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Dialyzer

Unblinded THERANOVA-500 dialyzer for Kidney Disease

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
Awards & highlights

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 Disease

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Post-dialysis recovery time (intervention period)
Secondary outcome measures
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).

Find a Location

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Second Clinical Evaluation of THERANOVA-500 Dialyzer in Chronic Hemodialysis (HD)
2018. "Second Clinical Evaluation of THERANOVA-500 Dialyzer in Chronic Hemodialysis (HD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03618368.
All > Dialysis
~10 spots leftby May 2025
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