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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on October 01, 2014