<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/NCT03820765</url>
  </required_header>
  <id_info>
    <org_study_id>CODIRAG-2019</org_study_id>
    <nct_id>NCT03820765</nct_id>
  </id_info>
  <brief_title>Cessation of Dialysis Treatment in Reinbek and Geesthacht</brief_title>
  <acronym>CoDiRaG</acronym>
  <official_title>Analysis of Cessation of the Dialysis Treatment in Reinbek-Northern Germany</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Luebeck</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Luebeck</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>
      Currently, approximately 80.000 patients with end stage renal disease (ESRD) in Germany&#xD;
      undergo chronic renal replacement therapy, either as hemodialysis or peritonealdialysis.&#xD;
      Since the nationwide registry for chronic dialysis patients (QuasiNiere) was terminated in&#xD;
      2006, no data exist from that time on regarding alterations in morbidity and mortality of&#xD;
      patients with end stage renal disease in Germany.&#xD;
&#xD;
      With this study we start a single center prospective registry of all patients undergoing&#xD;
      hemodialysis or peritonealdialysis therapy in our two nephrology departments Reinbek and&#xD;
      Geesthacht. In these centers we perform approximately 34.000 hemodialysis sessions and&#xD;
      supervise about 10.000 peritoneal treatment days of about 300 ESRD patients annually.&#xD;
&#xD;
      The aim of the study is to analyze all patients who stopped dialysis treatment in our centers&#xD;
      due to death, kidney transplantation, recovery of renal function or other causes. Patients&#xD;
      characteristics such as underlying renal diseases, duration of dialysis, co-morbidities as&#xD;
      well as laboratory parameters will be recorded.&#xD;
&#xD;
      The data is collected with an Microsoft Access Database and analyzed by a statistician of the&#xD;
      University of Luebeck (Germany). Power calculations revealed, that at least 200 patients were&#xD;
      necessary to detect differences in particular interesting variables such as vascular access&#xD;
      or the need of palliative care. During the last years at least 50 patients stopped chronic&#xD;
      renal replacement therapy at out centers annually. Thus, the first interims evaluation is&#xD;
      expected after 4 years.&#xD;
&#xD;
      The results of our study are important to estimate the development of patient age and renal&#xD;
      diseases responsible for dialysis therapy in our centers. Moreover, the results may add&#xD;
      important information to our internal quality assurance.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2016</start_date>
  <completion_date type="Anticipated">January 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2019</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>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>4 Years</target_duration>
  <primary_outcome>
    <measure>Dialysis time (months) as a function of patient age (years).</measure>
    <time_frame>4 years</time_frame>
    <description>Differences of the dialysis time (months) between patients &lt; 65 years, 65-80 years and &gt; 80 years.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Underlying renal disease of ESRD patients</measure>
    <time_frame>6 years</time_frame>
    <description>Differences of the underlying renal disease between patients with initiation of dialysis prior to 31.12.2012 or after 1.1.2013</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Albumin concentration of ESRD patients</measure>
    <time_frame>6 years</time_frame>
    <description>Serum albumin concentration of dialysis patients at initiation of treatment, after 6 months and at cessation of dialysis</description>
  </secondary_outcome>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Complication of Renal Dialysis</condition>
  <condition>Long-Term Disorder of Dialysis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients with the necessity of chronic renal replacement therapy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with end stage renal disease and hemodialyis or peritonealdialysis&#xD;
&#xD;
          -  Renal replacement therapy performed in our centers Reinbek or Geesthacht&#xD;
&#xD;
          -  at least 4 weeks of dialysis treatment in any of our two treatment sites&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  dialysis treatment period in our centers shorten than 4 weeks&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Markus Meier, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Luebeck</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Markus Meier, MD</last_name>
    <phone>++49-40-7277860</phone>
    <email>markus.meier@dialyse-reinbek.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Martin Nitschke, MD</last_name>
    <phone>++49-451-50044121</phone>
    <email>martin.nitschke@uksh.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Nephrology Center Reinbek and Geesthacht</name>
      <address>
        <city>Reinbek</city>
        <zip>21465</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Markus Meier, MD</last_name>
      <phone>++49-451-500-6406</phone>
      <email>markus.meier@uk-sh.de</email>
    </contact>
    <investigator>
      <last_name>Markus Meier, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <results_reference>
    <citation>McCullough K, Sharma P, Ali T, Khan I, Smith WC, MacLeod A, Black C. Measuring the population burden of chronic kidney disease: a systematic literature review of the estimated prevalence of impaired kidney function. Nephrol Dial Transplant. 2012 May;27(5):1812-21. doi: 10.1093/ndt/gfr547. Epub 2011 Sep 29.</citation>
    <PMID>21965592</PMID>
  </results_reference>
  <results_reference>
    <citation>Schober-Halstenberg HJ. End-stage renal disease in aging societies: a global perspective. J Ren Nutr. 2009 Sep;19(5 Suppl):S3-4. doi: 10.1053/j.jrn.2009.06.015. No abstract available.</citation>
    <PMID>19712874</PMID>
  </results_reference>
  <results_reference>
    <citation>Frei U, Schober-Halstenberg HJ. Annual Report of the German Renal Registry 1998. QuaSi-Niere Task Group for Quality Assurance in Renal Replacement Therapy. Nephrol Dial Transplant. 1999 May;14(5):1085-90. doi: 10.1093/ndt/14.5.1085.</citation>
    <PMID>10344342</PMID>
  </results_reference>
  <results_reference>
    <citation>Frei U. Quality assurance in renal replacement therapy (RRT)--background of a developing German National Registry for RRT. QuaSi-Niere Task Group. Nephrol Dial Transplant. 1995;10(4):442-3. doi: 10.1093/ndt/10.4.442. No abstract available.</citation>
    <PMID>7623980</PMID>
  </results_reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 23, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>January 25, 2019</last_update_submitted>
  <last_update_submitted_qc>January 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 29, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Luebeck</investigator_affiliation>
    <investigator_full_name>Markus Meier, MD</investigator_full_name>
    <investigator_title>Consultant Nephrologist Dialysis and Apheresis</investigator_title>
  </responsible_party>
  <keyword>Hemodialyis, Peritonealdialysis, Qualitiy assurance dialysis</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/NCT03820765
org study id: CODIRAG-2019
nct id: NCT03820765
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Currently, approximately 80.000 patients with end stage renal disease (ESRD) in Germany
      undergo chronic renal replacement therapy, either as hemodialysis or peritonealdialysis.
      Since the nationwide registry for chronic dialysis patients (QuasiNiere) was terminated in
      2006, no data exist from that time on regarding alterations in morbidity and mortality of
      patients with end stage renal disease in Germany.

