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

Evaluation of Dialyzers' Biocompatibility and Performances Compared in Different Dialysis Treatments : Conventional Hemodialysis and Post-dilution Hemodialfiltration

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • AIDER-Lapeyronie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hemodialysis; patients treated by conventionnal hemodialysis	Device: VIE A Hemodialyzer; polysulfon membrane coated with vitamin E; Device: Rexsys 27H hemodialyzer; polyethersulfon membrane with large surface area : 2,7m²; Device: Leoceed 21HX hemodialyzer; polyslfon membrane with gamma sterilization; Device: Polypure 22S+ hemodialyzer; polysulfon membrane with steam sterilization
Experimental: Hemodiafiltration post dilution; patients treated by HDF post-dilution	Device: VIE A Hemodialyzer; polysulfon membrane coated with vitamin E; Device: Rexsys 27H hemodialyzer; polyethersulfon membrane with large surface area : 2,7m²; Device: Leoceed 21HX hemodialyzer; polyslfon membrane with gamma sterilization; Device: Polypure 22S+ hemodialyzer; polysulfon membrane with steam sterilization

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Extraction of uremic toxins	Urea; Creatinin; inorganic phosphates	one week per dialyzer per patient
Biocompatibility assessment	Anaphylatoxins (C3a, C5a) during the session (T0, T15, Tend); TNF-α and IL-6 (T0 et Tend)	one week per dialyzer per patient
Monitoring of Nutrition status	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	one week per dialyzer per patient
Handling of the devices	- Evaluation of the priming and recovery for each dialysis session	one week per dialyzer per patient
Dialysis adequacy evaluation	Calculation of KT/V	one week per dialyzer per patient
Session tolerance	All secondary troubles will be noted: cramps, nauseas, hypotension…	one week per dialyzer per patient
Parameters inflammation	CRP (mg/l)	one week per dialyzer per patient
Parameters inflammation	- Calcul of PINI = [CRP(mg/l) x Orosomucoïd (mg/l)] / [Albumin(g/l) x Pre-albumin(mg/l)]	one week per dialyzer per patient

Collaborators and Investigators

• Sponsor: Hemotech
• Investigators: Study Director: Jean Paul CRISTOL, Professor, University Hospital, Montpellier

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2016
• Primary Completion (Actual): July 31, 2018
• Study Completion (Actual): October 31, 2018

Study Registration Dates

• First Submitted: July 12, 2017
• First Submitted That Met QC Criteria: August 22, 2017
• First Posted (Actual): August 25, 2017

Study Record Updates

• Last Update Posted (Actual): February 21, 2019
• Last Update Submitted That Met QC Criteria: February 20, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Inflammation; Kidney Failure, Chronic
• Other Study ID Numbers: BIOMODAL 2016-A01122-49

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No