Kidney DiseaseNCT00300066
Assessment of Serum Cystatin C as a Marker of Kidney Function in Children
An observational study of Kidney Disease, run by Aalborg University Hospital at 2 sites in Denmark.
Trial summary
The purpose of this study is to assess serum cystatin C as a marker of kidney function (glomerular filtration rate, GFR) in children aged 2-14. The individual production rate and possible extra renal elimination of cystatin C based on body composition data is included to develop new algorithms to estimate GFR. Read more about this study
- Who is it for?
- Ages 2 to 14 years
- Conditions the study is for
- Kidney Disease
- How many people
- 200 participants
- Where
- 2 sitesDenmark
- Study dates
- Mar 2006to Dec 2008
- 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 2 to 14 years
- All sexes
- No healthy volunteers
- Child
Study population: Children aged 2-14 years referrede for GFR measurement
Who may be able to join
- Children aged 2-14 years referred for GFR measurement by 51-CrEDTA
Who cannot join
- GFR measurement by capillary technique
- Immune compromising treatment
- Previous kidney transplant
- Hypo- or hyperthyroidism
- Increased C-reactive protein (CRP)
- Rheumatoid arthritis
- Ascites
- Pacemaker (only exclusion for BIS and DEXA)
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Department of Clinical Physiology, University Hospital of Aarhus, Aalborg
Aalborg, Hobrovej 18-22, 9000
Department of Nuclear Medicine, University Hospital Aarhus, Skejby
Aarhus, Brendstrupgaardsvej 100, 8200
About this study
Official title: Prediction Equations for Glomerular Filtration Rate in Children Based on Serum Cystatin C and Body Cell Mass
The purpose of this study is to assess serum cystatin C as a marker of kidney function (glomerular filtration rate, GFR) in children aged 2-14. The individual production rate and possible extra renal elimination of cystatin C based on body composition data is included to develop new algorithms to estimate GFR.
Furthermore, day-to-day variation on serum cystatin C is investigated.
Read the detailed description
Today, children's kidney function (glomerular filtration rate, GFR) can be monitored by two methods:
- indirectly by serum creatinine, or
- directly by injection of a radioactive substance followed by several blood samples.
The first method is inaccurate with many drawbacks, whereas the latter is precise but time-consuming and unpleasant for the child. Therefore, there is a need for a new method for investigating GFR in children.
Serum cystatin C is a small protein that is produced with a constant rate in all nucleated cells in the body. It meets many of the characteristics of an ideal marker of GFR because of the way it is excreted in the kidneys. However, earlier studies have not proven serum cystatin C to be convincingly better than serum creatinine. Why? If there is considerable extra renal elimination, serum cystatin C alone isn't enough to estimate GFR. Therefore, the individual production rate and possible extra renal elimination of cystatin C are included in this study. To assess these factors, the children are submitted to bioelectrical impedance spectroscopy (BIS) to estimate their body composition, including body cell mass as cystatin C is produced in all nucleated cells. To validate the BIS data, dual energy x-ray absorptiometry (DEXA) will be conducted on 100 of the included children.
Based on serum cystatin C and the individual, age-corrected extra renal elimination rate of cystatin C, new algorithms to calculate GFR can be developed.
Furthermore, day-to-day variation in serum cystatin C and BIS data, which is expected to be low, is investigated in 100 of the included children.
Hypotheses:
- Day-to-day variation on serum cystatin C is low.
- Serum cystatin C raises parallel to falling GFR with time, which means that serum cystatin C can be used to monitor changes in kidney function in each patient.
- Based on body composition, regression analysis and serum cystatin C values, GFR can be estimated in children aged 2-14.
- GFR calculated as stated above is a more precise measurement of kidney function and changes in kidney function than GFR estimated from serum creatinine.
- Data of body composition estimated by BIS do not deviate from data estimated by DEXA
- Day-to-day variation in data for body composition measured by BIS is low.
The project includes 200 children aged 2-14 who are referred for routine examination of GFR in two Departments of Nuclear Medicine.
