Evaluation of Biocompatibility and Performances of 4 Dialyzers in Different Mode Treatments (BIOMODAL)

Hemotech

Status: Completed

Conditions: Inflammation; End Stage Renal Disease

Treatments: Device: Polypure 22S+ hemodialyzer; Device: Rexsys 27H hemodialyzer; Device: Leoceed 21HX hemodialyzer; Device: VIE A Hemodialyzer

Study type: Interventional

Funder types: Industry

Identifiers

NCT03262272

BIOMODAL 2016-A01122-49

Details and patient eligibility

About

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.

Full 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

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Hemodialysis

Experimental group

Description:

patients treated by conventionnal hemodialysis

Treatment:

Device: Polypure 22S+ hemodialyzer

Device: Rexsys 27H hemodialyzer

Device: VIE A Hemodialyzer

Device: Leoceed 21HX hemodialyzer

Hemodiafiltration post dilution

Experimental group

Description:

patients treated by HDF post-dilution

Treatment:

Device: Polypure 22S+ hemodialyzer

Device: Rexsys 27H hemodialyzer

Device: VIE A Hemodialyzer

Device: Leoceed 21HX hemodialyzer