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

NCT ID: NCT00735059

Last Updated: 2009-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2009-04-30

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.

Conditions

Chronic Kidney Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

treatment with dialyzer ELISIO 170H

Group Type: EXPERIMENTAL

treatment with the dialyzer ELISIO 170H

Intervention Type: DEVICE

one week of three consecutive dialysis treatments, \> 3 hours

2

treatment with dialyzer PES-170DS

Group Type: ACTIVE_COMPARATOR

treatment with the dialyzer PES-170DS

Intervention Type: DEVICE

one week of three consecutive dialysis treatments, \> 3 hours

Interventions

treatment with the dialyzer ELISIO 170H

one week of three consecutive dialysis treatments, \> 3 hours

Intervention Type: DEVICE

treatment with the dialyzer PES-170DS

one week of three consecutive dialysis treatments, \> 3 hours

Intervention Type: DEVICE

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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nipro Europe N.V.

INDUSTRY

Sponsor Role: collaborator

EXcorLab GmbH

OTHER

Sponsor Role: lead

Responsible Party

EXcorLab GmbH

Principal Investigators

Raymond Vanholder, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Ghent, Nephrology Section

Locations

University Hospital

Ghent, , Belgium

Countries

Belgium

Other Identifiers

KSEL0702

Identifier Type: -

Identifier Source: org_study_id