Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-29 @ 7:56 AM
Study NCT ID:
NCT00323128
Status:
COMPLETED
Last Update Posted:
2011-06-02
First Post:
2006-05-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of Serum Creatinine Dosage and Renal Clearance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'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': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-01', 'studyFirstSubmitDate': '2006-05-08', 'studyFirstSubmitQcDate': '2006-05-08', 'lastUpdatePostDateStruct': {'date': '2011-06-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-05-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glomerular filtration ratio', 'timeFrame': 'At time T0'}, {'measure': 'Serum creatinine', 'timeFrame': 'At time T0'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Kidney Failure']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.uzgent.be', 'label': 'Website University Hospital Ghent'}]}, 'descriptionModule': {'briefSummary': 'This study has an open study design. The GFR will be measured using the renal clearance of inulin (Inutest) in volunteers with different stage of renal disease or without renal disease. A blood sample will be obtained for measuring serum creatinine in different laboratories.', 'detailedDescription': 'In this study we will investigate the correlation between the GFR as measured by inulin clearance (golden standard) and the estimated GFR as measured by laboratories which used different serum creatinine assays in patients without renal disease and in patients with different stage of kidney failure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Normal weight as defined by a Body Mass Index of 18 to 30 kg/m2.\n* Subject is competent and willing to sign informed consent form after being given all the detailed information about the study. Informed consent form signed voluntarily.\n* The subjects must be in stable clinical condition, with stable serum creatinin at least for 6 months.\n* Persons with different stage of chronic renal disease and without kidney disease (living donors) who need an evaluation of the GFR or Admitted volunteers who easily obtain urine samples.\n\nExclusion Criteria:\n\n* Transplant patients\n* Medication that will influence the serumcreatinine.\n* Morbid obesity\n* Pregnant, lactating females or females with childbearing potential without adequate contraception (use of oral contraceptives, IUD or condoms with spermicide).\n* History of allergy or hypersensitivity to inulin\n* Donation of blood in the 60 days preceding the first visit.\n* Liver disease, heart failure, nephrotic syndrome.\n* Patients in critically ill conditions.\n* Malnutrition\n* Postrenal kidney failure'}, 'identificationModule': {'nctId': 'NCT00323128', 'briefTitle': 'Validation of Serum Creatinine Dosage and Renal Clearance', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Ghent'}, 'officialTitle': 'Validation of Serum Creatinine Dosage and Renal Clearance', 'orgStudyIdInfo': {'id': '2006/037'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Calculation of inuline clearance', 'type': 'PROCEDURE', 'description': 'Calculation of inuline clearance.'}, {'name': 'Measuring serum creatinine', 'type': 'PROCEDURE', 'description': 'Measuring serum creatinine.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aalst', 'country': 'Belgium', 'facility': 'Algemeen Stedelijk Ziekenhuis Aalst', 'geoPoint': {'lat': 50.93604, 'lon': 4.0355}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'University Hospital Ghent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'overallOfficials': [{'name': 'Raymond Van Holder, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Ghent'}, {'name': 'Arjan Van der Tol, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Ghent'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Ghent', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Arjan Van Der Tol', 'oldOrganization': 'University Hospital Ghent'}}}}