Safety and Efficacy of PG102P for the coNtrol of prUritus in Patients underGoing Hemodialysis (SNUG Trial): Study Protocol for a Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- VAS change from baseline
研究概览
简要总结
In this study (SNUG trial), the investigators aim to investigate the anti-pruritic effect of PG102P in comparison with placebo in 80 patients undergoing HD.
详细描述
This is a multicenter, randomized, double-blind, placebo-controlled trial in which one group will be treated with PG102P (1.5 g/day) and the other with a placebo. It is an investigator-initiated clinical trial. A superiority trial is planned to test the hypothesis that PG102P is effective in relieving pruritus for patients with ESRD undergoing HD.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 19 years
- •Patients with adequate HD (Kt/V > 1.2)
- •Maintenance patients undergoing HD with chronic pruritus
- •Mean visual analog scale (VAS) over 4 of the last 5 days in the 14-day pre-observation period
- •Participants who allowed to continue the anti-pruritic drug treatment at the same dosage and administration schedule as used at baseline throughout the study period
- •Patients who agreed to participate in this trial and had written an informed consent
排除标准
- •Intact parathyroid hormone (iPTH) > 1000 pg/mL within 1 month
- •Serum potassium > 7.0 mg/dL
- •Aspartate transaminase (AST) (glutamic oxaloacetic transaminase) or alanine transaminase (ALT) (glutamic pyruvic transaminase) > 3 times the upper limit of normal
- •Scheduled to have kidney transplantation within 3 months
- •Cancer history with current treatment
- •Active infection with current treatment
- •Current itching with dermatologic diseases other than uremic pruritus
- •Pregnancy, childbearing potential during the study period, or breastfeeding
- •Allergy or hypersensitivity reaction to PG102P
- •History of participating another clinical trial within 2 months or planning to participate another clinical trial
- •Not eligible to participate this trial as researchers' decision
研究组 & 干预措施
a treatment group
PG102P 1.5 g/day
干预措施: PG102P (Drug)
a control group
placebo
干预措施: Placebo (Drug)
结局指标
主要结局
VAS change from baseline
时间窗: the change in VAS between visit 2 (week 0) and visits 3, 4, 5, and 6 (weeks 2, 4, 8, 10)
The primary endpoint is the change in VAS
次要结局
- serum total IgE(week 0, week 8)
- serum ECP(week 0, week 8)
- serum P(week 0, week 8)
- serum iPTH(week 0, week 8)
- Questionnaire #2 (BDI, Beck's Depression Inventory)(week 0, week 8)
- serum Ca(week 0, week 8)
- serum K(week 0, week 8)
- blood Eosinophil count(week 0, week 8)
- Questionnaire #1 (KDQOL, Kidney Disease and Quality of Life)(week 0, week 8)
- serum IL-31(week 0, week 8)
研究者
Chun Soo Lim
Professor
Seoul National University Boramae Hospital