xml: <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/NCT06016283</url>
    </required_header>
    <id_info>
      <org_study_id>NT Gender</org_study_id>
      <nct_id>NCT06016283</nct_id>
    </id_info>
    <brief_title>The Impact of Gender on Graft Outcomes Following Living Donor Kidney Transplantation</brief_title>
    <official_title>The Impact of Donor and Recipient Gender on Long-term Outcomes Following Living Donor</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Erasmus Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Erasmus Medical Center</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>
        The impact of donor and recipient gender combination on kidney transplant outcomes has been&#xD;
        reported in several studies. The results vary greatly due to different factors, such as minor&#xD;
        histocompatibility antigens, nephron overload, sex hormones, etc. Despite advancements in&#xD;
        clinical practice, no large-scale studies exploring this question in living donor kidney&#xD;
        transplantation have been conducted in the subsequent two decades. Our study aims to address&#xD;
        this research gap and provide updated information on outcomes in relation to the gender&#xD;
        combination following living donor kidney transplantation.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The impact of donor and recipient gender combination on kidney transplant outcomes has been&#xD;
        reported in several studies, but with inconclusive results. From an immunologic perspective,&#xD;
        the transplantation of male donor kidneys into female recipients was associated with an&#xD;
        increased risk of graft failure and mortality due to H-Y minor histocompatibility antigens.&#xD;
        Another theory, based on nephron overload and hyperfiltration, suggests that male recipients&#xD;
        of female donor kidneys tend to experience worse outcomes due to the smaller size of female&#xD;
        kidneys. Additionally, the influence of sex hormones has been explored. Aufhauser et al.&#xD;
        found that estrogen acts as a protective factor against ischemia-reperfusion injury (IRI),&#xD;
        resulting in a significantly lower incidence of delayed graft function (DGF) in female&#xD;
        recipients compared to male recipients. These findings seem conflicting, and most of studies&#xD;
        have primarily focused on deceased donor kidney transplantation.&#xD;
  &#xD;
        In addition, Kayler et al. analyzed a transplant database encompassing 30,258 living donor&#xD;
        kidney transplantations between 1990 and 1999. Their study revealed a significant advantage&#xD;
        in graft survival for male recipients of male donor kidneys compared to the other&#xD;
        combinations. Another study involving 5,716 HLA-identical sibling kidney transplantations&#xD;
        between 1985 and 2000 demonstrated that female recipients tend to have better graft survival&#xD;
        rates regardless of the donor's gender. Despite advancements in clinical practice, no such&#xD;
        large-scale studies exploring this question have been conducted in the subsequent two&#xD;
        decades. Our study aims to address this research gap and provide updated information on&#xD;
        outcomes in relation to the gender combination following living donor kidney transplantation.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">April 1, 2022</start_date>
    <completion_date type="Actual">June 30, 2023</completion_date>
    <primary_completion_date type="Actual">April 1, 2023</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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Death-censored graft survival</measure>
      <time_frame>From the date of kidney transplantation until the date of graft loss from any cause or the end of follow-up, whichever came first, assessed up to 10 years.</time_frame>
      <description>Graft failure is defined as return to dialysis, transplant nephrectomy or retransplant. Death-censored graft failure was defined as the time from transplant to graft failure, with censoring for death with a functioning graft.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Patient survival</measure>
      <time_frame>From the date of kidney transplantation until the date of death from any cause or the end of follow-up, whichever came first, assessed up to 10 years.</time_frame>
      <description>All-cause mortality is included in the patient survival.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>DGF</measure>
      <time_frame>From the date of kidney transplantation till the end of first posttransplant week, assessed up to one week.</time_frame>
      <description>Delayed graft function (DGF) is defined as either the need for dialysis or the failure of a fall in serum creatinine of 10% on three consecutive days in the first posttransplant week.</description>
    </secondary_outcome>
    <number_of_groups>4</number_of_groups>
    <enrollment type="Actual">1276</enrollment>
    <condition>Kidney Transplant Failure and Rejection</condition>
    <condition>Gender</condition>
    <arm_group>
      <arm_group_label>MDMR</arm_group_label>
      <description>Male recipient receiving kidney graft from male donor</description>
    </arm_group>
    <arm_group>
      <arm_group_label>FDMR</arm_group_label>
      <description>Male recipient receiving kidney graft from female donor</description>
    </arm_group>
    <arm_group>
      <arm_group_label>MDFR</arm_group_label>
      <description>Female recipient receiving kidney graft from male donor</description>
    </arm_group>
    <arm_group>
      <arm_group_label>FDFR</arm_group_label>
      <description>Female recipient receiving kidney graft from female donor</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Patients undergoing living donor kidney transplantation in the Erasmus Medical Center&#xD;
          between January 2010 and December 2020.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients undergoing living donor kidney transplantation in the Erasmus Medical Center&#xD;
