NCT02084381已完成不适用
Permeability Enhancement to Reduce Chronic Inflammation _ Medium Cut Off (MCO) (Study no 1502)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- TNF-alpha mRNA
研究概览
简要总结
The medium cut-off dialysis membrane has been developed to provide a significantly extended molecular cut-off compared to conventional high-flux membranes. The medium cut-off membrane allows for a high permeability of molecules up to a molecular weight of 45 kDa and has a still limited permeability for albumin (68 kDa).
The main goal of this project is the evaluation of the new, highly porous and selective dialysis membrane (MCO-Ci 400) for the treatment of patients with end-stage renal disease in hemodialysis mode and to study its potential to improve chronic inflammation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CKD5 ( GFR < 15ml/min/ 1.73m2)
- •Dialysis treatment for ≥ 3 months
- •Dialysis 3x weekly
- •Vascular access by fistula or CVC
- •Age > 18 and < 99 Years
- •Ability to give written informed consent
排除标准
- •Missing informed consent form
- •current clinically manifested infection or within the last two weeks
- •current CRP-value > 50mg/L or within the last two weeks
- •Intake of any medication applied for immunosuppressive purposes
- •Pregnancy or lactation
- •Participation in a different interventional study
结局指标
主要结局
TNF-alpha mRNA
时间窗: 4 weeks treatment time
Significant lower pre- dialytic TNF-α mRNA expression level in circulating peripheral blood mononuclear cells
次要结局
- safety related events(6 month)
研究者
研究点 (4)
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