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

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

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.

Study Overview

• Status: Completed
• Conditions: End Stage Renal Disease; Dialysis Related Complication; Dialysis Amyloidosis
• Intervention / Treatment: Device: Theranova-500 dialyzer; Device: Elisio-21H

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Poitiers, France, 86021
    • Chu de Poitiers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Theranova-500	Device: Theranova-500 dialyzer; hemodialysis with Theranova-500 dialyzer.; Device: Elisio-21H; hemodialysis with Elisio-21H dialyzer
Sham Comparator: Elisio-21H	Device: Theranova-500 dialyzer; hemodialysis with Theranova-500 dialyzer.; Device: Elisio-21H; hemodialysis with Elisio-21H dialyzer

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

Collaborators and Investigators

• Sponsor: Poitiers University Hospital
• Collaborators: Baxter Healthcare Corporation
• Investigators: Principal Investigator: Mohamed BELMOUAZ, Poitiers University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2017
• Primary Completion (Actual): March 14, 2018
• Study Completion (Actual): June 14, 2018

Study Registration Dates

• First Submitted: May 18, 2017
• First Submitted That Met QC Criteria: July 6, 2017
• First Posted (Actual): July 7, 2017

Study Record Updates

• Last Update Posted (Actual): April 13, 2020
• Last Update Submitted That Met QC Criteria: April 10, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: dialyzer; beta2-microglobilin; myoglobin
• Additional Relevant MeSH Terms: Metabolic Diseases; Kidney Diseases; Urologic Diseases; Renal Insufficiency; Proteostasis Deficiencies; Renal Insufficiency, Chronic; Amyloidosis; Kidney Failure, Chronic
• Other Study ID Numbers: 2016-A01679-42

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No