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

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

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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