<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/NCT04502784</url>
  </required_header>
  <id_info>
    <org_study_id>18195BR-SS</org_study_id>
    <nct_id>NCT04502784</nct_id>
  </id_info>
  <brief_title>Investigation of Hypophosphataemia Following Intravenous Iron</brief_title>
  <official_title>Investigation of the Mechanisms for the Development of Hypophosphataemia Following Administration of Intravenous Iron in Patients With Severe Anaemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Belfast Health and Social Care Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Belfast Health and Social Care Trust</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Anaemia (low haemoglobin levels) can develop in a number of conditions, including chronic&#xD;
      kidney disease (CKD) and intestinal conditions (e.g. inflammatory bowel disease, intestinal&#xD;
      failure). Intravenous iron can be given to patients with these conditions to help correct&#xD;
      their aneaemia. However, intravenous iron has been associated with the development of low&#xD;
      phosphate levels - hypophophosphataemia. The aim of this study is to determine potential&#xD;
      causes of hypophosphataemia following administration of intravenous iron.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Low levels of iron can lead to anaemia, known as iron deficiency anaemia, which can be&#xD;
      debilitating due to symptoms such as shortness of breath, fatigue, and dizziness. Iron&#xD;
      deficiency anaemia can be treated by giving iron supplementation. Iron supplements can be&#xD;
      taken orally or can be given intravenously (through the veins). Giving iron intravenously has&#xD;
      advantages over iron supplements taken orally, which can cause side effects such as stomach&#xD;
      pain and cramping. However, giving iron intravenously has been associated with the&#xD;
      development of low levels of phosphate in the blood. This is known as hypophosphataemia.&#xD;
      Phosphate is an important salt in the body and has a number of important functions. Very low&#xD;
      levels of phosphate can cause muscle pain, disorientation, seizures and heart problems. It is&#xD;
      unclear why giving iron intravenously can cause hypophosphataemia. This project aims to&#xD;
      investigate the potential causes of hypophosphataemia in patients who receive intravenous&#xD;
      iron as treatment for anaemia associated with their condition. Patients with chronic kidney&#xD;
      disease (CKD) and intestinal failure will be recruited to the study, since people with CKD&#xD;
      may handle iron differently than those with healthy kidneys. Samples will be taken at two&#xD;
      time points: prior to giving the intravenous iron and at the patient's next appointment.&#xD;
      Healthy volunteers will also be recruited to the study to allow comparison between the groups&#xD;
      receiving iron and those who do not receive iron. Samples will be analysed to determine&#xD;
      potential causes of hypophosphataemia. Results from before and after iron is given will be&#xD;
      compared to determine if any of the participants developed hypophosphataemia and if any other&#xD;
      test are affected which may explain why this has developed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">October 7, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>FGF23 levels before and after intravenous iron</measure>
    <time_frame>8 weeks</time_frame>
    <description>Measurement of FGF23 levels in patients with CKD before and after intravenous iron administration</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>FGF23 levels in patients with CKD and healthy volunteers</measure>
    <time_frame>1 week</time_frame>
    <description>Comparison of measured FGF23 levels in patients with CKD and healthy volunteers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Characterisation of pre-analytical factors affecting FGF23 levels</measure>
    <time_frame>1 week</time_frame>
    <description>To examine the effect of delayed separation and fasting vs non-fasting on FGF23 levels</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Hypophosphatemia</condition>
  <condition>Chronic Kidney Diseases</condition>
  <condition>Intestinal Disease</condition>
  <condition>Anemia</condition>
  <arm_group>
    <arm_group_label>Chronic Kidney Disease</arm_group_label>
    <description>This group will consist of 10 patients who have previously been diagnosed with chronic kidney disease and are receiving intravenous iron due to anaemia.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intestinal failure</arm_group_label>
    <description>This group will consist of 10 patients who have previously been diagnosed with intestinal conditions and are receiving intravenous iron due to anaemia.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Volunteers</arm_group_label>
    <description>This group will consist of 20 healthy volunteers. This group will act as a comparator for the CKD and intestinal failure groups.</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum, EDTA plasma, and urine samples will be collected and stored for batch analysis.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with intestinal failure or CKD will be recruited from iron infusion clinics, which&#xD;
        are based in secondary care. Healthy Volunteers will be recruited from laboratory staff&#xD;
        from within the Belfast Health and Social Care Trust&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        For Patients&#xD;
&#xD;
          -  aged 18 years or older&#xD;
&#xD;
          -  previously diagnosed with intestinal failure or advanced CKD&#xD;
&#xD;
          -  have anaemia requiring administration of intravenous iron&#xD;
&#xD;
