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Completed

NCT Number: NCT03751397

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

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.

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Key information

Conditions

Renal Biomarkers in Children

Age range

Up to 12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Basel Children's Hospital

Basel, 4031, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

blood test for renal biomarkers (creatinine, cystatin C, Neutrophil gelatinase-associated lipocalin, beta-trace protein, beta-2 microglobulin, uromodulin)

Other

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.

urine test for renal biomarkers (creatinine, cystatin C, Neutrophil gelatinase-associated lipocalin, beta-trace protein beta-2 microglobulin, uromodulin, albumin)

Other

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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

Estimation of Kidney Function Through Combination of Renal Biomarkers in Blood and Urine of Healthy Infants and Children

Acronym: KidMaCare

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Nov 23, 2018
Registry last updated
Jul 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.