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Completed

NCT Number: NCT01653808

In Vivo Evaluation of the Nipro Elisio™ Dialyzer

The purpose of this study is to compare the efficacy and biocompatibility of the Nipro Elisio 210H dialyzer between two dialysis modalities, conventional hemodialysis and on line hemodiafiltration.

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Key information

About this study

Hemodiafiltration, a convective-based therapy combining both diffusive and convective transports appears as the treatment modality of choice for hemodialysis patients. Indeed, this innovative technique offers an effective dialysis modality removing spectrum of uremic solutes with an optimized biocompatibility of the extracorporeal circuit obtained with use of ultrapure dialysis and sterile substitution fluids. However, such therapy can not be proposed in all dialysis centers due to major drawbacks of this technique over conventional hemodialysis, the complexity of the system and its increased costs. Alternatively, enhancement of convective transport may now be achieved by use of innovative dialyzers allowing more internal filtration. This is the case of ELISIO™-H dialyzers which possess fibers of a greater internal length which potentially allow more internal filtration. Aim of the present study was therefore to evaluate efficacy and biocompatibility of internal filtration-enhanced hemodialysis using this dialyzer compared to hemodiafiltration, over a four-month period.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • CKD dialysis patients on treatment with three times a week HD for more than three months
  • with a stable anticoagulation scheme
  • with haemoglobin level >10.5 g/dL
  • with vascular access allowing a stable blood flow of 300 mL/min during treatment

Exclusion criteria

  • patient already enrolled in another study
  • pregnancy
  • symptoms or signs of acute/chronic inflammatory or infectious diseases

Treatment and study plan

Elisio-210H

Device

comparison of efficacy and biocompatibility of Elisio-210H dialyzer between conventional hemodialysis and on line hemodiafiltration

Conventional Hemodialysis

Procedure

comparison of conventional hemodialysis with on line hemodiafiltration using Elisio-210H dialyzer

On line Hemodiafiltration

Procedure

comparison of on line hemodiafiltration with conventional hemodialysis using Elisio-210H dialyzer

Primary outcomes

  1. pre-dialytic serum beta-2 microglobulin level

    Time frame: Month 1 (after one month)

Secondary outcomes

  1. reduction rate of low molecular weight solutes (urea and creatinine)

    Time frame: Month 0, 1, 2, 3, 4

  2. dialysis dose (urea KT/V)

    Time frame: Month 0, 1, 2, 3, 4

  3. instantaneous clearance of low molecular weight solutes (urea and creatinine)

    Time frame: Month 0, 1, 2, 3, 4

  4. inflammatory markers (CRP, fibrinogen, orosomucoide)

    Time frame: month 0, 1, 2, 3, 4

  5. inflammatory marker (interkeukin 6)

    Time frame: month 0, 4

  6. nutritional status (albumin, transthyretin, homocysteine)

    Time frame: Month 0, 1, 2, 3, 4

  7. endothelial progenitor cells

    Time frame: Month 0, 1, 2, 3, 4

  8. inflammatory mononuclear cell activation

    Time frame: Month 0, 1, 2, 3, 4

  9. kappa and lambda light chains

    Time frame: Month 0, 4

  10. oxidative stress parameters (superoxide anion, AOPPs, AGEs)

    Time frame: Month 0, 4

  11. coagulation factors (TFPI, PAI-1, tPA, von willebrand factor and factor VIII)

    Time frame: Month 0, 4

  12. apoptosis markers (soluble FAS and FAS ligand)

    Time frame: Month 0, 4

  13. bone markers (bone PAL, Cross Laps, TRAP5b)

    Time frame: Month 0, 4

Sponsors and collaborators

Lead sponsor

Nipro Europe N.V.

Industry

Registry information

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jul 31, 2012
Registry last updated
Sep 14, 2012

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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