Renal Biomarkers in ChildrenKidMaCareNCT03751397
Estimation of Kidney Function Through Combination of Renal Biomarkers in Blood and Urine of Healthy Infants and Children.
An observational study of Renal Biomarkers in Children, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Biomarkers in Children
- What is being tested?
- blood test for renal biomarkers (creatinine, cystatin C, Neutrophil gelatinase-associated lipocalin, beta-trace protein, beta-2 microglobulin, uromodulin) and urine test for renal biomarkers (creatinine, cystatin C, Neutrophil gelatinase-associated lipocalin, beta-trace protein beta-2 microglobulin, uromodulin, albumin)
- How many people
- 158 participants
- Where
- 1 siteSwitzerland
- Study dates
- 17 Dec 2018to 5 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 12 years
- All sexes
- Healthy volunteers accepted
- Child
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
Who may be able to join
- healthy patients for elective surgery, requiring venous access via peripheral venous canula
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Renal Biomarkers in Children
- Being tested
- blood test for renal biomarkers (creatinine, cystatin C, Neutrophil gelatinase-associated lipocalin, beta-trace protein, beta-2 microglobulin, uromodulin), urine test for renal biomarkers (creatinine, cystatin C, Neutrophil gelatinase-associated lipocalin, beta-trace protein beta-2 microglobulin, uromodulin, albumin)
- Keywords
- Creatinine, Albumin, Cystatin C, Neutrophil gelatinase-associated lipocalin (NGAL), beta-trace Protein, beta-2 Microglobulin, Uromodulin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum concentration of creatinine (ymol/l)
blood test for renal biomarker
Measured: single point in time at subject enrollment
Serum concentration of cystatin C (mg/l)
blood test for renal biomarker
Measured: single point in time at subject enrollment
Serum concentration of Neutrophil gelatinase-associated lipocalin (ng/ml)
blood test for renal biomarker
Measured: single point in time at subject enrollment
Serum concentration of beta-trace Protein (mg/l)
blood test for renal biomarker
Measured: single point in time at subject enrollment
Serum concentration of beta-2 Microglobulin (mg/l)
blood test for renal biomarker
Measured: single point in time at subject enrollment
Serum concentration of Uromodulin (ng/ml)
blood test for renal biomarker
Measured: single point in time at subject enrollment
Urine concentration of creatinine (mmols/kg/24h)
Urine test for renal biomarker
Measured: single point in time at subject enrollment
Urine concentration of cystatin C (mg/l)
Urine test for renal biomarker
Measured: single point in time at subject enrollment
Urine concentration of Neutrophil gelatinase-associated lipocalin (yg/l)
Urine test for renal biomarker
Measured: single point in time at subject enrollment
Urine concentration of beta-trace Protein (mg/l)
Urine test for renal biomarker
Measured: single point in time at subject enrollment
Urine concentration of beta-2 microglobulin (mg/l)
Urine test for renal biomarker
Measured: single point in time at subject enrollment
Urine concentration of uromodulin (ng/ml)
Urine test for renal biomarker
Measured: at time of enrollment
Urine concentration of Albumin (mg/l)
Urine test for renal biomarker
Measured: at time of enrollment
Plasma protein binding of survival motor neuron (SMN) 2 splicing modifiers
blood test for spinal muscular atrophy
Measured: single point in time at subject enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start17 Dec 2018
- Primary completion5 Jun 2019
- Study completion5 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Biomarkers in ChildrenStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Pfister, Prof. Dr. MD, Principal investigator, University of Basel Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03751397
- Sponsor's protocol ID
- 2016-00884; ks18Pfister
- Other IDs
- 2016
- Acronym
- KidMaCare
- Status last verified
- Jul 2020
- First submitted
- 13 Nov 2018
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimation of Kidney Function Through Combination of Renal Biomarkers in Blood and Urine of Healthy Infants and Children
- ClinicalTrials.gov ID
- NCT03751397
- Acronym / sponsor ID
- KidMaCare / 2016-00884; ks18Pfister
- Conditions
- Renal Biomarkers in Children
- Keywords
- Creatinine, Albumin, Cystatin C, Neutrophil gelatinase-associated lipocalin (NGAL), beta-trace Protein, beta-2 Microglobulin, Uromodulin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 17 Dec 2018 (actual)
- Primary completion
- 5 Jun 2019 (actual)
- Study completion
- 5 Jun 2020 (actual)
- First posted
- 23 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- Up to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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
Key inclusion criteria (1 listed)
- healthy patients for elective surgery, requiring venous access via peripheral venous canula
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | – |
Primary outcome
Serum concentration of creatinine (ymol/l)
Time frame: single point in time at subject enrollment
blood test for renal biomarker
Serum concentration of cystatin C (mg/l)
Time frame: single point in time at subject enrollment
blood test for renal biomarker
Serum concentration of Neutrophil gelatinase-associated lipocalin (ng/ml)
Time frame: single point in time at subject enrollment
blood test for renal biomarker
Serum concentration of beta-trace Protein (mg/l)
Time frame: single point in time at subject enrollment
blood test for renal biomarker
Serum concentration of beta-2 Microglobulin (mg/l)
Time frame: single point in time at subject enrollment
blood test for renal biomarker
Serum concentration of Uromodulin (ng/ml)
Time frame: single point in time at subject enrollment
blood test for renal biomarker
Urine concentration of creatinine (mmols/kg/24h)
Time frame: single point in time at subject enrollment
Urine test for renal biomarker
Urine concentration of cystatin C (mg/l)
Time frame: single point in time at subject enrollment
Urine test for renal biomarker
Urine concentration of Neutrophil gelatinase-associated lipocalin (yg/l)
Time frame: single point in time at subject enrollment
Urine test for renal biomarker
Urine concentration of beta-trace Protein (mg/l)
Time frame: single point in time at subject enrollment
Urine test for renal biomarker
Urine concentration of beta-2 microglobulin (mg/l)
Time frame: single point in time at subject enrollment
Urine test for renal biomarker
Urine concentration of uromodulin (ng/ml)
Time frame: at time of enrollment
Urine test for renal biomarker
Urine concentration of Albumin (mg/l)
Time frame: at time of enrollment
Urine test for renal biomarker
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Pfister, Prof. Dr. MD principal investigator
University of Basel Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Biomarkers in Children, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum concentration of creatinine (ymol/l) (time frame: single point in time at subject enrollment). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2020.