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NCT06032208Not yet recruiting

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

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)
Lawson Health Research InstituteClinicalTrials.govdeviceDevice trial
Study focus
Drug/Device/Intervention
Theranova Dialyzer
Study type
Interventional
Intervention type
device
Sponsor & location
Primary sponsor
Lawson Health Research Institute
Timeline & enrollment
Phase
N/A
Start date
Nov 01, 2023
End date
Dec 31, 2024
Enrollment
100 participants
Primary outcome

Determine if the clearance of larger middle molecular weight toxins using medium-cut-off dialyzer (HDx -Theranova) effects patient reported symptoms as determined by LEVIL.

Summary

Investigators know that many patients who are on dialysis suffer from burden of unwanted
 symptoms, which can affect quality of life. The understanding and treatment of symptom burden
 by healthcare providers is limited and should be recognized as a high priority in the care of
 the dialysis population. In this study, the investigators will be assessing symptom burden
 using the London Evaluation of Illness LEVIL, an application based platform where patients
 self-report their symptoms with one to three hemodialysis treatments per week for 28 weeks.
 The investigators would like to compare the currently available dialyzer with a new dialyzer
 that is capable of removing solutes of higher molecular weight that may or may not cause
 patients to experience symptoms related to increased amounts of toxins in their blood.

ICD-10 classifications
Chronic kidney disease, stage 1Chronic kidney disease, stage 5Chronic kidney disease, stage 2Chronic kidney disease, stage 3Chronic kidney disease, stage 4
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06032208
Type
Device Trial
About this record

Access comprehensive clinical trial information for NCT06032208 through Pure Global AI's free database. This phase not specified trial is sponsored by Lawson Health Research Institute and is currently Not yet recruiting. The study focuses on End Stage Renal Disease. Target enrollment is 100 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.