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CompletedNCT01783626Updated Mar 13, 2025

Evaluation of Evodial Hemodialyzer Selectivity Modifications (Evodial +)

An interventional study of Evodial and Evodial+ Condition B1 in End Stage Renal Disease (ESRD), sponsored by Vantive Health LLC. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-13.

Sponsored by Vantive Health LLC · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
6
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • End Stage Renal Disease (ESRD)
03

In context

Kidney Failure, Chronic

2,085 studies on the registry are indexed under Kidney Failure, Chronic; 260 are open to participants now.

This study's enrollment of 6 is below the median of 55 across 1,557 interventional studies indexed under Kidney Failure, Chronic.

Browse Kidney Failure, Chronic studies →

Lead sponsor

Vantive Health LLC is the lead sponsor of 55 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • 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

Interventions

  • DeviceEvodial
  • DeviceEvodial+ Condition B1
  • DeviceEvodial+ Condition B2
  • DeviceEvodial+ Condition C
06

What researchers measure

Primary outcomes

  1. Efficacy: Beta 2 Microglobulin elimination

    Time frame: Change from T0 (dialysis start) at T4 hours (dialysis stop)

Secondary outcomes

  1. Efficacy: -Elimination of Myoglobin,alpha 1 Microglobulin, alpha amylase and Factor D

    Time frame: Change from T0 (dialysis start) at T 4hours (dialysis stop)

  2. Efficacy:Profile of ultrafiltrated proteins

    Time frame: at T4 hours

  3. Safety: Follow-up of all AEs/SAEs

    Time frame: during the study period

  4. Safety: Measurement of Albumin loss

    Time frame: At T4 hours

  5. Efficacy: Cumulative Purified volume (Kt)

    Time frame: At T4 hours

  6. Safety: Total protein

    Time frame: Change from T0 and T4 hours

07

Study locations

1 site
  • Hôpital Louis-Pasteur (Cherbourg-Octeville)
    Cherbourg-Octeville, 50102, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01783626
Lead sponsor
Vantive Health LLC
Collaborators
Gambro Lundia AB, Baxter Healthcare Corporation
Responsible party
Sponsor
First posted
Feb 5, 2013
Start date
Oct 2012
Primary completion
Mar 2013
Completion
Mar 2013
Last update
Mar 13, 2025

Study contacts

Nathalie Loughraieb
study director · Gambro Industries

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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