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.

Study Overview

• Status: Completed
• Conditions: End Stage Renal Disease (ESRD)
• Intervention / Treatment: Device: Evodial; Device: Evodial+ Condition B1; Device: Evodial+ Condition B2; Device: Evodial+ Condition C

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Cherbourg-Octeville, France, 50102
    • Hôpital Louis-Pasteur (Cherbourg-Octeville)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: 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)	Device: Evodial
Experimental: 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)	Device: Evodial+ Condition B1
Experimental: 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)	Device: Evodial+ Condition B2
Experimental: 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)	Device: Evodial+ Condition C

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Baxter Healthcare Corporation
• Collaborators: Gambro Lundia AB
• Investigators: Study Director: Nathalie Loughraieb, Gambro Industries

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: January 28, 2013
• First Submitted That Met QC Criteria: February 1, 2013
• First Posted (Estimate): February 5, 2013

Study Record Updates

• Last Update Posted (Actual): May 8, 2017
• Last Update Submitted That Met QC Criteria: May 5, 2017
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic
• Other Study ID Numbers: 1498 (CSL Behring)