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

February 20, 2019 updated by: Hemotech

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Evaluation of middle molecules extraction
Time Frame: 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)
one week per dialyzer per patient

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Extraction of uremic toxins
Time Frame: one week per dialyzer per patient
  • Urea
  • Creatinin
  • inorganic phosphates
one week per dialyzer per patient
Biocompatibility assessment
Time Frame: one week per dialyzer per patient
  • 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
Time Frame: 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
one week per dialyzer per patient
Handling of the devices
Time Frame: one week per dialyzer per patient
- Evaluation of the priming and recovery for each dialysis session
one week per dialyzer per patient
Dialysis adequacy evaluation
Time Frame: one week per dialyzer per patient
Calculation of KT/V
one week per dialyzer per patient
Session tolerance
Time Frame: one week per dialyzer per patient
All secondary troubles will be noted: cramps, nauseas, hypotension…
one week per dialyzer per patient
Parameters inflammation
Time Frame: one week per dialyzer per patient
CRP (mg/l)
one week per dialyzer per patient
Parameters inflammation
Time Frame: one week per dialyzer per patient
- 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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hemotech

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Jean Paul CRISTOL, Professor, University Hospital, Montpellier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 21, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 12, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 25, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 21, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

Rare Diseases

Drug Interventions

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