Evaluation of Evodial Hemodialyzer Selectivity Modifications (Evodial +)

Evaluation of Evodial Hemodialyzer Selectivity Modifications (Evodial +) - A Prospective, Monocenter, Open and Non-randomized Pilot Study

Evodial +hemodialyzer consists of an evolution of the existing CE marked Evodial device, with respect to the hemodialyzer membrane removal characteristics. Different membrane prototypes configurations are proposed (3 versions in total), with the objective to modulate the hemodialyzer removal capacities (convective and adsorptive capacities).

Materials(including heparin grafted specifications) as well as the sterilization process are identical to the Evodial hemodialyzer. Based on available preclinical data , a clinical study is requested to document in vivo the different prototypes removal capacities with respect to middle Molecular Weight (MW) reference toxins such as b2 Microglobulin and collect data with regards to protein loss.

Inclusion Criteria:

1. Anuric patient (diuresis<300ml) ,
2. ESRD patient treated for at least 3 months,
3. Patient treated in HDF post-dilution,
4. Vascular access functioning properly (Qb > 250 ml/min),
5. Patient aged 18 years or more,
6. Written consent to participate in the study (informed consent).

Exclusion Criteria:

1. Patient with pre-dialytic albuminemia <3.3 g/dl(Nephelometry assay)
2. Patient with known allergy to heparin or type II heparininduced thrombocytopenia (HIT type II);
3. Patient under guardianship;
4. Women pregnant or breast feeding;
5. Patient included in other studies that could interfere with the goals of the current study.
6. Patient that are not affiliated to the health system(beneficiary or dependent).
7. Patient with positive serology (HIV, Hepatitis).