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Estimation of Kidney Function Through Combination of Renal Biomarkers in Blood and Urine of Healthy Infants and Children. (KidMaCare)

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ClinicalTrials.gov Identifier: NCT03751397
Recruitment Status : Active, not recruiting
First Posted : November 22, 2018
Last Update Posted : June 12, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief Summary:
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.

Condition or disease Intervention/treatment
Renal Biomarkers in Children Other: blood test for renal biomarkers (creatinine, cystatin C, Neutrophil gelatinase-associated lipocalin, beta-trace protein, beta-2 microglobulin, uromodulin) Other: urine test for renal biomarkers (creatinine, cystatin C, Neutrophil gelatinase-associated lipocalin, beta-trace protein beta-2 microglobulin, uromodulin, albumin)

Detailed Description:

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.


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Study Type : Observational
Estimated Enrollment : 180 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Estimation of Kidney Function Through Combination of Renal Biomarkers in Blood and Urine of Healthy Infants and Children
Actual Study Start Date : December 17, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: blood test for renal biomarkers (creatinine, cystatin C, Neutrophil gelatinase-associated lipocalin, beta-trace protein, beta-2 microglobulin, uromodulin)
    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.
  • Other: urine test for renal biomarkers (creatinine, cystatin C, Neutrophil gelatinase-associated lipocalin, beta-trace protein beta-2 microglobulin, uromodulin, albumin)
    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.


Primary Outcome Measures :
  1. Serum concentration of creatinine (ymol/l) [ Time Frame: single point in time at subject enrollment ]
    blood test for renal biomarker

  2. Serum concentration of cystatin C (mg/l) [ Time Frame: single point in time at subject enrollment ]
    blood test for renal biomarker

  3. Serum concentration of Neutrophil gelatinase-associated lipocalin (ng/ml) [ Time Frame: single point in time at subject enrollment ]
    blood test for renal biomarker

  4. Serum concentration of beta-trace Protein (mg/l) [ Time Frame: single point in time at subject enrollment ]
    blood test for renal biomarker

  5. Serum concentration of beta-2 Microglobulin (mg/l) [ Time Frame: single point in time at subject enrollment ]
    blood test for renal biomarker

  6. Serum concentration of Uromodulin (ng/ml) [ Time Frame: single point in time at subject enrollment ]
    blood test for renal biomarker

  7. Urine concentration of creatinine (mmols/kg/24h) [ Time Frame: single point in time at subject enrollment ]
    Urine test for renal biomarker

  8. Urine concentration of cystatin C (mg/l) [ Time Frame: single point in time at subject enrollment ]
    Urine test for renal biomarker

  9. Urine concentration of Neutrophil gelatinase-associated lipocalin (yg/l) [ Time Frame: single point in time at subject enrollment ]
    Urine test for renal biomarker

  10. Urine concentration of beta-trace Protein (mg/l) [ Time Frame: single point in time at subject enrollment ]
    Urine test for renal biomarker

  11. Urine concentration of beta-2 microglobulin (mg/l) [ Time Frame: single point in time at subject enrollment ]
    Urine test for renal biomarker

  12. Urine concentration of uromodulin (ng/ml) [ Time Frame: at time of enrollment ]
    Urine test for renal biomarker

  13. Urine concentration of Albumin (mg/l) [ Time Frame: at time of enrollment ]
    Urine test for renal biomarker

  14. Plasma protein binding of survival motor neuron (SMN) 2 splicing modifiers [ Time Frame: single point in time at subject enrollment ]
    blood test for spinal muscular atrophy



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Ages Eligible for Study:   up to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Healthy patients between the age of 0 and 15 years visiting the Short Stay Unit of the University of Basel Children`s Hospital for elective surgery and requiring venous access via peripheral venous canula are eligible for study participation
Criteria

Inclusion Criteria:

  • healthy patients for elective surgery, requiring venous access via peripheral venous canula

Exclusion Criteria:

  • chronic kidney disease
  • acute kidney failure (stage 2 or above as defined by Kidney Disease Improving Global Outcomes (KDIGO) consensus 2012))
  • sepsis
  • shock
  • major haemorrhage
  • second or third degree burns
  • liver failure
  • chronic diseases with effecting the kidney (systemic lupus erythematosus, amyloidosis)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03751397


Locations
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Switzerland
University of Basel Children's Hospital
Basel, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Marc Pfister, Prof. Dr. MD University of Basel Children's Hospital

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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT03751397     History of Changes
Other Study ID Numbers: 2016-00884; ks18Pfister
First Posted: November 22, 2018    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Basel, Switzerland:
Creatinine
Albumin
Cystatin C
Neutrophil gelatinase-associated lipocalin (NGAL)
beta-trace Protein
beta-2 Microglobulin
Uromodulin
Additional relevant MeSH terms:
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Cystatins
Cysteine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action