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Completed

NCT Number: NCT03211676

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 ).

Treatment and study plan

Theranova-500 dialyzer

Device

hemodialysis with Theranova-500 dialyzer.

Elisio-21H

Device

hemodialysis with Elisio-21H dialyzer

Primary outcomes

  1. Removal of myoglobin

    Time frame: After 3 months

    myoglobin Reduction ratio.

Secondary outcomes

  1. Removal of beta2 microglobulin

    Time frame: After 3 months

    Reduction rate and clearances of beta2 microglobulin

  2. Removal of urea

    Time frame: After 3 months

    Reduction ratio and clearances of urea

  3. Removal of creatinine

    Time frame: After 3 months

    Reduction ratio and clearances of creatinine

  4. Removal of interleukin 6

    Time frame: After 3 months

    Reduction ratio and clearances of interleukin 6

  5. Removal of IL-1beta

    Time frame: After 3 months

    Reduction ratio and clearances of IL-1beta

  6. Removal of TNF alpha

    Time frame: After 3 months

    Reduction ratio and clearances of TNF alpha

  7. Removal of leptin

    Time frame: After 3 months

    Reduction ratio and clearances of leptin

  8. Removal of alpha 1 microglobulin

    Time frame: After 3 months

    Reduction ratio and clearances of alpha 1 microglobulin

  9. Removal of retinol binding protein

    Time frame: After 3 months

    Reduction ratio and clearances of retinol binding protein

  10. Removal of hyaluronic acid

    Time frame: After 3 months

    Reduction ratio and clearances of hyaluronic acid

  11. Removal of FGF 23 (fibroblast growth factor 23)

    Time frame: After 3 months

    Reduction ratio and clearances of FGF 23

  12. Removal of prolactin

    Time frame: After 3 months

    Reduction ratio and clearances of prolactin

  13. Removal of free light chain kappa

    Time frame: After 3 months

    Reduction ratio and clearances of free light chain kappa

  14. Removal of free light chain lambda

    Time frame: After 3 months

    Reduction ratio and clearances of free light chain lambda

  15. comparison of pre dialysis level of hepcidin

    Time frame: After 3 months

    comparison of average of pre dialysis level of hepcidin

  16. comparison of pre dialysis level of superoxide dismutase

    Time frame: After 3 months

    comparison of average of pre dialysis level of superoxide dismutase

  17. comparison of pre dialysis level of isoprostan

    Time frame: After 3 months

    comparison of average of pre dialysis level of isoprostan

  18. 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

  19. comparison of pre dialysis level of albumin

    Time frame: After 3 months

    comparison of average of pre dialysis level of albumin

  20. comparison of pre dialysis level of prealbumin

    Time frame: After 3 months

    comparison of average of pre dialysis level of prealbumin

  21. comparison of post dialysis level of albumin

    Time frame: After 3 months

    comparison of average of post dialysis level of albumin

  22. 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

  23. comparison of use of erythrpoietin

    Time frame: After 3 months

    Comparison of the erythropoietin resistance index

  24. comparison of hemoglobin levels

    Time frame: After 3 months

    comparison of average of predialysis hemoglobin levels

  25. comparison of pre dialysis level of CRP

    Time frame: After 3 months

    comparison of average of pre dialysis level of CRP

  26. comparison of pre dialysis level of SAA

    Time frame: After 3 months

    comparison of average of pre dialysis level of SAA

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Collaborators

  • Baxter Healthcare Corporation

Registry information

Official study 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

Acronym: THERANOVA

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 7, 2017
Registry last updated
Apr 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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