<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/NCT03782519</url>
  </required_header>
  <id_info>
    <org_study_id>N/2016/75</org_study_id>
    <nct_id>NCT03782519</nct_id>
  </id_info>
  <brief_title>Quality of Life of Frail Aged Patients in Incremental Hemodialysis</brief_title>
  <acronym>Qualifragilys</acronym>
  <official_title>Quality of Life of Frail Aged Patients in Incremental Hemodialysis: a Phase III Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Besancon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Besancon</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>
      End stage renal disease (ESRD) is a major public health problem. The dialysis population is&#xD;
      aging. As a result we observe a high prevalence of frailty among dialysis patients (ranges&#xD;
      from 3 to 10 fold higher than in the comparably aged general public). Frailty is a medical&#xD;
      syndrome characterized by diminished strength, endurance, and reduced physiologic function&#xD;
      that increases an individual's vulnerability for developing increased dependency and/or&#xD;
      death. Without systematic approach it is difficult for physicians to detect frailty phenotype&#xD;
      which however might be reversible or attenuated by interventions. Fried et al. developed a&#xD;
      frailty phenotype consisting of 3 or more of: unintentional weight loss, exhaustion, physical&#xD;
      inactivity, slow gait speed, and weak grip strength. The primary care of hemodialysis patient&#xD;
      is often supported by the nephrologist. Identification of frailty is integrated into the&#xD;
      primary care setting as one of the steps necessary for the overall assessment of the person&#xD;
      and planning to formal prevention interventions in an individualized care plan. Thrice-weekly&#xD;
      hemodialysis (HD) schedules are the standard default hemodialysis prescription in Western&#xD;
      countries, imposed in the 70s. For incremental HD, the weekly dose of dialysis is based on&#xD;
      variety of clinical factors such as residual kidney function, volume status, cardiovascular&#xD;
      symptoms, potassium level, nutritional status and, comorbid conditions. Incremental HD scheme&#xD;
      generally starts with 2 weekly sessions and then periodic monitoring of criteria mentioned&#xD;
      above are used to determine the timing for increasing dialysis dose and frequency to 3 weekly&#xD;
      sessions.&#xD;
&#xD;
      An approach that integrates systematic frailty phenotype assessment by nephrologists and&#xD;
      individualized incremental HD therapy can be beneficial within the first year of HD. It could&#xD;
      optimize health-related quality of life and other pertinent outcomes without affecting&#xD;
      negatively the quality of dialysis. The purpose of this study is to evaluate for frail aged&#xD;
      incidents hemodialysis patients the impact of implementation of an incremental HD on HRQoL&#xD;
      compared to conventional HD.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 9, 2019</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2022</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>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mental and physical health summary scores of the Medical Outcome Study - Short Form 36 (MOS SF-36)</measure>
    <time_frame>One year after the initiation of HD</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Symptom/problem, effects of kidney disease and burden of kidney disease dimensions of the Kidney Disease Quality of Life (KDQOL)</measure>
    <time_frame>One year after the initiation of HD</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">783</enrollment>
  <condition>Renal Dialysis</condition>
  <condition>Kidney Failure, Chronic</condition>
  <condition>Frailty</condition>
  <arm_group>
    <arm_group_label>Incremental hemodialysis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients who will begin HD with two treatment sessions per week</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional hemodialysis</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients who will begin HD three times a week</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Dialysis frequency reduction</intervention_name>
    <description>At initiation, frequency of dialysis will be reduced to 2 weekly sessions (incremental HD)</description>
    <arm_group_label>Incremental hemodialysis</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Frailty diagnosis</intervention_name>
    <description>Before randomization, we will determine whether patients are frail. We will define frailty as the presence of at least three of the following five conditions: malnourished according to dietitian assessment and/or short form of Mini Nutritional Assessment (MNA), grip strength and gait speed using participants' scores on the SF-36 Physical Functioning (PF) scale, exhaustion using in the quality of life questionnaire SF-36 vitality (VT) scale and physical activity according to patient assessment (one single question)</description>
    <arm_group_label>Conventional hemodialysis</arm_group_label>
    <arm_group_label>Incremental hemodialysis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        For all patients (incident HD patients):&#xD;
&#xD;
          -  Patient aged over 60 years&#xD;
&#xD;
          -  Signature of informed consent&#xD;
&#xD;
          -  Affiliation to a French social security or receiving such a scheme&#xD;
&#xD;
          -  Patient with Chronic Kidney Disease Stage 5 (GFR &lt;15 ml/min/1.73m2)&#xD;
&#xD;
          -  Urine output &gt; 0,5 L per day&#xD;
&#xD;
          -  Kru ≥ 2 ml/min&#xD;
&#xD;
          -  Outpatient with scheduled start of HD&#xD;
&#xD;
          -  Understand and read french&#xD;
&#xD;
        For randomized patients (frail incident HD patients):&#xD;
&#xD;
        - Frailty according to L. Fried criteria: score greater than or equal to 3/5&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to understand the reasons for the study; psychiatric disorders&#xD;
&#xD;
          -  Active and/or treated neoplastic disease&#xD;
&#xD;
          -  Scheduled kidney transplantation within 6 months&#xD;
&#xD;
          -  Solid organ transplanted patient receiving immunosuppressive therapy&#xD;
&#xD;
          -  Estimated life expectancy &lt; 6 months&#xD;
&#xD;
          -  Patient with diagnosis of severe chronic heart failure (&gt; 2 congestive heart failure&#xD;
             episodes requiring hospitalization in the year preceding the start of HD)&#xD;
&#xD;
          -  Legal disability or limited legal capacity&#xD;
&#xD;
