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Second Clinical Evaluation of THERANOVA-500 Dialyzer in Chronic Hemodialysis (HD)

NCT03618368 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2020-11-06

No results posted yet for this 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).

Conditions

  • End Stage Renal Disease on Dialysis

Interventions

DEVICE

THERANOVA-500 dialyzer

THERANOVA-500 dialyzer is a hemofilter that enables Expanded Hemodialysis (HDx) therapy.

DEVICE

REVACLEAR-400 dialyzer

REVACLEAR-400 dialyzer is an usual hemofilter that enables conventional hemodialysis (HD).

Sponsors & Collaborators

  • Réseau de Santé Vitalité Health Network

    lead OTHER

Principal Investigators

  • Marc Dorval, MD,MPH,MBA · Dr Georges-L.-Dumont University Hospital Centre

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-25
Primary Completion
2018-10-23
Completion
2021-06-04

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03618368 on ClinicalTrials.gov