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

Inflammation Clinical Trial

— BIOMODAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03262272
• Other study ID #: BIOMODAL 2016-A01122-49
• Status: Completed
• Phase: N/A
• Start date: November 21, 2016
• Est. completion date: October 31, 2018

Study information

• Verified date: February 2019
• Source: Hemotech
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: October 31, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• End Stage Renal Disease
• Inflammation
• Kidney Failure, Chronic

Intervention

Device:
• VIE A Hemodialyzer
polysulfon membrane coated with vitamin E
• Rexsys 27H hemodialyzer
polyethersulfon membrane with large surface area : 2,7m²
• Leoceed 21HX hemodialyzer
polyslfon membrane with gamma sterilization
• Polypure 22S+ hemodialyzer
polysulfon membrane with steam sterilization

Locations

Country	Name	City	State
France	AIDER-Lapeyronie	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
Hemotech

Country where clinical trial is conducted

France, 

References & Publications (2)

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. Review. — View Citation

Maduell F, Moreso F, Mora-Macià 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of middle molecules extraction	Measurements of ß 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	Extraction of uremic toxins	Urea; Creatinin; inorganic phosphates	one week per dialyzer per patient
Secondary	Biocompatibility assessment	Anaphylatoxins (C3a, C5a) during the session (T0, T15, Tend); TNF-a and IL-6 (T0 et Tend)	one week per dialyzer per patient
Secondary	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
Secondary	Handling of the devices	- Evaluation of the priming and recovery for each dialysis session	one week per dialyzer per patient
Secondary	Dialysis adequacy evaluation	Calculation of KT/V	one week per dialyzer per patient
Secondary	Session tolerance	All secondary troubles will be noted: cramps, nauseas, hypotension…	one week per dialyzer per patient
Secondary	Parameters inflammation	CRP (mg/l)	one week per dialyzer per patient
Secondary	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