Evaluation of Biocompatibility and Performances of 4 Dialyzers in Different Mode Treatments

NCT03262272 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2019-02-21

No results posted yet for this study

Summary

Prospective multicenter randomized cross-over study Number of patients : 32 (8 patients per group) Obtain objectives data to advise each hemodialyzer according to dialysis treatment and patient profile.

To evaluate the different hemodialyzers and judge their extraction performances in HD and post HDF.

Evaluation of the biocompatibility of the hemodialyzers and the patients' inflammatory status.

Conditions

Interventions

DEVICE

VIE A Hemodialyzer

polysulfon membrane coated with vitamin E

DEVICE

Rexsys 27H hemodialyzer

polyethersulfon membrane with large surface area : 2,7m²

DEVICE

Leoceed 21HX hemodialyzer

polyslfon membrane with gamma sterilization

DEVICE

Polypure 22S+ hemodialyzer

polysulfon membrane with steam sterilization

Sponsors & Collaborators

  • Hemotech

    lead INDUSTRY

Principal Investigators

  • Jean Paul CRISTOL, Professor · University Hospital, Montpellier

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-21
Primary Completion
2018-07-31
Completion
2018-10-31

Countries

  • France

Study Locations

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Entities

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 NCT03262272 on ClinicalTrials.gov