Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT07214818
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-09
First Post:
2025-10-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
SGLT2 Inhibitors in Adult Primary Nephrotic Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009404', 'term': 'Nephrotic Syndrome'}, {'id': 'D011507', 'term': 'Proteinuria'}], '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': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C529054', 'term': 'dapagliflozin'}, {'id': 'C570240', 'term': 'empagliflozin'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This interventional study will use a parallel assignment model with three treatment arms:\n\nDapagliflozin plus standard therapy. Empagliflozin plus standard therapy. Standard therapy alone (control).\n\nRandomization will be employed to allocate participants to one of the three groups in a 1:1:1 ratio. Due to the nature of the interventions, this is an open-label study, and blinding will not be feasible.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-09-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-06', 'studyFirstSubmitDate': '2025-10-06', 'studyFirstSubmitQcDate': '2025-10-06', 'lastUpdatePostDateStruct': {'date': '2025-10-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-07-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '1. Change in Proteinuria (uPCR)', 'timeFrame': 'Baseline to 6 months', 'description': 'Change from baseline in urine protein/creatinine ratio'}, {'measure': 'Change in TNF-α Levels', 'timeFrame': 'Baseline to 6 months', 'description': 'Change in serum TNF-α measured by ELISA as an exploratory biomarker.'}], 'secondaryOutcomes': [{'measure': 'Change in Estimated Glomerular Filtration Rate (eGFR)', 'timeFrame': 'Baseline to 6 months', 'description': 'Mean change in eGFR calculated by CKD-EPI formula.'}, {'measure': 'Incidence of Adverse Events', 'timeFrame': 'Throughout the 6-month study perio', 'description': 'Frequency and severity of adverse effects including infection, gastrointestinal upset, oral candidiasis, and other safety concerns.'}, {'measure': 'Treatment Compliance', 'timeFrame': 'Up to 6 months', 'description': 'Proportion of participants with documented adherence to study medication and standard therapy.'}, {'measure': 'Remission Rate', 'timeFrame': 'Up to 6 months', 'description': 'Proportion of patients achieving remission'}, {'measure': 'Relapse Rate', 'timeFrame': 'Up to 6 months', 'description': 'Proportion of patients experiencing relapse'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SGLT2 inhibitors', 'Dapagliflozin', 'Empagliflozin', 'Proteinuria', 'Primary Nephrotic Syndrome'], 'conditions': ['Nephrotic Syndrome']}, 'descriptionModule': {'briefSummary': 'This randomized controlled clinical trial aims to evaluate the efficacy and safety of sodium-glucose cotransporter 2 (SGLT2) inhibitors (dapagliflozin and empagliflozin) in adult patients with primary nephrotic syndrome. The study will compare three groups: dapagliflozin plus standard therapy, empagliflozin plus standard therapy, and standard therapy alone.\n\nThe primary objective is to assess whether SGLT2 inhibitors reduce proteinuria, maintain remission, and prevent relapse. Secondary objectives include evaluating effects on kidney function (eGFR, serum creatinine) and monitoring safety outcomes.\n\nParticipants will continue their baseline standard care and will be followed for 6 months with regular clinical evaluations, laboratory tests, and adverse event monitoring.', 'detailedDescription': 'This randomized, controlled, open-label, single-center clinical trial is designed to investigate the efficacy and safety of sodium-glucose cotransporter 2 (SGLT2) inhibitors, specifically dapagliflozin and empagliflozin, in adult patients with primary nephrotic syndrome (PNS).\n\nPrimary nephrotic syndrome is characterized by significant proteinuria, hypoalbuminemia, and related complications. While traditional therapies such as corticosteroids and immunosuppressive agents remain the cornerstone of treatment, their limited efficacy and adverse effects highlight the need for novel therapeutic options. Evidence from large clinical trials has shown that SGLT2 inhibitors improve renal outcomes in patients with chronic kidney disease and type 2 diabetes; however, their role in primary nephrotic syndrome patients has not been fully established.\n\nIn this trial, eligible participants will be adults (≥18 years) with biopsy-confirmed primary nephrotic syndrome and an estimated glomerular filtration rate (eGFR) ≥25 mL/min/1.73m². Patients with secondary causes of nephrotic syndrome (e.g., diabetic nephropathy, lupus nephritis, amyloidosis), significant liver impairment, or contraindications to SGLT2 inhibitors will be excluded.