Comparison of Hemodialysis With Medium Cut-off Dialyzer (Theranova) and High Flux Dialyzer
NCT ID: NCT03211676
Last Updated: 2020-04-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
49 participants
INTERVENTIONAL
2017-06-07
2018-06-14
Brief Summary
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Evaluation of nutritional parameters, inflamatory parameters and oxidative stress will also be carried out.
Finally, the investigators will compare hepcidin levels and the erythropoietin resistance index between the two groups.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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Theranova-500
Theranova-500 dialyzer
hemodialysis with Theranova-500 dialyzer.
Elisio-21H
hemodialysis with Elisio-21H dialyzer
Elisio-21H
Theranova-500 dialyzer
hemodialysis with Theranova-500 dialyzer.
Elisio-21H
hemodialysis with Elisio-21H dialyzer
Interventions
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Theranova-500 dialyzer
hemodialysis with Theranova-500 dialyzer.
Elisio-21H
hemodialysis with Elisio-21H dialyzer
Eligibility Criteria
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Inclusion Criteria
* Patient suffering from chronic terminal renal failure excluding nephropathy with myelomatous cylinders, hemodialysis for more than 6 months,
* Patient under dialyser Elisio-21H ™ for more than 3 months
* Patient including the protocol scheme and able to comply with it
* Free subject, without guardianship or curatorship or subordination
* Patients benefiting from a Social Security scheme or benefiting from it through a third party
* Non-opposition given by the patient after clear and fair information on the study
Exclusion Criteria
* Patient with an associated pathology (evolutionary cancer, progressive infectious disease or chronic inflammatory disease) that may excessively influence CRP levels (CRP\> 60 mg / L)
* Patient following another protocol of research or period of exclusion of another protocol
* Patients not benefiting from a Social Security scheme or not benefiting from it through a third party
* Persons benefiting from enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social institution, adults under legal protection, and finally patients in emergencies .
* Pregnant or nursing women, women of childbearing age who do not have effective contraception (hormonal / mechanical: oral, injectable, transcutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total ovariectomy ).
18 Years
ALL
No
Sponsors
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Baxter Healthcare Corporation
INDUSTRY
Poitiers University Hospital
OTHER
Responsible Party
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Principal Investigators
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Mohamed BELMOUAZ
Role: PRINCIPAL_INVESTIGATOR
Poitiers University Hospital
Locations
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CHU DE Poitiers
Poitiers, , France
Countries
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Other Identifiers
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2016-A01679-42
Identifier Type: -
Identifier Source: org_study_id
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