Evaluation of Evodial Hemodialyzer Selectivity Modifications (Evodial +)

Study Overview
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Brief Summary
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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.

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

Conditions
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End Stage Renal Disease (ESRD)

Intervention / Treatment
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* Device: Evodial
* Device: Evodial+ Condition B1
* Device: Evodial+ Condition B2
* Device: Evodial+ Condition C


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Anuric patient (diuresis<300ml) , ESRD patient treated for at least 3 months, Patient treated in HDF post-dilution, Vascular access functioning properly (Qb > 250 ml/min), Patient aged 18 years or more, Written consent to participate in the study (informed consent). Exclusion Criteria: Patient with pre-dialytic albuminemia <3.3 g/dl(Nephelometry assay) Patient with known allergy to heparin or type II heparininduced thrombocytopenia (HIT type II); Patient under guardianship; Women pregnant or breast feeding; Patient included in other studies that could interfere with the goals of the current study. Patient that are not affiliated to the health system(beneficiary or dependent). Patient with positive serology (HIV, Hepatitis).

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: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Evodial<br>Period I: HDF post dilution Total Volume 8 liters : 1 HD session (2nd HD of the week) Period II: HDF post dilution Total Volume 20 liters : 1 HD session (2nd HD of the week) | Device: Evodial<br> <br> |
| Experimental: Evodial+ Condition B1<br>Period I: HDF post dilution Total Volume 8 liters : 1 HD session (2nd HD of the week) Period II: HDF post dilution Total Volume 20 liters : 1 HD session (2nd HD of the week) | Device: Evodial+ Condition B1<br> <br> |
| Experimental: Evodial+ Condition B2<br>Period I: HDF post dilution Total Volume 8 liters : 1 HD session (2nd HD of the week) Period II: HDF post dilution Total Volume 20 liters : 1 HD session (2nd HD of the week) | Device: Evodial+ Condition B2<br> <br> |
| Experimental: Evodial+ Condition C<br>Period I: HDF post dilution Total Volume 8 liters : 1 HD session (2nd HD of the week) Period II: HDF post dilution Total Volume 20 liters : 1 HD session (2nd HD of the week) | Device: Evodial+ Condition C<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: Beta 2 Microglobulin elimination |  | Change from T0 (dialysis start) at T4 hours (dialysis stop) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: -Elimination of Myoglobin,alpha 1 Microglobulin, alpha amylase and Factor D |  | Change from T0 (dialysis start) at T 4hours (dialysis stop) | 
| Efficacy:Profile of ultrafiltrated proteins |  | at T4 hours | 
| Safety: Follow-up of all AEs/SAEs |  | during the study period | 
| Safety: Measurement of Albumin loss |  | At T4 hours | 
| Efficacy: Cumulative Purified volume (Kt) |  | At T4 hours | 
| Safety: Total protein |  | Change from T0 and T4 hours |