<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/NCT02240004</url>
  </required_header>
  <id_info>
    <org_study_id>CRB2014</org_study_id>
    <nct_id>NCT02240004</nct_id>
  </id_info>
  <brief_title>Hemo Filtration Reinfusion (HFR) Clearance Efficiency Towards P-bound Toxins and Effects on Inflammatory and Endothelial Damage Markers</brief_title>
  <acronym>SUPREMO</acronym>
  <official_title>Removal of Uremic Toxins and Improvement of Chronic Inflammation With HFR in Comparison With &quot;On-Line&quot; Hemodiafiltration and High Flux Hemodialysis.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Universitario Reina Sofia de Cordoba</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Universitario Reina Sofia de Cordoba</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to compare purification efficiency of HFR in terms of clearance of&#xD;
      protein-bound toxins and the effects on markers of inflammation and endothelial damage, in&#xD;
      comparison to HF-HD and OL-HDF.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Protein-bound uremic toxins are poorly removed by current dialysis techniques because of&#xD;
      their size, which is larger than the pore size of dialysis membranes available in the market.&#xD;
      These protein-bound uremic toxins have emerged as important risk factors for progression of&#xD;
      CKD, as well as for cardiovascular disease. Several studies have demonstrated that&#xD;
      protein-bound uremic toxins induce vascular inflammation, endothelial dysfunction and&#xD;
      vascular calcification.&#xD;
&#xD;
      In dialysis patients, serum concentrations of p-cresyl sulphate and indoxyl sulphate are&#xD;
      approximately 17 and 54 times higher, respectively, than in healthy subjects. Because these&#xD;
      toxins are bound to proteins, only a 30% or less is removed efficiently by hemodialysis.&#xD;
      Traditional renal replacement therapies depend upon diffusion and convection for solute&#xD;
      clearances and the use of an adsorbent in combination with dialysis membranes may be a new&#xD;
      therapeutic option to increase removal rate of these uremic protein-bound toxins.&#xD;
&#xD;
      HFR technique uses a dual dialyzer with a resin between chambers. The first chamber is a&#xD;
      high-flux membrane where convective process takes place. The ultrafiltrate obtained from this&#xD;
      first chamber passes through the cartridge and is reinfused before the second chamber, a&#xD;
      low-flux membrane, where diffusive process is performed.&#xD;
&#xD;
      In HFR, adsorption and haemodiafiltration are attached, using ultrafiltrate as a replacement&#xD;
      fluid and being capable of theoretically removing most medium and high molecular weight&#xD;
      uremic toxins. A potential benefit has been regarded for toxicity, biocompatibility,&#xD;
      tolerance, and preservation of essential elements such as albumin, vitamins, amino acids or&#xD;
      growth factors. An improvement on oxidative stress has also been described in HFR.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2014</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Inflammatory status: (CD14+ CD16+, CD14++ CD16+, cytokines levels)</measure>
    <time_frame>12 weeks</time_frame>
  </primary_outcome>
  <enrollment type="Actual">9</enrollment>
  <condition>Inflammation</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SUPRA HFR</intervention_name>
    <description>usual dialytic prescription for duration, frequency, acid buffer and anticoagulation regimen</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing dialysis three times week&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Stable patients on hemodialysis for al least 3 month&#xD;
&#xD;
          -  older than 18 year old&#xD;
&#xD;
          -  dialyzed at least for two months with a high-flux membrane permeability&#xD;
&#xD;
          -  arteriovenous fistula with high blood flow (&gt; 350 ml / min)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  active neoplasia&#xD;
&#xD;
          -  positive viral markers (HBsAg, anti-HCV and HIV),&#xD;
&#xD;
          -  clinical signs of active infection and/or inflammation,&#xD;
&#xD;
          -  albumin &lt; 3.5 g/dl.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>HU Reina Sofia</name>
      <address>
        <city>Cordoba</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>September 10, 2014</study_first_submitted>
  <study_first_submitted_qc>September 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 15, 2014</study_first_posted>
  <last_update_submitted>March 27, 2015</last_update_submitted>
  <last_update_submitted_qc>March 27, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 30, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Universitario Reina Sofia de Cordoba</investigator_affiliation>
    <investigator_full_name>Alejandro Martin-Malo</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Inflammation</mesh_term>
  </condition_browse>
  <!-- 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/NCT02240004
org study id: CRB2014
nct id: NCT02240004
lead sponsor: 
has dmc: No
The aim of this study is to compare purification efficiency of HFR in terms of clearance of
      protein-bound toxins and the effects on markers of inflammation and endothelial damage, in
      comparison to HF-HD and OL-HDF.
Protein-bound uremic toxins are poorly removed by current dialysis techniques because of
      their size, which is larger than the pore size of dialysis membranes available in the market.
      These protein-bound uremic toxins have emerged as important risk factors for progression of
      CKD, as well as for cardiovascular disease. Several studies have demonstrated that
      protein-bound uremic toxins induce vascular inflammation, endothelial dysfunction and
      vascular calcification.

      In dialysis patients, serum concentrations of p-cresyl sulphate and indoxyl sulphate are
      approximately 17 and 54 times higher, respectively, than in healthy subjects. Because these
      toxins are bound to proteins, only a 30% or less is removed efficiently by hemodialysis.
      Traditional renal replacement therapies depend upon diffusion and convection for solute
      clearances and the use of an adsorbent in combination with dialysis membranes may be a new
      therapeutic option to increase removal rate of these uremic protein-bound toxins.

      HFR technique uses a dual dialyzer with a resin between chambers. The first chamber is a
      high-flux membrane where convective process takes place. The ultrafiltrate obtained from this
      first chamber passes through the cartridge and is reinfused before the second chamber, a
      low-flux membrane, where diffusive process is performed.

      In HFR, adsorption and haemodiafiltration are attached, using ultrafiltrate as a replacement
      fluid and being capable of theoretically removing most medium and high molecular weight
      uremic toxins. A potential benefit has been regarded for toxicity, biocompatibility,
      tolerance, and preservation of essential elements such as albumin, vitamins, amino acids or
      growth factors. An improvement on oxidative stress has also been described in HFR.
observational model: Cohort
time perspective: Cross-Sectional
measure: Inflammatory status: (CD14+ CD16+, CD14++ CD16+, cytokines levels)
time frame: 12 weeks
intervention type: Device
intervention name: SUPRA HFR
description: usual dialytic prescription for duration, frequency, acid buffer and anticoagulation regimen
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Hospital Universitario Reina Sofia de Cordoba
investigator full name: Alejandro Martin-Malo
investigator title: MD
mesh term: Inflammation