Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-28 @ 11:52 PM
Study NCT ID:
NCT07074951
Status:
RECRUITING
Last Update Posted:
2025-07-20
First Post:
2025-06-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tonsillectomy and Immunosuppression in Caucasian Patients With High-risk IgA-nephropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005922', 'term': 'Glomerulonephritis, IGA'}, {'id': 'D018450', 'term': 'Disease Progression'}], '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'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014068', 'term': 'Tonsillectomy'}], 'ancestors': [{'id': 'D013517', 'term': 'Otorhinolaryngologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Experimental group comprises patients, who will receive immunosuppression combined with tonsillectomy (the IST+TE group, n=120).\n\nControl group includes subjects, fulfilled the same eligibility criteria and underwent only immunosuppression without tonsillectomy in the same time period (the IST group, n=120).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-12-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-10', 'studyFirstSubmitDate': '2025-06-25', 'studyFirstSubmitQcDate': '2025-07-10', 'lastUpdatePostDateStruct': {'date': '2025-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression', 'timeFrame': 'From date of inclusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months', 'description': 'The composite end-point of disease progression includes: eGFR decline \\>40% of baseline level, ESKD (defined as long-term eGFR \\<15 ml/min/1.73m2 for more than 3 months or need of initiation of renal replacement therapy (RRT).'}, {'measure': 'Overall remission (partial or complete remission)', 'timeFrame': 'From date of inclusion until the date of first documented overall remission, assessed up to 120 months', 'description': 'Partial remission (PR) is defined as a decrease in proteinuria by more than 50% in cases with baseline daily proteinuria (DP) \\<3.5 g, and in those with DP ≥3.5 g, as its decrease \\>50% to level \\<3.5 g/day in combination with regression of hematuria by at least 70% (in 3 consecutive measurements). Complete remission (CR) is defined as DP \\<0.5 g/day and the disappearance of hematuria (URBC \\<5/HPF). Any remission is registered in the absence of eGFR decrease \\>20% from the baseline.'}, {'measure': 'Time to clinical remission', 'timeFrame': 'From date of inclusion until the date of first documented remission, assessed up to 120 months', 'description': 'Cumulative rate of overall (partial or complete) clinical remission'}], 'secondaryOutcomes': [{'measure': 'Partial remission', 'timeFrame': 'From date of inclusion until the date of first documented partial remission, assessed up to 120 months', 'description': 'Partial remission is defined as a decrease in proteinuria by more than 50% in cases with baseline DP \\<3.5 g, and in those with DP ≥3.5 g, as its decrease \\>50% to level \\<3.5 g/day in combination with regression of hematuria by at least 70% (in 3 consecutive measurements)'}, {'measure': 'Complete remission', 'timeFrame': 'From date of inclusion until the date of first documented complete remission, assessed up to 120 months', 'description': 'Complete remission is defined as daily proteinuria (DP) \\<0.5 g/day and the disappearance of hematuria (URBC \\<5/HPF). Any remission is registered in the absence of eGFR decrease \\>20% from the baseline.'}, {'measure': 'Relapses', 'timeFrame': 'From date of inclusion until the date of first documented relapse, assessed up to 120 months', 'description': 'In subjects with CR, relapse is defined as the recurrence of proteinuria \\>1g/day and haematuria (URBC\\>5/HPF) and, in those with PR, as the increase in proteinuria and haematuria \\>50% compared to their levels at the time of remission.'}, {'measure': 'The change in proteinuria', 'timeFrame': 'Through study completion, an average of 120 months', 'description': 'Change from baseline in proteinuria'}, {'measure': 'The change in eGFR', 'timeFrame': 'Through study completion, an average of 120 months', 'description': 'Change from baseline in eGFR by CKD-EPI equation'}, {'measure': 'Adverse events per 100 patient-years', 'timeFrame': 'From date of inclusion until the date of first documented AE, assessed up to 120 months', 'description': 'This rate will be expressed as number of adverse events (AEs) per 100 patient-years of observation in every study group. AE grades are based on the NCI Common Terminology Criteria for Adverse Events version 5.0. Serious adverse events (SAEs) are defined according to FDA recommendations.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Primary IgA-nephropathy', 'Corticosteroids', 'Tonsillectomy', 'High-risk', 'Caucasians', 'Progression', 'Remission'], 'conditions': ['Primary IgA-nephropathy', 'High-risk', 'Caucasians']}, 'referencesModule': {'references': [{'pmid': '30980653', 'type': 'BACKGROUND', 'citation': 'Barbour SJ, Coppo R, Zhang H, Liu ZH, Suzuki Y, Matsuzaki K, Katafuchi R, Er L, Espino-Hernandez G, Kim SJ, Reich HN, Feehally J, Cattran DC; International IgA Nephropathy Network. Evaluating a New International Risk-Prediction Tool in IgA Nephropathy. JAMA Intern Med. 2019 Jul 1;179(7):942-952. doi: 10.1001/jamainternmed.2019.0600.'