Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-03-08 @ 11:00 PM
Study NCT ID:
NCT03687905
Status:
UNKNOWN
Last Update Posted:
2018-09-27
First Post:
2018-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Proliferative Lupus Nephritis Treatment With Chloroquine and Hydroxychloroquine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002738', 'term': 'Chloroquine'}, {'id': 'D006886', 'term': 'Hydroxychloroquine'}], 'ancestors': [{'id': 'D000634', 'term': 'Aminoquinolines'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-09-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2019-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-09-25', 'studyFirstSubmitDate': '2018-09-18', 'studyFirstSubmitQcDate': '2018-09-25', 'lastUpdatePostDateStruct': {'date': '2018-09-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fundus examination as screening test', 'timeFrame': '12 months', 'description': 'Detection of chloroquine and hydroxychloroquine related retinal toxicity at early stage.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Proliferative Nephritis', 'Chloroquine Retinopathy']}, 'referencesModule': {'references': [{'pmid': '36752895', 'type': 'DERIVED', 'citation': 'Gheet FS, Dawoud HE, El-Shahaby WA, Elrifaey SM, Abdelnabi HH. Hydroxychloroquine in children with proliferative lupus nephritis: a randomized clinical trial. Eur J Pediatr. 2023 Apr;182(4):1685-1695. doi: 10.1007/s00431-023-04837-0. Epub 2023 Feb 8.'}]}, 'descriptionModule': {'briefSummary': 'Evaluation the efficacy of chloroquine and hydroxychloroquine in the treatment of proliferative lupus nephritis class III and IV in children and adolescents and evaluate the side effects of both drugs .', 'detailedDescription': 'All patients will fulfill the diagnostic criteria of SLE. The diagnosis of systemic lupus erythematosus is based on clinical and laboratory criteria. The criteria set developed by the American College of Rheumatology (ACR) and diagnosed wih lupus nephritis class III and IV .\n\nInclusion Criteria:\n\n* Children and adolescents who fulfill diagnostics criteria of SLE and diagnosed with lupus nephritis class III and IV.\n* All patients will be received steroids , MMF and Angiotensin Converting Enzyme.\n\nExclusion Criteria:\n\n* Patients diagnosed with lupus nephritis class I,II,V and VI.\n* Patients received Cyclophosphamide in stead of MMF.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '10 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '• All patients will fulfill the diagnostic criteria of SLE. The diagnosis of systemic lupus erythematosus is based on clinical and laboratory criteria. The criteria set developed by the American College of Rheumatology (ACR) and diagnosed wih lupus nephritis class III and IV', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children and adolescents who fulfill diagnostics criteria of SLE and diagnosed with lupus nephritis class III and IV.\n* All patients will be received steroids , MMF and Angiotensin Converting Enzyme.\n\nExclusion Criteria:\n\n* Patients diagnosed with lupus nephritis class I,II,V and VI.\n* Patients received Cyclophosphamide in stead of MMF.'}, 'identificationModule': {'nctId': 'NCT03687905', 'briefTitle': 'Proliferative Lupus Nephritis Treatment With Chloroquine and Hydroxychloroquine', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Comparative Study Between Chloroquine and Hydroxychloroquine as Therapeutic Modalities for Children and Adolescents With Proliferative Lupus Nephritis', 'orgStudyIdInfo': {'id': 'Fatma'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Lupus nephritis III or IV/chloroquine', 'description': 'receiving chloroquine with daily dose 5 mg/kg', 'interventionNames': ['Drug: Chloroquine']}, {'label': 'Lupus nephritis III or IV/hydroxychloroquine', 'description': 'receiving hydroxycholorquine with daily dose 5 mg/kg', 'interventionNames': ['Drug: Hydroxychloroquine']}, {'label': 'Systemic lupus erythematosus', 'description': 'not received hydroxychloroquine nor chloroquine .'}], 'interventions': [{'name': 'Chloroquine', 'type': 'DRUG', 'otherNames': ['alexoquine'], 'description': 'group1 received chloroquine .', 'armGroupLabels': ['Lupus nephritis III or IV/chloroquine']}, {'name': 'Hydroxychloroquine', 'type': 'DRUG', 'otherNames': ['hydroquine'], 'description': 'Group 2 received hydroxychloroquine', 'armGroupLabels': ['Lupus nephritis III or IV/hydroxychloroquine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tanta', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Fatma S Gheet, M.B.,BCh', 'role': 'CONTACT', 'email': 'fatmagheet@gmail.com', 'phone': '+201148157993'}], 'facility': 'Fatma Gheet', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'centralContacts': [{'name': 'Fatma S Gheet, M.B.,BCh', 'role': 'CONTACT', 'email': 'fatmagheet@gmail.com', 'phone': '+201148157993'}], 'overallOfficials': [{'name': 'Fatma S Gheet, M.B.,BCh', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tanta University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data is secret.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident Pediatercian', 'investigatorFullName': 'Fatma Sayed Ahmed Gheet', 'investigatorAffiliation': 'Tanta University'}}}}