with sleep disorders need to stop sleeping pills
- •Be able to complete the form by yourself or with the help of others
- •Informed consent
排除标准
- •Participants in other clinical trials within 1 month
- •People with thalidomide allergy
- •Accompanied by severe calcium and phosphorus metabolism disorder (serum calcium≥3.0mmol/L or Serum phosphorus≥2.8mmol/L or Serum iPTH≥800pg/mL)
- •Patients with other medical conditions that cause itchy skin
- •With severe systemic infection, severe anemia and other serious complications
- •Patients with peripheral neuropathy
- •Other serious systemic diseases include systemic lupus erythematosus, multiple myeloma, thrombotic microangiopathy, and extensive metastasis of malignant tumors
- •Patients with a history of thromboembolism were excluded from PICC-induced thrombosis
- •Pregnant woman
研究组 & 干预措施
Thalidomide group
Experimental
Thalidomide tablets, 50mg/day, increase or decrease dose according to itch score. The maximum dose is 100mg/day.
干预措施: Thalidomide (Drug)
Placebo group
Placebo Comparator
Palacebo tablets, 50mg/day, increase or decrease dose according to itch score. The maximum dose is 100mg/day.
干预措施: Placebo (Drug)
结局指标
主要结局
Pruritus score
时间窗: 12 weeks
Comparison of pruritus score between treatment group and control group at 12 weeks
次要结局
- Pittsburgh sleep quality score(12 weeks)
- Efficacy index and response rate(12 weeks)
研究者
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