<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/NCT04413916</url>
  </required_header>
  <id_info>
    <org_study_id>P20190104</org_study_id>
    <nct_id>NCT04413916</nct_id>
  </id_info>
  <brief_title>MiRNA in Kidney Transplantation: Association With Kidney Graft Function and Disease Process</brief_title>
  <official_title>ASSOCIATION OF miRNA WITH ALLOGRAFT FUNCTION AND EXPRESSION PROFILES PREDICTIVE OF DISEASES OCCURING AFTER KIDNEY TRANSPLANTATION</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Medical Centre Ljubljana</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Medical Centre Ljubljana</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>
      MicroRNAs (miRNAs) belong to a class of small non-coding RNAs that modulate physiological and&#xD;
      pathological processes by post-transcriptional regulation of gene expression mainly via&#xD;
      translational inhibition of target messenger RNAs. Recently, many miRNAs were found to be&#xD;
      involved in pathological processes that occur following kidney transplantation, like&#xD;
      allograft rejection, de novo disease or disease recurrence after kidney transplantation. As&#xD;
      most of the miRNAs involved in kidney diseases are extracted by urine, the diagnostic&#xD;
      accuracy of such molecules as biomarkers is questionable.&#xD;
&#xD;
      The aim of this study is to analyze expression of selected miRNAs (miR-29c, miR-126,&#xD;
      miR-146a, miR-150, miR-155, miR-223) and evaluate whether their regulation is associated with&#xD;
      kidney graft function and disease processes after kidney transplantation (KTx).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      MicroRNAs (miRNA) are short, endogenous non-coding RNAs involved in the modulation of gene&#xD;
      expression mainly by inhibition of messenger RNAs translation. Recent studies have indicated&#xD;
      association of miRNAs with pathological processes following kidney transplantation.&#xD;
&#xD;
      The aim of the study is to determine whether selected miRNAs are related to specific disease&#xD;
      process or only reflect kidney graft function.&#xD;
&#xD;
      The study enrolled 100 Caucasian KTRs, who presented with stable renal function (as indicated&#xD;
      by stable serum creatinine (Cr) for 3 months and whose kidney graft function was thereafter&#xD;
      estimated with various methods, including: cystatin C concentration, three different CKD EPI&#xD;
      equations and measured with chromium-51 ethylenediamine tetraacetic acid clearance.&#xD;
&#xD;
      Expression of 6 selected miRNAs (miR-29c, miR-126, miR-146a, miR-150, miR-155, and miR-223)&#xD;
      was determined by qPCR using miRNA-103a, miR-191, and miR-423 as reference genes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Association of miRNA and kidney graft function</measure>
    <time_frame>sample collection within one month of enrollement</time_frame>
    <description>correlation of selected miRNAs expression with parameters of kidney graft function</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Association of miRNAs expression and kidney graft rejection or disease recurrence</measure>
    <time_frame>2 years</time_frame>
    <description>Correlation of selected miRNAs expression and kidney graft rejection or disease recurrence</description>
  </secondary_outcome>
  <enrollment type="Actual">100</enrollment>
  <condition>Kidney Transplant Failure and Rejection</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>miRNA expression</intervention_name>
    <description>Analysis of expression of selected miRNAs (miR-29c, miR-126, miR-146a, miR-150, miR-155, miR-223) by qPCR.</description>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serums from kidney transplant recipients&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The study included 100 kidney transplant recipients (KTRs) with at least 3 months of stable&#xD;
        kidney graft function established with estimated GFR (eGFR) according to CKD Epidemiology&#xD;
        Collaboration equations, serum creatinine concentration (CKD-EPI Cr), serum cystatin C&#xD;
        concentration (CKD-EPI CysC) and measured GFR with 51Cr-EDTA clearance.&#xD;
&#xD;
        Evaluation of kidney graft function was subject to previous, already completed, and&#xD;
        published study (Borštnar Š, et al. Clin Nephrol. 2019;92(6):287-292.&#xD;
        doi:10.5414/CN109882). Serum samples from patients participating in this study (taken at&#xD;
        the moment of 51Cr-EDTA clearance measurement) were further analyzed in the contemporary&#xD;
        study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  time of kidney transplantation at least 2 years before the study entry,&#xD;
&#xD;
          -  stable function of the transplanted kidney during the previous 3 months (changes in&#xD;
             s-creatinine ≤ 20%).&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  age less than 18 years,&#xD;
&#xD;
          -  symptomatic heart failure,&#xD;
&#xD;
          -  malignancy,&#xD;
&#xD;
          -  pregnancy or lactation,&#xD;
&#xD;
          -  acute conditions and diseases that can affect the GFR,&#xD;
&#xD;
          -  newly-introduced drugs that may affect the function of the graft,&#xD;
&#xD;
          -  treatment with trimethoprim-sulfamethoxazole or cimetidine,&#xD;
&#xD;
          -  the presence of a pacemaker or any other electronic device in the body.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University Medical Centre Ljubljana</name>
      <address>
        <city>Ljubljana</city>
        <zip>1000</zip>
        <country>Slovenia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Slovenia</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 25, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>May 28, 2020</last_update_submitted>
  <last_update_submitted_qc>May 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Medical Centre Ljubljana</investigator_affiliation>
    <investigator_full_name>Veceric-Haler Zeljka</investigator_full_name>
    <investigator_title>assist. prof.</investigator_title>
  </responsible_party>
  <keyword>miRNA</keyword>
  <keyword>kidney transplant function</keyword>
  <keyword>kidney transplant rejection</keyword>
  <keyword>disease recurrence</keyword>
  <keyword>cystatin</keyword>
  <keyword>micro RNA</keyword>
  <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/NCT04413916
org study id: P20190104
nct id: NCT04413916
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
MicroRNAs (miRNAs) belong to a class of small non-coding RNAs that modulate physiological and
      pathological processes by post-transcriptional regulation of gene expression mainly via
      translational inhibition of target messenger RNAs. Recently, many miRNAs were found to be
      involved in pathological processes that occur following kidney transplantation, like
      allograft rejection, de novo disease or disease recurrence after kidney transplantation. As
      most of the miRNAs involved in kidney diseases are extracted by urine, the diagnostic
      accuracy of such molecules as biomarkers is questionable.

