NCT01092260

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 24, 2010

Completed
8 days until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

January 5, 2012

Status Verified

January 1, 2012

Enrollment Period

1.7 years

First QC Date

March 23, 2010

Last Update Submit

January 3, 2012

Conditions

Renal Function Disorder

Keywords

Glomerular Filtration RateKidney diseaseChildIohexolCystatin CMeasurement of kidney function in children

Eligibility Criteria

AgeUp to 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children with clinical indication for measurement of renal function

You may qualify if:

  • Age \< 18 years
  • Clinical indication for measurement of glomerular filtration rate

You may not qualify if:

  • Previous serious reaction on Iohexol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haukeland University Hospital

Bergen, 5021, Norway

Location

Related Publications (6)

  • 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.

    PMID: 37517327DERIVED

  • Eide 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.

    PMID: 34853376DERIVED

  • Salvador 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.

    PMID: 33636843DERIVED

  • Salvador 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.

    PMID: 30171354DERIVED

  • Tondel 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.

    PMID: 29134449DERIVED

  • Tondel 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.

    PMID: 27369694DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum and urine

MeSH Terms

Conditions

Kidney Diseases

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Camilla Tondel, MD

    Haukeland University Hospital, Bergen, Norway

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2010

First Posted

March 24, 2010

Study Start

April 1, 2010

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

January 5, 2012

Record last verified: 2012-01

Locations

NO(1)