Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:37 PM
Study NCT ID:
NCT06565351
Status:
COMPLETED
Last Update Posted:
2024-08-21
First Post:
2024-08-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
S-cystatin C vs.Injection Clearance Measurements to Estimate Kidney Function in Patients With Spinal Cord Injuries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055316', 'term': 'Cystatin C'}], 'ancestors': [{'id': 'D015891', 'term': 'Cystatins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 248}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-20', 'studyFirstSubmitDate': '2024-08-16', 'studyFirstSubmitQcDate': '2024-08-20', 'lastUpdatePostDateStruct': {'date': '2024-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Estimated clearance of Cystatin C (eGFR cystatin C)', 'timeFrame': 'through study period (2 years)', 'description': 'The estimated clearance of cystatin (eGFR) C is calculated from s-cystatin C and the age and height and weight of the individual. It is corrected for Body Surface area. In this study it is compared to the Gold Standard examination DTPA-clearance'}], 'secondaryOutcomes': [{'measure': 'Test/ retest variability of eGFR cystatin C', 'timeFrame': 'Up to three months', 'description': 'Blood samples for determination of Cystatin C is taken twice within maximally three months, to determine the repeatability of eGFR cystatin C'}, {'measure': 'Long term repeatability of eGFR cystatin C', 'timeFrame': 'Up to three years', 'description': 'Blood samples for determination of cystatin C is taken twice with an interval of two-three years to determine long term repeatability. This is compared to simultaneously acquired measurements of DTPA-clearance'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['spinal cord injury', 'renal Failure', 'GFR', 'Glomerular filtration rate', 'DTPA clearance', 'Cystatin C', 'eGFR'], 'conditions': ['Spinal Cord Injuries', 'Renal Failure']}, 'descriptionModule': {'briefSummary': '* In individuals with spinal cord injury (SCI) kidney function defined as Glomerular Filtration Rate (GFR) is monitored by injection of e.g.99mDTPA and subsequent blood sampling (DTPA-clearance)\n* GFR calculated from plasma samples of the endogenous substance s-Cystatin C (eGFR cystatin C) was compared to DTPA-clearance in 248 individuals with SCI.\n* It is concluded that eGFR based on plasma s-cystatin C can replace the more tedious 99mDTPA-clearance procedures in individuals with SCI'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '248 consecutive individuals with neurogenic bladder dysfunction due to spinal cord injury coming to routine control of their kidney function every 2-3 years according to international guidelines', 'eligibilityCriteria': 'Inclusion Criteria:\n\nNeurogenic bladder dysfunction due to spinal cord injury\n\nExclusion Criteria:\n\nNone'}, 'identificationModule': {'nctId': 'NCT06565351', 'briefTitle': 'S-cystatin C vs.Injection Clearance Measurements to Estimate Kidney Function in Patients With Spinal Cord Injuries', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Feasibility of Replacing 99mTc-DTPA GFR Measurements With eGFR From s-Cystatin C in Individuals With Spinal Cord Injuries', 'orgStudyIdInfo': {'id': 'Rigshospitalet; Glostrup'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Spinal Cord Injury Individuals', 'description': '248 individuals with spinal cord injury and neurogenic bladder dysfunction, coming to routine controls of the renal function. Glomerular filtration rate (GFR) was measured by 99mTc-DTPA clearance and estimated by eGFR from creatinine and Cystatine C', 'interventionNames': ['Other: eGFR estimated from creatinine and cystatin C']}], 'interventions': [{'name': 'eGFR estimated from creatinine and cystatin C', 'type': 'OTHER', 'description': 'eGFR estimated from creatinine and cystatin C was compared to GFR measured by 99mTc-DTPA clearance (gold standard)', 'armGroupLabels': ['Spinal Cord Injury Individuals']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DK-2600', 'city': 'Glostrup Municipality', 'country': 'Denmark', 'facility': 'Dept. of Clinical Physiology and Nuclear Medicine, Copenhagen University Hospital, Rigshospitalet; Glostrup', 'geoPoint': {'lat': 55.6666, 'lon': 12.40377}}], 'overallOfficials': [{'name': 'Ulrik B. Andersen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rigshospitalet: Glostrup'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': '9-24 months after publication', 'ipdSharing': 'YES', 'description': 'Data obtained through this study may be provided to qualified researchers. Data or samples shared will be coded, with no personal health information included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.', 'accessCriteria': 'Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA)'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Consultant', 'investigatorFullName': 'Ulrik Bjoern Andersen', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}