Test of the Nipro ELISIO H Dialyzer in Different Dialysis Treatment Procedures

August 20, 2009 updated by: EXcorLab GmbH
A current trend in dialysis membrane engineering is to maximize the permeability for larger low-molecular weight proteins while retaining albumin. Protein-leaking dialysis membranes do not meet these requirements. Particularly in convective procedures, such as hemodiafiltration, their albumin leakage is too high [10]. POLYNEPHRON™, the membrane which is built in to the new Nipro ELISIO® dialyzer, is a new dialysis membrane, produced by applying an innovative spinning technique. The incentive of its development was to improve the characteristics of existing dialysis membranes, i.e., realizing a steeper sieving profile for low-molecular weight proteins without significant loss of essential larger proteins at best biocompatibility properties, for a more adequate dialysis therapy. Purpose of the planned study is to demonstrate the superior performance at lower albumin loss in different dialysis procedures of the new Nipro ELISIO® dialyzer compared with a control dialyzer with regard to the removal of the whole range of uremic toxins.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

14

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

  • Belgium
      • Ghent, Belgium, B-9000
        • University Hospital

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥18 years
  • CKD stage 5 with hemodialysis or hemodiafiltration treatment for more than three months
  • Hematocrit >30 %
  • Routine anticoagulation and erythropoietin regimen
  • No vascular access related problems (A/V-fistula, graft or bi-flow catheter)
  • No ongoing infection
  • Signed informed consent form

Exclusion Criteria:

  • Inclusion criteria not met
  • Known HIV or active hepatitis B or C infection (positive PCR). Pregnancy
  • Unstable clinical condition (e.g. cardiac or vascular instability)
  • Life expectancy less than 12 months
  • Known coagulation problems
  • Patients participating in another study interfering with the planned study

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: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
treatment with dialyzer ELISIO 170H
Device: treatment with the dialyzer ELISIO 170H
one week of three consecutive dialysis treatments, > 3 hours
Active Comparator: 2
treatment with dialyzer PES-170DS
Device: treatment with the dialyzer PES-170DS
one week of three consecutive dialysis treatments, > 3 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
protein-bound toxin removal
Time Frame: pre and post dialysis treatment
pre and post dialysis treatment
low-molecular weight protein removal
Time Frame: pre and post dialysis treatment
pre and post dialysis treatment
small solute removal
Time Frame: pre and post dialysis treatment
pre and post dialysis treatment

Collaborators and Investigators

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

Sponsor

EXcorLab GmbH

Collaborators

Nipro Europe N.V.

Investigators

  • Principal Investigator: Raymond Vanholder, Prof. Dr., University Hospital Ghent, Nephrology Section

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

August 1, 2008

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

August 13, 2008

First Submitted That Met QC Criteria

August 13, 2008

First Posted (Estimate)

August 14, 2008

Study Record Updates

Last Update Posted (Estimate)

August 21, 2009

Last Update Submitted That Met QC Criteria

August 20, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KSEL0702

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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