A Phase II Clinical Study of MR13A9 in Hemodialysis Patients With Pruritus.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 247
- 试验地点
- 1
- 主要终点
- Change From Baseline in the Mean NRS Score at Week 8 of the Treatment Period
研究概览
简要总结
Double-blind, Placebo-controlled study to evaluate the dose-response relationship of safety, efficacy and pharmacokinetics of MA13A9 in hemodialysis patients with 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Japanese with male or female aged ≥ 20
- •Patient with Chronic Kidney Disease (CKD) has been on hemodialysis 3 times per week
- •Patient receiving treatment for itch
- •Patient has a baseline NRS score > 4
排除标准
- •Patient has pruritus cause other than CKD or its complications
- •Patients has hepatic cirrhosis
- •Patient has a known history of allergic reaction to opiates
研究组 & 干预措施
MR13A9 low dose
干预措施: MR13A9 (Drug)
MR13A9 medium dose
干预措施: MR13A9 (Drug)
MR13A9 high dose
干预措施: MR13A9 (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in the Mean NRS Score at Week 8 of the Treatment Period
时间窗: 8 weeks
The primary analysis was performed using an MMRM with change from baseline in the mean NRS score at each time point as an objective variable; treatment group, time point, and treatment group-by-time point interaction as fixed effects; baseline mean NRS score and dynamic allocation factors, presence of prior treatment with nalfurafine hydrochloride, and presence of specific signs or symptoms to be confirmed in the screening period, as covariates; and subject as a random effect. Looking back on the period between the time of awakening on the previous day of assessment and the time of awakening on the day of assessment (including sleeping hours) once daily, subjects will assess the NRS score for the most severe itching by themselves. The most severe itching within the day will be assessed in integer on a scale ranging from 0 to 10, where 0 represents no itching and 10 represents worst itching imaginable.
次要结局
未报告次要终点