               between January 2010 and December 2020.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Recipients who were under 18 years at transplant or had no follow-up.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Participant eligibility is based on biological gender.</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Yitian Fang</name>
        <address>
          <city>Rotterdam</city>
          <state>Zuid Holland</state>
          <zip>3015 GD</zip>
          <country>Netherlands</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Netherlands</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Erasmus Medical Center</investigator_affiliation>
      <investigator_full_name>Yitian Fang, MD</investigator_full_name>
      <investigator_title>MD</investigator_title>
    </responsible_party>
    <keyword>gender</keyword>
    <keyword>kidney transplantation</keyword>
    <keyword>minor histocompatibility</keyword>
    <keyword>graft survival</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>The data that support this study are not publicly available due to the reasons of sensitivity and are available from the corresponding author upon reasonable request.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06016283
  org study id: NT Gender
  nct id: NCT06016283
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The impact of donor and recipient gender combination on kidney transplant outcomes has been
        reported in several studies. The results vary greatly due to different factors, such as minor
        histocompatibility antigens, nephron overload, sex hormones, etc. Despite advancements in
        clinical practice, no large-scale studies exploring this question in living donor kidney
        transplantation have been conducted in the subsequent two decades. Our study aims to address
        this research gap and provide updated information on outcomes in relation to the gender
        combination following living donor kidney transplantation.
  The impact of donor and recipient gender combination on kidney transplant outcomes has been
        reported in several studies, but with inconclusive results. From an immunologic perspective,
        the transplantation of male donor kidneys into female recipients was associated with an
        increased risk of graft failure and mortality due to H-Y minor histocompatibility antigens.
        Another theory, based on nephron overload and hyperfiltration, suggests that male recipients
        of female donor kidneys tend to experience worse outcomes due to the smaller size of female
        kidneys. Additionally, the influence of sex hormones has been explored. Aufhauser et al.
        found that estrogen acts as a protective factor against ischemia-reperfusion injury (IRI),
        resulting in a significantly lower incidence of delayed graft function (DGF) in female
        recipients compared to male recipients. These findings seem conflicting, and most of studies
        have primarily focused on deceased donor kidney transplantation.
  
        In addition, Kayler et al. analyzed a transplant database encompassing 30,258 living donor
        kidney transplantations between 1990 and 1999. Their study revealed a significant advantage
        in graft survival for male recipients of male donor kidneys compared to the other
        combinations. Another study involving 5,716 HLA-identical sibling kidney transplantations
        between 1985 and 2000 demonstrated that female recipients tend to have better graft survival
        rates regardless of the donor's gender. Despite advancements in clinical practice, no such
        large-scale studies exploring this question have been conducted in the subsequent two
        decades. Our study aims to address this research gap and provide updated information on
        outcomes in relation to the gender combination following living donor kidney transplantation.
  observational model: Cohort
  time perspective: Retrospective
  measure: Death-censored graft survival
  time frame: From the date of kidney transplantation until the date of graft loss from any cause or the end of follow-up, whichever came first, assessed up to 10 years.
  description: Graft failure is defined as return to dialysis, transplant nephrectomy or retransplant. Death-censored graft failure was defined as the time from transplant to graft failure, with censoring for death with a functioning graft.
  measure: Patient survival
  time frame: From the date of kidney transplantation until the date of death from any cause or the end of follow-up, whichever came first, assessed up to 10 years.
  description: All-cause mortality is included in the patient survival.
  measure: DGF
  time frame: From the date of kidney transplantation till the end of first posttransplant week, assessed up to one week.
  description: Delayed graft function (DGF) is defined as either the need for dialysis or the failure of a fall in serum creatinine of 10% on three consecutive days in the first posttransplant week.
  arm group label: MDMR
  description: Male recipient receiving kidney graft from male donor
  arm group label: FDMR
  description: Male recipient receiving kidney graft from female donor
  arm group label: MDFR
  description: Female recipient receiving kidney graft from male donor
  arm group label: FDFR
  description: Female recipient receiving kidney graft from female donor
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  gender based: Yes
  gender description: Participant eligibility is based on biological gender.
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: Netherlands
  responsible party type: Principal Investigator
  investigator affiliation: Erasmus Medical Center
  investigator full name: Yitian Fang, MD
  investigator title: MD
  sharing ipd: No
  ipd description: The data that support this study are not publicly available due to the reasons of sensitivity and are available from the corresponding author upon reasonable request.