Chronic Kidney Disease
Conditions
Keywords
dialysis membrane, Polynephron, Elisio H, Polyethersulfone, Diapes, PES-DS, online post-dilution hemodiafiltration, hemodialysis, protein-bound toxins, beta-2-microglobulin, hemodialysis patients
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.
Interventions
DEVICEtreatment with the dialyzer ELISIO 170H
one week of three consecutive dialysis treatments, \> 3 hours
DEVICEtreatment with the dialyzer PES-170DS
one week of three consecutive dialysis treatments, \> 3 hours
Sponsors
Nipro Europe N.V.
EXcorLab GmbH
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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 |
Countries
Belgium
Outcome results
None listed