Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2026-01-09 @ 10:13 AM
Study NCT ID:
NCT06491602
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Clinical Characteristics ,Risk Factors and Outcome of Lupus Nephritis Among Children With Systemic Lupus Erthromatousus in Sohag Univeristy Hospital
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008181', 'term': 'Lupus Nephritis'}], 'ancestors': [{'id': 'D005921', 'term': 'Glomerulonephritis'}, {'id': 'D009393', 'term': 'Nephritis'}, {'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': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-06-24', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-01', 'studyFirstSubmitDate': '2024-07-01', 'studyFirstSubmitQcDate': '2024-07-01', 'lastUpdatePostDateStruct': {'date': '2024-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'remission of LN', 'timeFrame': '1 year', 'description': 'acute on top of chronic'}, {'measure': 'progress to CKD', 'timeFrame': '1 year', 'description': 'affection of kidney become perment'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lupus Nephritis']}, 'referencesModule': {'references': [{'pmid': '22129255', 'type': 'BACKGROUND', 'citation': 'Tsokos GC. Systemic lupus erythematosus. N Engl J Med. 2011 Dec 1;365(22):2110-21. doi: 10.1056/NEJMra1100359. No abstract available.'}, {'pmid': '22847366', 'type': 'BACKGROUND', 'citation': 'Hiraki LT, Feldman CH, Liu J, Alarcon GS, Fischer MA, Winkelmayer WC, Costenbader KH. Prevalence, incidence, and demographics of systemic lupus erythematosus and lupus nephritis from 2000 to 2004 among children in the US Medicaid beneficiary population. Arthritis Rheum. 2012 Aug;64(8):2669-76. doi: 10.1002/art.34472.'}, {'pmid': '33826705', 'type': 'BACKGROUND', 'citation': 'Demir S, Gulhan B, Ozen S, Celegen K, Batu ED, Tas N, Orhan D, Bilginer Y, Duzova A, Ozaltin F, Topaloglu R. Long-term renal survival of paediatric patients with lupus nephritis. Nephrol Dial Transplant. 2022 May 25;37(6):1069-1077. doi: 10.1093/ndt/gfab152.'}, {'pmid': '18346514', 'type': 'BACKGROUND', 'citation': 'Hiraki LT, Benseler SM, Tyrrell PN, Hebert D, Harvey E, Silverman ED. Clinical and laboratory characteristics and long-term outcome of pediatric systemic lupus erythematosus: a longitudinal study. J Pediatr. 2008 Apr;152(4):550-6. doi: 10.1016/j.jpeds.2007.09.019. Epub 2007 Nov 5.'}]}, 'descriptionModule': {'briefSummary': 'systemic lupus erthrematosus is an inflamatory and autoimmune condition characterized by multisystem affection and chronic course with unpredictable flares despite potentially afffecting every oragan . kidney involvment are the most common'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Month', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'all children with diagnostic criteria of SLE atteding to pediatric rheumatology and immunology clinic', 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- aim to include all children fulfilling diagnostic criteria\n\nExclusion Criteria:\n\n* children with other rheumatological disorder neonates chidren with other nephrolgy disorder'}, 'identificationModule': {'nctId': 'NCT06491602', 'briefTitle': 'A Study of Clinical Characteristics ,Risk Factors and Outcome of Lupus Nephritis Among Children With Systemic Lupus Erthromatousus in Sohag Univeristy Hospital', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'A Study of Clinical Characteristics ,Risk Factors and Outcome of Lupus Nephritis Among Children With Systemic Lupus Erthromatousus in Sohag Univeristy Hospital', 'orgStudyIdInfo': {'id': 'Soh-Med-24-06-22MS'}}, 'armsInterventionsModule': {'interventions': [{'name': 'renal biobsy', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['abdomial us', 'laboratory investigation for lupus nephritis'], 'description': 'analsis of renal biobsy and decide grade of renal affection'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'Sohag', 'city': 'Sohag', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Magdy M Amin, professor', 'role': 'CONTACT'}], 'facility': 'Sohag university Hospital', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'randa A ali, resident', 'role': 'CONTACT', 'email': 'randa.abdelgawaad@med.sohag.edu.eg', 'phone': '01100128936'}, {'name': 'dr monser M Mohammed, assistant professor', 'role': 'CONTACT', 'phone': '01026372799'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident-pediatric department-sohag hospital university', 'investigatorFullName': 'Randa Abdelgawad Hussien', 'investigatorAffiliation': 'Sohag University'}}}}