<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/NCT04445558</url>
  </required_header>
  <id_info>
    <org_study_id>2020-A01267-32</org_study_id>
    <nct_id>NCT04445558</nct_id>
  </id_info>
  <brief_title>Study of 2 Modalities of Dialysis and Nutrition on the Nutritional Status of Malnourished Chronic Renal Disease Patients</brief_title>
  <official_title>Study of Two Modalities of Dialysis and Nutrition on the Nutritional Status of Malnourished Chronic End-stage Renal Disease Patients Dependent on Intradialytic Parenteral Nutrition</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GCS Ramsay Santé pour l'Enseignement et la Recherche</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GCS Ramsay Santé pour l'Enseignement et la Recherche</source>
  <oversight_info>
    <has_dmc>No</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>
      Describe the impact of dialysis by high permeability and adsorbent membrane (PEPA®)&#xD;
      associated with oral nutritional supplementation on the nutritional status of malnourished&#xD;
      chronic end-stage renal disease patients dependent on intradialytic parenteral nutrition.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study proposes to compare the nutritional state after 6 months of dialysis with standard&#xD;
      membrane associated with intradialytic parenteral nutrition (retrospective phase) with the&#xD;
      nutritional state after 6 months of dialysis with high permeability membrane associated with&#xD;
      oral nutritional supplementation (prospective phase).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 21, 2020</start_date>
  <completion_date type="Actual">June 4, 2021</completion_date>
  <primary_completion_date type="Actual">June 4, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evolution of the nutritional status</measure>
    <time_frame>Month 6</time_frame>
    <description>The main endpoint is the evolution between M0 and M6 of the nutritional status measured by the serum albumin level.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evolution of nutritional assessment</measure>
    <time_frame>Month 6</time_frame>
    <description>Evolution of the percentage of weight loss (in Kg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Appearance of adverse events</measure>
    <time_frame>Month 6</time_frame>
    <description>Incidence and characteristics of adverse events / effects</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure of the Quality of life</measure>
    <time_frame>Month 6</time_frame>
    <description>Evolution of the quality of life, evaluated by the EORTC QLQ-C30 questionnaire of the quality of life with 28 questions with 4 possible answers from &quot;not at all&quot; to &quot;a lot of&quot;</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Renal Insufficiency</condition>
  <arm_group>
    <arm_group_label>Membrane PEPA®</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient will use the membrane PEPA® for the dialysis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard membrane of dialysis</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patient will use a standard membrane for the dialysis</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>oral nutritional supplementation</intervention_name>
    <description>Adjunction of oral nutritional supplementation</description>
    <arm_group_label>Membrane PEPA®</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>intradialytic parenteral nutrition</intervention_name>
    <description>Adjunction of intradialytic parenteral nutrition</description>
    <arm_group_label>Standard membrane of dialysis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with renal failure, on hemodialysis for at least 12 months;&#xD;
&#xD;
          -  Hemodialysis patient in 3 weekly sessions on a device with a standard permeability&#xD;
             membrane (polysulfone, polyethersulfone or polyartylethersulfone type);&#xD;
&#xD;
          -  Malnourished patient, on intradialytic parenteral nutrition for at least 6 months;&#xD;
&#xD;
          -  Patient who may benefit, according to the doctor, from a change in dialysis and&#xD;
             nutrition strategy:&#xD;
&#xD;
          -  Patient who signed an informed consent form to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known allergy to PEPA® ;&#xD;
&#xD;
          -  Protected patient (under legal protection, or deprived of liberty by judicial or&#xD;
             administrative decision);&#xD;
&#xD;
          -  Patient with a chronic infection in progress;&#xD;
&#xD;
          -  Patient with life expectancy &lt;6 months according to the investigator;&#xD;
&#xD;
          -  Inability to understand information related to the study (linguistic, psychological,&#xD;
             cognitive reason, etc.);&#xD;
&#xD;
          -  Pregnant woman or likely to be (of childbearing age, without effective contraception)&#xD;
             or breastfeeding;&#xD;
&#xD;
          -  Patient participating in another clinical trial, or in a period of exclusion from&#xD;
             another clinical trial;&#xD;
&#xD;
          -  Patient not benefiting from a social security scheme.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hôpital Privé La Louvière</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>January 4, 2022</last_update_submitted>
  <last_update_submitted_qc>January 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 5, 2022</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>Renal Insufficiency</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/NCT04445558
org study id: 2020-A01267-32
nct id: NCT04445558
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Describe the impact of dialysis by high permeability and adsorbent membrane (PEPA®)
      associated with oral nutritional supplementation on the nutritional status of malnourished
      chronic end-stage renal disease patients dependent on intradialytic parenteral nutrition.
The study proposes to compare the nutritional state after 6 months of dialysis with standard
      membrane associated with intradialytic parenteral nutrition (retrospective phase) with the
      nutritional state after 6 months of dialysis with high permeability membrane associated with
      oral nutritional supplementation (prospective phase).
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Evolution of the nutritional status
time frame: Month 6
description: The main endpoint is the evolution between M0 and M6 of the nutritional status measured by the serum albumin level.
measure: Evolution of nutritional assessment
time frame: Month 6
description: Evolution of the percentage of weight loss (in Kg)
measure: Appearance of adverse events
time frame: Month 6
description: Incidence and characteristics of adverse events / effects
measure: Measure of the Quality of life
time frame: Month 6
description: Evolution of the quality of life, evaluated by the EORTC QLQ-C30 questionnaire of the quality of life with 28 questions with 4 possible answers from "not at all" to "a lot of"
arm group label: Membrane PEPA®
arm group type: Experimental
description: Patient will use the membrane PEPA® for the dialysis
arm group label: Standard membrane of dialysis
arm group type: Active Comparator
description: Patient will use a standard membrane for the dialysis
intervention type: Dietary Supplement
intervention name: oral nutritional supplementation
description: Adjunction of oral nutritional supplementation
arm group label: Membrane PEPA®
intervention type: Dietary Supplement
intervention name: intradialytic parenteral nutrition
description: Adjunction of intradialytic parenteral nutrition
arm group label: Standard membrane of dialysis
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Renal Insufficiency
sharing ipd: No