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临床试验/NCT00735059
NCT00735059已完成不适用

Test of the Nipro ELISIO H Dialyzer in Different Dialysis Treatment Procedures

EXcorLab GmbH2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2008年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
EXcorLab GmbH
入组人数
14
试验地点
2
主要终点
protein-bound toxin removal

研究概览

简要总结

A current trend in dialysis membrane engineering is to maximize the permeability for larger low-molecular weight proteins while retaining albumin. Protein-leaking dialysis membranes do not meet these requirements. Particularly in convective procedures, such as hemodiafiltration, their albumin leakage is too high [10]. POLYNEPHRON™, the membrane which is built in to the new Nipro ELISIO® dialyzer, is a new dialysis membrane, produced by applying an innovative spinning technique. The incentive of its development was to improve the characteristics of existing dialysis membranes, i.e., realizing a steeper sieving profile for low-molecular weight proteins without significant loss of essential larger proteins at best biocompatibility properties, for a more adequate dialysis therapy. Purpose of the planned study is to demonstrate the superior performance at lower albumin loss in different dialysis procedures of the new Nipro ELISIO® dialyzer compared with a control dialyzer with regard to the removal of the whole range of uremic toxins.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥18 years
  • CKD stage 5 with hemodialysis or hemodiafiltration treatment for more than three months
  • Hematocrit >30 %
  • Routine anticoagulation and erythropoietin regimen
  • No vascular access related problems (A/V-fistula, graft or bi-flow catheter)
  • No ongoing infection
  • Signed informed consent form

排除标准

  • Inclusion criteria not met
  • Known HIV or active hepatitis B or C infection (positive PCR). Pregnancy
  • Unstable clinical condition (e.g. cardiac or vascular instability)
  • Life expectancy less than 12 months
  • Known coagulation problems
  • Patients participating in another study interfering with the planned study

结局指标

主要结局

protein-bound toxin removal

时间窗: pre and post dialysis treatment

low-molecular weight protein removal

时间窗: pre and post dialysis treatment

small solute removal

时间窗: pre and post dialysis treatment

次要结局

未报告次要终点

研究者

发起方
EXcorLab GmbH
申办方类型
Other

研究点 (2)

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