<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/NCT01679184</url>
  </required_header>
  <id_info>
    <org_study_id>XM-One</org_study_id>
    <nct_id>NCT01679184</nct_id>
  </id_info>
  <brief_title>XM-One Study for Living Donor Program</brief_title>
  <official_title>XM-One Study for Living Donor Program</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Miami</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Miami</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Donor-Specific Antibody (DSA) (HLA) levels and non-HLA antibody levels in recipients prior to&#xD;
      living kidney transplantation and randomize these individuals into a desensitization protocol&#xD;
      in order to evaluate shifts that can occur with the Luminex and XM-One assay after treatment&#xD;
      and up to 6 months post transplant.&#xD;
&#xD;
      If desensitization is needed prior to transplantation in individuals with a negative&#xD;
      crossmatch but positive DSA and/or XM-one - patients will be evaluated clinically with&#xD;
      routine lab tests (serum creatinine levels, spot urine protein and spot urine creatinine&#xD;
      levels) as well as protocol biopsy evaluations.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Rates of acute rejection including subclinical rejection - acute T cell mediated&#xD;
           (cellular) rejection, antibody mediated acute rejection, and chronic antibody-associated&#xD;
           injury (i.e.: Transplant Glomerulopathy, Chronic allograft arteriopathy) between the&#xD;
           groups.&#xD;
&#xD;
        2. Evaluation of endothelial cell activation and injury on biopsies by checking markers for&#xD;
           endothelial cell activation and injury (intercellular adhesion molecule-1, ICAM-1/CD54;&#xD;
           vascular cell adhesion molecule-1, VCAM-1/CD106; and E-selectin, ELAM-1/CD62E) in&#xD;
           two-color stains of tissue with classical endothelial markers (CD34 and Factor VIII).&#xD;
&#xD;
        3. Measurement of serum/plasma levels of TNF-alpha and VEGF and decreased levels of protein&#xD;
           C and protein S in the circulation, as an assessment of graft vascular perturbation.&#xD;
&#xD;
        4. Circulating Endothelial Cells (CECs) will be measured by flow cytometry with markers for&#xD;
           endothelial cell activation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Lack of staff to enroll patients in this study&#xD;
  </why_stopped>
  <start_date>June 2013</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">September 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>DSA</measure>
    <time_frame>1 year</time_frame>
    <description>To evaluate Donor-Specific Antibody (DSA) (HLA) levels with Luminex testing and non-HLA antibody levels using XM-One assay in recipients before and after transplantation for up to 6 months as well as in those recipients undergoing desensitization treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>DSA</measure>
    <time_frame>1 year</time_frame>
    <description>Rates of acute rejection including subclinical rejection - acute T cell mediated (cellular) rejection, antibody mediated acute rejection, and chronic antibody-associated injury (i.e.: Transplant Glomerulopathy, Chronic allograft arteriopathy) between the groups.&#xD;
Determine role of desensitization prior to transplantation in individuals with a negative crossmatch but positive DSA and/or XM-one - based on Luminex and XM-One testing. Patients will be evaluated clinically with routine lab tests (serum creatinine levels, spot urine protein and spot urine creatinine levels) as well as protocol biopsy evaluations.</description>
  </secondary_outcome>
  <enrollment type="Actual">4</enrollment>
  <condition>Transplant; Failure, Kidney</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      A total of 6 teaspoons of blood will be drawn.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Living donor kidney transplant recipients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Recipients receiving deceased donor transplants.&#xD;
&#xD;
          -  Living donor transplant that is T-cell flow crossmatch positive.&#xD;
&#xD;
          -  HIV, Hepatitis C and B positive patients.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant women and children will be excluded from the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Giselle Guerra, R.N.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Miami</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Miami</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33186</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>August 31, 2012</study_first_submitted>
  <study_first_submitted_qc>September 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2012</study_first_posted>
  <last_update_submitted>November 10, 2015</last_update_submitted>
  <last_update_submitted_qc>November 10, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 13, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Miami</investigator_affiliation>
    <investigator_full_name>Giselle Guerra</investigator_full_name>
    <investigator_title>Assistant Professor of Clinical</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Renal Insufficiency</mesh_term>
  </condition_browse>
  <!-- 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/NCT01679184
org study id: XM-One
nct id: NCT01679184
lead sponsor: 
has dmc: No
Donor-Specific Antibody (DSA) (HLA) levels and non-HLA antibody levels in recipients prior to
      living kidney transplantation and randomize these individuals into a desensitization protocol
      in order to evaluate shifts that can occur with the Luminex and XM-One assay after treatment
      and up to 6 months post transplant.

      If desensitization is needed prior to transplantation in individuals with a negative
      crossmatch but positive DSA and/or XM-one - patients will be evaluated clinically with
      routine lab tests (serum creatinine levels, spot urine protein and spot urine creatinine
      levels) as well as protocol biopsy evaluations.
1. Rates of acute rejection including subclinical rejection - acute T cell mediated
           (cellular) rejection, antibody mediated acute rejection, and chronic antibody-associated
           injury (i.e.: Transplant Glomerulopathy, Chronic allograft arteriopathy) between the
           groups.

        2. Evaluation of endothelial cell activation and injury on biopsies by checking markers for
           endothelial cell activation and injury (intercellular adhesion molecule-1, ICAM-1/CD54;
           vascular cell adhesion molecule-1, VCAM-1/CD106; and E-selectin, ELAM-1/CD62E) in
           two-color stains of tissue with classical endothelial markers (CD34 and Factor VIII).

        3. Measurement of serum/plasma levels of TNF-alpha and VEGF and decreased levels of protein
           C and protein S in the circulation, as an assessment of graft vascular perturbation.

        4. Circulating Endothelial Cells (CECs) will be measured by flow cytometry with markers for
           endothelial cell activation.
observational model: Case-Only
time perspective: Prospective
measure: DSA
time frame: 1 year
description: To evaluate Donor-Specific Antibody (DSA) (HLA) levels with Luminex testing and non-HLA antibody levels using XM-One assay in recipients before and after transplantation for up to 6 months as well as in those recipients undergoing desensitization treatment.
measure: DSA
time frame: 1 year
description: Rates of acute rejection including subclinical rejection - acute T cell mediated (cellular) rejection, antibody mediated acute rejection, and chronic antibody-associated injury (i.e.: Transplant Glomerulopathy, Chronic allograft arteriopathy) between the groups.
Determine role of desensitization prior to transplantation in individuals with a negative crossmatch but positive DSA and/or XM-one - based on Luminex and XM-One testing. Patients will be evaluated clinically with routine lab tests (serum creatinine levels, spot urine protein and spot urine creatinine levels) as well as protocol biopsy evaluations.
A total of 6 teaspoons of blood will be drawn.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Giselle Guerra, R.N.
role: Principal Investigator
affiliation: University of Miami
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Miami
investigator full name: Giselle Guerra
investigator title: Assistant Professor of Clinical
mesh term: Renal Insufficiency