Test of the Nipro ELISIO H Dialyzer in Different Dialysis Treatment Procedures
- Conditions
- Chronic Kidney Disease
- Registration Number
- NCT00735059
- Lead Sponsor
- EXcorLab GmbH
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method protein-bound toxin removal pre and post dialysis treatment low-molecular weight protein removal pre and post dialysis treatment small solute removal pre and post dialysis treatment
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University Hospital
🇧🇪Ghent, Belgium
University Hospital🇧🇪Ghent, Belgium