<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03262272</url>
  </required_header>
  <id_info>
    <org_study_id>BIOMODAL 2016-A01122-49</org_study_id>
    <nct_id>NCT03262272</nct_id>
  </id_info>
  <brief_title>Evaluation of Biocompatibility and Performances of 4 Dialyzers in Different Mode Treatments</brief_title>
  <acronym>BIOMODAL</acronym>
  <official_title>Evaluation of Dialyzers' Biocompatibility and Performances Compared in Different Dialysis Treatments : Conventional Hemodialysis and Post-dilution Hemodialfiltration</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hemotech</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hemotech</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective multicenter randomized cross-over study Number of patients : 32 (8 patients per&#xD;
      group) Obtain objectives data to advise each hemodialyzer according to dialysis treatment and&#xD;
      patient profile.&#xD;
&#xD;
      To evaluate the different hemodialyzers and judge their extraction performances in HD and&#xD;
      post HDF.&#xD;
&#xD;
      Evaluation of the biocompatibility of the hemodialyzers and the patients' inflammatory&#xD;
      status.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Medical devices studied :&#xD;
&#xD;
        -  Leoceed 21HX, hemodialyzer, High permeability PS membrane 2,1 m² , made by Nx Stage in&#xD;
           Germany&#xD;
&#xD;
        -  Polypure 22S, hemodialyzer, High permeability PS membrane 2,2 m² , made by Allmed in&#xD;
           Germany&#xD;
&#xD;
        -  VIE 21A hemodialyzer, High permeability PS membrane 2,1 m² coated in vitamin E, made by&#xD;
           Asahi Kasei Medical in Japan&#xD;
&#xD;
        -  Rexsys 27H, hemodialyzer , High permeability PES membrane 2,7 m² , made by Medica in&#xD;
           Italia&#xD;
&#xD;
      These hemodialyzers are EC marked and are used in their own indications.&#xD;
&#xD;
      Schema&#xD;
&#xD;
      Details of the cross-over plan :&#xD;
&#xD;
      8 patients will be treated successively with the 4 hemodialyzers. Patients will be treated&#xD;
      with the dialyzer &quot;test&quot; for the two first sessions of the week. During the last dialysis&#xD;
      session of each week, only their usual dialyzer will be used as wash-out. A randomization&#xD;
      will define the order of use of the dialyzers in the 4 centers. This order will be identical&#xD;
      in a center.&#xD;
&#xD;
      Number of patients :&#xD;
&#xD;
      32 (8 patients per center (4 centers))&#xD;
&#xD;
      Duration :&#xD;
&#xD;
      One week per dialyzer&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 21, 2016</start_date>
  <completion_date type="Actual">October 31, 2018</completion_date>
  <primary_completion_date type="Actual">July 31, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>Prospective randomized cross-over study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of middle molecules extraction</measure>
    <time_frame>one week per dialyzer per patient</time_frame>
    <description>Measurements of β 2 microglobulin (11,8kDa), myoglobin (17kDa), Beta Trace (21kDa), Free immunoglobulin light chains Kappa (23kDa), myostatin (40kDa), glycoprotein orosomucoïd (44kDa)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Extraction of uremic toxins</measure>
    <time_frame>one week per dialyzer per patient</time_frame>
    <description>Urea&#xD;
Creatinin&#xD;
inorganic phosphates</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biocompatibility assessment</measure>
    <time_frame>one week per dialyzer per patient</time_frame>
    <description>Anaphylatoxins (C3a, C5a) during the session (T0, T15, Tend)&#xD;
TNF-α and IL-6 (T0 et Tend)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Monitoring of Nutrition status</measure>
    <time_frame>one week per dialyzer per patient</time_frame>
    <description>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.&#xD;
2 analysis modalities will be used: &quot; pull and push &quot; syringe Plastipak BD 50mL or collection of the whole dialysate in a 200 L tank&#xD;
Dosage Albumin et pre-albumin before dialysis session</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Handling of the devices</measure>
    <time_frame>one week per dialyzer per patient</time_frame>
    <description>- Evaluation of the priming and recovery for each dialysis session</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dialysis adequacy evaluation</measure>
    <time_frame>one week per dialyzer per patient</time_frame>
    <description>Calculation of KT/V</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Session tolerance</measure>
    <time_frame>one week per dialyzer per patient</time_frame>
    <description>All secondary troubles will be noted: cramps, nauseas, hypotension…</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parameters inflammation</measure>
    <time_frame>one week per dialyzer per patient</time_frame>
    <description>CRP (mg/l)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parameters inflammation</measure>
    <time_frame>one week per dialyzer per patient</time_frame>
    <description>- Calcul of PINI = [CRP(mg/l) x Orosomucoïd (mg/l)] / [Albumin(g/l) x Pre-albumin(mg/l)]</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>End Stage Renal Disease</condition>
  <condition>Inflammation</condition>
  <arm_group>
    <arm_group_label>Hemodialysis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients treated by conventionnal hemodialysis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hemodiafiltration post dilution</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients treated by HDF post-dilution</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>VIE A Hemodialyzer</intervention_name>
    <description>polysulfon membrane coated with vitamin E</description>
    <arm_group_label>Hemodiafiltration post dilution</arm_group_label>
