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

Not Applicable

Completed

• Conditions: Dialysis Amyloidosis; End Stage Renal Disease; Dialysis Related Complication
• Interventions: Device: Theranova-500 dialyzer; Device: Elisio-21H

• Registration Number: NCT03211676
• Lead Sponsor: Poitiers University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-18
• Study Start: 2017-06-07
• Study First Submitted QC: 2017-07-06
• Study First Posted: 2017-07-07
• Primary Completion: 2018-03-14
• Study Completion: 2018-06-14
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-10
• Last Update Posted: 2020-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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 ).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Elisio-21H	Theranova-500 dialyzer	-
Elisio-21H	Elisio-21H	-
Theranova-500	Elisio-21H	-
Theranova-500	Theranova-500 dialyzer	-

Primary Outcome Measures

Name	Time	Method
Removal of myoglobin	After 3 months	myoglobin Reduction ratio.

Secondary Outcome Measures

Name	Time	Method
Removal of creatinine	After 3 months	Reduction ratio and clearances of creatinine
Removal of beta2 microglobulin	After 3 months	Reduction rate and clearances of beta2 microglobulin
Removal of interleukin 6	After 3 months	Reduction ratio and clearances of interleukin 6
Removal of leptin	After 3 months	Reduction ratio and clearances of leptin
Removal of alpha 1 microglobulin	After 3 months	Reduction ratio and clearances of alpha 1 microglobulin
Removal of retinol binding protein	After 3 months	Reduction ratio and clearances of retinol binding protein
comparison of pre dialysis level of isoprostan	After 3 months	comparison of average of pre dialysis level of isoprostan
comparison of post dialysis level of albumin	After 3 months	comparison of average of post dialysis level of albumin
Removal of IL-1beta	After 3 months	Reduction ratio and clearances of IL-1beta
Removal of TNF alpha	After 3 months	Reduction ratio and clearances of TNF alpha
comparison of pre dialysis level of superoxide dismutase	After 3 months	comparison of average of pre dialysis level of superoxide dismutase
Removal of urea	After 3 months	Reduction ratio and clearances of urea
Removal of hyaluronic acid	After 3 months	Reduction ratio and clearances of hyaluronic acid
comparison of level of middle molecules and albumin in the dialysate	After 3 months	comparison of average level of midlle molecules and albumin in dialysate
comparison of hemoglobin levels	After 3 months	comparison of average of predialysis hemoglobin levels
comparison of pre dialysis level of CRP	After 3 months	comparison of average of pre dialysis level of CRP
Removal of free light chain kappa	After 3 months	Reduction ratio and clearances of free light chain kappa
Removal of free light chain lambda	After 3 months	Reduction ratio and clearances of free light chain lambda
comparison of pre dialysis level of hepcidin	After 3 months	comparison of average of pre dialysis level of hepcidin
comparison of pre dialysis level of prealbumin	After 3 months	comparison of average of pre dialysis level of prealbumin
comparison of use of erythrpoietin	After 3 months	Comparison of the erythropoietin resistance index
comparison of pre dialysis level of SAA	After 3 months	comparison of average of pre dialysis level of SAA
Removal of FGF 23 (fibroblast growth factor 23)	After 3 months	Reduction ratio and clearances of FGF 23
Removal of prolactin	After 3 months	Reduction ratio and clearances of prolactin
comparison of pre dialysis level of human oxidized LDL	After 3 months	comparison of average of pre dialysis level of human oxidized LDL
comparison of pre dialysis level of albumin	After 3 months	comparison of average of pre dialysis level of albumin

Trial Locations

Locations (1)

CHU DE Poitiers; 🇫🇷 Poitiers, France