<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/NCT04491916</url>
  </required_header>
  <id_info>
    <org_study_id>KMUHIRB-F(I)-20190110</org_study_id>
    <nct_id>NCT04491916</nct_id>
  </id_info>
  <brief_title>Iron Therapy in Patients With End-Stage Renal Disease</brief_title>
  <official_title>A Cross-over Trial to Evaluate the Efficacy and Safety Between Increasing the Dose of Iron and Original Iron Dosage in Patients With Maintenance Hemodialysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kaohsiung Medical University Chung-Ho Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kaohsiung Medical University Chung-Ho Memorial Hospital</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will compare the clinical outcome of patients with maintenance dialysis room after&#xD;
      changing the iron treatment guidelines from original upper limit with ferritin&gt;500ng/ml, or&#xD;
      TSAT&gt;20% to Ferritin&gt; 800ng / ml, or TSAT&gt; 50%.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After two years of treatments, we will compare the incidence of clinical events, monthly&#xD;
      blood, and biochemical examination data for the two years before and after the change.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mortality</measure>
    <time_frame>2 years</time_frame>
    <description>the death events following up until 2022</description>
  </primary_outcome>
  <primary_outcome>
    <measure>coronary artery disease</measure>
    <time_frame>2 years</time_frame>
    <description>new onset coronary artery disease diagnosed with electrocardiogram (ST-segment changes, T inversion and Q wave appearance)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>coronary artery disease</measure>
    <time_frame>2 years</time_frame>
    <description>Progression of coronary artery disease (SCCT grading increase : 0% = no visible stenosis, 1-24% = minimal stenosis, 25-49% = mild stenosis, 50-69% = moderate stenosis, 70-99% = severe stenosis, 100% = occlusion)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>coronary artery disease</measure>
    <time_frame>2 years</time_frame>
    <description>new onset coronary artery disease diagnosed with cardiac enzyme (&gt;troponins I upper limit 99%)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>congestive heart failure</measure>
    <time_frame>2 years</time_frame>
    <description>new onset congestive heart failure diagnosed with sonocardiogram (HF-REF, heart failure with reduced EF≦ 35%)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>congestive heart failure</measure>
    <time_frame>2 years</time_frame>
    <description>Progression of congestive heart failure (increase of NYHA classification)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>congestive heart failure</measure>
    <time_frame>2 years</time_frame>
    <description>new onset congestive heart failure with symptoms (Framingham's clinical criteria: orthopnea, pulmonary rales, S3, paroxysmal nocturnal dyspnea, cough, dyspnea on ordinary exertion, pleural effusion, hepatomegaly, tachycardia with a heart rate over 120 beats/min, bilateral leg edema, and weight loss under 4.5 kg in five days) diagnosed by cardiologists</description>
  </primary_outcome>
  <primary_outcome>
    <measure>congestive heart failure</measure>
    <time_frame>2 yearts</time_frame>
    <description>new onset congestive heart failure (brain natriuretic peptide&gt; 400pg/ml)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>diabetes</measure>
    <time_frame>2 years</time_frame>
    <description>fasting blood sugar</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>diabetes</measure>
    <time_frame>2 years</time_frame>
    <description>postprandial blood sugar</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>diabetes</measure>
    <time_frame>2 years</time_frame>
    <description>glycated hemoglobin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>anemia</measure>
    <time_frame>2 years</time_frame>
    <description>serum hemoglobin level&#xD;
serum hematocrit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>calcium</measure>
    <time_frame>2 years</time_frame>
    <description>serum total calcium level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>phospate</measure>
    <time_frame>2 years</time_frame>
    <description>serum phosphate level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>nutrition status</measure>
    <time_frame>2 years</time_frame>
    <description>serum albumin level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>liver function</measure>
    <time_frame>2 years</time_frame>
    <description>serum AST/ALT level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>liver function</measure>
    <time_frame>2 years</time_frame>
    <description>abdominal sonography with Child classification of liver cirrhosis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>sodium</measure>
    <time_frame>2 years</time_frame>
    <description>serum sodium level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>potassium</measure>
    <time_frame>2 years</time_frame>
    <description>serum potassium level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>parathyroid function</measure>
    <time_frame>2 years</time_frame>
    <description>serum parathyroid level</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>End-stage Renal Disease</condition>
  <condition>Anemia</condition>
  <condition>Cardiovascular Risk Factor</condition>
  <condition>Inflammation</condition>
  <arm_group>
    <arm_group_label>Iron Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment with iron sucrose with orginal guideline from ferritin&gt;500ng/ml, or TSAT&gt;20% to ferritin&gt;800ng/ml, or TSAT&gt;50%.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>irone sucrose</intervention_name>
    <description>drug ingredient: Ferric Hydroxide in complex with sucrose drug dosage form: 270injection/100mg/5ml/Amp</description>
    <arm_group_label>Iron Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients receiving maintenance dialysis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  less than 20 year-old, oncological patients undergoing chemotherapy, abnormal liver&#xD;
             function, infection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hugo Y Lin, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kaohsiung Medical University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hugo Y Lin, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kaohsiung Municipal Ta-Tung Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hugo Y Lin, MD, PhD</last_name>
    <phone>886-7-2911101</phone>
    <phone_ext>8737</phone_ext>
    <email>yukenlin@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Kaohsiung Medical University Hospital</name>
      <address>
        <city>Kaohsiung</city>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hugo Y Lin, MD,PhD</last_name>
      <phone>886-7-2911101</phone>
      <phone_ext>8737</phone_ext>
      <email>yukenlin@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>April 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>July 27, 2020</last_update_submitted>
  <last_update_submitted_qc>July 27, 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>
  <keyword>iron</keyword>
  <keyword>End-Stage Renal Disease</keyword>
  <keyword>Anemia</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>
    <mesh_term>Inflammation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 29, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/16/NCT04491916/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04491916
org study id: KMUHIRB-F(I)-20190110
nct id: NCT04491916
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
This study will compare the clinical outcome of patients with maintenance dialysis room after
      changing the iron treatment guidelines from original upper limit with ferritin>500ng/ml, or
      TSAT>20% to Ferritin> 800ng / ml, or TSAT> 50%.
