Back to resultsEvaluation of Evodial Hemodialyzer Selectivity Modifications (Evodial +)
Primary Purpose
End Stage Renal Disease (ESRD)
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Evodial
Evodial+ Condition B1
Evodial+ Condition B2
Evodial+ Condition C
Sponsored by
About this trial
This is an interventional treatment trial for End Stage Renal Disease (ESRD)
Eligibility Criteria
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).
Sites / Locations
- Hôpital Louis-Pasteur (Cherbourg-Octeville)
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Sham Comparator
Experimental
Experimental
Experimental
Arm Label
Evodial
Evodial+ Condition B1
Evodial+ Condition B2
Evodial+ Condition C
Arm Description
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)
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)
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)
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)
Outcomes
Primary Outcome Measures
Efficacy: Beta 2 Microglobulin elimination
Secondary Outcome Measures
Efficacy: -Elimination of Myoglobin,alpha 1 Microglobulin, alpha amylase and Factor D
Efficacy:Profile of ultrafiltrated proteins
Safety: Follow-up of all AEs/SAEs
Safety: Measurement of Albumin loss
Efficacy: Cumulative Purified volume (Kt)
Safety: Total protein
Full Information
NCT ID
NCT01783626
First Posted
January 28, 2013
Last Updated
May 5, 2017
Sponsor
Baxter Healthcare Corporation
Collaborators
Gambro Lundia AB
1. Study Identification
Unique Protocol Identification Number
NCT01783626
Brief Title
Evaluation of Evodial Hemodialyzer Selectivity Modifications (Evodial +)
Official Title
Evaluation of Evodial Hemodialyzer Selectivity Modifications (Evodial +) - A Prospective, Monocenter, Open and Non-randomized Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baxter Healthcare Corporation
Collaborators
Gambro Lundia AB
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease (ESRD)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Evodial
Arm Type
Sham Comparator
Arm Description
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)
Arm Title
Evodial+ Condition B1
Arm Type
Experimental
Arm Description
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)
Arm Title
Evodial+ Condition B2
Arm Type
Experimental
Arm Description
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)
Arm Title
Evodial+ Condition C
Arm Type
Experimental
Arm Description
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)
Intervention Type
Device
Intervention Name(s)
Evodial
Intervention Type
Device
Intervention Name(s)
Evodial+ Condition B1
Intervention Type
Device
Intervention Name(s)
Evodial+ Condition B2
Intervention Type
Device
Intervention Name(s)
Evodial+ Condition C
Primary Outcome Measure Information:
Title
Efficacy: Beta 2 Microglobulin elimination
Time Frame
Change from T0 (dialysis start) at T4 hours (dialysis stop)
Secondary Outcome Measure Information:
Title
Efficacy: -Elimination of Myoglobin,alpha 1 Microglobulin, alpha amylase and Factor D
Time Frame
Change from T0 (dialysis start) at T 4hours (dialysis stop)
Title
Efficacy:Profile of ultrafiltrated proteins
Time Frame
at T4 hours
Title
Safety: Follow-up of all AEs/SAEs
Time Frame
during the study period
Title
Safety: Measurement of Albumin loss
Time Frame
At T4 hours
Title
Efficacy: Cumulative Purified volume (Kt)
Time Frame
At T4 hours
Title
Safety: Total protein
Time Frame
Change from T0 and T4 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathalie Loughraieb
Organizational Affiliation
Gambro Industries
Official's Role
Study Director
Facility Information:
Facility Name
Hôpital Louis-Pasteur (Cherbourg-Octeville)
City
Cherbourg-Octeville
ZIP/Postal Code
50102
Country
France
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Evodial Hemodialyzer Selectivity Modifications (Evodial +)
We'll reach out to this number within 24 hrs