- Conditions
- Kidney Disease
- Keywords
- Glomerular Filtration Rate, Serum Cystatin C, Body Composition, bioelectrical impedance spectroscopy
- Medical subject headings
- Kidney Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2006 (estimated)
- Study startMar 2006
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Investigators
- Trine B Andersen, MD, Principal investigator, University Hospital of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00300066
- Sponsor's protocol ID
- VN-20050065MCH
- Status last verified
- May 2010
- First submitted
- 6 Mar 2006
- Last updated
- 28 May 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction Equations for Glomerular Filtration Rate in Children Based on Serum Cystatin C and Body Cell Mass
- ClinicalTrials.gov ID
- NCT00300066
- Acronym / sponsor ID
- VN-20050065MCH
- Conditions
- Kidney Disease
- Keywords
- Glomerular Filtration Rate, Serum Cystatin C, Body Composition, bioelectrical impedance spectroscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- Mar 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 8 Mar 2006 (estimated)
- 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.
The purpose of this study is to assess serum cystatin C as a marker of kidney function (glomerular filtration rate, GFR) in children aged 2-14. The individual production rate and possible extra renal elimination of cystatin C based on body composition data is included to develop new algorithms to estimate GFR.
Furthermore, day-to-day variation on serum cystatin C is investigated.
Detailed description
Today, children's kidney function (glomerular filtration rate, GFR) can be monitored by two methods:
- indirectly by serum creatinine, or
- directly by injection of a radioactive substance followed by several blood samples.
The first method is inaccurate with many drawbacks, whereas the latter is precise but time-consuming and unpleasant for the child. Therefore, there is a need for a new method for investigating GFR in children.
Serum cystatin C is a small protein that is produced with a constant rate in all nucleated cells in the body. It meets many of the characteristics of an ideal marker of GFR because of the way it is excreted in the kidneys. However, earlier studies have not proven serum cystatin C to be convincingly better than serum creatinine. Why? If there is considerable extra renal elimination, serum cystatin C alone isn't enough to estimate GFR. Therefore, the individual production rate and possible extra renal elimination of cystatin C are included in this study. To assess these factors, the children are submitted to bioelectrical impedance spectroscopy (BIS) to estimate their body composition, including body cell mass as cystatin C is produced in all nucleated cells. To validate the BIS data, dual energy x-ray absorptiometry (DEXA) will be conducted on 100 of the included children.
Based on serum cystatin C and the individual, age-corrected extra renal elimination rate of cystatin C, new algorithms to calculate GFR can be developed.
Furthermore, day-to-day variation in serum cystatin C and BIS data, which is expected to be low, is investigated in 100 of the included children.
Hypotheses:
- Day-to-day variation on serum cystatin C is low.
- Serum cystatin C raises parallel to falling GFR with time, which means that serum cystatin C can be used to monitor changes in kidney function in each patient.
- Based on body composition, regression analysis and serum cystatin C values, GFR can be estimated in children aged 2-14.
- GFR calculated as stated above is a more precise measurement of kidney function and changes in kidney function than GFR estimated from serum creatinine.
- Data of body composition estimated by BIS do not deviate from data estimated by DEXA
- Day-to-day variation in data for body composition measured by BIS is low.
The project includes 200 children aged 2-14 who are referred for routine examination of GFR in two Departments of Nuclear Medicine.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children aged 2-14 years referrede for GFR measurement
Key inclusion criteria (1 listed)
- Children aged 2-14 years referred for GFR measurement by 51-CrEDTA
Key exclusion criteria (8 listed)
- GFR measurement by capillary technique
- Immune compromising treatment
- Previous kidney transplant
- Hypo- or hyperthyroidism
- Increased C-reactive protein (CRP)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 28 May 2010.
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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.
Trine B Andersen, MD principal investigator
University Hospital of Aarhus
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Disease, run by Aalborg University Hospital at 2 sites in Denmark.
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 28 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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.
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 28 May 2010.