Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2026-03-29 @ 7:19 PM
Study NCT ID:
NCT06417320
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Sodium-glucose Cotransporter-2 Inhibitors (SGLT-2i) on Proteinuria in Nephrotic Children Older Than 10 Years
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000806', 'term': 'Angiotensin-Converting Enzyme Inhibitors'}, {'id': 'D002216', 'term': 'Captopril'}, {'id': 'C529054', 'term': 'dapagliflozin'}], 'ancestors': [{'id': 'D011480', 'term': 'Protease Inhibitors'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D011392', 'term': 'Proline'}, {'id': 'D007098', 'term': 'Imino Acids'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-11', 'studyFirstSubmitDate': '2024-05-11', 'studyFirstSubmitQcDate': '2024-05-11', 'lastUpdatePostDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Protein free period, eGFR', 'timeFrame': '12 weeks following end of treatment', 'description': 'Protein free period by test strips (dipstick) and microscopy, urine protein/creatinine ratio and Estimated GFR will be evaluated by Schwartz formula'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nephrotic Syndrome in Children']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate the effect of ACE inhibitors and SGLT-2 inhibitors on:\n\n1. Proteinuria\n2. Renal survival indices', 'detailedDescription': 'This is a randomized, double blind study. Patients are randomized to receive oral ACE inhibitors or combined ACEI and SGLT-2inhibitrs once daily for12 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age between 10 and 18 years old,\n* Nephrotic resistant patients,\n* No history of diabetes,\n* Estimated GFR≥60ml/min/1.73m2, will be evaluated by Schwartz formula,\n* Caregivers' acceptance to be enrolled in the study.\n\nExclusion Criteria:\n\n* Uncontrolled urinary tract infection at screening,\n* Blood pressure is less than 5th percentile of the same gender, age, height,\n* At risk of dehydration or volume depletion,\n* Evidence of liver disease: defined by serum levels of alanine transaminase or aspartate transaminase \\>2 times the upper limit of normal during screening,\n* History of organ transplantation, cancer, liver disease,\n* History of noncompliance to medical regimens or unwillingness to comply with the study protocol."}, 'identificationModule': {'nctId': 'NCT06417320', 'briefTitle': 'Effect of Sodium-glucose Cotransporter-2 Inhibitors (SGLT-2i) on Proteinuria in Nephrotic Children Older Than 10 Years', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Effect of Sodium-glucose Cotransporter-2 Inhibitors (SGLT-2i) on Proteinuria in Nephrotic Children Older Than 10 Years', 'orgStudyIdInfo': {'id': 'MS.22.11.2207'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1', 'description': 'Group 1 (ACEI group)', 'interventionNames': ['Drug: ACEI, SGLT-2i']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2', 'description': 'Group 2 (combined ACEI and SGLT-2i group)', 'interventionNames': ['Drug: ACEI, SGLT-2i']}], 'interventions': [{'name': 'ACEI, SGLT-2i', 'type': 'DRUG', 'otherNames': ['Captopril, forxiga'], 'description': 'Group 1 (ACEI group) will receive a single dose of oral ACE inhibitors tablets per day (0.2-0.6mg) /kg/ day)\n\n❖ Group 2 (combined ACEI and SGLT-2inhibitrs group) patients on a single dose of oral ACE inhibitors tablets per day (0.2-0.6mg /kg/ day) presenting with persistent nephrotic range proteinuria will add a single dose of oral SGLT-2 inhibitors tablets 5mg per day (weight≤30kg) or 10mg per day (weight \\>30kg)', 'armGroupLabels': ['Group 1', 'Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35516', 'city': 'Al Mansurah', 'state': 'Dakahlia Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ayman Hammad, MBBCh,MSc,MD', 'role': 'CONTACT', 'email': 'pediatrics@mans.edu.eg', 'phone': '20502262307'}], 'facility': "Mansoura University Children's Hospital", 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'centralContacts': [{'name': 'Ayman Hammad, MBBCh,MSc,MD', 'role': 'CONTACT', 'email': 'pediatrics@mans.edu.eg', 'phone': '+20502262307'}], 'overallOfficials': [{'name': 'Ahmed El Refaey, MBBCh,MSc,MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mansoura University-Faculty of Medicine-Pediatric'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': '1year', 'ipdSharing': 'YES', 'description': 'sharing of study protocol', 'accessCriteria': 'any one'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}