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

EXcorLab

Status: Completed

Conditions: Chronic Kidney Disease

Treatments: Device: treatment with the dialyzer PES-170DS; Device: treatment with the dialyzer ELISIO 170H

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00735059

KSEL0702

Details and patient eligibility

About

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.

Enrollment: 14 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

1

Experimental group

Description:

treatment with dialyzer ELISIO 170H

Treatment:

Device: treatment with the dialyzer ELISIO 170H

2

Active Comparator group

Description:

treatment with dialyzer PES-170DS

Treatment:

Device: treatment with the dialyzer PES-170DS