Study Summary
This trial will be testing a new dialyzer to see if it causes less symptoms in patients than the current one.
Eligible Conditions
- Kidney Failure
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 4 Secondary · Reporting Duration: Beginning week 3 and ending at the end of the dialysis week on week 14 and again week 23 and ending week 46
Week 46
A change in larger middle molecule induced symptoms as assessed by the LEVIL application
Week 54
A change in symptoms with a change in dialyzer (usual to Theranova and vice versa)
Correlation between large middle molecules and patient symptoms
Week 46
Effect on microcirculation and/or hemodialysis induced circulatory stress with the Theranova dialyzer
Week 1
A change in larger middle molecule clearance using the Theranova dialyzer
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Patients receiving hemodialysis
1 of 1
Experimental Treatment
120 Total Participants · 1 Treatment Group
Primary Treatment: Theranova Dialyzer · No Placebo Group · N/A
Patients receiving hemodialysis
Device
Experimental Group · 1 Intervention: Theranova Dialyzer · Intervention Types: DeviceTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: beginning week 3 and ending at the end of the dialysis week on week 14 and again week 23 and ending week 46
Who is running the clinical trial?
Baxter Healthcare CorporationIndustry Sponsor
300 Previous Clinical Trials
197,839 Total Patients Enrolled
6 Trials studying Kidney Failure
352 Patients Enrolled for Kidney Failure
Lawson Health Research InstituteLead Sponsor
614 Previous Clinical Trials
402,051 Total Patients Enrolled
2 Trials studying Kidney Failure
41 Patients Enrolled for Kidney Failure
Christopher McIntyre, MBBS DMPrincipal InvestigatorLondon Health Sciences Centre
1 Previous Clinical Trials
14 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You must be on hemodialysis for at least 3 months.
References
- Penny, Jarrin D., Patricia Jarosz, Fabio R. Salerno, Sandrine Lemoine, and Christopher W. McIntyre. 2021. “Impact of Expanded Hemodialysis Using Medium Cut-off Dialyzer on Quality of Life: Application of Dynamic Patient-reported Outcome Measurement Tool”. Kidney Medicine. Elsevier BV. doi:10.1016/j.xkme.2021.05.010.
- Chris McIntyre 2019. "Effect of Expanded Dialysis on Patient Reported Symptoms Using LEVIL". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03640858.
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Conditions
Cancer Related
Treatments