Skip to main content
OpenTrials
Completed

NCT Number: NCT00735059

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital

Ghent, B-9000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

treatment with the dialyzer ELISIO 170H

Device

one week of three consecutive dialysis treatments, > 3 hours

treatment with the dialyzer PES-170DS

Device

one week of three consecutive dialysis treatments, > 3 hours

Primary outcomes

  1. protein-bound toxin removal

    Time frame: pre and post dialysis treatment

  2. low-molecular weight protein removal

    Time frame: pre and post dialysis treatment

  3. small solute removal

    Time frame: pre and post dialysis treatment

Sponsors and collaborators

Lead sponsor

EXcorLab GmbH

Other

Collaborators

  • Nipro Europe N.V.

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Aug 14, 2008
Registry last updated
Aug 21, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.