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In Vivo Evaluation of the Nipro Elisio™ Dialyzer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01653808
First Posted: July 31, 2012
Last Update Posted: September 14, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nipro Europe N.V.
  Purpose
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.

Condition Intervention
Chronic Kidney Disease Device: Elisio-210H Procedure: conventional hemodialysis Procedure: on line hemodiafiltration

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: In Vivo Evaluation of the Nipro Elisio™ Dialyzer

Resource links provided by NLM:


Further study details as provided by Nipro Europe N.V.:

Primary Outcome Measures:
  • pre-dialytic serum beta-2 microglobulin level [ Time Frame: Month 1 (after one month) ]

Secondary Outcome Measures:
  • reduction rate of low molecular weight solutes (urea and creatinine) [ Time Frame: Month 0, 1, 2, 3, 4 ]
  • dialysis dose (urea KT/V) [ Time Frame: Month 0, 1, 2, 3, 4 ]
  • instantaneous clearance of low molecular weight solutes (urea and creatinine) [ Time Frame: Month 0, 1, 2, 3, 4 ]
  • inflammatory markers (CRP, fibrinogen, orosomucoide) [ Time Frame: month 0, 1, 2, 3, 4 ]
  • inflammatory marker (interkeukin 6) [ Time Frame: month 0, 4 ]
  • nutritional status (albumin, transthyretin, homocysteine) [ Time Frame: Month 0, 1, 2, 3, 4 ]
  • endothelial progenitor cells [ Time Frame: Month 0, 1, 2, 3, 4 ]
  • inflammatory mononuclear cell activation [ Time Frame: Month 0, 1, 2, 3, 4 ]
  • kappa and lambda light chains [ Time Frame: Month 0, 4 ]
  • oxidative stress parameters (superoxide anion, AOPPs, AGEs) [ Time Frame: Month 0, 4 ]
  • coagulation factors (TFPI, PAI-1, tPA, von willebrand factor and factor VIII) [ Time Frame: Month 0, 4 ]
  • apoptosis markers (soluble FAS and FAS ligand) [ Time Frame: Month 0, 4 ]
  • bone markers (bone PAL, Cross Laps, TRAP5b) [ Time Frame: Month 0, 4 ]

Enrollment: 20
Study Start Date: April 2009
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Elisio-210H with HD
hemodialysis patients treated with conventional hemodialysis (HD) modality using Elisio-210H dialyzer
Device: Elisio-210H
comparison of efficacy and biocompatibility of Elisio-210H dialyzer between conventional hemodialysis and on line hemodiafiltration
Procedure: conventional hemodialysis
comparison of conventional hemodialysis with on line hemodiafiltration using Elisio-210H dialyzer
Active Comparator: Elisio-210H with on line HDF
hemodialysis patients treated with on line hemodiafiltration (HDF) modality using Elisio-210H dialyzer
Device: Elisio-210H
comparison of efficacy and biocompatibility of Elisio-210H dialyzer between conventional hemodialysis and on line hemodiafiltration
Procedure: on line hemodiafiltration
comparison of on line hemodiafiltration with conventional hemodialysis using Elisio-210H dialyzer

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01653808


Locations
France
University Hospital Center
Montpellier, France, 34295
Sponsors and Collaborators
Nipro Europe N.V.
Investigators
Principal Investigator: Bernard CANAUD, MD, Prof. University Hospital Center of Montpellier, France
  More Information

Responsible Party: Nipro Europe N.V.
ClinicalTrials.gov Identifier: NCT01653808     History of Changes
Other Study ID Numbers: Nipro-Elisio 210H
First Submitted: July 27, 2012
First Posted: July 31, 2012
Last Update Posted: September 14, 2012
Last Verified: November 2008

Keywords provided by Nipro Europe N.V.:
CKD dialysis
hemodialysis
hemodiafiltration
Elisio dialyzer
efficacy
biocompatibility

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency