Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-30 @ 9:37 AM
Study NCT ID:
NCT07035834
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-25
First Post:
2025-06-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SGLT-2 Inhibitors on Albuminuria in Chronic Kidney Disease Patients With Lupus Nephritis and ANCA- Associated Vasculitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008181', 'term': 'Lupus Nephritis'}, {'id': 'D056648', 'term': 'Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis'}], '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'}, {'id': 'D056647', 'term': 'Systemic Vasculitis'}, {'id': 'D014657', 'term': 'Vasculitis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D012871', 'term': 'Skin Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077203', 'term': 'Sodium-Glucose Transporter 2 Inhibitors'}], 'ancestors': [{'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D007004', 'term': 'Hypoglycemic Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-16', 'studyFirstSubmitDate': '2025-06-16', 'studyFirstSubmitQcDate': '2025-06-16', 'lastUpdatePostDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The variation of albuminuria', 'timeFrame': 'From enrollment to the end of treatment at 6 months'}, {'measure': 'The primary outcome is the variation of albuminuria after 6 months of treatment with SGLT-2i.', 'timeFrame': 'From enrollment to the end of treatment at 6 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lupus Nephritis', 'ANCA associated vasculitis', 'SGLT-2 inhibitors', 'nephroprotection'], 'conditions': ['Lupus Nephritis (LN)', 'ANCA Associated Vasculitis (AAV)']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to investigate the effect of the glifozines on albuminuria in chronic kidney disease patients affected by lupus nephritis and ANCA associated renal vasculitis. It will also learn about the safety of glifozines. The main questions it aims to answer are:\n\n* Does glifozines lower the albuminuria of participants with chronic kidney disease secondary to lupus nephritis and ANCA associated renal vasculitis?\n* What medical problems do participants have when taking glifozines?\n\nParticipants will:\n\n* Take glifozines every day for 6 months.\n* Baseline, 1 month and 6-month visits will be scheduled to collect demographic, clinical, biochemical, and urinary data.\n* A psychosocial assessment will be performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients aged more than18 years with chronic kidney disease from stage 1 to3, secondary to confirmed LN, without active LN, and AAV\n\nExclusion Criteria:\n\n* 1\\) allergy or intolerance to SGLT2i exposure within 1month before screening; 2) recurrent urinary tract infections; 3) hepatic dysfunction (aspartate aminotransferase or alanine aminotransferase levels \\>2 times the upper normal limits); 4) an eGFR ˂30 ml/min/1.73 m2; 5) DM type I and II.'}, 'identificationModule': {'nctId': 'NCT07035834', 'briefTitle': 'SGLT-2 Inhibitors on Albuminuria in Chronic Kidney Disease Patients With Lupus Nephritis and ANCA- Associated Vasculitis', 'organization': {'class': 'OTHER', 'fullName': 'Federico II University'}, 'officialTitle': 'SGLT-2 Inhibitors on Albuminuria in Chronic Kidney Disease Patients With Lupus Nephritis and ANCA- Associated Vasculitis: Study Design and Protocol', 'orgStudyIdInfo': {'id': 'IC001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lupus nephritis and ANCA associated vasculitis patients treated with glifozines', 'interventionNames': ['Drug: Gliflozin']}], 'interventions': [{'name': 'Gliflozin', 'type': 'DRUG', 'description': 'Our study will enroll non diabetic patients affected by chronic kidney disease secondary to lupus nephritis and ANCA associated vasculitis. Other studies have so far investigated only diabetic patients affected by the above mentioned diseases.', 'armGroupLabels': ['Lupus nephritis and ANCA associated vasculitis patients treated with glifozines']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ivana Capuano Researcher, Medicine', 'role': 'CONTACT', 'email': 'ivana.capuano@unina.it', 'phone': '+39 0817464521'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federico II University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Researcher', 'investigatorFullName': 'Ivana Capuano', 'investigatorAffiliation': 'Federico II University'}}}}