Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2025-12-28 @ 10:05 PM
Study NCT ID:
NCT07056595
Status:
RECRUITING
Last Update Posted:
2025-07-09
First Post:
2025-06-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Finerenone in Patients With IgA-nephropathy: Prospective Interventional Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005922', 'term': 'Glomerulonephritis, IGA'}], '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': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C576501', 'term': 'finerenone'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-05-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-30', 'studyFirstSubmitDate': '2025-06-30', 'studyFirstSubmitQcDate': '2025-06-30', 'lastUpdatePostDateStruct': {'date': '2025-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Median change in eGFR from baseline', 'timeFrame': '6 months', 'description': 'calculated based on creatinine level'}], 'primaryOutcomes': [{'measure': 'Median change in albuminuria from baseline', 'timeFrame': '6 months', 'description': '24-hour urinary albumin excretion'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['IgA Nephropathy (IgAN)']}, 'descriptionModule': {'briefSummary': ': IgA-nephropathy is the most common glomerulonephritis with the unfavorable prognosis in patients with persistent albuminuria. Finerenone is a new nonsteroidal mineralocorticoid receptor antagonist that has demonstrated efficacy in reducing albuminuria in patients with CKD and type 2 diabetes in two major trials, FIGARO-DKD and FIDELIO. This finding supported the approval of finerenone by the U.S. Food and Drug Administration (FDA) for the treatment of chronic kidney disease (CKD). A subgroup analysis in the pooled FIDELITY trial demonstrated that in patients with CKD stages 1-4 and type 2 diabetes (T2D), the cardio- and nephroprotective effects of finerenone were independent of concomitant therapy with SGLT-2 inhibitors or GLP-1 receptor agonists. Thus, the role of finerenone in slowing CKD progression in T2D can be considered well-established. Given its albuminuria-reducing effects, finerenone is being investigated in multiple trials, including studies on non-diabetic kidney disease and IgA nephropathy, though no published results are available yet. In this trial finerenone will be used as a nephroprotective agent above standard treatment in terms of assessing adverse events and potential efficacy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (\\> 18 years) with the primary IgAN diagnosed by kidney biopsy;\n* Treatment with stable doses of iRAS or/and iSGLT2 inhibitors for at least 3 months prior inclusion into the trial;\n* Blood pressure \\< 140/90 mm Hg\n* 24-hour urinary albumin excretion \\> 300 mg\n\nExclusion Criteria:\n\n* Kidney transplantation in medical history\n* Chronic hepatic disease, including hepatitis, malignant tumor, active malignancy;\n* Heart failure with ejection fraction \\<40%;\n* Acute myocardial infarction and/or stroke less then 3 months before including in trial;\n* Presence ANCA in serum\n* Ongoing immunosuppressive treatment\n* eGFR \\< 20 ml/min\n* Pregnancy and breastfeeding\n* Uncontrolled blood pressure'}, 'identificationModule': {'nctId': 'NCT07056595', 'briefTitle': 'Finerenone in Patients With IgA-nephropathy: Prospective Interventional Trial', 'organization': {'class': 'OTHER', 'fullName': 'Botkin Hospital'}, 'officialTitle': 'Finerenone in Patients With IgA-nephropathy: Prospective Interventional Trial', 'orgStudyIdInfo': {'id': 'IEC-6/13052025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'iRAS', 'interventionNames': ['Drug: Finerenone']}, {'type': 'EXPERIMENTAL', 'label': 'iSGLT2', 'interventionNames': ['Drug: Finerenone']}, {'type': 'EXPERIMENTAL', 'label': 'iRAS+iSGLT2', 'interventionNames': ['Drug: Finerenone']}], 'interventions': [{'name': 'Finerenone', 'type': 'DRUG', 'description': 'Finerenone is a new nonsteroidal mineralocorticoid receptor antagonist. Planned dose - 10 mg/day', 'armGroupLabels': ['iRAS', 'iRAS+iSGLT2', 'iSGLT2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Moscow', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Anastasiia Zykova', 'role': 'CONTACT', 'email': 'ansezy@gmail.com', 'phone': '89151345432'}], 'facility': 'Botkin Hospital', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'centralContacts': [{'name': 'Evgeny Shytov, PhD', 'role': 'CONTACT', 'email': 'shutov_e_v@mail.ru', 'phone': '+7 499 490 03 03', 'phoneExt': '5844'}, {'name': 'Anastasiia Zykova, PhD', 'role': 'CONTACT', 'email': 'ansezy@gmail.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Botkin Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Researcher', 'investigatorFullName': 'Evgeny Shutov', 'investigatorAffiliation': 'Botkin Hospital'}}}}