<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/NCT04482920</url>
  </required_header>
  <id_info>
    <org_study_id>20-0572</org_study_id>
    <nct_id>NCT04482920</nct_id>
  </id_info>
  <brief_title>Effect of Hormone Therapy on Renal Function</brief_title>
  <official_title>The Effects of Hormone Therapy on Renal Hemodynamic Function in Transgender Youth</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to understand the effects of testosterone or estradiol on kidney&#xD;
      function in transgender adolescents and young adults.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 15, 2021</start_date>
  <completion_date type="Anticipated">December 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in measured glomerular filtration rate (GFR)</measure>
    <time_frame>Baseline, 3 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in effective renal plasma flow</measure>
    <time_frame>Baseline, 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in biomarkers of tubular injury and repair (Neutrophil gelatinase-associated lipocalin [NGAL], Kidney injury molecule-1 [KIM-1], Chitinase-3-like protein 1 [YKL-40])</measure>
    <time_frame>Baseline, 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fat mass</measure>
    <time_frame>Baseline, 3 months</time_frame>
    <description>Quantified noninvasively by ImpediMed SFB7 single channel, tetra polar bioimpedance spectroscopy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fat-free mass</measure>
    <time_frame>Baseline, 3 months</time_frame>
    <description>Quantified noninvasively by ImpediMed SFB7 single channel, tetra polar bioimpedance spectroscopy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in intracellular fluid</measure>
    <time_frame>Baseline, 3 months</time_frame>
    <description>Quantified noninvasively by ImpediMed SFB7 single channel, tetra polar bioimpedance spectroscopy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in extracellular fluid</measure>
    <time_frame>Baseline, 3 months</time_frame>
    <description>Quantified noninvasively by ImpediMed SFB7 single channel, tetra polar bioimpedance spectroscopy</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Transgenderism</condition>
  <condition>Kidney Diseases</condition>
  <condition>Kidney Injury</condition>
  <arm_group>
    <arm_group_label>Transgender males</arm_group_label>
    <description>Transgender males who are clinically ready to start testosterone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Transgender females</arm_group_label>
    <description>Transgender females who are clinically ready to start estradiol</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>p-aminohippurate clearance study</intervention_name>
    <description>To measure kidney blood flow, small doses of a substance called p-aminohippurate (PAH) are used.</description>
    <arm_group_label>Transgender females</arm_group_label>
    <arm_group_label>Transgender males</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Iohexol infusion</intervention_name>
    <description>To measure glomerular filtration rate (GFR)</description>
    <arm_group_label>Transgender females</arm_group_label>
    <arm_group_label>Transgender males</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood, urine&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        20 transgender youth and young adults (10 transgender females, 10 transgender males) before&#xD;
        and 3 months after initiation of gender affirming hormone therapy to determine the impact&#xD;
        of gender affirming hormone therapy on intrarenal hemodynamic function and tubular&#xD;
        function.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Identify as transgender&#xD;
&#xD;
          -  Age 17-30 years (inclusive)&#xD;
&#xD;
          -  Plan to start gender affirming hormone therapy (testosterone or estradiol) clinically&#xD;
             in ≤ 1 months and remain on for at least 3 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cognitive, psychiatric or physical impairment resulting in inability to tolerate the&#xD;
             study procedures (e.g. intellectual disability, schizophrenia, hallucinations)&#xD;
&#xD;
          -  Type 1 or Type 2 diabetes&#xD;
&#xD;
          -  Chronic kidney disease, or eGFR &lt;60ml/min/1.73m2 by CKD-EPI formulation&#xD;
&#xD;
          -  Uncontrolled hypertension (resting BP ≥ 140/90 mm/Hg)&#xD;
&#xD;
          -  Allergy to shellfish, iodine or iohexol&#xD;
&#xD;
          -  Currently taking: sulfonamides, procaine, thiazolesulfone and probenecid (renal&#xD;
             clearance measurements of PAH cannot be made accurately if individuals are on these&#xD;
             medications)&#xD;
&#xD;
          -  Prior gender affirming hormone therapy use&#xD;
&#xD;
          -  Prior gonadectomy&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>17 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Natalie J Nokoff, MD, MSCS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Natalie J Nokoff, MD, MSCS</last_name>
    <phone>720-777-6128</phone>
    <email>Natalie.Nokoff@childrenscolorado.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Children's Hospital Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045'</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Natalie Nokoff, MD</last_name>
      <phone>720-777-3607</phone>
      <email>natalie.nokoff@childrenscolorado.org</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>May 8, 2023</last_update_submitted>
  <last_update_submitted_qc>May 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 10, 2023</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 Diseases</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/NCT04482920
org study id: 20-0572
nct id: NCT04482920
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to understand the effects of testosterone or estradiol on kidney
      function in transgender adolescents and young adults.
observational model: Cohort
time perspective: Prospective
measure: Change in measured glomerular filtration rate (GFR)
time frame: Baseline, 3 months
measure: Change in effective renal plasma flow
time frame: Baseline, 3 months
measure: Change in biomarkers of tubular injury and repair (Neutrophil gelatinase-associated lipocalin [NGAL], Kidney injury molecule-1 [KIM-1], Chitinase-3-like protein 1 [YKL-40])
time frame: Baseline, 3 months
measure: Change in fat mass
time frame: Baseline, 3 months
description: Quantified noninvasively by ImpediMed SFB7 single channel, tetra polar bioimpedance spectroscopy
measure: Change in fat-free mass
time frame: Baseline, 3 months
description: Quantified noninvasively by ImpediMed SFB7 single channel, tetra polar bioimpedance spectroscopy
measure: Change in intracellular fluid
time frame: Baseline, 3 months
description: Quantified noninvasively by ImpediMed SFB7 single channel, tetra polar bioimpedance spectroscopy
measure: Change in extracellular fluid
time frame: Baseline, 3 months
description: Quantified noninvasively by ImpediMed SFB7 single channel, tetra polar bioimpedance spectroscopy
arm group label: Transgender males
description: Transgender males who are clinically ready to start testosterone
arm group label: Transgender females
description: Transgender females who are clinically ready to start estradiol
intervention type: Diagnostic Test
intervention name: p-aminohippurate clearance study
description: To measure kidney blood flow, small doses of a substance called p-aminohippurate (PAH) are used.
arm group label: Transgender females
arm group label: Transgender males
intervention type: Diagnostic Test
intervention name: Iohexol infusion
description: To measure glomerular filtration rate (GFR)
arm group label: Transgender females
arm group label: Transgender males
Blood, urine
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 17 Years
maximum age: 30 Years
last name: Natalie J Nokoff, MD, MSCS
role: Principal Investigator
affiliation: University of Colorado, Denver
last name: Natalie J Nokoff, MD, MSCS
phone: 720-777-6128
email: Natalie.Nokoff@childrenscolorado.org
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Kidney Diseases
sharing ipd: Undecided