<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/NCT02229435</url>
  </required_header>
  <id_info>
    <org_study_id>URO-MD-040</org_study_id>
    <nct_id>NCT02229435</nct_id>
  </id_info>
  <brief_title>Urologic-nephrological Care of Chronic Kidney Disease in Saxony-Anhalt/Magdeburg.</brief_title>
  <acronym>UroCKDisS</acronym>
  <official_title>Laboratory Database-based Analysis of the Interdisciplinary Urologic-nephrological Care of the Chronic Kidney Disease (CKD) With Estimated Glomerular Filtration Rate (eGFR) Under 60 ml/Min of the Population in Saxony-Anhalt / Metropolitan Area Magdeburg.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Magdeburg</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medical Laboratory Schenk-Ansorge Magdeburg Germany.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Magdeburg</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Statement:&#xD;
&#xD;
      Patients with Chronic kidney disease (CKD) with an estimated glomerular filtration rate&#xD;
      (eGFR) under 60 ml/min using the MDRD-6 (Modification of Diet in Renal Disease) formula&#xD;
      and/or CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) formula should undergo&#xD;
      nephrological and urological care (diagnosis and treatment) to prevent chronic kidney&#xD;
      failure. This is recommended by the National Kidney Foundation Kidney Disease Outcomes&#xD;
      Quality Initiative (KDOQI), Kidney Disease Improving Global Outcomes (KDIGO) and European&#xD;
      Urological Association (EAU). Renal and postrenal diseases can cause or worsen CKD.&#xD;
      Internistic and intrarenal diseases can caused or worsen CKD. All diseases affecting CKD&#xD;
      should be treated and the medical care should be optimized.&#xD;
&#xD;
      Hypothesis:&#xD;
&#xD;
      Not all patients with CKD receive urological and nephrological care. Interdisciplinary work&#xD;
      of outpatient working urologists and nephrologists in the metropolitan area Magdeburg /&#xD;
      Saxony-Anhalt Germany is unknown. An descriptive analysis of interdisciplinary treatment&#xD;
      connection of CKD patients for an orientating statement is needed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Medical Laboratory Schenk-Ansorge Magdeburg Saxony-Anhalt Germany receives all blood&#xD;
      samples of outpatient patients of the medical practices of the metropolitan area Magdeburg&#xD;
      Saxony-Anhalt Germany. Every patient has a lifetime identification number Independent of the&#xD;
      submitting practice. Every submitting medical doctor has a lifetime identification number and&#xD;
      is identified by her/his medical subject /specialization. This analysis is based on that&#xD;
      laboratory database. For that study a cohort of 1.031.336 patients from 12/2004 to 08/2014 is&#xD;
      evaluated, that had been received blood tests with measurement of serum creatinine. For every&#xD;
      serum creatinine an eGGR is calculated with the guideline recommended formula.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2004</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">August 2014</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
  </study_design_info>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>Chronic kidney disease</measure>
    <time_frame>1 year</time_frame>
    <description>% of outpatient patients with eGFR &lt; 60 ml/min and interdisciplinary urological and nephrological care in metropolitan area Magdeburg, Saxony-Anhalt, Germany.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1031336</enrollment>
  <condition>Chronic Kidney Disease (CKD)</condition>
  <arm_group>
    <arm_group_label>eGFR &lt;60ml/min</arm_group_label>
    <description>Patients with CKD with eGFR &lt;60 ml/min (CKD-EPI or MDRD) 12/2004-08/2014 of Medical Laboratory, Prof. Schenk / Dr. Ansorge and Colleagues, GbR, Am Neustädter Feld 47, 39124 Magdeburg, Germany.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        All sampled outpatient patients (blood tests with measurement of serum creatinine)&#xD;
        12/2004-08/2014 of the medical laboratory Prof. Schenk / Dr. Ansorge and Colleagues, GbR,&#xD;
        Am Neustädter Feld 47, 39124 Magdeburg, metroplitan area Magdeburg Saxony-Anhalt, Germany.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Measured serum creatinine and estimated glomerular filtration rate&#xD;
&#xD;
          -  eGFR &lt; 60 ml/min&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  dialysis&#xD;
&#xD;
          -  no serum creatinine measured&#xD;
&#xD;
          -  Age &lt; 18 years&#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>Johann J Wendler, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Urology University Magdeburg</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Martin Schostak, Prof. Dr.</last_name>
    <role>Study Chair</role>
    <affiliation>Urology University Magdeburg</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Herwart Schenk, Prof. Dr.</last_name>
    <role>Study Director</role>
    <affiliation>Medical Laboratory Am Neustädter Feld 47, 39124 Magdeburg, Saxony-Anhalt, Germany.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Constanze Tienken, Cand. med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Doctorand Urology University Magdeburg</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Urology University Magdeburg</name>
      <address>
        <city>Magdeburg</city>
        <state>Saxony-Anhalt</state>
        <zip>39108</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>http://www.schenk-ansorge.de/Kontakt.aspx</url>
    <description>Medical Laboratory Schenk-Ansorge Magdeburg, Germany.</description>
  </link>
  <link>
    <url>http://urologie.uni-magdeburg.de/urologie.html</url>
    <description>Department of Urology University Magdeburg, Germany.</description>
  </link>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 26, 2014</study_first_submitted>
  <study_first_submitted_qc>August 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 1, 2014</study_first_posted>
  <last_update_submitted>August 28, 2014</last_update_submitted>
  <last_update_submitted_qc>August 28, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 1, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Magdeburg</investigator_affiliation>
    <investigator_full_name>Johann J. Wendler, MD</investigator_full_name>
    <investigator_title>Dr. med.</investigator_title>
  </responsible_party>
  <keyword>Chronic kidney disease</keyword>
  <keyword>Urological care</keyword>
  <keyword>Nephrological care</keyword>
  <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>
  <!-- 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/NCT02229435
org study id: URO-MD-040
nct id: NCT02229435
lead sponsor: 
collaborator: 
has dmc: No
Statement:

      Patients with Chronic kidney disease (CKD) with an estimated glomerular filtration rate
      (eGFR) under 60 ml/min using the MDRD-6 (Modification of Diet in Renal Disease) formula
      and/or CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) formula should undergo
      nephrological and urological care (diagnosis and treatment) to prevent chronic kidney
      failure. This is recommended by the National Kidney Foundation Kidney Disease Outcomes
      Quality Initiative (KDOQI), Kidney Disease Improving Global Outcomes (KDIGO) and European
      Urological Association (EAU). Renal and postrenal diseases can cause or worsen CKD.
      Internistic and intrarenal diseases can caused or worsen CKD. All diseases affecting CKD
      should be treated and the medical care should be optimized.

      Hypothesis:

      Not all patients with CKD receive urological and nephrological care. Interdisciplinary work
      of outpatient working urologists and nephrologists in the metropolitan area Magdeburg /
      Saxony-Anhalt Germany is unknown. An descriptive analysis of interdisciplinary treatment
      connection of CKD patients for an orientating statement is needed.
The Medical Laboratory Schenk-Ansorge Magdeburg Saxony-Anhalt Germany receives all blood
      samples of outpatient patients of the medical practices of the metropolitan area Magdeburg
      Saxony-Anhalt Germany. Every patient has a lifetime identification number Independent of the
      submitting practice. Every submitting medical doctor has a lifetime identification number and
      is identified by her/his medical subject /specialization. This analysis is based on that
      laboratory database. For that study a cohort of 1.031.336 patients from 12/2004 to 08/2014 is
      evaluated, that had been received blood tests with measurement of serum creatinine. For every
      serum creatinine an eGGR is calculated with the guideline recommended formula.
observational model: Cohort
measure: Chronic kidney disease
time frame: 1 year
description: % of outpatient patients with eGFR < 60 ml/min and interdisciplinary urological and nephrological care in metropolitan area Magdeburg, Saxony-Anhalt, Germany.
arm group label: eGFR <60ml/min
description: Patients with CKD with eGFR <60 ml/min (CKD-EPI or MDRD) 12/2004-08/2014 of Medical Laboratory, Prof. Schenk / Dr. Ansorge and Colleagues, GbR, Am Neustädter Feld 47, 39124 Magdeburg, Germany.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Johann J Wendler, Dr.
role: Principal Investigator
affiliation: Urology University Magdeburg
last name: Martin Schostak, Prof. Dr.
role: Study Chair
affiliation: Urology University Magdeburg
last name: Herwart Schenk, Prof. Dr.
role: Study Director
affiliation: Medical Laboratory Am Neustädter Feld 47, 39124 Magdeburg, Saxony-Anhalt, Germany.
last name: Constanze Tienken, Cand. med.
role: Principal Investigator
affiliation: Doctorand Urology University Magdeburg
facility: 
country: Germany
url: http://www.schenk-ansorge.de/Kontakt.aspx
description: Medical Laboratory Schenk-Ansorge Magdeburg, Germany.
url: http://urologie.uni-magdeburg.de/urologie.html
description: Department of Urology University Magdeburg, Germany.
responsible party type: Principal Investigator
investigator affiliation: University of Magdeburg
investigator full name: Johann J. Wendler, MD
investigator title: Dr. med.
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic