<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/NCT03780101</url>
  </required_header>
  <id_info>
    <org_study_id>GN18RE474</org_study_id>
    <secondary_id>248675</secondary_id>
    <nct_id>NCT03780101</nct_id>
  </id_info>
  <brief_title>Pathology and Imaging in Kidney Allografts</brief_title>
  <acronym>PIKA</acronym>
  <official_title>Pathology and Imaging in Kidney Allografts</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NHS Greater Glasgow and Clyde</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NHS Greater Glasgow and Clyde</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will perform multi-parametric renal MRI in 70 patients with a renal transplant who&#xD;
      are undergoing a clinically indicated biopsy of their transplant. The aim of this study is to&#xD;
      compare findings on renal MRI with those seen on histology.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Renal transplantation is the optimal treatment for patients with renal failure.&#xD;
      However, transplant life-span is finite and commonly limited due to the development of&#xD;
      chronic rejection and other causes of irreversible fibrosis. At present, renal transplant&#xD;
      biopsy is required to diagnose the cause of transplant dysfunction. Renal biopsies are&#xD;
      invasive procedures that carry risks of bleeding, damage to the transplant and discomfort to&#xD;
      patients. Functional magnetic resonance imaging (MRI) of the kidneys is an emerging field of&#xD;
      research that has potential to non-invasively define and quantify parenchymal renal disease&#xD;
      including fibrosis and inflammation. There is a paucity of data correlating multi-parametric&#xD;
      renal MRI sequences with histological findings on biopsy, especially in patients with renal&#xD;
      transplants.&#xD;
&#xD;
      Study participants: 70 adult renal transplant recipients who have been referred for a&#xD;
      clinically indicated biopsy of their transplant kidney.&#xD;
&#xD;
      Study design: Participants will undergo multi-parametric renal MRI at time of biopsy. In&#xD;
      patients who receive treatment for acute rejection, a second renal MRI will be undertaken at&#xD;
      completion of treatment. Blood tests for fibrosis biomarkers and routine clinical measures of&#xD;
      transplant function will be obtained at time of MRI scanning.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
        1. Assess the correlation between functional renal MRI sequences and histological markers&#xD;
           of fibrosis and inflammation.&#xD;
&#xD;
        2. Assess the change in functional MRI sequences in response to treatment for acute&#xD;
           rejection in renal transplant recipients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    recruitment difficulties due to impact of COVID-19 pandemic&#xD;
  </why_stopped>
  <start_date type="Actual">February 15, 2019</start_date>
  <completion_date type="Actual">May 24, 2022</completion_date>
  <primary_completion_date type="Actual">May 24, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of MRI biomarkers for fibrosis with histology</measure>
    <time_frame>Baseline</time_frame>
    <description>Correlation between diffusion weighted imaging on renal MRI and reported percentage of cortical area on biopsy showing interstitial fibrosis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Renal MRI following treatment for acute rejection</measure>
    <time_frame>2 weeks</time_frame>
    <description>Correlation between change in native T1 and serum creatinine following treatment for acute rejection.</description>
  </secondary_outcome>
  <enrollment type="Actual">29</enrollment>
  <condition>Renal Transplant Rejection</condition>
  <condition>Chronic Kidney Diseases</condition>
  <condition>Fibrosis</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Multi-parametric renal MRI</intervention_name>
    <description>Multi-parametric functional magnetic resonance imaging of a transplant kidney including sequences for T1, T2, diffusion-weighted imaging, diffusion tensor imaging and arterial spin labelling.</description>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Fibrosis biomarkers, which may include galactin-3, microRNA (including miR-214, miR-21 and&#xD;
      miR-29), tissue inhibitor metalloproteinases (TIMP)&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Renal transplant recipients referred for a clinically-indicated biopsy of their transplant&#xD;
        kidney&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 18 years&#xD;
&#xD;
          -  Recipient of a kidney transplant&#xD;
&#xD;
          -  Referred for clinically indicated biopsy of transplant kidney&#xD;
&#xD;
          -  Ability to comply with study procedures.&#xD;
&#xD;
          -  Ability to give informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any contraindication to MRI&#xD;
&#xD;
          -  Known pregnancy or intent to conceive during the study period&#xD;
&#xD;
          -  Clinical suspicion of delayed graft function as the cause of transplant dysfunction&#xD;
&#xD;
          -  Any other reason considered by a study physician to make the subject inappropriate for&#xD;
             inclusion.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alastair J Rankin, MBChB</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Glasgow</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NHS Greater Glasgow &amp; Clyde</name>
      <address>
        <city>Glasgow</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>May 31, 2022</last_update_submitted>
  <last_update_submitted_qc>May 31, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 3, 2022</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>
    <mesh_term>Renal Insufficiency, Chronic</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/NCT03780101
org study id: GN18RE474
secondary id: 248675
nct id: NCT03780101
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will perform multi-parametric renal MRI in 70 patients with a renal transplant who
      are undergoing a clinically indicated biopsy of their transplant. The aim of this study is to
      compare findings on renal MRI with those seen on histology.
Background: Renal transplantation is the optimal treatment for patients with renal failure.
      However, transplant life-span is finite and commonly limited due to the development of
      chronic rejection and other causes of irreversible fibrosis. At present, renal transplant
      biopsy is required to diagnose the cause of transplant dysfunction. Renal biopsies are
      invasive procedures that carry risks of bleeding, damage to the transplant and discomfort to
      patients. Functional magnetic resonance imaging (MRI) of the kidneys is an emerging field of
      research that has potential to non-invasively define and quantify parenchymal renal disease
      including fibrosis and inflammation. There is a paucity of data correlating multi-parametric
      renal MRI sequences with histological findings on biopsy, especially in patients with renal
      transplants.

      Study participants: 70 adult renal transplant recipients who have been referred for a
      clinically indicated biopsy of their transplant kidney.

      Study design: Participants will undergo multi-parametric renal MRI at time of biopsy. In
      patients who receive treatment for acute rejection, a second renal MRI will be undertaken at
      completion of treatment. Blood tests for fibrosis biomarkers and routine clinical measures of
      transplant function will be obtained at time of MRI scanning.

      Objectives:

        1. Assess the correlation between functional renal MRI sequences and histological markers
           of fibrosis and inflammation.

        2. Assess the change in functional MRI sequences in response to treatment for acute
           rejection in renal transplant recipients.
observational model: Other
time perspective: Prospective
measure: Comparison of MRI biomarkers for fibrosis with histology
time frame: Baseline
description: Correlation between diffusion weighted imaging on renal MRI and reported percentage of cortical area on biopsy showing interstitial fibrosis.
measure: Renal MRI following treatment for acute rejection
time frame: 2 weeks
description: Correlation between change in native T1 and serum creatinine following treatment for acute rejection.
intervention type: Diagnostic Test
intervention name: Multi-parametric renal MRI
description: Multi-parametric functional magnetic resonance imaging of a transplant kidney including sequences for T1, T2, diffusion-weighted imaging, diffusion tensor imaging and arterial spin labelling.
Fibrosis biomarkers, which may include galactin-3, microRNA (including miR-214, miR-21 and
      miR-29), tissue inhibitor metalloproteinases (TIMP)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alastair J Rankin, MBChB
role: Principal Investigator
affiliation: University of Glasgow
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
sharing ipd: Undecided