Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2025-12-25 @ 7:03 PM
Study NCT ID:
NCT06315504
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-19
First Post:
2024-03-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Circulating Factors in Nephrotic Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009404', 'term': 'Nephrotic Syndrome'}, {'id': 'D015433', 'term': 'Glomerulonephritis, Membranous'}, {'id': 'D009402', 'term': 'Nephrosis, Lipoid'}], 'ancestors': [{'id': 'D009401', 'term': 'Nephrosis'}, {'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'}, {'id': 'D005921', 'term': 'Glomerulonephritis'}, {'id': 'D009393', 'term': 'Nephritis'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood and kidney tissue'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 104}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2034-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-16', 'studyFirstSubmitDate': '2024-03-11', 'studyFirstSubmitQcDate': '2024-03-11', 'lastUpdatePostDateStruct': {'date': '2024-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2034-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'levels of anti-nephrin in blood by ELISA', 'timeFrame': 'up to 12 months', 'description': 'temporal association of anti-nephrin with clinical remission of nephrotic syndrome'}], 'secondaryOutcomes': [{'measure': 'changes in auto-antibodies in blood associated with membranous nephropathy', 'timeFrame': 'up to 24 months', 'description': 'temporal association of auto-antibodies with clinical remission of nephrotic syndrome'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nephrotic Syndrome', 'Membranous Nephropathy', 'Minimal Change Disease', 'Primary Focal Segmental Glomerulosclerosis']}, 'descriptionModule': {'briefSummary': 'A prospective observational study to investigate the treatment-associated changes of circulating factors associated with glomerular diseases among patients with de novo nephrotic syndrome admitted to hospital for a kidney biopsy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'De novo nephrotic syndrome admitted to hospital for a clinically indicated kidney biopsy.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Plasma albumin \\< 36 g/L\n* Urine protein \\>3.5 g/day or urine protein/creatinine-ratio (UPCR) \\> 3.5 or urine albumin/creatinine-ratio (UACR) \\>2200 mg/g\n* Planned kidney biopsy\n* Able to give written informed consent\n\nExclusion Criteria:\n\n* Kidney transplant recipient\n* Previously undergone a kidney biopsy\n* Unable to understand written information in Danish'}, 'identificationModule': {'nctId': 'NCT06315504', 'briefTitle': 'Circulating Factors in Nephrotic Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Herlev Hospital'}, 'officialTitle': 'Circulating Factors in Nephrotic Syndrome - A Prospective Observational Cohort Study', 'orgStudyIdInfo': {'id': 'Nephrotic Syndrome Cohort'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with de novo nephrotic syndrome', 'interventionNames': ['Other: Observation']}], 'interventions': [{'name': 'Observation', 'type': 'OTHER', 'description': 'Observation', 'armGroupLabels': ['Patients with de novo nephrotic syndrome']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Iain Bressendorff, MD PhD', 'role': 'CONTACT', 'email': 'iain.oshoej.bressendorff@regionh.dk', 'phone': '+4524277139'}, {'name': 'Ditte Hansen, MD PhD', 'role': 'CONTACT', 'email': 'ditte.hansen.04@regionh.dk', 'phone': '+4538682056'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Upon reasonable request to the primary investigator.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Iain Bressendorff', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD PhD', 'investigatorFullName': 'Iain Bressendorff', 'investigatorAffiliation': 'Herlev Hospital'}}}}