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| Name | Class |
|---|---|
| Gambro Lundia AB | INDUSTRY |
| Baxter Healthcare Corporation | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 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) |
|
| 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) |
|
| 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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evodial | Device |
| ||
| Evodial+ Condition B1 |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: Beta 2 Microglobulin elimination | Change from T0 (dialysis start) at T4 hours (dialysis stop) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nathalie Loughraieb | Gambro Industries | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Louis-Pasteur (Cherbourg-Octeville) | Cherbourg-Octeville | 50102 | France |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| Evodial+ Condition B2 | Device |
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| Evodial+ Condition C | Device |
|
| 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 |
| Safety: Total protein | Change from T0 and T4 hours |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |