A Phase III Clinical Study of MR13A9 in Hemodialysis Patients With Pruritus
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 178
- 试验地点
- 1
- 主要终点
- Change From Baseline in the Mean NRS Score at Week 4
研究概览
简要总结
Double-blind, Placebo-controlled study to confirm the superiority of MR13A9 to placebo, and followed by extension, open-label treatment to confirm long-term safety 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •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/MR13A9
Patients are administered MR13A9 for 6 weeks (double-blind period), followed by MR13A9 for 52 weeks (open-label period).
干预措施: MR13A9 (Drug)
Placebo/MR13A9
Patients are administered Placebo for 6 weeks (double-blind period), followed by MR13A9 for 52 weeks (open-label period).
干预措施: MR13A9 (Drug)
Placebo/MR13A9
Patients are administered Placebo for 6 weeks (double-blind period), followed by MR13A9 for 52 weeks (open-label period).
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in the Mean NRS Score at Week 4
时间窗: 4 weeks
The change from baseline in the mean NRS score at each time point was calculated using an MMRM with the change from baseline in the mean NRS score at each time point as an objective variable, group, time point, and group-by-time point interaction as fixed effects, mean NRS score at baseline and presence or absence of prior treatment with nalfurafine hydrochloride as dynamic allocation factors as a covariate, and subjects as a random effect for data up to Week 4 of the double-blind period in FAS. 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