Theranova Dialyzer for Kidney Failure

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Kidney FailureTheranova Dialyzer - Device
Eligibility
18+
All Sexes
What conditions do you have?
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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

1 of 3

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

1 of 3

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: Device

Trial 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.