      With this study we start a single center prospective registry of all patients undergoing
      hemodialysis or peritonealdialysis therapy in our two nephrology departments Reinbek and
      Geesthacht. In these centers we perform approximately 34.000 hemodialysis sessions and
      supervise about 10.000 peritoneal treatment days of about 300 ESRD patients annually.

      The aim of the study is to analyze all patients who stopped dialysis treatment in our centers
      due to death, kidney transplantation, recovery of renal function or other causes. Patients
      characteristics such as underlying renal diseases, duration of dialysis, co-morbidities as
      well as laboratory parameters will be recorded.

      The data is collected with an Microsoft Access Database and analyzed by a statistician of the
      University of Luebeck (Germany). Power calculations revealed, that at least 200 patients were
      necessary to detect differences in particular interesting variables such as vascular access
      or the need of palliative care. During the last years at least 50 patients stopped chronic
      renal replacement therapy at out centers annually. Thus, the first interims evaluation is
      expected after 4 years.

      The results of our study are important to estimate the development of patient age and renal
      diseases responsible for dialysis therapy in our centers. Moreover, the results may add
      important information to our internal quality assurance.
observational model: Cohort
time perspective: Prospective
measure: Dialysis time (months) as a function of patient age (years).
time frame: 4 years
description: Differences of the dialysis time (months) between patients < 65 years, 65-80 years and > 80 years.
measure: Underlying renal disease of ESRD patients
time frame: 6 years
description: Differences of the underlying renal disease between patients with initiation of dialysis prior to 31.12.2012 or after 1.1.2013
measure: Albumin concentration of ESRD patients
time frame: 6 years
description: Serum albumin concentration of dialysis patients at initiation of treatment, after 6 months and at cessation of dialysis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Markus Meier, MD
role: Principal Investigator
affiliation: University of Luebeck
last name: Markus Meier, MD
phone: ++49-40-7277860
email: markus.meier@dialyse-reinbek.de
last name: Martin Nitschke, MD
phone: ++49-451-50044121
email: martin.nitschke@uksh.de
facility: 
status: Recruiting
contact: 
investigator: 
country: Germany
citation: McCullough K, Sharma P, Ali T, Khan I, Smith WC, MacLeod A, Black C. Measuring the population burden of chronic kidney disease: a systematic literature review of the estimated prevalence of impaired kidney function. Nephrol Dial Transplant. 2012 May;27(5):1812-21. doi: 10.1093/ndt/gfr547. Epub 2011 Sep 29.
PMID: 21965592
citation: Schober-Halstenberg HJ. End-stage renal disease in aging societies: a global perspective. J Ren Nutr. 2009 Sep;19(5 Suppl):S3-4. doi: 10.1053/j.jrn.2009.06.015. No abstract available.
PMID: 19712874
citation: Frei U, Schober-Halstenberg HJ. Annual Report of the German Renal Registry 1998. QuaSi-Niere Task Group for Quality Assurance in Renal Replacement Therapy. Nephrol Dial Transplant. 1999 May;14(5):1085-90. doi: 10.1093/ndt/14.5.1085.
PMID: 10344342
citation: Frei U. Quality assurance in renal replacement therapy (RRT)--background of a developing German National Registry for RRT. QuaSi-Niere Task Group. Nephrol Dial Transplant. 1995;10(4):442-3. doi: 10.1093/ndt/10.4.442. No abstract available.
PMID: 7623980
responsible party type: Principal Investigator
investigator affiliation: University of Luebeck
investigator full name: Markus Meier, MD
investigator title: Consultant Nephrologist Dialysis and Apheresis
sharing ipd: No