<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/NCT03751397</url>
  </required_header>
  <id_info>
    <org_study_id>2016-00884; ks18Pfister</org_study_id>
    <nct_id>NCT03751397</nct_id>
  </id_info>
  <brief_title>Estimation of Kidney Function Through Combination of Renal Biomarkers in Blood and Urine of Healthy Infants and Children.</brief_title>
  <acronym>KidMaCare</acronym>
  <official_title>Estimation of Kidney Function Through Combination of Renal Biomarkers in Blood and Urine of Healthy Infants and Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Basel, Switzerland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Basel, Switzerland</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>
      To characterize the relationship of renal biomarkers (Creatinine, albumin, Cystatin C, NGAL,&#xD;
      beta-trace protein, beta-2 microglobulin, and uromodulin) between each other and the&#xD;
      variation over age, measured in serum and urine of healthy children. Unused residual blood&#xD;
      and urine samples will be used for testing the renal Parameters.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Despite relevant research in renal biomarkers, there is currently no optimal marker available&#xD;
      that reliably quantifies kidney function and indicates kidney injury in its early stages. The&#xD;
      combination of two or more biomarkers might be a more promising approach than investigating a&#xD;
      single parameter. The relationship of renal biomarkers (creatinine, albumin, Cystatin C,&#xD;
      NGAL, beta-trace protein, beta-2 microglobulin, and uromodulin) between each other and the&#xD;
      variation over age in infants and children (without chronic kidney disease) is investigated.&#xD;
&#xD;
      The biomarkers in urine samples are explored to find less invasive means of quantifying renal&#xD;
      health.&#xD;
&#xD;
      Patients between the age of 0 and 12 years undergoing blood with or without urine sampling as&#xD;
      part of their diagnostic workup are eligible for the study. Unused residual blood and urine&#xD;
      samples will be used for testing the renal parameters.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 17, 2018</start_date>
  <completion_date type="Actual">June 5, 2020</completion_date>
  <primary_completion_date type="Actual">June 5, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Serum concentration of creatinine (ymol/l)</measure>
    <time_frame>single point in time at subject enrollment</time_frame>
    <description>blood test for renal biomarker</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum concentration of cystatin C (mg/l)</measure>
    <time_frame>single point in time at subject enrollment</time_frame>
    <description>blood test for renal biomarker</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum concentration of Neutrophil gelatinase-associated lipocalin (ng/ml)</measure>
    <time_frame>single point in time at subject enrollment</time_frame>
    <description>blood test for renal biomarker</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum concentration of beta-trace Protein (mg/l)</measure>
    <time_frame>single point in time at subject enrollment</time_frame>
    <description>blood test for renal biomarker</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum concentration of beta-2 Microglobulin (mg/l)</measure>
    <time_frame>single point in time at subject enrollment</time_frame>
    <description>blood test for renal biomarker</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum concentration of Uromodulin (ng/ml)</measure>
    <time_frame>single point in time at subject enrollment</time_frame>
    <description>blood test for renal biomarker</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Urine concentration of creatinine (mmols/kg/24h)</measure>
    <time_frame>single point in time at subject enrollment</time_frame>
    <description>Urine test for renal biomarker</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Urine concentration of cystatin C (mg/l)</measure>
    <time_frame>single point in time at subject enrollment</time_frame>
    <description>Urine test for renal biomarker</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Urine concentration of Neutrophil gelatinase-associated lipocalin (yg/l)</measure>
    <time_frame>single point in time at subject enrollment</time_frame>
    <description>Urine test for renal biomarker</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Urine concentration of beta-trace Protein (mg/l)</measure>
    <time_frame>single point in time at subject enrollment</time_frame>
    <description>Urine test for renal biomarker</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Urine concentration of beta-2 microglobulin (mg/l)</measure>
    <time_frame>single point in time at subject enrollment</time_frame>
    <description>Urine test for renal biomarker</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Urine concentration of uromodulin (ng/ml)</measure>
    <time_frame>at time of enrollment</time_frame>
    <description>Urine test for renal biomarker</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Urine concentration of Albumin (mg/l)</measure>
    <time_frame>at time of enrollment</time_frame>
    <description>Urine test for renal biomarker</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma protein binding of survival motor neuron (SMN) 2 splicing modifiers</measure>
    <time_frame>single point in time at subject enrollment</time_frame>
    <description>blood test for spinal muscular atrophy</description>
  </primary_outcome>
  <enrollment type="Actual">158</enrollment>
  <condition>Renal Biomarkers in Children</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>blood test for renal biomarkers (creatinine, cystatin C, Neutrophil gelatinase-associated lipocalin, beta-trace protein, beta-2 microglobulin, uromodulin)</intervention_name>
    <description>relationship between the different biomarkers by linear regression analysis is assessed; influence of demographic variables (age, body weight, body surface area) is investigated by multivariate regression.</description>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>urine test for renal biomarkers (creatinine, cystatin C, Neutrophil gelatinase-associated lipocalin, beta-trace protein beta-2 microglobulin, uromodulin, albumin)</intervention_name>
    <description>relationship between the different biomarkers by linear regression analysis is assessed; influence of demographic variables (age, body weight, body surface area) is investigated by multivariate regression.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy patients between the age of 0 and 15 years visiting the Short Stay Unit of the&#xD;
