<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/NCT01728012</url>
  </required_header>
  <id_info>
    <org_study_id>REK2010/2926</org_study_id>
    <nct_id>NCT01728012</nct_id>
  </id_info>
  <brief_title>Long-term Cardiovascular Risk Following Successful Renal Transplantation</brief_title>
  <official_title>The Prevalence of Cardiovascular Risk Factors in Patients More Than 10 Years Following Successful Renal Transplant.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Helse Stavanger HF</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Helse Stavanger HF</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Mineral metabolism disturbances occur early during the course of chronic kidney disease and&#xD;
      eventually affect most patients. For how long such disturbances persist after a successful&#xD;
      renal transplantation is mainly unknown. This study will investigate the prevalence of such&#xD;
      disturbances in patients more than 10 years following a successful renal transplantation. The&#xD;
      patients will be recruited from an existing registry in Norway.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">November 2013</completion_date>
  <primary_completion_date type="Actual">October 2013</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Fibroblast growth factor 23 (FGF23)</measure>
    <time_frame>More than 10 years after successful renal transplantation</time_frame>
    <description>To evaluate the long-term effect of a successful renal transplant on this biomarker.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intact parathyroid hormone (iPTH)</measure>
    <time_frame>More than 10 years after successful renal transplantation</time_frame>
    <description>To evaluate the long-term effect of a successful renal transplant on this biomarker.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Klotho</measure>
    <time_frame>More than 10 years after successful renal transplantation</time_frame>
    <description>To evaluate the long-term effect of a successful renal transplant on this biomarker.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neutrophil gelatinase-associated lipocalin (NGAL)</measure>
    <time_frame>More than 10 years after successful renal transplantation</time_frame>
    <description>To evaluate the long-term effect of a successful renal transplant on this biomarker.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">60</enrollment>
  <condition>Renal Transplant</condition>
  <arm_group>
    <arm_group_label>eGFR &gt;=60ml/min/1.73m2</arm_group_label>
    <description>Patients with an estimated glomerular filtration rate of &gt;=60 ml/min/1.73m2.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>eGFR 45-60ml/min/1.73m2</arm_group_label>
    <description>Patients with estimated glomerular filtration rate &gt;=45 ml/min/1.73m2 and &lt;60ml/min/1.73m2.</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood and urine will be collected along with the clinical observations. Serum, plasma and&#xD;
      urine will be frozen for later analyses.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients registered in the Norwegian Renal Registry with transplan more than 10 years ago.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Registered in the Norwegian Renal Registry&#xD;
&#xD;
          -  Documented elevated iPTH at Tx and 10 weeks post-tx&#xD;
&#xD;
          -  Well functioning transplant 10 years following tx&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Lack of ability to comply with the protocol&#xD;
&#xD;
          -  Refused written informed consent&#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>Inger Hjørdis Bleskestad, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Helse Stavanger HF</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stavanger University Hospital</name>
      <address>
        <city>Stavanger</city>
        <zip>NO-4011</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>November 8, 2012</study_first_submitted>
  <study_first_submitted_qc>November 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 16, 2012</study_first_posted>
  <last_update_submitted>August 14, 2014</last_update_submitted>
  <last_update_submitted_qc>August 14, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Successful transplantation</keyword>
  <keyword>Long-term observation</keyword>
  <!-- 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/NCT01728012
org study id: REK2010/2926
nct id: NCT01728012
lead sponsor: 
has dmc: No
Mineral metabolism disturbances occur early during the course of chronic kidney disease and
      eventually affect most patients. For how long such disturbances persist after a successful
      renal transplantation is mainly unknown. This study will investigate the prevalence of such
      disturbances in patients more than 10 years following a successful renal transplantation. The
      patients will be recruited from an existing registry in Norway.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Fibroblast growth factor 23 (FGF23)
time frame: More than 10 years after successful renal transplantation
description: To evaluate the long-term effect of a successful renal transplant on this biomarker.
measure: Intact parathyroid hormone (iPTH)
time frame: More than 10 years after successful renal transplantation
description: To evaluate the long-term effect of a successful renal transplant on this biomarker.
measure: Klotho
time frame: More than 10 years after successful renal transplantation
description: To evaluate the long-term effect of a successful renal transplant on this biomarker.
measure: Neutrophil gelatinase-associated lipocalin (NGAL)
time frame: More than 10 years after successful renal transplantation
description: To evaluate the long-term effect of a successful renal transplant on this biomarker.
arm group label: eGFR >=60ml/min/1.73m2
description: Patients with an estimated glomerular filtration rate of >=60 ml/min/1.73m2.
arm group label: eGFR 45-60ml/min/1.73m2
description: Patients with estimated glomerular filtration rate >=45 ml/min/1.73m2 and <60ml/min/1.73m2.
Blood and urine will be collected along with the clinical observations. Serum, plasma and
      urine will be frozen for later analyses.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Inger Hjørdis Bleskestad, MD
role: Principal Investigator
affiliation: Helse Stavanger HF
facility: 
country: Norway
responsible party type: Sponsor