Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 6:30 PM
Study NCT ID:
NCT01092260
Status:
COMPLETED
Last Update Posted:
2012-01-05
First Post:
2010-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Renal Function Measurements in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007674', 'term': 'Kidney Diseases'}], 'ancestors': [{'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'serum and urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-03', 'studyFirstSubmitDate': '2010-03-23', 'studyFirstSubmitQcDate': '2010-03-23', 'lastUpdatePostDateStruct': {'date': '2012-01-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['Glomerular Filtration Rate', 'Kidney disease', 'Child', 'Iohexol', 'Cystatin C', 'Measurement of kidney function in children'], 'conditions': ['Renal Function Disorder']}, 'referencesModule': {'references': [{'pmid': '37517327', 'type': 'DERIVED', 'citation': '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': '34853376', 'type': 'DERIVED', 'citation': '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': '33636843', 'type': 'DERIVED', 'citation': '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': '30171354', 'type': 'DERIVED', 'citation': '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': '29134449', 'type': 'DERIVED', 'citation': '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': '27369694', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nDifferent parameters of renal function will be compared to the gold standard multiple sample points procedure of iohexol clearance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children with clinical indication for measurement of renal function', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\< 18 years\n* Clinical indication for measurement of glomerular filtration rate\n\nExclusion Criteria:\n\n* Previous serious reaction on Iohexol'}, 'identificationModule': {'nctId': 'NCT01092260', 'briefTitle': 'Renal Function Measurements in Children', 'organization': {'class': 'OTHER', 'fullName': 'Haukeland University Hospital'}, 'officialTitle': 'Glomerular Filtration Rate in Children - a Methodological Study With Iohexol Clearance', 'orgStudyIdInfo': {'id': '2009/741'}}, 'contactsLocationsModule': {'locations': [{'zip': '5021', 'city': 'Bergen', 'country': 'Norway', 'facility': 'Haukeland University Hospital', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}], 'overallOfficials': [{'name': 'Camilla Tondel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Haukeland University Hospital, Bergen, Norway'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Haukeland University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Oslo University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}