NCT01783626

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 5, 2013

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

March 13, 2025

Status Verified

March 1, 2025

Enrollment Period

5 months

First QC Date

January 28, 2013

Last Update Submit

March 11, 2025

Conditions

End Stage Renal Disease (ESRD)

Outcome Measures

Primary Outcomes (1)

  • Efficacy: Beta 2 Microglobulin elimination

    Change from T0 (dialysis start) at T4 hours (dialysis stop)

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (4)

Evodial

SHAM COMPARATOR

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

Evodial+ Condition B1

EXPERIMENTAL

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

Evodial+ Condition B2

EXPERIMENTAL

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

Evodial+ Condition C

EXPERIMENTAL

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

EvodialDEVICE
Evodial
Evodial+ Condition B1DEVICE
Evodial+ Condition B1
Evodial+ Condition B2DEVICE
Evodial+ Condition B2
Evodial+ Condition CDEVICE
Evodial+ Condition C

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Louis-Pasteur (Cherbourg-Octeville)

Cherbourg-Octeville, 50102, France

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Nathalie Loughraieb

    Gambro Industries

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2013

First Posted

February 5, 2013

Study Start

October 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

March 13, 2025

Record last verified: 2025-03

Locations

FR(1)