Evaluation of Evodial Hemodialyzer Selectivity Modifications (Evodial +)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-03-31

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.

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Detailed Description

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Conditions

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End Stage Renal Disease (ESRD)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Evodial

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)

Group Type SHAM_COMPARATOR

Evodial

Intervention Type DEVICE

Evodial+ Condition B1

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)

Group Type EXPERIMENTAL

Evodial+ Condition B1

Intervention Type DEVICE

Evodial+ Condition B2

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)

Group Type EXPERIMENTAL

Evodial+ Condition B2

Intervention Type DEVICE

Evodial+ Condition C

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)

Group Type EXPERIMENTAL

Evodial+ Condition C

Intervention Type DEVICE

Interventions

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Evodial

Intervention Type DEVICE

Evodial+ Condition B1

Intervention Type DEVICE

Evodial+ Condition B2

Intervention Type DEVICE

Evodial+ Condition C

Intervention Type DEVICE

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No