In Vivo Evaluation of the Nipro Elisio™ Dialyzer

September 13, 2012 updated by: Nipro Europe N.V.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • University Hospital Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
pre-dialytic serum beta-2 microglobulin level
Time Frame: Month 1 (after one month)
Month 1 (after one month)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nipro Europe N.V.

Investigators

  • Principal Investigator: Bernard CANAUD, MD, Prof., University Hospital Center of Montpellier, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

July 27, 2012

First Submitted That Met QC Criteria

July 27, 2012

First Posted (Estimate)

July 31, 2012

Study Record Updates

Last Update Posted (Estimate)

September 14, 2012

Last Update Submitted That Met QC Criteria

September 13, 2012

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Nipro-Elisio 210H

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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