- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00735059
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
-
-
-
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
16 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
|
one week of three consecutive dialysis treatments, > 3 hours
|
Active Comparator: 2
treatment with 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
Collaborators
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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