Clinical trial NCT03262272: Evaluation of Biocompatibility and Performances of 4 Dialyzers in Different Mode Treatments
Official title: Evaluation of Dialyzers' Biocompatibility and Performances Compared in Different Dialysis Treatments : Conventional Hemodialysis and Post-dilution Hemodialfiltration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Disease
Inflammation
Lead sponsor: Hemotech
Sponsor class: INDUSTRY
First posted: 2017-08-25
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Prospective randomized cross-over study
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* Adult patient with chronic kidney disease dialyzed for at least one month and treated with the treatment mode that we will test
* Patient using post-dilution HDF mode have to use EuDIAL volume guidelines (20-22L minimum)
* Patient treated before with high permeability membrane
* Patient with vascular access allowing a blood flow rate with a minimum of 300 mL/min
* Patient treated with a high surface area dialyzer ≥ 1,8 m²
* Patient covered by the social French health organism
* Patient informed of the study goals and having signed the informed consent

Exclusion Criteria:

* Patient with a vascular access not allowing a blood flow rate minimum of 300 mL/min
* Patient with a fast progressive chronic disease
* Patient with an uncontrolled anemia
* Patient refusing to sign the informed consent
* Pregnant or nursing patient
* Pediatric patient
* Patient under tutorship

Primary outcomes:
measure: Evaluation of middle molecules extraction
timeFrame: one week per dialyzer per patient
Secondary outcomes:
measure: Extraction of uremic toxins
timeFrame: one week per dialyzer per patient
measure: Biocompatibility assessment
timeFrame: one week per dialyzer per patient
measure: Monitoring of Nutrition status
timeFrame: one week per dialyzer per patient
measure: Handling of the devices
timeFrame: one week per dialyzer per patient
measure: Dialysis adequacy evaluation
timeFrame: one week per dialyzer per patient
measure: Session tolerance
timeFrame: one week per dialyzer per patient
measure: Parameters inflammation
timeFrame: one week per dialyzer per patient
measure: Parameters inflammation
timeFrame: one week per dialyzer per patient
Other outcomes:
Locations:
city: Montpellier
country: France
facility: AIDER-Lapeyronie
Study officials:
affiliation: University Hospital, Montpellier
name: Jean Paul CRISTOL, Professor
role: STUDY_DIRECTOR
References:
citation: Kokubo K, Kurihara Y, Kobayashi K, Tsukao H, Kobayashi H. Evaluation of the Biocompatibility of Dialysis Membranes. Blood Purif. 2015;40(4):293-7. doi: 10.1159/000441576. Epub 2015 Nov 17.
citation: Maduell F, Moreso F, Mora-Macia J, Pons M, Ramos R, Carreras J, Soler J, Torres F; study group ESHOL. ESHOL study reanalysis: All-cause mortality considered by competing risks and time-dependent covariates for renal transplantation. Nefrologia. 2016;36(2):156-63. doi: 10.1016/j.nefro.2015.10.007. Epub 2015 Dec 8. English, Spanish.