End Stage Renal Disease (ESRD)
Conditions
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.
Interventions
Sponsors
Gambro Lundia AB
Baxter Healthcare Corporation
Vantive Health LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy: Beta 2 Microglobulin elimination | Change from T0 (dialysis start) at T4 hours (dialysis stop) |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy:Profile of ultrafiltrated proteins | at T4 hours |
| Safety: Follow-up of all AEs/SAEs | during the study period |
| Efficacy: -Elimination of Myoglobin,alpha 1 Microglobulin, alpha amylase and Factor D | Change from T0 (dialysis start) at T 4hours (dialysis stop) |
| Efficacy: Cumulative Purified volume (Kt) | At T4 hours |
| Safety: Total protein | Change from T0 and T4 hours |
| Safety: Measurement of Albumin loss | At T4 hours |
Countries
France
Outcome results
None listed