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

This study is currently recruiting participants.
See Contacts and Locations
Verified July 2017 by Poitiers University Hospital
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Poitiers University Hospital
ClinicalTrials.gov Identifier:
NCT03211676
First received: May 18, 2017
Last updated: July 6, 2017
Last verified: July 2017
  Purpose

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.


Condition Intervention
End Stage Renal Disease Dialysis Related Complication Dialysis Amyloidosis Device: Theranova-500 dialyzer Device: Elisio-21H

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: No masking
Primary Purpose: Other
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

Resource links provided by NLM:


Further study details as provided by Poitiers University Hospital:

Primary Outcome Measures:
  • Removal of myoglobin [ Time Frame: After 3 months ]
    myoglobin Reduction ratio.


Secondary Outcome Measures:
  • Removal of beta2 microglobulin [ Time Frame: After 3 months ]
    Reduction rate and clearances of beta2 microglobulin

  • Removal of urea [ Time Frame: After 3 months ]
    Reduction ratio and clearances of urea

  • Removal of creatinine [ Time Frame: After 3 months ]
    Reduction ratio and clearances of creatinine

  • Removal of interleukin 6 [ Time Frame: After 3 months ]
    Reduction ratio and clearances of interleukin 6

  • Removal of IL-1beta [ Time Frame: After 3 months ]
    Reduction ratio and clearances of IL-1beta

  • Removal of TNF alpha [ Time Frame: After 3 months ]
    Reduction ratio and clearances of TNF alpha

  • Removal of leptin [ Time Frame: After 3 months ]
    Reduction ratio and clearances of leptin

  • Removal of alpha 1 microglobulin [ Time Frame: After 3 months ]
    Reduction ratio and clearances of alpha 1 microglobulin

  • Removal of retinol binding protein [ Time Frame: After 3 months ]
    Reduction ratio and clearances of retinol binding protein

  • Removal of hyaluronic acid [ Time Frame: After 3 months ]
    Reduction ratio and clearances of hyaluronic acid

  • Removal of FGF 23 (fibroblast growth factor 23) [ Time Frame: After 3 months ]
    Reduction ratio and clearances of FGF 23

  • Removal of prolactin [ Time Frame: After 3 months ]
    Reduction ratio and clearances of prolactin

  • Removal of free light chain kappa [ Time Frame: After 3 months ]
    Reduction ratio and clearances of free light chain kappa

  • Removal of free light chain lambda [ Time Frame: After 3 months ]
    Reduction ratio and clearances of free light chain lambda

  • comparison of pre dialysis level of hepcidin [ Time Frame: After 3 months ]
    comparison of average of pre dialysis level of hepcidin

  • comparison of pre dialysis level of superoxide dismutase [ Time Frame: After 3 months ]
    comparison of average of pre dialysis level of superoxide dismutase

  • comparison of pre dialysis level of isoprostan [ Time Frame: After 3 months ]
    comparison of average of pre dialysis level of isoprostan

  • comparison of pre dialysis level of human oxidized LDL [ Time Frame: After 3 months ]
    comparison of average of pre dialysis level of human oxidized LDL

  • comparison of pre dialysis level of albumin [ Time Frame: After 3 months ]
    comparison of average of pre dialysis level of albumin

  • comparison of pre dialysis level of prealbumin [ Time Frame: After 3 months ]
    comparison of average of pre dialysis level of prealbumin

  • comparison of post dialysis level of albumin [ Time Frame: After 3 months ]
    comparison of average of post dialysis level of albumin

  • comparison of level of middle molecules and albumin in the dialysate [ Time Frame: After 3 months ]
    comparison of average level of midlle molecules and albumin in dialysate

  • comparison of use of erythrpoietin [ Time Frame: After 3 months ]
    Comparison of the erythropoietin resistance index

  • comparison of hemoglobin levels [ Time Frame: After 3 months ]
    comparison of average of predialysis hemoglobin levels

  • comparison of pre dialysis level of CRP [ Time Frame: After 3 months ]
    comparison of average of pre dialysis level of CRP

  • comparison of pre dialysis level of SAA [ Time Frame: After 3 months ]
    comparison of average of pre dialysis level of SAA


Estimated Enrollment: 40
Actual Study Start Date: June 7, 2017
Estimated Study Completion Date: December 14, 2017
Estimated Primary Completion Date: December 14, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 ).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03211676

Contacts
Contact: Mohamed BELMOUAZ, PH 05.49.44.40.78 mohamed.belmouaz@chu-poitiers.fr
Contact: Fabien DUTHE 05.49.44.13.59 fabien.duthe@chu-poitiers.fr

Locations
France
CHU DE Poitiers Recruiting
Poitiers, France, 86021
Contact: Mohamed BELMOUAZ    05.49.44.40.78      
Sponsors and Collaborators
Poitiers University Hospital
Baxter Healthcare Corporation
Investigators
Principal Investigator: Mohamed BELMOUAZ Poitiers University Hospital
  More Information

Responsible Party: Poitiers University Hospital
ClinicalTrials.gov Identifier: NCT03211676     History of Changes
Other Study ID Numbers: 2016-A01679-42
Study First Received: May 18, 2017
Last Updated: July 6, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Poitiers University Hospital:
dialyzer
beta2-microglobilin
myoglobin

Additional relevant MeSH terms:
Kidney Failure, Chronic
Amyloidosis
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Proteostasis Deficiencies
Metabolic Diseases

ClinicalTrials.gov processed this record on July 11, 2017