eMPORAIIIComparing FX CorAL 600, FX CorDiax 600 and xevonta Hi 15 Dialyzers' Efficacy in Uremic Toxin Removal and Hemocompatibility
This study aims to compare the efficacy of FX CorAL 600, FX CorDiax 600 and xevonta Hi 15 dialyzers in removing uremic toxins, specifically focusing on the removal rate of β2-microglobulin in your blood.
Dialyser
Urogenital Diseases+10
+ Chronic Disease
+ Female Urogenital Diseases and Pregnancy Complications
Treatment Study
Summary
Study start date: February 3, 2021
Actual date on which the first participant was enrolled.This study focuses on comparing the clinical performance and compatibility with blood of different dialyzers used during a specific type of dialysis called post-dilution online hemodiafiltration. The main goal is to test if a dialyzer named FX CorAL 600 is as good as or better than two other dialyzers, FX CorDiax 600 and xevonta Hi 15, in removing a substance called ß2-microglobulin from the blood. This research is important as it aims to improve the treatment of people undergoing dialysis by finding the most effective dialyzer. During the study, participants will use each of the three dialyzers. The study will measure how well each dialyzer removes ß2-microglobulin and other harmful substances from the blood. It will also compare how well each dialyzer interacts with the blood. The results will help determine the efficacy and safety of each dialyzer, which could lead to improved dialysis treatments in the future.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.82 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: General: * Minimum age of 18 years * Existing informed consent form signed and dated by study patient as well as investigator/authorized physician * The patient is legally competent and able to understand the nature, risks, meaning, and consequences of the clinical trial and can subsequently declare her/his consent for participation in the clinical trial (cf. European Medical Device Directive and corresponding national regulations) * Patients with a chronic kidney disease stage 5D (end stage renal disease with a glomerular filtration rate of 15 ml/min or less) on hemodiafiltration as extracorporeal renal replacement therapy Study-specific: * On online post-dilution hemodiafiltration (HDF), at least 4 h treatment time thrice weekly with FX or FX CorDiax dialyzer ≥ 1 month * Vascular access (fistula or graft) which enables blood flow rate ≥ 300 ml/min Exclusion Criteria: General: * Any condition which could interfere with the patient's ability to comply with the study. This decision is at the discretion of the treating physician and relates to the general stable condition of the patient (e.g. any acute condition, e.g. infection or mental problem which might give reason for concern etc.) * Ongoing participation in an interventional clinical study during the preceding 30 days * Previous participation in this study * Pregnancy (pregnancy test will be conducted at start and end of study with female patients aged \< 55 years) or lactation period * Patient is not able to give informed consent according to the European Medical Device Directive and corresponding national regulations Study-specific: * Recurrent episodes of vascular access failure characterized by e.g. repeated cannulation problems or unstable blood flows within the last 2 months prior to study start (\>3 times, respectively) * Repeated single needle treatments (\>3 times within the last 2 months prior to study start) * Catheter as vascular access * Unstable patients (due to e.g. acute intercurrent disease like cardiovascular infarction, decompensated heart failure, cerebrovascular accident, severe infection, active malignant disease) * Patients with NYHA ≥ 3, COPD (GOLD 2-4), frequent intradialytic symptomatic hypotension * Patients with known or suspected allergy to trial product and related products * Patients with known inborn or acquired deficiencies of the innate and/or adaptive immune system * Patients with acute (use within last 4 weeks) and/or chronic immunosuppressive medication e.g. due to immune-mediated disease including autoimmune diseases, transplantation, or cancer (oral and systemic corticosteroids, calcineurin and mTOR-inhibitors, immunosuppressive monoclonal antibodies, cytotoxic chemotherapy) * Planned absence from dialysis unit within the 14 weeks of study duration e.g. due to scheduled hospitalization, holidays or any other reason * Active HBV, HCV, HIV, SARS-CoV-2 infection, as well as any other febrile illness * Reported SARS-CoV-2 infection with or without symptoms within the 12 weeks before inclusion into the study * Unwillingness to undergo repeated SARS-CoV-2 infection testing
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Study 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 8 locations
Fresenius Nephrocare Praha 9 - Vysocany
Prague, CzechiaDiakonissenkrankenhaus Flensburg
Flensburg, GermanyPHV-Dialysezentrum Goslar
Goslar, Germany