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NCT Number: NCT01783626

Evaluation of Evodial Hemodialyzer Selectivity Modifications (Evodial +)

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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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Evodial

Device

Evodial+ Condition B1

Device

Evodial+ Condition B2

Device

Evodial+ Condition C

Device

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

Sponsors and collaborators

Lead sponsor

Vantive Health LLC

Industry

Collaborators

  • Baxter Healthcare Corporation
  • Gambro Lundia AB

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Feb 5, 2013
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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