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

NCT00735059 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2009-08-21

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

treatment with the dialyzer ELISIO 170H

one week of three consecutive dialysis treatments, \> 3 hours

DEVICE

treatment with the dialyzer PES-170DS

one week of three consecutive dialysis treatments, \> 3 hours

Sponsors & Collaborators

  • Nipro Europe N.V.

    collaborator INDUSTRY

  • EXcorLab GmbH

    lead OTHER

Principal Investigators

  • Raymond Vanholder, Prof. Dr. · University Hospital Ghent, Nephrology Section

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2009-04-30
Completion
2009-04-30

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00735059 on ClinicalTrials.gov