Clinical trial NCT01783626: 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
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Disease (ESRD)
Lead sponsor: Vantive Health LLC
Sponsor class: INDUSTRY
Collaborators: name: Gambro Lundia AB
name: Baxter Healthcare Corporation
First posted: 2013-02-05
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Efficacy: Beta 2 Microglobulin elimination
timeFrame: Change from T0 (dialysis start) at T4 hours (dialysis stop)
Secondary outcomes:
measure: Efficacy: -Elimination of Myoglobin,alpha 1 Microglobulin, alpha amylase and Factor D
timeFrame: Change from T0 (dialysis start) at T 4hours (dialysis stop)
measure: Efficacy:Profile of ultrafiltrated proteins
timeFrame: at T4 hours
measure: Safety: Follow-up of all AEs/SAEs
timeFrame: during the study period
measure: Safety: Measurement of Albumin loss
timeFrame: At T4 hours
measure: Efficacy: Cumulative Purified volume (Kt)
timeFrame: At T4 hours
measure: Safety: Total protein
timeFrame: Change from T0 and T4 hours
Other outcomes:
Locations:
city: Cherbourg-Octeville
country: France
facility: Hôpital Louis-Pasteur (Cherbourg-Octeville)
Study officials:
affiliation: Gambro Industries
name: Nathalie Loughraieb
role: STUDY_DIRECTOR
References: