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| Name | Class |
|---|---|
| Baxter Healthcare Corporation | INDUSTRY |
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The aim of this study is to evaluate the removal of midle molecules and inflammatory cytokines with the Theranova-500 ™ dialyzer (medium cut-off membrane, Baxter®) versus a high flux dialyzer Elisio-21H ™ (High-flux membrane, Nipro®) in chronic hemodialysis.
Evaluation of nutritional parameters, inflamatory parameters and oxidative stress will also be carried out.
Finally, the investigators will compare hepcidin levels and the erythropoietin resistance index between the two groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Theranova-500 | Active Comparator |
| |
| Elisio-21H | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Theranova-500 dialyzer | Device | hemodialysis with Theranova-500 dialyzer. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Removal of myoglobin | myoglobin Reduction ratio. | After 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Removal of beta2 microglobulin | Reduction rate and clearances of beta2 microglobulin | After 3 months |
| Removal of urea | Reduction ratio and clearances of urea |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed BELMOUAZ | Poitiers University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU DE Poitiers | Poitiers | 86021 | 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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| Elisio-21H | Device | hemodialysis with Elisio-21H dialyzer |
|
| After 3 months |
| Removal of creatinine | Reduction ratio and clearances of creatinine | After 3 months |
| Removal of interleukin 6 | Reduction ratio and clearances of interleukin 6 | After 3 months |
| Removal of IL-1beta | Reduction ratio and clearances of IL-1beta | After 3 months |
| Removal of TNF alpha | Reduction ratio and clearances of TNF alpha | After 3 months |
| Removal of leptin | Reduction ratio and clearances of leptin | After 3 months |
| Removal of alpha 1 microglobulin | Reduction ratio and clearances of alpha 1 microglobulin | After 3 months |
| Removal of retinol binding protein | Reduction ratio and clearances of retinol binding protein | After 3 months |
| Removal of hyaluronic acid | Reduction ratio and clearances of hyaluronic acid | After 3 months |
| Removal of FGF 23 (fibroblast growth factor 23) | Reduction ratio and clearances of FGF 23 | After 3 months |
| Removal of prolactin | Reduction ratio and clearances of prolactin | After 3 months |
| Removal of free light chain kappa | Reduction ratio and clearances of free light chain kappa | After 3 months |
| Removal of free light chain lambda | Reduction ratio and clearances of free light chain lambda | After 3 months |
| comparison of pre dialysis level of hepcidin | comparison of average of pre dialysis level of hepcidin | After 3 months |
| comparison of pre dialysis level of superoxide dismutase | comparison of average of pre dialysis level of superoxide dismutase | After 3 months |
| comparison of pre dialysis level of isoprostan | comparison of average of pre dialysis level of isoprostan | After 3 months |
| comparison of pre dialysis level of human oxidized LDL | comparison of average of pre dialysis level of human oxidized LDL | After 3 months |
| comparison of pre dialysis level of albumin | comparison of average of pre dialysis level of albumin | After 3 months |
| comparison of pre dialysis level of prealbumin | comparison of average of pre dialysis level of prealbumin | After 3 months |
| comparison of post dialysis level of albumin | comparison of average of post dialysis level of albumin | After 3 months |
| comparison of level of middle molecules and albumin in the dialysate | comparison of average level of midlle molecules and albumin in dialysate | After 3 months |
| comparison of use of erythrpoietin | Comparison of the erythropoietin resistance index | After 3 months |
| comparison of hemoglobin levels | comparison of average of predialysis hemoglobin levels | After 3 months |
| comparison of pre dialysis level of CRP | comparison of average of pre dialysis level of CRP | After 3 months |
| comparison of pre dialysis level of SAA | comparison of average of pre dialysis level of SAA | After 3 months |
| 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 |