Evaluation of Evodial Hemodialyzer Selectivity Modifications (Evodial +)

Not Applicable

Completed

• Conditions: End Stage Renal Disease (ESRD)
• Interventions: Device: Evodial; Device: Evodial+ Condition B2; Device: Evodial+ Condition B1; Device: Evodial+ Condition C

• Registration Number: NCT01783626
• Lead Sponsor: Vantive Health LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2013-01-28
• Study First Submitted QC: 2013-02-01
• Study First Posted: 2013-02-05
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Evodial	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)
Evodial+ Condition B2	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)
Evodial+ Condition B1	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)
Evodial+ Condition C	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)

Primary Outcome Measures

Name	Time	Method
Efficacy: Beta 2 Microglobulin elimination	Change from T0 (dialysis start) at T4 hours (dialysis stop)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hôpital Louis-Pasteur (Cherbourg-Octeville); 🇫🇷 Cherbourg-Octeville, France