Test of the Nipro ELISIO H Dialyzer in Different Dialysis Treatment Procedures
treatment with the dialyzer ELISIO 170H
+ treatment with the dialyzer PES-170DS
Urogenital Diseases+9
+ Chronic Disease
+ Female Urogenital Diseases and Pregnancy Complications
Treatment Study
Summary
Study start date: August 1, 2008
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.14 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location