After two years of treatments, we will compare the incidence of clinical events, monthly
      blood, and biochemical examination data for the two years before and after the change.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Mortality
time frame: 2 years
description: the death events following up until 2022
measure: coronary artery disease
time frame: 2 years
description: new onset coronary artery disease diagnosed with electrocardiogram (ST-segment changes, T inversion and Q wave appearance)
measure: coronary artery disease
time frame: 2 years
description: Progression of coronary artery disease (SCCT grading increase : 0% = no visible stenosis, 1-24% = minimal stenosis, 25-49% = mild stenosis, 50-69% = moderate stenosis, 70-99% = severe stenosis, 100% = occlusion)
measure: coronary artery disease
time frame: 2 years
description: new onset coronary artery disease diagnosed with cardiac enzyme (>troponins I upper limit 99%)
measure: congestive heart failure
time frame: 2 years
description: new onset congestive heart failure diagnosed with sonocardiogram (HF-REF, heart failure with reduced EF≦ 35%)
measure: congestive heart failure
time frame: 2 years
description: Progression of congestive heart failure (increase of NYHA classification)
measure: congestive heart failure
time frame: 2 years
description: new onset congestive heart failure with symptoms (Framingham's clinical criteria: orthopnea, pulmonary rales, S3, paroxysmal nocturnal dyspnea, cough, dyspnea on ordinary exertion, pleural effusion, hepatomegaly, tachycardia with a heart rate over 120 beats/min, bilateral leg edema, and weight loss under 4.5 kg in five days) diagnosed by cardiologists
measure: congestive heart failure
time frame: 2 yearts
description: new onset congestive heart failure (brain natriuretic peptide> 400pg/ml)
measure: diabetes
time frame: 2 years
description: fasting blood sugar
measure: diabetes
time frame: 2 years
description: postprandial blood sugar
measure: diabetes
time frame: 2 years
description: glycated hemoglobin
measure: anemia
time frame: 2 years
description: serum hemoglobin level
serum hematocrit
measure: calcium
time frame: 2 years
description: serum total calcium level
measure: phospate
time frame: 2 years
description: serum phosphate level
measure: nutrition status
time frame: 2 years
description: serum albumin level
measure: liver function
time frame: 2 years
description: serum AST/ALT level
measure: liver function
time frame: 2 years
description: abdominal sonography with Child classification of liver cirrhosis
measure: sodium
time frame: 2 years
description: serum sodium level
measure: potassium
time frame: 2 years
description: serum potassium level
measure: parathyroid function
time frame: 2 years
description: serum parathyroid level
arm group label: Iron Treatment
arm group type: Experimental
description: Treatment with iron sucrose with orginal guideline from ferritin>500ng/ml, or TSAT>20% to ferritin>800ng/ml, or TSAT>50%.
intervention type: Drug
intervention name: irone sucrose
description: drug ingredient: Ferric Hydroxide in complex with sucrose drug dosage form: 270injection/100mg/5ml/Amp
arm group label: Iron Treatment
criteria: 
gender: All
minimum age: 20 Years
maximum age: 99 Years
healthy volunteers: No
last name: Hugo Y Lin, MD,PhD
role: Principal Investigator
affiliation: Kaohsiung Medical University
last name: Hugo Y Lin, MD,PhD
role: Principal Investigator
affiliation: Kaohsiung Municipal Ta-Tung Hospital
last name: Hugo Y Lin, MD, PhD
phone: 886-7-2911101
phone ext: 8737
email: yukenlin@gmail.com
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Kidney Failure, Chronic
mesh term: Inflammation
sharing ipd: No
provided document: 