}]}, 'descriptionModule': {'briefSummary': 'The open-label prospective non-randomised controlled aims to assess the efficacy of the combination of immunosupression (IST) and tonsillectomy (TE) in Caucasian patients at high risk of the IgA-nephropathy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPrimary IgA-nephropathy (IgAN) patients with:\n\n1. DP \\>1 g with haematuria (\\>5 RBC/HPF)\n2. DP \\<1 g with haematuria AND probability of starting dialysis within 5 years \\>11% (estimated by the International risk-prediction tool in IgAN) AND at least one of the following histologic changes: at least one of the following histologic changes: mesangial proliferation, endocapillary hypercellularity, cellular crescents\n\nExclusion Criteria:\n\n1. Age \\<18 or \\>75 years;\n2. eGFR ≤20 ml/min/1.73m2\n3. Patients with mild renal lesions (M0, E0, S0, T0, C0), minor urinary findings, DP \\<1.0 g\n4. Contraindications to IST or TE\n5. Patients with any co-existing kidney disease\n6. Patients with secondary IgAN (Schoenlein-Henoch purpura, liver cirrhosis, etc.)\n7. Patients with diabetes mellitus\n8. Any clinically significant acute illness within 60 days prior to kidney biopsy (including infection, aseptic necrosis of any bone, patients with myocardial infarction or cerebrovascular stroke, other conditions that can be exacerbated by corticosteroids\n9. Incomplete empiric IST administered prior to kidney biopsy\n10. Pregnancy'}, 'identificationModule': {'nctId': 'NCT07074951', 'briefTitle': 'Tonsillectomy and Immunosuppression in Caucasian Patients With High-risk IgA-nephropathy', 'organization': {'class': 'OTHER', 'fullName': 'St. Petersburg State Pavlov Medical University'}, 'officialTitle': 'Effectiveness of Immunosuppression Combined With Tonsillectomy in Caucasian Patients With High-risk IgA-nephropathy (the Pragmatic Study)', 'orgStudyIdInfo': {'id': 'VD285/IgAN/TE+IST'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Immunosuppression combined with tonsillectomy (IST+TE group)', 'description': 'Experimental group comprises patients, who will receive immunosuppression combined with tonsillectomy (the IST+TE group, n=120).', 'interventionNames': ['Drug: Immunosuppressive treatment', 'Procedure: Tonsillectomy']}, {'type': 'OTHER', 'label': 'Control group (Active comparator): IST without TE (IST group)', 'description': 'Сontrol group includes subjects with the same eligibility criteria and who will underwent only IST without TE in the same time period.', 'interventionNames': ['Drug: Immunosuppressive treatment']}], 'interventions': [{'name': 'Immunosuppressive treatment', 'type': 'DRUG', 'description': 'Patients will be able to receive the corticosteroid (CS) monotherapy or CS in combination with other immunosuppressive drugs (e.g. cyclophosphamide, mycophenolic acid) by a decision of treating physician.\n\nCS treatment will start with intravenous or oral induction. In the first case, methylprednisolone will be administered intravenously for 1-3 days at the dosage of 500-1000 mg. Oral prednisolone will be initiated at a dose of 0.5 to 1.0 mg/kg body weight, not exceeded 60 mg/day (week 1) with a rapid decrease by 5 mg each subsequent week until a maintenance dose of 5 mg/day will be reached. Patients will receive maintenance dose for 6 to 12 months.', 'armGroupLabels': ['Control group (Active comparator): IST without TE (IST group)', 'Immunosuppression combined with tonsillectomy (IST+TE group)']}, {'name': 'Tonsillectomy', 'type': 'PROCEDURE', 'description': 'Tonsillectomy will be done in accordance with local clinical practice. TE has to be performed no earlier than 12 months before and no later than 12 months after the initiation of IST.', 'armGroupLabels': ['Immunosuppression combined with tonsillectomy (IST+TE group)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '197022', 'city': 'Saint Petersburg', 'status': 'RECRUITING', 'country': 'Russia', 'facility': 'Research Institute of Nephrology (Pavlov Medical University)', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '197022', 'city': 'Saint Petersburg', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Vladimir Dobronravov, Professor, MD, PhD, DMedSci', 'role': 'CONTACT', 'email': 'dobronravov@nephrolog.ru', 'phone': '(812)338-69-01'}], 'facility': 'St. Petersburg State Pavlov Medical University', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}], 'centralContacts': [{'name': 'Vladimir Dobronravov, Professor, MD, PhD, DMedSci', 'role': 'CONTACT', 'email': 'dobronravov@nephrolog.ru', 'phone': '(812)338-69-01'}, {'name': 'Zinaida Kochoyan, Nephrologist', 'role': 'CONTACT', 'email': 'zinshak@gmail.com', 'phone': '(812)338-69-21'}], 'overallOfficials': [{'name': 'Vladimir Dobronravov, Professor, MD, PhD, DMedSci', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St. Petersburg State Pavlov Medical University'}, {'name': 'Zinaida Kochoyan, Nephrologist', 'role': 'STUDY_CHAIR', 'affiliation': 'St. Petersburg State Pavlov Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St. Petersburg State Pavlov Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice-director for science RM Gorbacheva Institute', 'investigatorFullName': 'Ivan S Moiseev', 'investigatorAffiliation': 'St. Petersburg State Pavlov Medical University'}}}}