eMPORAIIIComparaison de l'efficacité des dialyseurs FX CorAL 600, FX CorDiax 600 et xevonta Hi 15 dans l'élimination des toxines urémiques et l'hémocompatibilité
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
Maladies génito-urinaires+10
+ Maladie chronique
+ Maladies urogénitales féminines et complications de la grossesse
Étude thérapeutique
Résumé
Date de début de l'étude : 3 février 2021
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.82 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Un seul groupe d'intervention est désigné dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
Objectifs de l'étude
Objectifs principaux
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 8 sites
Fresenius Nephrocare Praha 9 - Vysocany
Prague, CzechiaDiakonissenkrankenhaus Flensburg
Flensburg, GermanyPHV-Dialysezentrum Goslar
Goslar, Germany