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Hemodialysis Device
Expanded Dialysis with Theranova Dialyzer for Kidney Failure
N/A
Recruiting
Led By Christopher McIntyre, MBBS DM
Research Sponsored by Lawson Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Chronic hemodialysis patient
Must be on hemodialysis for at least 3 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up beginning week 3 and ending at the end of the dialysis week on week 14 and again week 23 and ending week 46
Awards & highlights
Study Summary
This trial will be testing a new dialyzer to see if it causes less symptoms in patients than the current one.
Who is the study for?
This trial is for adults over 18 who have been on hemodialysis for chronic kidney failure for at least three months and can consent to participate. It's not suitable for those with a life expectancy less than one year, current cancer or infection, or patients already using advanced dialysis methods like Hemodiafiltration.Check my eligibility
What is being tested?
The study tests a new Theranova Dialyzer against the standard one used in hemodialysis. The focus is on whether the new dialyzer better removes certain toxins that might cause symptoms affecting quality of life. Patients will report their symptoms through an app called LEVIL.See study design
What are the potential side effects?
While specific side effects are not detailed here, dialyzers can sometimes cause low blood pressure, muscle cramps, itching, sleep problems, and anemia. The new Theranova Dialyzer may have similar or different side effects based on its design.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You are a patient who needs regular hemodialysis.
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You must have been receiving hemodialysis treatment for at least 3 months.
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You are 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ beginning week 3 and ending at the end of the dialysis week on week 14 and again week 23 and ending week 46
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~beginning week 3 and ending at the end of the dialysis week on week 14 and again week 23 and ending week 46
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
A change in larger middle molecule induced symptoms as assessed by the LEVIL application
Secondary outcome measures
A change in larger middle molecule clearance using the Theranova dialyzer
A change in symptoms with a change in dialyzer (usual to Theranova and vice versa)
Correlation between large middle molecules and patient symptoms
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Patients receiving hemodialysisExperimental Treatment1 Intervention
A group of hemodialysis patients will be receiving the Theranova dialyzer during their regularly scheduled sessions to remove larger middle molecules
Find a Location
Who is running the clinical trial?
Lawson Health Research InstituteLead Sponsor
654 Previous Clinical Trials
413,095 Total Patients Enrolled
2 Trials studying Kidney Failure
41 Patients Enrolled for Kidney Failure
Baxter Healthcare CorporationIndustry Sponsor
313 Previous Clinical Trials
199,630 Total Patients Enrolled
6 Trials studying Kidney Failure
352 Patients Enrolled for Kidney Failure
Christopher McIntyre, MBBS DMPrincipal InvestigatorLondon Health Sciences Centre
2 Previous Clinical Trials
114 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your doctor thinks you have less than a year to live.You are currently undergoing specific types of dialysis treatments.You are a patient who needs regular hemodialysis.You must have been receiving hemodialysis treatment for at least 3 months.You currently have an infection.You currently have cancer that is growing or spreading.You are 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Patients receiving hemodialysis
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent is the subject pool of this trial populated?
"Affirmative. According to clinicaltrials.gov, this study has been open since May 8th 2019 and was recently updated on September 20th 2022. 120 participants are sought from 2 medical sites."
Answered by AI
Are there still vacancies in this research endeavor for participants?
"Affirmative. Clinicaltrials.gov has listed this study, which was created on May 8th 2019, as actively recruiting patients. The researchers are now looking for 120 participants from two distinct medical locales."
Answered by AI
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