        University of Basel Children's Hospital for elective surgery and requiring venous access&#xD;
        via peripheral venous canula are eligible for study participation&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy patients for elective surgery, requiring venous access via peripheral venous&#xD;
             canula&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  chronic kidney disease&#xD;
&#xD;
          -  acute kidney failure (stage 2 or above as defined by Kidney Disease Improving Global&#xD;
             Outcomes (KDIGO) consensus 2012))&#xD;
&#xD;
          -  sepsis&#xD;
&#xD;
          -  shock&#xD;
&#xD;
          -  major haemorrhage&#xD;
&#xD;
          -  second or third degree burns&#xD;
&#xD;
          -  liver failure&#xD;
&#xD;
          -  chronic diseases with effecting the kidney (systemic lupus erythematosus, amyloidosis)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marc Pfister, Prof. Dr. MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Basel Children's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Basel Children's Hospital</name>
      <address>
        <city>Basel</city>
        <zip>4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>November 13, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>July 13, 2020</last_update_submitted>
  <last_update_submitted_qc>July 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Creatinine</keyword>
  <keyword>Albumin</keyword>
  <keyword>Cystatin C</keyword>
  <keyword>Neutrophil gelatinase-associated lipocalin (NGAL)</keyword>
  <keyword>beta-trace Protein</keyword>
  <keyword>beta-2 Microglobulin</keyword>
  <keyword>Uromodulin</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cystatins</mesh_term>
  </intervention_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/NCT03751397
org study id: 2016-00884; ks18Pfister
nct id: NCT03751397
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To characterize the relationship of renal biomarkers (Creatinine, albumin, Cystatin C, NGAL,
      beta-trace protein, beta-2 microglobulin, and uromodulin) between each other and the
      variation over age, measured in serum and urine of healthy children. Unused residual blood
      and urine samples will be used for testing the renal Parameters.
Despite relevant research in renal biomarkers, there is currently no optimal marker available
      that reliably quantifies kidney function and indicates kidney injury in its early stages. The
      combination of two or more biomarkers might be a more promising approach than investigating a
      single parameter. The relationship of renal biomarkers (creatinine, albumin, Cystatin C,
      NGAL, beta-trace protein, beta-2 microglobulin, and uromodulin) between each other and the
      variation over age in infants and children (without chronic kidney disease) is investigated.

      The biomarkers in urine samples are explored to find less invasive means of quantifying renal
      health.

      Patients between the age of 0 and 12 years undergoing blood with or without urine sampling as
      part of their diagnostic workup are eligible for the study. Unused residual blood and urine
      samples will be used for testing the renal parameters.
observational model: Cohort
time perspective: Cross-Sectional
measure: Serum concentration of creatinine (ymol/l)
time frame: single point in time at subject enrollment
description: blood test for renal biomarker
measure: Serum concentration of cystatin C (mg/l)
time frame: single point in time at subject enrollment
description: blood test for renal biomarker
measure: Serum concentration of Neutrophil gelatinase-associated lipocalin (ng/ml)
time frame: single point in time at subject enrollment
description: blood test for renal biomarker
measure: Serum concentration of beta-trace Protein (mg/l)
time frame: single point in time at subject enrollment
description: blood test for renal biomarker
measure: Serum concentration of beta-2 Microglobulin (mg/l)
time frame: single point in time at subject enrollment
description: blood test for renal biomarker
measure: Serum concentration of Uromodulin (ng/ml)
time frame: single point in time at subject enrollment
description: blood test for renal biomarker
measure: Urine concentration of creatinine (mmols/kg/24h)
time frame: single point in time at subject enrollment
description: Urine test for renal biomarker
measure: Urine concentration of cystatin C (mg/l)
time frame: single point in time at subject enrollment
description: Urine test for renal biomarker
measure: Urine concentration of Neutrophil gelatinase-associated lipocalin (yg/l)
time frame: single point in time at subject enrollment
description: Urine test for renal biomarker
measure: Urine concentration of beta-trace Protein (mg/l)
time frame: single point in time at subject enrollment
description: Urine test for renal biomarker
measure: Urine concentration of beta-2 microglobulin (mg/l)
time frame: single point in time at subject enrollment
description: Urine test for renal biomarker
measure: Urine concentration of uromodulin (ng/ml)
time frame: at time of enrollment
description: Urine test for renal biomarker
measure: Urine concentration of Albumin (mg/l)
time frame: at time of enrollment
description: Urine test for renal biomarker
measure: Plasma protein binding of survival motor neuron (SMN) 2 splicing modifiers
time frame: single point in time at subject enrollment
description: blood test for spinal muscular atrophy
intervention type: Other
intervention name: blood test for renal biomarkers (creatinine, cystatin C, Neutrophil gelatinase-associated lipocalin, beta-trace protein, beta-2 microglobulin, uromodulin)
description: relationship between the different biomarkers by linear regression analysis is assessed; influence of demographic variables (age, body weight, body surface area) is investigated by multivariate regression.
intervention type: Other
intervention name: urine test for renal biomarkers (creatinine, cystatin C, Neutrophil gelatinase-associated lipocalin, beta-trace protein beta-2 microglobulin, uromodulin, albumin)
description: relationship between the different biomarkers by linear regression analysis is assessed; influence of demographic variables (age, body weight, body surface area) is investigated by multivariate regression.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 12 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Marc Pfister, Prof. Dr. MD
role: Principal Investigator
affiliation: University of Basel Children's Hospital
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Cystatins