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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03751397
Acronym
KidMaCare
Enrollment
158
Registered
2018-11-23
Start date
2018-12-17
Completion date
2020-06-05
Last updated
2020-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Biomarkers in Children

Keywords

Creatinine, Albumin, Cystatin C, Neutrophil gelatinase-associated lipocalin (NGAL), beta-trace Protein, beta-2 Microglobulin, Uromodulin

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.

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.

Interventions

OTHERblood 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.

OTHERurine 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.

Sponsors

University Hospital, Basel, Switzerland
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
No minimum to 12 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Serum concentration of creatinine (ymol/l)single point in time at subject enrollmentblood test for renal biomarker
Serum concentration of cystatin C (mg/l)single point in time at subject enrollmentblood test for renal biomarker
Serum concentration of Neutrophil gelatinase-associated lipocalin (ng/ml)single point in time at subject enrollmentblood test for renal biomarker
Serum concentration of beta-trace Protein (mg/l)single point in time at subject enrollmentblood test for renal biomarker
Serum concentration of beta-2 Microglobulin (mg/l)single point in time at subject enrollmentblood test for renal biomarker
Serum concentration of Uromodulin (ng/ml)single point in time at subject enrollmentblood test for renal biomarker
Urine concentration of creatinine (mmols/kg/24h)single point in time at subject enrollmentUrine test for renal biomarker
Urine concentration of cystatin C (mg/l)single point in time at subject enrollmentUrine test for renal biomarker
Urine concentration of Neutrophil gelatinase-associated lipocalin (yg/l)single point in time at subject enrollmentUrine test for renal biomarker
Urine concentration of beta-trace Protein (mg/l)single point in time at subject enrollmentUrine test for renal biomarker
Urine concentration of beta-2 microglobulin (mg/l)single point in time at subject enrollmentUrine test for renal biomarker
Urine concentration of uromodulin (ng/ml)at time of enrollmentUrine test for renal biomarker
Urine concentration of Albumin (mg/l)at time of enrollmentUrine test for renal biomarker
Plasma protein binding of survival motor neuron (SMN) 2 splicing modifierssingle point in time at subject enrollmentblood test for spinal muscular atrophy

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026