<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/NCT03302546</url>
  </required_header>
  <id_info>
    <org_study_id>034/17</org_study_id>
    <nct_id>NCT03302546</nct_id>
  </id_info>
  <brief_title>Incremental Hemodialysis as a Starting Way of Renal Replacement Therapy</brief_title>
  <official_title>Incremental Hemodialysis as a Starting Way of Renal Replacement Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal</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>
      The Hemodialysis Unit of the Hospital Ramon y Cajal is a pioneer in the implementation of a&#xD;
      program of incremental hemodialysis, starting with two sessions a week in patients with&#xD;
      residual renal function.&#xD;
&#xD;
      The main objective is to compare whether the initiation of hemodialysis with two sessions a&#xD;
      week over conventional pattern of initiation of three sessions a week better preserves&#xD;
      residual renal function.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary specific objective is to assess the loss of renal function defined as 24 hours&#xD;
      diuresis less than 100 ml at 12 months of starting treatment. Secondary objectives are:&#xD;
      erythropoietin dose, concentration of beta 2-microglobulin, p-cresol, fenol, the state of&#xD;
      hydration and nutrition, adverse effects, hospital admissions, mortality and quality of life,&#xD;
      comparing both arms of treatment.&#xD;
&#xD;
      DESIGN: Multicenter randomized clinical trial. Randomization will be performed by an external&#xD;
      agent that guarantees an homogeneous balance between both arms. The randomization sequence&#xD;
      will not be available for the investigators responsible of the patients.&#xD;
&#xD;
      Inclusion criteria: Patients starting hemodialysis that maintain residual diuresis and urea&#xD;
      clearance greater than or equal to 2.5 ml / min with a minimum follow-up of one year.&#xD;
&#xD;
      Exclusion criteria: Anuric patients, patients with acute renal failure and patients who start&#xD;
      hemodialysis after having going through a renal transplant.&#xD;
&#xD;
      The variables that will be analyzed are 24h diuresis, urea clearance, creatinin clearance,&#xD;
      haemoglobin, leukocytes, platelets, creatinin, urea, Na, K, albumin, prealbumin, Ca, P, PTH,&#xD;
      PCR, ferritin, B2microglobulin, BNP, KT/V, Erythropoietin dose, state of hydratation and life&#xD;
      quality.&#xD;
&#xD;
      Sample size should be of 42 patients on each arm of treatment to obtain a 95% confidence&#xD;
      (α=0,05) and a 80% of statistical power (β=0,20).&#xD;
&#xD;
      The normality of the data will be analyzed with Kolmogorov-Smirnov test which will allow to&#xD;
      use parametric tests (T-student) or non-parametric tests (U-Mann-Whitney). Association of&#xD;
      categoric variables of both arms will be analyzed with Chi2 test, or using Fisher statistic.&#xD;
&#xD;
      Loss of renal function will be analyzed up to 12 months and time studies will be performed&#xD;
      through non-parametric test (Kaplan-Meier), obtaining the estimated probability of loss of&#xD;
      renal function in both arms and comparing survival functions through &quot;Log-Rank&quot; statistic.&#xD;
&#xD;
      The demonstration of efficacy and safety through a clinical trial would spread this clinical&#xD;
      practice in the nephrology community and therefore in our national health system.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 4, 2017</start_date>
  <completion_date type="Anticipated">December 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2020</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Asses the loss of residual renal function in patients who started chronic hemodialysis</measure>
    <time_frame>Measurements of multiple variables to measure renal function each two months during one year period</time_frame>
    <description>Assess the loss of renal function evolution in patients starting hemodialysis therapy 2 days per week, versus patients with hemodialysis 3 days per week.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">7</enrollment>
  <condition>Chronic Renal Failure</condition>
  <arm_group>
    <arm_group_label>Incremental Hemodialysis</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects on this arm will be treated with 2 hemodialysis sessions of at least 4 hour per week.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional hemodialysis</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects on this arms will be treated with 3 hemodialysis sessions of at least 3.5 hour per week.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Incremental hemodialysis</intervention_name>
    <description>Patients randomized to this arm of treatment will be treated during at least 4 hours of hemodialysis twice per week</description>
    <arm_group_label>Incremental Hemodialysis</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Conventional hemodialysis</intervention_name>
    <description>Patients randomized to this arm of treatment will be treated during at least 3.5 hours of hemodialysis three times per week</description>
    <arm_group_label>Conventional hemodialysis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects starting renal replacement therapy from January 2017 to June 2018.&#xD;
&#xD;
          -  Subjects who consent to sign the Informed Consent Form.&#xD;
&#xD;
          -  Subject who maintain residual diuresis and urea clearance equal or superior to 2,5&#xD;
             ml/min.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Anuric patients.&#xD;
&#xD;
          -  Patients with acute renal failure.&#xD;
&#xD;
          -  Patients who revoke the Informed Consent Form.&#xD;
&#xD;
          -  Patients who start hemodialysis after having going through a renal transplant.&#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_contact>
    <last_name>Milagros Fernández-Lucas, MD</last_name>
    <phone>913368810</phone>
    <email>milagros.fernandez@salud.madrid.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Andrea Collado, PhD</last_name>
    <phone>913368018</phone>
    <email>andrea.collado@salud.madrid.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hospital Ramón y Cajal</name>
      <address>
        <city>Madrid</city>
        <zip>28034</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Milagros Fernández-Lucas, MD</last_name>
      <phone>913368810</phone>
      <email>milagros.fernandez@salud.madrid.org</email>
    </contact>
    <contact_backup>
      <last_name>Andrea Collado, PhD</last_name>
      <phone>913368018</phone>
      <email>andrea.collado@salud.madrid.org</email>
    </contact_backup>
    <investigator>
      <last_name>Milagros Fernández-Lucas, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Gloria Ruiz-Roso, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 3, 2017</study_first_submitted>
  <study_first_submitted_qc>October 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 5, 2017</study_first_posted>
  <last_update_submitted>July 29, 2020</last_update_submitted>
  <last_update_submitted_qc>July 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2020</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>
  </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/NCT03302546
org study id: 034/17
nct id: NCT03302546
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The Hemodialysis Unit of the Hospital Ramon y Cajal is a pioneer in the implementation of a
      program of incremental hemodialysis, starting with two sessions a week in patients with
      residual renal function.

