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

Chronic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00735059
• Other study ID #: KSEL0702
• Status: Completed
• Phase: N/A
• First received: August 13, 2008
• Last updated: August 20, 2009
• Start date: August 2008
• Est. completion date: April 2009

Study information

• Verified date: August 2009
• Source: EXcorLab GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Device:
• treatment with the dialyzer ELISIO 170H
one week of three consecutive dialysis treatments, > 3 hours
• treatment with the dialyzer PES-170DS
one week of three consecutive dialysis treatments, > 3 hours

Locations

Country	Name	City	State
Belgium	University Hospital	Ghent

Sponsors (2)

Lead Sponsor	Collaborator
EXcorLab GmbH	Nipro Europe N.V.

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	protein-bound toxin removal		pre and post dialysis treatment	No
Primary	low-molecular weight protein removal		pre and post dialysis treatment	No
Primary	small solute removal		pre and post dialysis treatment	No