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

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ClinicalTrials.gov Identifier: NCT00735059
Recruitment Status : Completed
First Posted : August 14, 2008
Last Update Posted : August 21, 2009
Sponsor:
Collaborator:
Nipro Europe N.V.
Information provided by:
EXcorLab GmbH

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Device: treatment with the dialyzer ELISIO 170H Device: treatment with the dialyzer PES-170DS Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Test of the Nipro ELISIO H Dialyzer in Different Dialysis Treatment Procedures
Study Start Date : August 2008
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

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



Primary Outcome Measures :
  1. protein-bound toxin removal [ Time Frame: pre and post dialysis treatment ]
  2. low-molecular weight protein removal [ Time Frame: pre and post dialysis treatment ]
  3. small solute removal [ Time Frame: pre and post dialysis treatment ]


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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:

  • 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

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): 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

Responsible Party: Dr. Horst-Dieter Lemke, Biochemist, Chief Executive Officer, EXcorLab GmbH
ClinicalTrials.gov Identifier: NCT00735059     History of Changes
Other Study ID Numbers: KSEL0702
First Posted: August 14, 2008    Key Record Dates
Last Update Posted: August 21, 2009
Last Verified: August 2009

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
Urologic Diseases
Renal Insufficiency