An Extension of an Interventional Study to Assess the Effect of Expanded Dialysis (HDx-Theranova) on Patient Reported Symptoms Using London Evaluation of Illness (LEVIL)

What this Trial Is About

Researchers are evaluating symptom burden in patients with end stage renal disease on hemodialysis, focusing on how different dialyzers might affect patient-reported symptoms and quality of life. This study compares a new dialyzer called Theranova, which can remove larger toxins from the blood, with the currently available dialyzers. The goal is to see if removing these larger molecules improves symptoms that patients experience during dialysis. Participants will use the Theranova dialyzer starting from week 5 through week 28 during their regular hemodialysis sessions, which usually happen one to three times per week. Symptom burden will be tracked using the London Evaluation of Illness (LEVIL) application where patients self-report symptoms in real-time. Additional assessments include cognitive testing and sexual desire questionnaires at baseline and at week 28 to evaluate other effects of the Theranova dialyzer. During the 28-week study, participants will report symptoms using LEVIL with each dialysis session. Cognitive function and sexual desire will be assessed twice, once at the beginning and once at the end of the study. Researchers will measure how the new dialyzer affects symptoms, cognition, sexual desire, and dialysis recovery time compared to standard dialyzers. The study is investigator-initiated and supported by Baxter Canada, with no extra cost to participants for the dialyzer or study-related procedures.

An Extension to Assess the Effect of Expanded Dialysis on Patient Reported Symptoms Using LEVIL