<?xml version="1.0" encoding="UTF-8"?>
<clinical_study>
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    http://clinicaltrials.gov/ct2/html/images/info/public.xsd
 and an XML DTD at:
    http://clinicaltrials.gov/ct2/html/images/info/public.dtd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on June 17, 2013</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>http://clinicaltrials.gov/show/NCT01293786</url>
  </required_header>
  <id_info>
    <org_study_id>03-02-2011</org_study_id>
    <nct_id>NCT01293786</nct_id>
  </id_info>
  <brief_title>Serum Magnesium and Vascular Calcification</brief_title>
  <official_title>Comparison of Vascular Calcification Between Kidney Transplant Recipients and Predialysis Chronic Kidney Disease and Its Association With Serum Magnesium</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ramathibodi Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ramathibodi Hospital</source>
  <oversight_info>
    <authority>Thailand: Mahidol University</authority>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Both Kidney transplantation (KT) and Chronic Kidney Disease (CKD) patients have reduced
      kidney function. Low serum magnesium is more prevalent in KT recipients. The present study
      examines the difference in vascular calcification between KT and CKD and its association
      with serum magnesium.
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Kidney transplantation (KT) improved quality of life and longevity of CKD patients.
      Nevertheless, kidney function deteriorates overtime in a manner not different from CKD
      counterparts. Hypomagnesemia is prevalent in KT recipients secondary to immunosuppressive
      therapy. In addition to serum calcium, phosphate and elemental calcium intake, the
      relationship between low serum magnesium and vascular calcification (VC) has been observed
      in small studies in CKD. Whether low serum magnesium associates with VC in KT has never been
      elucidated. The present study compares vascular calcification between KT and CKD and its
      association with serum magnesium.
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2011</start_date>
  <completion_date type="Actual">May 2011</completion_date>
  <primary_completion_date type="Actual">May 2011</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Observational</study_type>
  <study_design>Observational Model:  Case Control, Time Perspective:  Cross-Sectional</study_design>
  <primary_outcome>
    <measure>The difference in vascular calcification score between KT and CKD</measure>
    <time_frame>Baseline</time_frame>
    <safety_issue>No</safety_issue>
  </primary_outcome>
  <secondary_outcome>
    <measure>The association of serum magnesium with vascular calcification in KT</measure>
    <time_frame>Baseline</time_frame>
    <safety_issue>No</safety_issue>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The association of serum magnesium with vascular calcification in CKD</measure>
    <time_frame>Baseline</time_frame>
    <safety_issue>No</safety_issue>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Vascular Calcification</condition>
  <condition>Chronic Kidney Disease</condition>
  <arm_group>
    <arm_group_label>Kidney transplant recipients</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Chronic kidney disease</arm_group_label>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      serum
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Kidney transplant recipients and predialysis chronic kidney disease patients from
        outpatient nephrology clinic of Ramathibodi hospital, Mahidol University
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:

          -  kidney transplant recipients at least 1 year post surgery

          -  predialysis chronic kidney disease with serum creatinine &gt; 1.1 mg/dL in female and
             1.3 mg/dL in male

        Exclusion Criteria:

          -  acute kidney injury

          -  parathyroidectomy
      </textblock>
    </criteria>
    <gender>Both</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sinee Disthabanchong, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ramathibodi Hospital, Mahidol University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculty of Medicine, Ramathibodi Hospital, Mahidol University</name>
      <address>
        <city>Phayathai</city>
        <state>Bangkok</state>
        <zip>10400</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>May 2011</verification_date>
  <lastchanged_date>May 25, 2011</lastchanged_date>
  <firstreceived_date>February 10, 2011</firstreceived_date>
  <responsible_party>
    <name_title>Sinee Disthabanchong, MD</name_title>
    <organization>Division of Nephrology, Department of Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand</organization>
  </responsible_party>
  <keyword>magnesium</keyword>
  <keyword>kidney transplantation</keyword>
  <keyword>hypomagnesemia</keyword>
  <is_fda_regulated>No</is_fda_regulated>
  <has_expanded_access>No</has_expanded_access>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm  -->
    <mesh_term>Calcinosis</mesh_term>
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
    <mesh_term>Kidney Failure, Chronic</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                -->
</clinical_study>
