<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/NCT03803514</url>
  </required_header>
  <id_info>
    <org_study_id>ID-11102-23</org_study_id>
    <nct_id>NCT03803514</nct_id>
  </id_info>
  <brief_title>Effect of rEPO in FGF23 in ESRD Patients</brief_title>
  <official_title>Effect of Recombinant Erythropoietin in Plasma Levels of FGF23 in End-Stage Renal Disease Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Chile</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Chile</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Objective: To evaluate the effects of recombinant Erythropoietin (rEPO) in plasma levels of&#xD;
      Fibroblast Growth Factor 23 (FGF23) in End-Stage Renal Disease (ESRD) patients in&#xD;
      hemodialysis.&#xD;
&#xD;
      Method: Prospective cohort of ESRD patients in HD, where patients with or without rEPO&#xD;
      therapy were compared. Measurements of plasma FGF23 were performed at baseline and during the&#xD;
      complete study. Demographic, clinical and laboratory data will be obtained.&#xD;
&#xD;
      Follow-up period: 12 weeks.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Experimental data has shown that recombinant erythropoietin (rEPO) increases plasma levels of&#xD;
      Fibroblast Growth Factor 23 (FGF23) in murines, both health and with acute or chronic renal&#xD;
      disease. Also, observational studies indicate an association between EPO and FGF23 levels in&#xD;
      patients. Until now, it has not been demonstrated whether the use of rEPO does increase&#xD;
      plasma FGF23 in End-Stage Renal Disease (ESRD) patients in hemodialysis (a population with a&#xD;
      high use of this therapy for the management of chronic anemia).&#xD;
&#xD;
      Our objective was to evaluate whether the administration of rEPO increases plasma FGF23&#xD;
      levels in ESRD patients in hemodialysis.&#xD;
&#xD;
      We performed a prospective cohort with ESRD patients without rEPO therapy. We performed 2&#xD;
      groups: patients with requirements of rEPO therapy due to anemia (Hb &lt; 10 g/dL) and patients&#xD;
      without rEPO therapy (Hb &gt; 10 g/dL).&#xD;
&#xD;
      We measured plasma FGF23 (intact and C-terminal) at baseline and during 12 weeks.&#xD;
&#xD;
      Demographic, clinical and laboratory data was obtained. Patients treated with rEPO received&#xD;
      beta-epoetin (Recormon, Roche), according to current recommendations.&#xD;
&#xD;
      Patients were follow-up during 3 months to evaluate the effects of rEPO. Our primary outcome&#xD;
      was changes in plasma intact FGF23 at 12 weeks, between both groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 15, 2017</start_date>
  <completion_date type="Actual">October 20, 2019</completion_date>
  <primary_completion_date type="Actual">March 31, 2019</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in plasma intact FGF23 levels</measure>
    <time_frame>12 weeks</time_frame>
    <description>Measurements of plasma intact FGF23 levels</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in plasma C-terminal FGF23 levels</measure>
    <time_frame>12 weeks</time_frame>
    <description>Measurements of plasma C-terminal FGF23 levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in hematocrit and hemoglobin</measure>
    <time_frame>12 weeks</time_frame>
    <description>Measurements of hematocrit and hemoglobin in blood samples</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in parathormone levels</measure>
    <time_frame>12 weeks</time_frame>
    <description>Measurements of parathormone levels in blood samples</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">60</enrollment>
  <condition>Anemia</condition>
  <condition>Chronic Kidney Diseases</condition>
  <arm_group>
    <arm_group_label>Treated group (rEPO)</arm_group_label>
    <description>Patients with ESRD in HD, and medical indication of recombinant EPO for management of anemia (Hb &lt; 10 g/dL). Ambulatory hemodialysis 3 times per week.&#xD;
Recombinant beta-epoetin (Recormon) will be used, according to current recommendations.&#xD;
Clinical and laboratory data will be obtained before and during the study. The primary outcome (changes of plasma intact FGF23) will be measured during the follow-up, up to 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>Patients with ESRD and HD, without medical indication of recombinant EPO (Hb &gt; 10 g/dL). Ambulatory hemodialysis 3 times per week.&#xD;
Follow-up for 3 months, similar than rEPO group. Clinical and laboratory data will be obtained before and during the study, similar periods than rEPO group.&#xD;
The primary outcome (changes of plasma FGF23) will be measured every 2 week during the evaluation period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Recombinant EPO</intervention_name>
    <description>Beta-epoetin (Recormon, Roche). Dosage was performed according to current recommendations.</description>
    <arm_group_label>Treated group (rEPO)</arm_group_label>
    <other_name>rEPO</other_name>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Plasma samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Pacients in chronic hemodialysis, will be measured with FGF23 levels&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  End-Stage Renal Disease&#xD;
&#xD;
          -  Requirements of Hemodialysis&#xD;
&#xD;
          -  At least 6 months since initiation of hemodialysis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Treatment with rhEPO or analogs during the previous 6 months or earlier&#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>Luis Michea, MD PhD</last_name>
    <role>Study Chair</role>
    <affiliation>University of Chile</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Clinico Universidad de Chile</name>
      <address>
        <city>Santiago</city>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Chile</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>January 10, 2019</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>May 25, 2020</last_update_submitted>
  <last_update_submitted_qc>May 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Chile</investigator_affiliation>
    <investigator_full_name>Luis Toro</investigator_full_name>
    <investigator_title>Co-researcher</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03803514
org study id: ID-11102-23
nct id: NCT03803514
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Objective: To evaluate the effects of recombinant Erythropoietin (rEPO) in plasma levels of
      Fibroblast Growth Factor 23 (FGF23) in End-Stage Renal Disease (ESRD) patients in
      hemodialysis.

