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

NCT03262272 | Completed DMC

• 1 other identifier: BIOMODAL 2016-A01122-49
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Renal Disease; Inflammation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Extraction of uremic toxins

  one week per dialyzer per patient

• Biocompatibility assessment

  one week per dialyzer per patient

• Monitoring of Nutrition status

  one week per dialyzer per patient

• Handling of the devices

  one week per dialyzer per patient

• Dialysis adequacy evaluation

  one week per dialyzer per patient

Study Arms (2)

Hemodialysis

EXPERIMENTAL

patients treated by conventionnal hemodialysis

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

Hemodiafiltration post dilution

EXPERIMENTAL

patients treated by HDF post-dilution

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

Interventions

VIE A Hemodialyzer DEVICE

polysulfon membrane coated with vitamin E

Hemodiafiltration post dilution; Hemodialysis

Rexsys 27H hemodialyzer DEVICE

polyethersulfon membrane with large surface area : 2,7m²

Hemodiafiltration post dilution; Hemodialysis

Leoceed 21HX hemodialyzer DEVICE

polyslfon membrane with gamma sterilization

Hemodiafiltration post dilution; Hemodialysis

Polypure 22S+ hemodialyzer DEVICE

polysulfon membrane with steam sterilization

Hemodiafiltration post dilution; Hemodialysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hemotech: lead

Study Sites (1)

AIDER-Lapeyronie

Montpellier, 34295, France

Location

Related 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.

  PMID: 26656534 BACKGROUND

• 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.

  PMID: 26672890 BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic; Inflammation

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jean Paul CRISTOL, Professor

  University Hospital, Montpellier

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective randomized cross-over study

Study Record Dates

• First Submitted: July 12, 2017
• First Posted: August 25, 2017
• Study Start: November 21, 2016
• Primary Completion: July 31, 2018
• Study Completion: October 31, 2018
• Last Updated: February 21, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)