Evaluation of Biocompatibility and Performances of 4 Dialyzers in Different Mode Treatments

Not Applicable

Completed

• Conditions: End Stage Renal Disease; Inflammation
• Interventions: Device: VIE A Hemodialyzer; Device: Rexsys 27H hemodialyzer; Device: Leoceed 21HX hemodialyzer; Device: Polypure 22S+ hemodialyzer

• Registration Number: NCT03262272
• Lead Sponsor: Hemotech

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

Study Timeline

• Study Start: 2016-11-21
• Study First Submitted: 2017-07-12
• Study First Submitted QC: 2017-08-22
• Study First Posted: 2017-08-25
• Primary Completion: 2018-07-31
• Study Completion: 2018-10-31
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-20
• Last Update Posted: 2019-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Hemodialysis	VIE A Hemodialyzer	patients treated by conventionnal hemodialysis
Hemodiafiltration post dilution	Leoceed 21HX hemodialyzer	patients treated by HDF post-dilution
Hemodialysis	Rexsys 27H hemodialyzer	patients treated by conventionnal hemodialysis
Hemodialysis	Leoceed 21HX hemodialyzer	patients treated by conventionnal hemodialysis
Hemodialysis	Polypure 22S+ hemodialyzer	patients treated by conventionnal hemodialysis
Hemodiafiltration post dilution	Rexsys 27H hemodialyzer	patients treated by HDF post-dilution
Hemodiafiltration post dilution	VIE A Hemodialyzer	patients treated by HDF post-dilution
Hemodiafiltration post dilution	Polypure 22S+ hemodialyzer	patients treated by HDF post-dilution

Primary Outcome Measures

Name	Time	Method
Evaluation of middle molecules extraction	one week per dialyzer per patient	Measurements of β 2 microglobulin (11,8kDa), myoglobin (17kDa), Beta Trace (21kDa), Free immunoglobulin light chains Kappa (23kDa), myostatin (40kDa), glycoprotein orosomucoïd (44kDa)

Secondary Outcome Measures

Name	Time	Method
Monitoring of Nutrition status	one week per dialyzer per patient	Quantification of the albumin loss in the used dialysate (1 center) during the middle session of the week for each dialyzer tested per patient, i.e 4 times/patient.; 2 analysis modalities will be used: " pull and push " syringe Plastipak BD 50mL or collection of the whole dialysate in a 200 L tank; Dosage Albumin et pre-albumin before dialysis session
Dialysis adequacy evaluation	one week per dialyzer per patient	Calculation of KT/V
Session tolerance	one week per dialyzer per patient	All secondary troubles will be noted: cramps, nauseas, hypotension...
Handling of the devices	one week per dialyzer per patient	- Evaluation of the priming and recovery for each dialysis session
Extraction of uremic toxins	one week per dialyzer per patient	* Urea; * Creatinin; * inorganic phosphates
Biocompatibility assessment	one week per dialyzer per patient	* Anaphylatoxins (C3a, C5a) during the session (T0, T15, Tend); * TNF-α and IL-6 (T0 et Tend)
Parameters inflammation	one week per dialyzer per patient	- Calcul of PINI = \[CRP(mg/l) x Orosomucoïd (mg/l)\] / \[Albumin(g/l) x Pre-albumin(mg/l)\]

Trial Locations

Locations (1)

AIDER-Lapeyronie; 🇫🇷 Montpellier, France