Comparison of Hemodialysis With Medium Cut-off Dialyzer (Theranova) and High Flux Dialyzer

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Comparison of Hemodialysis With Medium Cut-off Dialyzer (Theranova) and High Flux Dialyzer on Removal of Small and Middle Size Molecules, Inflammatory Parameters and Oxidative Stress. An Open Cross Over Randomized Study

Conditions
-----------------
End Stage Renal Disease, Dialysis Related Complication, Dialysis Amyloidosis

Intervention / Treatment
-----------------
* Device: Theranova-500 dialyzer
* Device: Elisio-21H


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years Patient suffering from chronic terminal renal failure excluding nephropathy with myelomatous cylinders, hemodialysis for more than 6 months, Patient under dialyser Elisio-21H ™ for more than 3 months Patient including the protocol scheme and able to comply with it Free subject, without guardianship or curatorship or subordination Patients benefiting from a Social Security scheme or benefiting from it through a third party Non-opposition given by the patient after clear and fair information on the study Exclusion Criteria: Age <18 years Patient with an associated pathology (evolutionary cancer, progressive infectious disease or chronic inflammatory disease) that may excessively influence CRP levels (CRP> 60 mg / L) Patient following another protocol of research or period of exclusion of another protocol Patients not benefiting from a Social Security scheme or not benefiting from it through a third party Persons benefiting from enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social institution, adults under legal protection, and finally patients in emergencies . Pregnant or nursing women, women of childbearing age who do not have effective contraception (hormonal / mechanical: oral, injectable, transcutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total ovariectomy ).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Theranova-500<br> | Device: Theranova-500 dialyzer<br>* hemodialysis with Theranova-500 dialyzer.<br>Device: Elisio-21H<br>* hemodialysis with Elisio-21H dialyzer<br>|
| Sham Comparator: Elisio-21H<br> | Device: Theranova-500 dialyzer<br>* hemodialysis with Theranova-500 dialyzer.<br>Device: Elisio-21H<br>* hemodialysis with Elisio-21H dialyzer<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Removal of myoglobin | myoglobin Reduction ratio. | After 3 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dialyzer, beta2-microglobilin, myoglobin