Clinical trial NCT03211676: Comparison of Hemodialysis With Medium Cut-off Dialyzer (Theranova) and High Flux Dialyzer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Disease
Dialysis Related Complication
Dialysis Amyloidosis
Keywords: dialyzer
beta2-microglobilin
myoglobin
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
Collaborators: name: Baxter Healthcare Corporation
First posted: 2017-07-07
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


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 ).

Primary outcomes:
measure: Removal of myoglobin
timeFrame: After 3 months
Secondary outcomes:
measure: Removal of beta2 microglobulin
timeFrame: After 3 months
measure: Removal of urea
timeFrame: After 3 months
measure: Removal of creatinine
timeFrame: After 3 months
measure: Removal of interleukin 6
timeFrame: After 3 months
measure: Removal of IL-1beta
timeFrame: After 3 months
measure: Removal of TNF alpha
timeFrame: After 3 months
measure: Removal of leptin
timeFrame: After 3 months
measure: Removal of alpha 1 microglobulin
timeFrame: After 3 months
measure: Removal of retinol binding protein
timeFrame: After 3 months
measure: Removal of hyaluronic acid
timeFrame: After 3 months
measure: Removal of FGF 23 (fibroblast growth factor 23)
timeFrame: After 3 months
measure: Removal of prolactin
timeFrame: After 3 months
measure: Removal of free light chain kappa
timeFrame: After 3 months
measure: Removal of free light chain lambda
timeFrame: After 3 months
measure: comparison of pre dialysis level of hepcidin
timeFrame: After 3 months
measure: comparison of pre dialysis level of superoxide dismutase
timeFrame: After 3 months
measure: comparison of pre dialysis level of isoprostan
timeFrame: After 3 months
measure: comparison of pre dialysis level of human oxidized LDL
timeFrame: After 3 months
measure: comparison of pre dialysis level of albumin
timeFrame: After 3 months
measure: comparison of pre dialysis level of prealbumin
timeFrame: After 3 months
measure: comparison of post dialysis level of albumin
timeFrame: After 3 months
measure: comparison of level of middle molecules and albumin in the dialysate
timeFrame: After 3 months
measure: comparison of use of erythrpoietin
timeFrame: After 3 months
measure: comparison of hemoglobin levels
timeFrame: After 3 months
measure: comparison of pre dialysis level of CRP
timeFrame: After 3 months
measure: comparison of pre dialysis level of SAA
timeFrame: After 3 months
Other outcomes:
Locations:
city: Poitiers
country: France
facility: CHU DE Poitiers
Study officials:
affiliation: Poitiers University Hospital
name: Mohamed BELMOUAZ
role: PRINCIPAL_INVESTIGATOR
References: