- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03211676
Comparison of Hemodialysis With Medium Cut-off Dialyzer (Theranova) and High Flux Dialyzer (THERANOVA)
Comparison of Hemodialysis With Medium Cut-off Dialyzer (Theranova) and High Flux Dialyzer on Removal of Small and Middle Size Molecules, Inflammatory Parameters and Oxidative Stress. An Open Cross Over Randomized Study
The aim of this study is to evaluate the removal of midle molecules and inflammatory cytokines with the Theranova-500 ™ dialyzer (medium cut-off membrane, Baxter®) versus a high flux dialyzer Elisio-21H ™ (High-flux membrane, Nipro®) in chronic hemodialysis.
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Poitiers, France, 86021
- CHU De Poitiers
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age ≥ 18 years
- 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:
- Age <18 years
- 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 ).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Theranova-500
|
hemodialysis with Theranova-500 dialyzer.
hemodialysis with Elisio-21H dialyzer
|
Sham Comparator: Elisio-21H
|
hemodialysis with Theranova-500 dialyzer.
hemodialysis with Elisio-21H dialyzer
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Removal of myoglobin
Time Frame: After 3 months
|
myoglobin Reduction ratio.
|
After 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Removal of beta2 microglobulin
Time Frame: After 3 months
|
Reduction rate and clearances of beta2 microglobulin
|
After 3 months
|
Removal of urea
Time Frame: After 3 months
|
Reduction ratio and clearances of urea
|
After 3 months
|
Removal of creatinine
Time Frame: After 3 months
|
Reduction ratio and clearances of creatinine
|
After 3 months
|
Removal of interleukin 6
Time Frame: After 3 months
|
Reduction ratio and clearances of interleukin 6
|
After 3 months
|
Removal of IL-1beta
Time Frame: After 3 months
|
Reduction ratio and clearances of IL-1beta
|
After 3 months
|
Removal of TNF alpha
Time Frame: After 3 months
|
Reduction ratio and clearances of TNF alpha
|
After 3 months
|
Removal of leptin
Time Frame: After 3 months
|
Reduction ratio and clearances of leptin
|
After 3 months
|
Removal of alpha 1 microglobulin
Time Frame: After 3 months
|
Reduction ratio and clearances of alpha 1 microglobulin
|
After 3 months
|
Removal of retinol binding protein
Time Frame: After 3 months
|
Reduction ratio and clearances of retinol binding protein
|
After 3 months
|
Removal of hyaluronic acid
Time Frame: After 3 months
|
Reduction ratio and clearances of hyaluronic acid
|
After 3 months
|
Removal of FGF 23 (fibroblast growth factor 23)
Time Frame: After 3 months
|
Reduction ratio and clearances of FGF 23
|
After 3 months
|
Removal of prolactin
Time Frame: After 3 months
|
Reduction ratio and clearances of prolactin
|
After 3 months
|
Removal of free light chain kappa
Time Frame: After 3 months
|
Reduction ratio and clearances of free light chain kappa
|
After 3 months
|
Removal of free light chain lambda
Time Frame: After 3 months
|
Reduction ratio and clearances of free light chain lambda
|
After 3 months
|
comparison of pre dialysis level of hepcidin
Time Frame: After 3 months
|
comparison of average of pre dialysis level of hepcidin
|
After 3 months
|
comparison of pre dialysis level of superoxide dismutase
Time Frame: After 3 months
|
comparison of average of pre dialysis level of superoxide dismutase
|
After 3 months
|
comparison of pre dialysis level of isoprostan
Time Frame: After 3 months
|
comparison of average of pre dialysis level of isoprostan
|
After 3 months
|
comparison of pre dialysis level of human oxidized LDL
Time Frame: After 3 months
|
comparison of average of pre dialysis level of human oxidized LDL
|
After 3 months
|
comparison of pre dialysis level of albumin
Time Frame: After 3 months
|
comparison of average of pre dialysis level of albumin
|
After 3 months
|
comparison of pre dialysis level of prealbumin
Time Frame: After 3 months
|
comparison of average of pre dialysis level of prealbumin
|
After 3 months
|
comparison of post dialysis level of albumin
Time Frame: After 3 months
|
comparison of average of post dialysis level of albumin
|
After 3 months
|
comparison of level of middle molecules and albumin in the dialysate
Time Frame: After 3 months
|
comparison of average level of midlle molecules and albumin in dialysate
|
After 3 months
|
comparison of use of erythrpoietin
Time Frame: After 3 months
|
Comparison of the erythropoietin resistance index
|
After 3 months
|
comparison of hemoglobin levels
Time Frame: After 3 months
|
comparison of average of predialysis hemoglobin levels
|
After 3 months
|
comparison of pre dialysis level of CRP
Time Frame: After 3 months
|
comparison of average of pre dialysis level of CRP
|
After 3 months
|
comparison of pre dialysis level of SAA
Time Frame: After 3 months
|
comparison of average of pre dialysis level of SAA
|
After 3 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Mohamed BELMOUAZ, Poitiers university hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016-A01679-42
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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