Loading clinical trials...
Loading clinical trials...
Evaluation of Dialyzers' Biocompatibility and Performances Compared in Different Dialysis Treatments : Conventional Hemodialysis and Post-dilution Hemodialfiltration
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.
Medical devices studied : * Leoceed 21HX, hemodialyzer, High permeability PS membrane 2,1 m² , made by Nx Stage in Germany * Polypure 22S, hemodialyzer, High permeability PS membrane 2,2 m² , made by Allmed in Germany * VIE 21A hemodialyzer, High permeability PS membrane 2,1 m² coated in vitamin E, made by Asahi Kasei Medical in Japan * Rexsys 27H, hemodialyzer , High permeability PES membrane 2,7 m² , made by Medica in Italia These hemodialyzers are EC marked and are used in their own indications. Schema Details of the cross-over plan : 8 patients will be treated successively with the 4 hemodialyzers. Patients will be treated with the dialyzer "test" for the two first sessions of the week. During the last dialysis session of each week, only their usual dialyzer will be used as wash-out. A randomization will define the order of use of the dialyzers in the 4 centers. This order will be identical in a center. Number of patients : 32 (8 patients per center (4 centers)) Duration : One week per dialyzer
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
AIDER-Lapeyronie
Montpellier, France
Start Date
November 21, 2016
Primary Completion Date
July 31, 2018
Completion Date
October 31, 2018
Last Updated
February 21, 2019
32
ACTUAL participants
VIE A Hemodialyzer
DEVICE
Rexsys 27H hemodialyzer
DEVICE
Leoceed 21HX hemodialyzer
DEVICE
Polypure 22S+ hemodialyzer
DEVICE
Lead Sponsor
Hemotech
NCT06200207
NCT00397280
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04638647