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A Multicentre, Open-label, Prospective, Randomized Study to Explore the Morbimortality in Patients Dialyzed With the Theranova HDx in Comparison to On-Line - Hemodiafiltration (Study MoTHER HDx)
study to evaluate the safety and efficacy of Expanded Hemodialysis (HDx) compared to hemodiafiltration (HDF) in patients with chronic kidney disease in Spain for up to 36 months. Approximately 700 patients will be included.
This is an open-label, prospective, 1:1 randomized, parallel-group, study to evaluate the safety and efficacy of Expanded Hemodialysis (HDx) compared to hemodiafiltration (HDF) in patients with chronic kidney disease in Spain for up to 36 months. Stable incident hemodialysis patients from hemodialysis in-hospital units and related satellite centers in Spain.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Hospital Universitario Infanta Leonor
Madrid, Spain
Start Date
April 3, 2019
Primary Completion Date
December 1, 2021
Completion Date
March 1, 2022
Last Updated
August 5, 2019
700
ESTIMATED participants
A synthetic high-flux dialyzer will be used for OL-HDF.
DEVICE
A medium cut-off dialyzer will be used for HDx.
DEVICE
Lead Sponsor
Fundación Senefro
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.
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View ClinicalTrials.gov Terms and ConditionsNCT03535922