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

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Kidney Disease

Intervention / Treatment
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* Device: treatment with the dialyzer ELISIO 170H
* Device: treatment with the dialyzer PES-170DS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>treatment with dialyzer ELISIO 170H | Device: treatment with the dialyzer ELISIO 170H<br>* one week of three consecutive dialysis treatments, > 3 hours<br>|
| Active Comparator: 2<br>treatment with dialyzer PES-170DS | Device: treatment with the dialyzer PES-170DS<br>* one week of three consecutive dialysis treatments, > 3 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dialysis membrane, Polynephron, Elisio H, Polyethersulfone, Diapes, PES-DS, online post-dilution hemodiafiltration, hemodialysis, protein-bound toxins, beta-2-microglobulin, hemodialysis patients