      The aim of this study is to analyze expression of selected miRNAs (miR-29c, miR-126,
      miR-146a, miR-150, miR-155, miR-223) and evaluate whether their regulation is associated with
      kidney graft function and disease processes after kidney transplantation (KTx).
MicroRNAs (miRNA) are short, endogenous non-coding RNAs involved in the modulation of gene
      expression mainly by inhibition of messenger RNAs translation. Recent studies have indicated
      association of miRNAs with pathological processes following kidney transplantation.

      The aim of the study is to determine whether selected miRNAs are related to specific disease
      process or only reflect kidney graft function.

      The study enrolled 100 Caucasian KTRs, who presented with stable renal function (as indicated
      by stable serum creatinine (Cr) for 3 months and whose kidney graft function was thereafter
      estimated with various methods, including: cystatin C concentration, three different CKD EPI
      equations and measured with chromium-51 ethylenediamine tetraacetic acid clearance.

      Expression of 6 selected miRNAs (miR-29c, miR-126, miR-146a, miR-150, miR-155, and miR-223)
      was determined by qPCR using miRNA-103a, miR-191, and miR-423 as reference genes.
observational model: Case-Only
time perspective: Retrospective
measure: Association of miRNA and kidney graft function
time frame: sample collection within one month of enrollement
description: correlation of selected miRNAs expression with parameters of kidney graft function
measure: Association of miRNAs expression and kidney graft rejection or disease recurrence
time frame: 2 years
description: Correlation of selected miRNAs expression and kidney graft rejection or disease recurrence
intervention type: Diagnostic Test
intervention name: miRNA expression
description: Analysis of expression of selected miRNAs (miR-29c, miR-126, miR-146a, miR-150, miR-155, miR-223) by qPCR.
Serums from kidney transplant recipients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Slovenia
responsible party type: Principal Investigator
investigator affiliation: University Medical Centre Ljubljana
investigator full name: Veceric-Haler Zeljka
investigator title: assist. prof.
sharing ipd: No