      Method: Prospective cohort of ESRD patients in HD, where patients with or without rEPO
      therapy were compared. Measurements of plasma FGF23 were performed at baseline and during the
      complete study. Demographic, clinical and laboratory data will be obtained.

      Follow-up period: 12 weeks.
Experimental data has shown that recombinant erythropoietin (rEPO) increases plasma levels of
      Fibroblast Growth Factor 23 (FGF23) in murines, both health and with acute or chronic renal
      disease. Also, observational studies indicate an association between EPO and FGF23 levels in
      patients. Until now, it has not been demonstrated whether the use of rEPO does increase
      plasma FGF23 in End-Stage Renal Disease (ESRD) patients in hemodialysis (a population with a
      high use of this therapy for the management of chronic anemia).

      Our objective was to evaluate whether the administration of rEPO increases plasma FGF23
      levels in ESRD patients in hemodialysis.

      We performed a prospective cohort with ESRD patients without rEPO therapy. We performed 2
      groups: patients with requirements of rEPO therapy due to anemia (Hb < 10 g/dL) and patients
      without rEPO therapy (Hb > 10 g/dL).

      We measured plasma FGF23 (intact and C-terminal) at baseline and during 12 weeks.

      Demographic, clinical and laboratory data was obtained. Patients treated with rEPO received
      beta-epoetin (Recormon, Roche), according to current recommendations.

      Patients were follow-up during 3 months to evaluate the effects of rEPO. Our primary outcome
      was changes in plasma intact FGF23 at 12 weeks, between both groups.
observational model: Cohort
time perspective: Prospective
measure: Changes in plasma intact FGF23 levels
time frame: 12 weeks
description: Measurements of plasma intact FGF23 levels
measure: Changes in plasma C-terminal FGF23 levels
time frame: 12 weeks
description: Measurements of plasma C-terminal FGF23 levels
measure: Changes in hematocrit and hemoglobin
time frame: 12 weeks
description: Measurements of hematocrit and hemoglobin in blood samples
measure: Changes in parathormone levels
time frame: 12 weeks
description: Measurements of parathormone levels in blood samples
arm group label: Treated group (rEPO)
description: Patients with ESRD in HD, and medical indication of recombinant EPO for management of anemia (Hb < 10 g/dL). Ambulatory hemodialysis 3 times per week.
Recombinant beta-epoetin (Recormon) will be used, according to current recommendations.
Clinical and laboratory data will be obtained before and during the study. The primary outcome (changes of plasma intact FGF23) will be measured during the follow-up, up to 12 weeks.
arm group label: Control group
description: Patients with ESRD and HD, without medical indication of recombinant EPO (Hb > 10 g/dL). Ambulatory hemodialysis 3 times per week.
Follow-up for 3 months, similar than rEPO group. Clinical and laboratory data will be obtained before and during the study, similar periods than rEPO group.
The primary outcome (changes of plasma FGF23) will be measured every 2 week during the evaluation period.
intervention type: Drug
intervention name: Recombinant EPO
description: Beta-epoetin (Recormon, Roche). Dosage was performed according to current recommendations.
arm group label: Treated group (rEPO)
other name: rEPO
Plasma samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Luis Michea, MD PhD
role: Study Chair
affiliation: University of Chile
facility: 
country: Chile
responsible party type: Principal Investigator
investigator affiliation: University of Chile
investigator full name: Luis Toro
investigator title: Co-researcher
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
sharing ipd: Undecided