<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/NCT01721421</url>
  </required_header>
  <id_info>
    <org_study_id>11-LL-0505</org_study_id>
    <nct_id>NCT01721421</nct_id>
  </id_info>
  <brief_title>Effects of Extended Haemodialysis Treatment Duration in Patients With End-stage Renal Disease</brief_title>
  <official_title>Feasibility and Physiological and Nutritional Effects of Extended Treatment Duration in Patients With End-stage Renal Disease on Haemodialysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Imperial College London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Imperial College London</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Design: Prospective randomised cross-over study. Fifty-two eligible patients will be&#xD;
      randomised to a treatment time of either 6 hours or 4 hours for a period of 24 weeks and&#xD;
      following a washout period of 4 weeks, switch to the alternative treatment time for an&#xD;
      additional 24 weeks.&#xD;
&#xD;
      Aims: To examine the feasibility and effect of extended dialysis treatment time, 6 hours&#xD;
      thrice weekly, versus the standard, 4 hours thrice weekly, comparing the differences from&#xD;
      baseline in outcome measures over a total 12-month period.&#xD;
&#xD;
      Primary outcome measure&#xD;
&#xD;
      1]Serum albumin&#xD;
&#xD;
      Secondary outcome measures Nutritional status&#xD;
&#xD;
        1. Malnutrition-inflammation score&#xD;
&#xD;
        2. Dietary intake&#xD;
&#xD;
        3. Hand-Grip strength&#xD;
&#xD;
        4. Energy expenditure&#xD;
&#xD;
      Quality of life&#xD;
&#xD;
        1. Patient reported quality of life and&#xD;
&#xD;
        2. time to recovery from dialysis&#xD;
&#xD;
      Serum biomarkers&#xD;
&#xD;
        1. BNP&#xD;
&#xD;
        2. Troponin&#xD;
&#xD;
        3. MCP-1&#xD;
&#xD;
      Others 24- hour Ambulatory blood pressure 24-hour accelerometer&#xD;
&#xD;
      Population: Local haemodialysis population of 1200 patients Eligibility: Minimum 90days on&#xD;
      haemodialysis treatment Duration: Fifty-six weeks&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2011</start_date>
  <completion_date type="Anticipated">February 2015</completion_date>
  <primary_completion_date type="Anticipated">March 2014</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>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Serum albumin</measure>
    <time_frame>baseline to 24 weeks</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">52</enrollment>
  <condition>End Stage Renal Disease</condition>
  <arm_group>
    <arm_group_label>Extended Treatment time</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Extended treatment time of 6 hours</description>
  </arm_group>
  <arm_group>
    <arm_group_label>standard treatment time</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard Treatment time of 4 hours</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>extended treatment time</intervention_name>
    <description>patients receive extended dialysis treatment time time of 6 hours</description>
    <arm_group_label>Extended Treatment time</arm_group_label>
    <arm_group_label>standard treatment time</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard treatment time</intervention_name>
    <arm_group_label>Extended Treatment time</arm_group_label>
    <arm_group_label>standard treatment time</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Dialysis dependant for over 90 days&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Haemodialysis for less than 90 days&#xD;
&#xD;
          2. Patients with anticipated life expectancy less than 6 months secondary to significant&#xD;
             morbidity e.g. metastatic malignancy, advanced human immunodeficiency virus&#xD;
&#xD;
          3. Patients with acute liver disease; History of underlying haematological condition;&#xD;
&#xD;
          4. Elective planned change of renal replacement modality within the 12 months.&#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>Peter Choi, MBcHB PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Imperial College London</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Seema Singh</last_name>
    <phone>+44 208 3835249</phone>
    <email>s.singh11@imperial.ac.uk</email>
  </overall_contact>
  <location>
    <facility>
      <name>Imperial College Healthcare NHS Trust</name>
      <address>
        <city>London</city>
        <zip>W12 0HS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Seema Singh, MSc</last_name>
      <phone>+44 2083835249</phone>
      <email>s.singh11@imperial.ac.uk</email>
    </contact>
    <investigator>
      <last_name>Seema Singh, MSc</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Charles Pusey</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Peter Choi, PhD MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 1, 2012</study_first_submitted>
  <study_first_submitted_qc>November 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 4, 2012</study_first_posted>
  <last_update_submitted>November 2, 2012</last_update_submitted>
  <last_update_submitted_qc>November 2, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 4, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>haemodialysis</keyword>
  <keyword>Crossover</keyword>
  <keyword>Treatment time</keyword>
  <keyword>nutritional status</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Kidney Failure, Chronic</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/NCT01721421
org study id: 11-LL-0505
nct id: NCT01721421
lead sponsor: 
has dmc: No
Design: Prospective randomised cross-over study. Fifty-two eligible patients will be
      randomised to a treatment time of either 6 hours or 4 hours for a period of 24 weeks and
      following a washout period of 4 weeks, switch to the alternative treatment time for an
      additional 24 weeks.

      Aims: To examine the feasibility and effect of extended dialysis treatment time, 6 hours
      thrice weekly, versus the standard, 4 hours thrice weekly, comparing the differences from
      baseline in outcome measures over a total 12-month period.

      Primary outcome measure

      1]Serum albumin

      Secondary outcome measures Nutritional status

        1. Malnutrition-inflammation score

        2. Dietary intake

        3. Hand-Grip strength

        4. Energy expenditure

      Quality of life

        1. Patient reported quality of life and

        2. time to recovery from dialysis

      Serum biomarkers

        1. BNP

        2. Troponin

        3. MCP-1

      Others 24- hour Ambulatory blood pressure 24-hour accelerometer

      Population: Local haemodialysis population of 1200 patients Eligibility: Minimum 90days on
      haemodialysis treatment Duration: Fifty-six weeks
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Serum albumin
time frame: baseline to 24 weeks
arm group label: Extended Treatment time
arm group type: Experimental
description: Extended treatment time of 6 hours
arm group label: standard treatment time
arm group type: Active Comparator
description: Standard Treatment time of 4 hours
intervention type: Other
intervention name: extended treatment time
description: patients receive extended dialysis treatment time time of 6 hours
arm group label: Extended Treatment time
arm group label: standard treatment time
intervention type: Other
intervention name: Standard treatment time
arm group label: Extended Treatment time
arm group label: standard treatment time
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Peter Choi, MBcHB PhD
role: Principal Investigator
affiliation: Imperial College London
last name: Seema Singh
phone: +44 208 3835249
email: s.singh11@imperial.ac.uk
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Kidney Failure, Chronic