Renal Function DisorderNCT01092260
Renal Function Measurements in Children
An observational study of Renal Function Disorder, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
The purpose of this study is to validate a feasible, safe and reliable iohexol plasma clearance method in routine monitoring of the renal function (GFR) in children. Different parameters of renal function will be compared to the gold standard multiple sample points procedure of iohexol clearance. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Renal Function Disorder
- How many people
- 96 participants
- Where
- 1 siteNorway
- Study dates
- Apr 2010to Dec 2011
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with clinical indication for measurement of renal function
Who may be able to join
- Age < 18 years
- Clinical indication for measurement of glomerular filtration rate
Who cannot join
- Previous serious reaction on Iohexol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Glomerular Filtration Rate in Children - a Methodological Study With Iohexol Clearance
The purpose of this study is to validate a feasible, safe and reliable iohexol plasma clearance method in routine monitoring of the renal function (GFR) in children.
Different parameters of renal function will be compared to the gold standard multiple sample points procedure of iohexol clearance.
- Conditions
- Renal Function Disorder
- Keywords
- Glomerular Filtration Rate, Kidney disease, Child, Iohexol, Cystatin C, Measurement of kidney function in children
- 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 posted24 Mar 2010 (estimated)
- Study startApr 2010
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Renal Function DisorderStudies of the same condition, open and under way.
- 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
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital
- Responsible party
- Sponsor
- Investigators
- Camilla Tondel, MD, Principal investigator, Haukeland University Hospital, Bergen, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01092260
- Sponsor's protocol ID
- 2009/741
- Status last verified
- Jan 2012
- First submitted
- 23 Mar 2010
- Last updated
- 5 Jan 2012
- Results posted
- No
Publications
Salvador CL, Flemmen PTK, Tondel C, Bliksrud YT, Tsui EFF, Brun A, Bjerre A, Morkrid L. Renal function, sex and age influence purines and pyrimidines in urine and could lead to diagnostic misinterpretation. Mol Genet Metab. 2023 Nov;140(3):107649. doi: 10.1016/j.ymgme.2023.107649. Epub 2023 Jul 5.
PubMed 37517327Eide TT, Hufthammer KO, Brun A, Brackman D, Svarstad E, Tondel C. Accuracy of single intravenous access iohexol GFR in children is hampered by marker contamination. Sci Rep. 2021 Dec 1;11(1):23224. doi: 10.1038/s41598-021-02759-1.
PubMed 34853376Salvador CL, Tondel C, Rowe AD, Bjerre A, Brun A, Brackman D, Bolstad N, Morkrid L. Renal Function Influences Diagnostic Markers in Serum and Urine: A Study of Guanidinoacetate, Creatine, Human Epididymis Protein 4, and Neutrophil Gelatinase-Associated Lipocalin in Children. J Appl Lab Med. 2017 Nov 1;2(3):297-308. doi: 10.1373/jalm.2016.022145.
PubMed 33636843Salvador CL, Tondel C, Rowe AD, Bjerre A, Brun A, Brackman D, Morkrid L. Estimating glomerular filtration rate in children: evaluation of creatinine- and cystatin C-based equations. Pediatr Nephrol. 2019 Feb;34(2):301-311. doi: 10.1007/s00467-018-4067-3. Epub 2018 Aug 31.
PubMed 30171354Tondel C, Salvador CL, Hufthammer KO, Bolann B, Brackman D, Bjerre A, Svarstad E, Brun A. Iohexol plasma clearance in children: validation of multiple formulas and single-point sampling times. Pediatr Nephrol. 2018 Apr;33(4):683-696. doi: 10.1007/s00467-017-3841-y. Epub 2017 Nov 13.
PubMed 29134449Tondel C, Bolann B, Salvador CL, Brackman D, Bjerre A, Svarstad E, Brun A. Iohexol plasma clearance in children: validation of multiple formulas and two-point sampling times. Pediatr Nephrol. 2017 Feb;32(2):311-320. doi: 10.1007/s00467-016-3436-z. Epub 2016 Jul 1.
