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

This study has been completed.
Sponsor:
Collaborator:
Nipro Europe N.V.
Information provided by:
EXcorLab GmbH
ClinicalTrials.gov Identifier:
NCT00735059
First received: August 13, 2008
Last updated: August 20, 2009
Last verified: August 2009
  Purpose

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.


Condition Intervention
Chronic Kidney Disease
Device: treatment with the dialyzer ELISIO 170H
Device: treatment with the dialyzer PES-170DS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Test of the Nipro ELISIO H Dialyzer in Different Dialysis Treatment Procedures

Resource links provided by NLM:


Further study details as provided by EXcorLab GmbH:

Primary Outcome Measures:
  • protein-bound toxin removal [ Time Frame: pre and post dialysis treatment ] [ Designated as safety issue: No ]
  • low-molecular weight protein removal [ Time Frame: pre and post dialysis treatment ] [ Designated as safety issue: No ]
  • small solute removal [ Time Frame: pre and post dialysis treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 14
Study Start Date: August 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00735059

Locations
Belgium
University Hospital
Ghent, Belgium, B-9000
Sponsors and Collaborators
EXcorLab GmbH
Nipro Europe N.V.
Investigators
Principal Investigator: Raymond Vanholder, Prof. Dr. University Hospital Ghent, Nephrology Section
  More Information

No publications provided

Responsible Party: Dr. Horst-Dieter Lemke, Biochemist, Chief Executive Officer, EXcorLab GmbH
ClinicalTrials.gov Identifier: NCT00735059     History of Changes
Other Study ID Numbers: KSEL0702
Study First Received: August 13, 2008
Last Updated: August 20, 2009
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by EXcorLab GmbH:
dialysis membrane
Polynephron
Elisio H
Polyethersulfone
Diapes
PES-DS
online post-dilution hemodiafiltration
hemodialysis
protein-bound toxins
beta-2-microglobulin
hemodialysis patients

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

ClinicalTrials.gov processed this record on April 17, 2014