Test of the Nipro ELISIO H Dialyzer in Different Dialysis Treatment Procedures
Primary Purpose
Chronic Kidney Disease
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
treatment with the dialyzer ELISIO 170H
treatment with the dialyzer PES-170DS
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease focused on measuring dialysis membrane, Polynephron, Elisio H, Polyethersulfone, Diapes, PES-DS, online post-dilution hemodiafiltration, hemodialysis, protein-bound toxins, beta-2-microglobulin, hemodialysis patients
Eligibility 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
Sites / Locations
- University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
treatment with dialyzer ELISIO 170H
treatment with dialyzer PES-170DS
Outcomes
Primary Outcome Measures
protein-bound toxin removal
low-molecular weight protein removal
small solute removal
Secondary Outcome Measures
Full Information
NCT ID
NCT00735059
First Posted
August 13, 2008
Last Updated
August 20, 2009
Sponsor
EXcorLab GmbH
Collaborators
Nipro Europe N.V.
1. Study Identification
Unique Protocol Identification Number
NCT00735059
Brief Title
Test of the Nipro ELISIO H Dialyzer in Different Dialysis Treatment Procedures
Official Title
Test of the Nipro ELISIO H Dialyzer in Different Dialysis Treatment Procedures
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
EXcorLab GmbH
Collaborators
Nipro Europe N.V.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
dialysis membrane, Polynephron, Elisio H, Polyethersulfone, Diapes, PES-DS, online post-dilution hemodiafiltration, hemodialysis, protein-bound toxins, beta-2-microglobulin, hemodialysis patients
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
treatment with dialyzer ELISIO 170H
Arm Title
2
Arm Type
Active Comparator
Arm Description
treatment with dialyzer PES-170DS
Intervention Type
Device
Intervention Name(s)
treatment with the dialyzer ELISIO 170H
Intervention Description
one week of three consecutive dialysis treatments, > 3 hours
Intervention Type
Device
Intervention Name(s)
treatment with the dialyzer PES-170DS
Intervention Description
one week of three consecutive dialysis treatments, > 3 hours
Primary Outcome Measure Information:
Title
protein-bound toxin removal
Time Frame
pre and post dialysis treatment
Title
low-molecular weight protein removal
Time Frame
pre and post dialysis treatment
Title
small solute removal
Time Frame
pre and post dialysis treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond Vanholder, Prof. Dr.
Organizational Affiliation
University Hospital Ghent, Nephrology Section
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Ghent
ZIP/Postal Code
B-9000
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
Test of the Nipro ELISIO H Dialyzer in Different Dialysis Treatment Procedures
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