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

Not Applicable

Completed

• Conditions: Chronic Kidney Disease
• Interventions: Device: treatment with the dialyzer ELISIO 170H; Device: treatment with the dialyzer PES-170DS

• Registration Number: NCT00735059
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-08-13
• Study First Submitted QC: 2008-08-13
• Study First Posted: 2008-08-14
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Status Verified: 2009-08
• Last Update Submitted: 2009-08-20
• Last Update Posted: 2009-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	treatment with the dialyzer ELISIO 170H	treatment with dialyzer ELISIO 170H
2	treatment with the dialyzer PES-170DS	treatment with dialyzer PES-170DS

Primary Outcome Measures

Name	Time	Method
protein-bound toxin removal	pre and post dialysis treatment
low-molecular weight protein removal	pre and post dialysis treatment
small solute removal	pre and post dialysis treatment

Trial Locations

Locations (1)

University Hospital; 🇧🇪 Ghent, Belgium