          -  Patient without health insurance&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
          -  Patient in the period of exclusion of another study&#xD;
&#xD;
          -  Uncooperative patient&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cécile Courivaud, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nephrology, Dialysis and Renal Transplantation - CHU Besançon</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Charline Vauchy, PhD</last_name>
    <phone>+33381218875</phone>
    <email>cvauchy@chu-besancon.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ingrid Tissot</last_name>
    <phone>+33381218427</phone>
    <email>itissot@chu-besancon.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Besançon</name>
      <address>
        <city>Besançon</city>
        <zip>25000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Charline Vauchy, PhD</last_name>
      <email>cvauchy@chu-besancon.fr</email>
    </contact>
    <investigator>
      <last_name>Cécile Courivaud, Prof.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Fiteni F, Pam A, Anota A, Vernerey D, Paget-Bailly S, Westeel V, Bonnetain F. Health-related quality-of-life as co-primary endpoint in randomized clinical trials in oncology. Expert Rev Anticancer Ther. 2015;15(8):885-91. doi: 10.1586/14737140.2015.1047768. Epub 2015 May 31.</citation>
    <PMID>26027598</PMID>
  </reference>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>December 7, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>April 4, 2022</last_update_submitted>
  <last_update_submitted_qc>April 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Incremental Hemodialysis</keyword>
  <keyword>Nephrology</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Renal Insufficiency</mesh_term>
    <mesh_term>Kidney Failure, Chronic</mesh_term>
    <mesh_term>Frailty</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/NCT03782519
org study id: N/2016/75
nct id: NCT03782519
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
End stage renal disease (ESRD) is a major public health problem. The dialysis population is
      aging. As a result we observe a high prevalence of frailty among dialysis patients (ranges
      from 3 to 10 fold higher than in the comparably aged general public). Frailty is a medical
      syndrome characterized by diminished strength, endurance, and reduced physiologic function
      that increases an individual's vulnerability for developing increased dependency and/or
      death. Without systematic approach it is difficult for physicians to detect frailty phenotype
      which however might be reversible or attenuated by interventions. Fried et al. developed a
      frailty phenotype consisting of 3 or more of: unintentional weight loss, exhaustion, physical
      inactivity, slow gait speed, and weak grip strength. The primary care of hemodialysis patient
      is often supported by the nephrologist. Identification of frailty is integrated into the
      primary care setting as one of the steps necessary for the overall assessment of the person
      and planning to formal prevention interventions in an individualized care plan. Thrice-weekly
      hemodialysis (HD) schedules are the standard default hemodialysis prescription in Western
      countries, imposed in the 70s. For incremental HD, the weekly dose of dialysis is based on
      variety of clinical factors such as residual kidney function, volume status, cardiovascular
      symptoms, potassium level, nutritional status and, comorbid conditions. Incremental HD scheme
      generally starts with 2 weekly sessions and then periodic monitoring of criteria mentioned
      above are used to determine the timing for increasing dialysis dose and frequency to 3 weekly
      sessions.

      An approach that integrates systematic frailty phenotype assessment by nephrologists and
      individualized incremental HD therapy can be beneficial within the first year of HD. It could
      optimize health-related quality of life and other pertinent outcomes without affecting
      negatively the quality of dialysis. The purpose of this study is to evaluate for frail aged
      incidents hemodialysis patients the impact of implementation of an incremental HD on HRQoL
      compared to conventional HD.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Mental and physical health summary scores of the Medical Outcome Study - Short Form 36 (MOS SF-36)
time frame: One year after the initiation of HD
measure: Symptom/problem, effects of kidney disease and burden of kidney disease dimensions of the Kidney Disease Quality of Life (KDQOL)
time frame: One year after the initiation of HD
arm group label: Incremental hemodialysis
arm group type: Experimental
description: Patients who will begin HD with two treatment sessions per week
arm group label: Conventional hemodialysis
arm group type: Active Comparator
description: Patients who will begin HD three times a week
intervention type: Other
intervention name: Dialysis frequency reduction
description: At initiation, frequency of dialysis will be reduced to 2 weekly sessions (incremental HD)
arm group label: Incremental hemodialysis
intervention type: Other
intervention name: Frailty diagnosis
description: Before randomization, we will determine whether patients are frail. We will define frailty as the presence of at least three of the following five conditions: malnourished according to dietitian assessment and/or short form of Mini Nutritional Assessment (MNA), grip strength and gait speed using participants' scores on the SF-36 Physical Functioning (PF) scale, exhaustion using in the quality of life questionnaire SF-36 vitality (VT) scale and physical activity according to patient assessment (one single question)
arm group label: Conventional hemodialysis
arm group label: Incremental hemodialysis
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Cécile Courivaud, MD, PhD
role: Principal Investigator
affiliation: Nephrology, Dialysis and Renal Transplantation - CHU Besançon
last name: Charline Vauchy, PhD
phone: +33381218875
email: cvauchy@chu-besancon.fr
last name: Ingrid Tissot
phone: +33381218427
email: itissot@chu-besancon.fr
facility: 
status: Recruiting
contact: 
investigator: 
country: France
citation: Fiteni F, Pam A, Anota A, Vernerey D, Paget-Bailly S, Westeel V, Bonnetain F. Health-related quality-of-life as co-primary endpoint in randomized clinical trials in oncology. Expert Rev Anticancer Ther. 2015;15(8):885-91. doi: 10.1586/14737140.2015.1047768. Epub 2015 May 31.
PMID: 26027598
responsible party type: Sponsor
mesh term: Renal Insufficiency
mesh term: Kidney Failure, Chronic
mesh term: Frailty
sharing ipd: No