          -  be able to adequately speak and understand English&#xD;
&#xD;
          -  Have capacity to give written informed consent&#xD;
&#xD;
        For Healthy Volunteers&#xD;
&#xD;
          -  aged 18 years or more&#xD;
&#xD;
          -  be able to adequately speak and understand English&#xD;
&#xD;
          -  have capacity to give written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        For patients&#xD;
&#xD;
          -  have dialysis-dependent CKD&#xD;
&#xD;
          -  participation in any other study which will affect results of the current study&#xD;
&#xD;
        For Healthy Volunteers&#xD;
&#xD;
          -  have CKD (eGFR &lt;60 mls/min/1.73^2)&#xD;
&#xD;
          -  history of any form of metabolic bone disease&#xD;
&#xD;
          -  Participation in any other study which will affect the results of the current study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Brona Roberts</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beflast Health and Social Care Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Belfast Health and Social Care Trust</name>
      <address>
        <city>Belfast</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 4, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>August 4, 2020</last_update_submitted>
  <last_update_submitted_qc>August 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 6, 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>Intestinal Diseases</mesh_term>
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
    <mesh_term>Anemia</mesh_term>
    <mesh_term>Hypophosphatemia</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/NCT04502784
org study id: 18195BR-SS
nct id: NCT04502784
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Anaemia (low haemoglobin levels) can develop in a number of conditions, including chronic
      kidney disease (CKD) and intestinal conditions (e.g. inflammatory bowel disease, intestinal
      failure). Intravenous iron can be given to patients with these conditions to help correct
      their aneaemia. However, intravenous iron has been associated with the development of low
      phosphate levels - hypophophosphataemia. The aim of this study is to determine potential
      causes of hypophosphataemia following administration of intravenous iron.
Low levels of iron can lead to anaemia, known as iron deficiency anaemia, which can be
      debilitating due to symptoms such as shortness of breath, fatigue, and dizziness. Iron
      deficiency anaemia can be treated by giving iron supplementation. Iron supplements can be
      taken orally or can be given intravenously (through the veins). Giving iron intravenously has
      advantages over iron supplements taken orally, which can cause side effects such as stomach
      pain and cramping. However, giving iron intravenously has been associated with the
      development of low levels of phosphate in the blood. This is known as hypophosphataemia.
      Phosphate is an important salt in the body and has a number of important functions. Very low
      levels of phosphate can cause muscle pain, disorientation, seizures and heart problems. It is
      unclear why giving iron intravenously can cause hypophosphataemia. This project aims to
      investigate the potential causes of hypophosphataemia in patients who receive intravenous
      iron as treatment for anaemia associated with their condition. Patients with chronic kidney
      disease (CKD) and intestinal failure will be recruited to the study, since people with CKD
      may handle iron differently than those with healthy kidneys. Samples will be taken at two
      time points: prior to giving the intravenous iron and at the patient's next appointment.
      Healthy volunteers will also be recruited to the study to allow comparison between the groups
      receiving iron and those who do not receive iron. Samples will be analysed to determine
      potential causes of hypophosphataemia. Results from before and after iron is given will be
      compared to determine if any of the participants developed hypophosphataemia and if any other
      test are affected which may explain why this has developed.
observational model: Case-Control
time perspective: Prospective
measure: FGF23 levels before and after intravenous iron
time frame: 8 weeks
description: Measurement of FGF23 levels in patients with CKD before and after intravenous iron administration
measure: FGF23 levels in patients with CKD and healthy volunteers
time frame: 1 week
description: Comparison of measured FGF23 levels in patients with CKD and healthy volunteers
measure: Characterisation of pre-analytical factors affecting FGF23 levels
time frame: 1 week
description: To examine the effect of delayed separation and fasting vs non-fasting on FGF23 levels
arm group label: Chronic Kidney Disease
description: This group will consist of 10 patients who have previously been diagnosed with chronic kidney disease and are receiving intravenous iron due to anaemia.
arm group label: Intestinal failure
description: This group will consist of 10 patients who have previously been diagnosed with intestinal conditions and are receiving intravenous iron due to anaemia.
arm group label: Healthy Volunteers
description: This group will consist of 20 healthy volunteers. This group will act as a comparator for the CKD and intestinal failure groups.
Serum, EDTA plasma, and urine samples will be collected and stored for batch analysis.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Brona Roberts
role: Principal Investigator
affiliation: Beflast Health and Social Care Trust
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Intestinal Diseases
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
mesh term: Anemia
mesh term: Hypophosphatemia
sharing ipd: No