\n\nParticipants will be randomized into three groups:\n\nGroup A: Dapagliflozin 10 mg once daily plus standard therapy. Group B: Empagliflozin 10 mg once daily plus standard therapy. Group C: Standard therapy alone (control).\n\nAll groups will continue to receive stable doses of background immunosuppressive therapy and renoprotective agents as part of standard of care.\n\nThe study duration will be 6 months. Baseline demographics, clinical data, and laboratory parameters will be collected. Follow-up assessments will include proteinuria (urine protein-to-creatinine ratio), serum albumin, serum creatinine, eGFR, uric acid, total cholestrol, liver enzyme(AST,ALT), TNF-α, complete blood count and serum sugar level. Clinical outcomes such as remission, relapse, and adverse events will be recorded.\n\nThe primary outcomes are changes in proteinuria, TNF-α levels, and rates of remission and relapse. Secondary outcomes include changes in kidney function (serum creatinine, eGFR), safety profile, and treatment compliance.\n\nThis study is expected to provide novel insights into the therapeutic role of SGLT2 inhibitors in primary nephrotic syndrome and may guide future clinical practice in the management of this condition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdult patients (≥18 years). Biopsy-confirmed primary nephrotic syndrome (e.g., idiopathic membranous nephropathy, minimal change disease, focal segmental glomerulosclerosis).\n\nEstimated glomerular filtration rate (eGFR) ≥25 mL/min/1.73m² using CKD-EPI formula.\n\nOn stable dose of immunosuppressive therapy and renoprotective agents for ≥4 weeks prior to randomization.\n\nAble to signed informed consent.\n\nExclusion Criteria:\n\nDiagnosis of secondary nephrotic syndrome as : diabetes mellitus, lupus nephritis, and amyloidosis.\n\n* Impaired liver functions (ALT or AST values exceeding 3 folds upper limit of normal (ULN) at the screening visit).\n* Glomerular hematuria (red blood cells more than ten cells per high power field (HPF) after routine urinalysis for more than three times in the last 2 weeks).\n* History of severe hypersensitivity or contraindications to dapagliflozin or empagliflozine.\n* Pregnancy or breastfeeding.'}, 'identificationModule': {'nctId': 'NCT07214818', 'acronym': 'SGLT2-NS', 'briefTitle': 'SGLT2 Inhibitors in Adult Primary Nephrotic Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Efficacy of Sodium-Glucose Cotransporter 2 Inhibitors in Adult Patients With Nephrotic Syndrome: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'MS.25.08.3285'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dapagliflozin + Standard of Care', 'interventionNames': ['Drug: Dapagliflozin', 'Other: Standard Therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Empagliflozin + Standard of Care', 'interventionNames': ['Drug: Empagliflozin', 'Other: Standard Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care Only', 'description': 'Standard treatment protocol(institutional standared) for 6 months without any additional SGLT2 inhibitor.', 'interventionNames': ['Other: Standard Therapy']}], 'interventions': [{'name': 'Dapagliflozin', 'type': 'DRUG', 'description': 'Dapagliflozin 10 mg PO once daily for 6 months', 'armGroupLabels': ['Dapagliflozin + Standard of Care']}, {'name': 'Empagliflozin', 'type': 'DRUG', 'description': 'Empagliflozin 10 mg PO once daily for 6 month', 'armGroupLabels': ['Empagliflozin + Standard of Care']}, {'name': 'Standard Therapy', 'type': 'OTHER', 'description': 'immunosuppressive therapy and renoprotective agents for 6 months', 'armGroupLabels': ['Dapagliflozin + Standard of Care', 'Empagliflozin + Standard of Care', 'Standard of Care Only']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35516', 'city': 'Al Mansurah', 'state': 'Dakahlia Governorate', 'country': 'Egypt', 'facility': 'Urology & Nephrology Center, Mansoura University', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'centralContacts': [{'name': 'Maged S Hariz, PhD Candidate', 'role': 'CONTACT', 'email': 'dr.m.s.binhariz85@gmail.com', 'phone': '00201029837454'}, {'name': 'Ahmed M Abdel-Rahman, Fellow of Nephrology', 'role': 'CONTACT', 'email': 'amans83@mans.edu.eg', 'phone': '00201006239797'}], 'overallOfficials': [{'name': 'Moetaza M Soliman, Associate Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Clinical Pharmacy and Pharmacy Practice Department, Faculty of Pharmacy, Mansoura University'}, {'name': 'Mustafa O Sharaf El-Deen, Lecturer', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Clinical Pharmacy and Pharmacy Practice Department, Faculty of Pharmacy, Mansoura University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Pharmacist', 'investigatorFullName': 'Maged Saleh Mohsen Ban Hariz', 'investigatorAffiliation': 'Mansoura University'}}}}