    <arm_group_label>Hemodialysis</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Rexsys 27H hemodialyzer</intervention_name>
    <description>polyethersulfon membrane with large surface area : 2,7m²</description>
    <arm_group_label>Hemodiafiltration post dilution</arm_group_label>
    <arm_group_label>Hemodialysis</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Leoceed 21HX hemodialyzer</intervention_name>
    <description>polyslfon membrane with gamma sterilization</description>
    <arm_group_label>Hemodiafiltration post dilution</arm_group_label>
    <arm_group_label>Hemodialysis</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Polypure 22S+ hemodialyzer</intervention_name>
    <description>polysulfon membrane with steam sterilization</description>
    <arm_group_label>Hemodiafiltration post dilution</arm_group_label>
    <arm_group_label>Hemodialysis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patient with chronic kidney disease dialyzed for at least one month and treated&#xD;
             with the treatment mode that we will test&#xD;
&#xD;
          -  Patient using post-dilution HDF mode have to use EuDIAL volume guidelines (20-22L&#xD;
             minimum)&#xD;
&#xD;
          -  Patient treated before with high permeability membrane&#xD;
&#xD;
          -  Patient with vascular access allowing a blood flow rate with a minimum of 300 mL/min&#xD;
&#xD;
          -  Patient treated with a high surface area dialyzer ≥ 1,8 m²&#xD;
&#xD;
          -  Patient covered by the social French health organism&#xD;
&#xD;
          -  Patient informed of the study goals and having signed the informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient with a vascular access not allowing a blood flow rate minimum of 300 mL/min&#xD;
&#xD;
          -  Patient with a fast progressive chronic disease&#xD;
&#xD;
          -  Patient with an uncontrolled anemia&#xD;
&#xD;
          -  Patient refusing to sign the informed consent&#xD;
&#xD;
          -  Pregnant or nursing patient&#xD;
&#xD;
          -  Pediatric patient&#xD;
&#xD;
          -  Patient under tutorship&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jean Paul CRISTOL, Professor</last_name>
    <role>Study Director</role>
    <affiliation>University Hospital, Montpellier</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>AIDER-Lapeyronie</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>26656534</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>26672890</PMID>
  </reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>July 12, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>February 20, 2019</last_update_submitted>
  <last_update_submitted_qc>February 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Failure, Chronic</mesh_term>
    <mesh_term>Inflammation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03262272
org study id: BIOMODAL 2016-A01122-49
nct id: NCT03262272
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Prospective randomized cross-over study
primary purpose: Treatment
masking: None (Open Label)
measure: Evaluation of middle molecules extraction
time frame: one week per dialyzer per patient
description: Measurements of β 2 microglobulin (11,8kDa), myoglobin (17kDa), Beta Trace (21kDa), Free immunoglobulin light chains Kappa (23kDa), myostatin (40kDa), glycoprotein orosomucoïd (44kDa)
measure: Extraction of uremic toxins
time frame: one week per dialyzer per patient
description: Urea
Creatinin
inorganic phosphates
measure: Biocompatibility assessment
time frame: one week per dialyzer per patient
description: Anaphylatoxins (C3a, C5a) during the session (T0, T15, Tend)
TNF-α and IL-6 (T0 et Tend)
measure: Monitoring of Nutrition status
time frame: one week per dialyzer per patient
description: 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
measure: Handling of the devices
time frame: one week per dialyzer per patient
description: - Evaluation of the priming and recovery for each dialysis session
measure: Dialysis adequacy evaluation
time frame: one week per dialyzer per patient
description: Calculation of KT/V
measure: Session tolerance
time frame: one week per dialyzer per patient
description: All secondary troubles will be noted: cramps, nauseas, hypotension…
measure: Parameters inflammation
time frame: one week per dialyzer per patient
description: CRP (mg/l)
measure: Parameters inflammation
time frame: one week per dialyzer per patient
description: - Calcul of PINI = [CRP(mg/l) x Orosomucoïd (mg/l)] / [Albumin(g/l) x Pre-albumin(mg/l)]
arm group label: Hemodialysis
arm group type: Experimental
description: patients treated by conventionnal hemodialysis
arm group label: Hemodiafiltration post dilution
arm group type: Experimental
description: patients treated by HDF post-dilution
intervention type: Device
intervention name: VIE A Hemodialyzer
description: polysulfon membrane coated with vitamin E
arm group label: Hemodiafiltration post dilution
arm group label: Hemodialysis
intervention type: Device
intervention name: Rexsys 27H hemodialyzer
description: polyethersulfon membrane with large surface area : 2,7m²
arm group label: Hemodiafiltration post dilution
arm group label: Hemodialysis
intervention type: Device
intervention name: Leoceed 21HX hemodialyzer
description: polyslfon membrane with gamma sterilization
arm group label: Hemodiafiltration post dilution
arm group label: Hemodialysis
intervention type: Device
intervention name: Polypure 22S+ hemodialyzer
description: polysulfon membrane with steam sterilization
arm group label: Hemodiafiltration post dilution
arm group label: Hemodialysis
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jean Paul CRISTOL, Professor
role: Study Director
affiliation: University Hospital, Montpellier
facility: 
country: France
citation: 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
citation: 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
responsible party type: Sponsor
mesh term: Kidney Failure, Chronic
mesh term: Inflammation
sharing ipd: No