Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2025-12-25 @ 1:21 PM
Study NCT ID:
NCT03501459
Status:
RECRUITING
Last Update Posted:
2019-08-28
First Post:
2018-04-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Lymphocyte Markers As Predictors Of Responsiveness To Rituximab Among Patients With Idiopathic Nephrotic Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009404', 'term': 'Nephrotic Syndrome'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069283', 'term': 'Rituximab'}], 'ancestors': [{'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-08-24', 'studyFirstSubmitDate': '2018-04-10', 'studyFirstSubmitQcDate': '2018-04-10', 'lastUpdatePostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response', 'timeFrame': '3 months', 'description': 'Resolution of proteinuria (urine protein:creatinine \\<0.02 g/mmol or urine protein excretion \\<0.3 g/1.73m2/day) and ability to wean off prednisolone and calcineurin inhibitor at three months after the last dose of rituximab.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nephrotic Syndrome']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate if lymphocyte markers predict response to rituximab among patients with idiopathic nephrotic syndrome'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 1-18 years old at the time of diagnosis of nephrotic syndrome\n* Steroid-dependent (SDNS) or steroid-resistant nephrotic syndrome (SDNS)\n\nExclusion Criteria:\n\n* eGFR \\<60 ml/min per 1.73m2\n* infantile onset of nephrotic syndrome\n* nephrotic syndrome secondary to chronic infections such as hepatitis B, hepatitis C or human immunodeficiency virus, systemic lupus erythematosus, Henoch-Schönlein purpura, IgA nephropathy, membranoproliferative glomerulonephritis or membranous nephropathy\n* current or previous therapy for tuberculosis\n* presence of mutations in WT1, NPHS1, NPHS2 and TRPC6.'}, 'identificationModule': {'nctId': 'NCT03501459', 'briefTitle': 'Lymphocyte Markers As Predictors Of Responsiveness To Rituximab Among Patients With Idiopathic Nephrotic Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'National University Health System, Singapore'}, 'officialTitle': 'Lymphocyte Markers As Predictors Of Responsiveness To Rituximab Among Patients With Idiopathic Nephrotic Syndrome', 'orgStudyIdInfo': {'id': 'NMRC/NIG/0026/2008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rituximab', 'interventionNames': ['Drug: Rituximab']}], 'interventions': [{'name': 'Rituximab', 'type': 'DRUG', 'armGroupLabels': ['Rituximab']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Singapore', 'status': 'RECRUITING', 'country': 'Singapore', 'contacts': [{'name': 'Hui-Kim Yap', 'role': 'CONTACT', 'email': 'hui_kim_yap@nuhs.edu.sg'}], 'facility': 'National University Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'centralContacts': [{'name': 'Hui-Kim Yap', 'role': 'CONTACT', 'email': 'hui_kim_yap@nuhs.edu.sg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National University Health System, Singapore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Yap Hui Kim', 'investigatorFullName': 'Isaac Liu', 'investigatorAffiliation': 'National University Health System, Singapore'}}}}