Comparison of Hemodialysis With Medium Cut-off Dialyzer (Theranova) and High Flux Dialyzer

End Stage Renal Disease Clinical Trial

— THERANOVA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03211676
• Other study ID #: 2016-A01679-42
• Status: Completed
• Phase: N/A
• Start date: June 7, 2017
• Est. completion date: June 14, 2018

Study information

• Verified date: April 2020
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: June 14, 2018
• Est. primary completion date: March 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ).

Related Conditions & MeSH terms

• Amyloidosis
• Dialysis Amyloidosis
• Dialysis Related Complication
• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Device:
• Theranova-500 dialyzer
hemodialysis with Theranova-500 dialyzer.
• Elisio-21H
hemodialysis with Elisio-21H dialyzer

Locations

Country	Name	City	State
France	CHU DE Poitiers	Poitiers

Sponsors (2)

Lead Sponsor	Collaborator
Poitiers University Hospital	Baxter Healthcare Corporation

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Removal of myoglobin	myoglobin Reduction ratio.	After 3 months
Secondary	Removal of beta2 microglobulin	Reduction rate and clearances of beta2 microglobulin	After 3 months
Secondary	Removal of urea	Reduction ratio and clearances of urea	After 3 months
Secondary	Removal of creatinine	Reduction ratio and clearances of creatinine	After 3 months
Secondary	Removal of interleukin 6	Reduction ratio and clearances of interleukin 6	After 3 months
Secondary	Removal of IL-1beta	Reduction ratio and clearances of IL-1beta	After 3 months
Secondary	Removal of TNF alpha	Reduction ratio and clearances of TNF alpha	After 3 months
Secondary	Removal of leptin	Reduction ratio and clearances of leptin	After 3 months
Secondary	Removal of alpha 1 microglobulin	Reduction ratio and clearances of alpha 1 microglobulin	After 3 months
Secondary	Removal of retinol binding protein	Reduction ratio and clearances of retinol binding protein	After 3 months
Secondary	Removal of hyaluronic acid	Reduction ratio and clearances of hyaluronic acid	After 3 months
Secondary	Removal of FGF 23 (fibroblast growth factor 23)	Reduction ratio and clearances of FGF 23	After 3 months
Secondary	Removal of prolactin	Reduction ratio and clearances of prolactin	After 3 months
Secondary	Removal of free light chain kappa	Reduction ratio and clearances of free light chain kappa	After 3 months
Secondary	Removal of free light chain lambda	Reduction ratio and clearances of free light chain lambda	After 3 months
Secondary	comparison of pre dialysis level of hepcidin	comparison of average of pre dialysis level of hepcidin	After 3 months
Secondary	comparison of pre dialysis level of superoxide dismutase	comparison of average of pre dialysis level of superoxide dismutase	After 3 months
Secondary	comparison of pre dialysis level of isoprostan	comparison of average of pre dialysis level of isoprostan	After 3 months
Secondary	comparison of pre dialysis level of human oxidized LDL	comparison of average of pre dialysis level of human oxidized LDL	After 3 months
Secondary	comparison of pre dialysis level of albumin	comparison of average of pre dialysis level of albumin	After 3 months
Secondary	comparison of pre dialysis level of prealbumin	comparison of average of pre dialysis level of prealbumin	After 3 months
Secondary	comparison of post dialysis level of albumin	comparison of average of post dialysis level of albumin	After 3 months
Secondary	comparison of level of middle molecules and albumin in the dialysate	comparison of average level of midlle molecules and albumin in dialysate	After 3 months
Secondary	comparison of use of erythrpoietin	Comparison of the erythropoietin resistance index	After 3 months
Secondary	comparison of hemoglobin levels	comparison of average of predialysis hemoglobin levels	After 3 months
Secondary	comparison of pre dialysis level of CRP	comparison of average of pre dialysis level of CRP	After 3 months
Secondary	comparison of pre dialysis level of SAA	comparison of average of pre dialysis level of SAA	After 3 months