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Dialyzer

Unblinded THERANOVA-500 dialyzer for Kidney Failure

N/A
Waitlist Available
Led By Marc Dorval, MD,MPH,MBA
Research Sponsored by Réseau de Santé Vitalité Health Network
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 10 of study

Summary

Single blinded randomized controlled trial comparing Expanded Hemodialysis (HDx) using THERANOVA-500 dialyzer versus conventional hemodialysis (HD) using REVACLEAR-400 dialyzer in chronic hemodialysis patients over a 6-week intervention period. Primary endpoint is post-hemodialysis recovery time. Secondary endpoints are six pre-dialysis biomarker levels (b2-microglobuline, procalcitonine, free light chains (gamma-lambda), IL-6, CRP) and three Quality of Life (QoL)(adapted KDQoL-SF questionnaire, EQ-5D, and rESAS).

Eligible Conditions
  • Kidney Failure

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 10 of study
This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 10 of study for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Post-dialysis recovery time (intervention period)
Secondary study objectives
Percentage of subjects who report no (zero) recovery time (THERANOVA-500 vs REVACLEAR-400)
Post-hemodialysis recovery time change (THERANOVA-500 vs REVACLEAR-400)
Post-hemodialysis recovery time difference (REVACLEAR-400)
+17 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Unblinded THERANOVA-500 dialyzerExperimental Treatment1 Intervention
This group of 10 subjects is dialyzed with unmasked THERANOVA-500 dialyzer which enables Expanded Hemodialysis (HDx) therapy.
Group II: Blinded THERANOVA-500 dialyzerExperimental Treatment1 Intervention
This group of 25 subjects is dialyzed with masked THERANOVA-500 dialyzer enabling Expanded Hemodialysis (HDx) therapy.
Group III: Unblinded REVACLEAR-400 dialyzerPlacebo Group1 Intervention
This group of 10 subjects is dialyzed with unmasked REVACLEAR-400 dialyzer which enables conventional hemodialysis (HD).
Group IV: Blinded REVACLEAR-400 dialyzerPlacebo Group1 Intervention
This group of 25 subjects is dialyzed with masked REVACLEAR-400 dialyzer enabling conventional hemodialysis (HD).

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Who is running the clinical trial?

Réseau de Santé Vitalité Health NetworkLead Sponsor
8 Previous Clinical Trials
1,873 Total Patients Enrolled
Marc Dorval, MD,MPH,MBAPrincipal InvestigatorDr Georges-L.-Dumont University Hospital Centre
~10 spots leftby Nov 2025
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