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

July 13, 2020 updated by: University Hospital, Basel, Switzerland

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
158

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • University of Basel Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 8 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Serum concentration of creatinine (ymol/l)
Time Frame: single point in time at subject enrollment
blood test for renal biomarker
single point in time at subject enrollment
Serum concentration of cystatin C (mg/l)
Time Frame: single point in time at subject enrollment
blood test for renal biomarker
single point in time at subject enrollment
Serum concentration of Neutrophil gelatinase-associated lipocalin (ng/ml)
Time Frame: single point in time at subject enrollment
blood test for renal biomarker
single point in time at subject enrollment
Serum concentration of beta-trace Protein (mg/l)
Time Frame: single point in time at subject enrollment
blood test for renal biomarker
single point in time at subject enrollment
Serum concentration of beta-2 Microglobulin (mg/l)
Time Frame: single point in time at subject enrollment
blood test for renal biomarker
single point in time at subject enrollment
Serum concentration of Uromodulin (ng/ml)
Time Frame: single point in time at subject enrollment
blood test for renal biomarker
single point in time at subject enrollment
Urine concentration of creatinine (mmols/kg/24h)
Time Frame: single point in time at subject enrollment
Urine test for renal biomarker
single point in time at subject enrollment
Urine concentration of cystatin C (mg/l)
Time Frame: single point in time at subject enrollment
Urine test for renal biomarker
single point in time at subject enrollment
Urine concentration of Neutrophil gelatinase-associated lipocalin (yg/l)
Time Frame: single point in time at subject enrollment
Urine test for renal biomarker
single point in time at subject enrollment
Urine concentration of beta-trace Protein (mg/l)
Time Frame: single point in time at subject enrollment
Urine test for renal biomarker
single point in time at subject enrollment
Urine concentration of beta-2 microglobulin (mg/l)
Time Frame: single point in time at subject enrollment
Urine test for renal biomarker
single point in time at subject enrollment
Urine concentration of uromodulin (ng/ml)
Time Frame: at time of enrollment
Urine test for renal biomarker
at time of enrollment
Urine concentration of Albumin (mg/l)
Time Frame: at time of enrollment
Urine test for renal biomarker
at time of enrollment
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
single point in time at subject enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Basel, Switzerland

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marc Pfister, Prof. Dr. MD, University of Basel Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 17, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 5, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 5, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 13, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 23, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 14, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2016-00884; ks18Pfister

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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