PubMed 27369694
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glomerular Filtration Rate in Children - a Methodological Study With Iohexol Clearance
- ClinicalTrials.gov ID
- NCT01092260
- Acronym / sponsor ID
- 2009/741
- Conditions
- Renal Function Disorder
- Keywords
- Glomerular Filtration Rate, Kidney disease, Child, Iohexol, Cystatin C, Measurement of kidney function in children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- Oslo University Hospital
- Study start
- Apr 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 24 Mar 2010 (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 validate a feasible, safe and reliable iohexol plasma clearance method in routine monitoring of the renal function (GFR) in children.
Different parameters of renal function will be compared to the gold standard multiple sample points procedure of iohexol clearance.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with clinical indication for measurement of renal function
Key inclusion criteria (2 listed)
- Age < 18 years
- Clinical indication for measurement of glomerular filtration rate
Key exclusion criteria (1 listed)
- Previous serious reaction on Iohexol
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 5 Jan 2012.
- Derived from this study: PubMed 37517327Salvador CL, Flemmen PTK, Tondel C, Bliksrud YT, Tsui EFF, Brun A, Bjerre A, Morkrid L. Renal function, sex and age influence purines and pyrimidines in urine and could lead to diagnostic misinterpretation. Mol Genet Metab. 2023 Nov;140(3):107649. doi: 10.1016/j.ymgme.2023.107649. Epub 2023 Jul 5.
- Derived from this study: PubMed 34853376Eide TT, Hufthammer KO, Brun A, Brackman D, Svarstad E, Tondel C. Accuracy of single intravenous access iohexol GFR in children is hampered by marker contamination. Sci Rep. 2021 Dec 1;11(1):23224. doi: 10.1038/s41598-021-02759-1.
- Derived from this study: PubMed 33636843Salvador CL, Tondel C, Rowe AD, Bjerre A, Brun A, Brackman D, Bolstad N, Morkrid L. Renal Function Influences Diagnostic Markers in Serum and Urine: A Study of Guanidinoacetate, Creatine, Human Epididymis Protein 4, and Neutrophil Gelatinase-Associated Lipocalin in Children. J Appl Lab Med. 2017 Nov 1;2(3):297-308. doi: 10.1373/jalm.2016.022145.
- Derived from this study: PubMed 30171354Salvador CL, Tondel C, Rowe AD, Bjerre A, Brun A, Brackman D, Morkrid L. Estimating glomerular filtration rate in children: evaluation of creatinine- and cystatin C-based equations. Pediatr Nephrol. 2019 Feb;34(2):301-311. doi: 10.1007/s00467-018-4067-3. Epub 2018 Aug 31.
- Derived from this study: PubMed 29134449Tondel C, Salvador CL, Hufthammer KO, Bolann B, Brackman D, Bjerre A, Svarstad E, Brun A. Iohexol plasma clearance in children: validation of multiple formulas and single-point sampling times. Pediatr Nephrol. 2018 Apr;33(4):683-696. doi: 10.1007/s00467-017-3841-y. Epub 2017 Nov 13.
- Derived from this study: PubMed 27369694Tondel C, Bolann B, Salvador CL, Brackman D, Bjerre A, Svarstad E, Brun A. Iohexol plasma clearance in children: validation of multiple formulas and two-point sampling times. Pediatr Nephrol. 2017 Feb;32(2):311-320. doi: 10.1007/s00467-016-3436-z. Epub 2016 Jul 1.
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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.
Camilla Tondel, MD principal investigator
Haukeland University Hospital, Bergen, Norway
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 Function Disorder, run by Haukeland University Hospital at 1 site in Norway.
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 2 inclusion and 1 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 5 Jan 2012. 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 Norway. 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?
On the ClinicalTrials.gov record for NCT01092260, which also lists 6 linked publications.
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 5 Jan 2012.