      The main objective is to compare whether the initiation of hemodialysis with two sessions a
      week over conventional pattern of initiation of three sessions a week better preserves
      residual renal function.
The primary specific objective is to assess the loss of renal function defined as 24 hours
      diuresis less than 100 ml at 12 months of starting treatment. Secondary objectives are:
      erythropoietin dose, concentration of beta 2-microglobulin, p-cresol, fenol, the state of
      hydration and nutrition, adverse effects, hospital admissions, mortality and quality of life,
      comparing both arms of treatment.

      DESIGN: Multicenter randomized clinical trial. Randomization will be performed by an external
      agent that guarantees an homogeneous balance between both arms. The randomization sequence
      will not be available for the investigators responsible of the patients.

      Inclusion criteria: Patients starting hemodialysis that maintain residual diuresis and urea
      clearance greater than or equal to 2.5 ml / min with a minimum follow-up of one year.

      Exclusion criteria: Anuric patients, patients with acute renal failure and patients who start
      hemodialysis after having going through a renal transplant.

      The variables that will be analyzed are 24h diuresis, urea clearance, creatinin clearance,
      haemoglobin, leukocytes, platelets, creatinin, urea, Na, K, albumin, prealbumin, Ca, P, PTH,
      PCR, ferritin, B2microglobulin, BNP, KT/V, Erythropoietin dose, state of hydratation and life
      quality.

      Sample size should be of 42 patients on each arm of treatment to obtain a 95% confidence
      (α=0,05) and a 80% of statistical power (β=0,20).

      The normality of the data will be analyzed with Kolmogorov-Smirnov test which will allow to
      use parametric tests (T-student) or non-parametric tests (U-Mann-Whitney). Association of
      categoric variables of both arms will be analyzed with Chi2 test, or using Fisher statistic.

      Loss of renal function will be analyzed up to 12 months and time studies will be performed
      through non-parametric test (Kaplan-Meier), obtaining the estimated probability of loss of
      renal function in both arms and comparing survival functions through "Log-Rank" statistic.

      The demonstration of efficacy and safety through a clinical trial would spread this clinical
      practice in the nephrology community and therefore in our national health system.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Asses the loss of residual renal function in patients who started chronic hemodialysis
time frame: Measurements of multiple variables to measure renal function each two months during one year period
description: Assess the loss of renal function evolution in patients starting hemodialysis therapy 2 days per week, versus patients with hemodialysis 3 days per week.
arm group label: Incremental Hemodialysis
arm group type: Active Comparator
description: Subjects on this arm will be treated with 2 hemodialysis sessions of at least 4 hour per week.
arm group label: Conventional hemodialysis
arm group type: Active Comparator
description: Subjects on this arms will be treated with 3 hemodialysis sessions of at least 3.5 hour per week.
intervention type: Procedure
intervention name: Incremental hemodialysis
description: Patients randomized to this arm of treatment will be treated during at least 4 hours of hemodialysis twice per week
arm group label: Incremental Hemodialysis
intervention type: Procedure
intervention name: Conventional hemodialysis
description: Patients randomized to this arm of treatment will be treated during at least 3.5 hours of hemodialysis three times per week
arm group label: Conventional hemodialysis
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Milagros Fernández-Lucas, MD
phone: 913368810
email: milagros.fernandez@salud.madrid.org
last name: Andrea Collado, PhD
phone: 913368018
email: andrea.collado@salud.madrid.org
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: Spain
responsible party type: Sponsor
mesh term: Kidney Failure, Chronic