Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2025-12-26 @ 1:43 AM
Study NCT ID:
NCT01268033
Status:
COMPLETED
Last Update Posted:
2015-03-23
First Post:
2010-12-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Rituximab For the Treatment of Calcineurin Inhibitors Dependent Nephrotic Syndrome During Childhood
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009404', 'term': 'Nephrotic Syndrome'}, {'id': 'D009402', 'term': 'Nephrosis, Lipoid'}, {'id': 'D005923', 'term': 'Glomerulosclerosis, Focal Segmental'}], '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': 'D005921', 'term': 'Glomerulonephritis'}, {'id': 'D009393', 'term': 'Nephritis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069283', 'term': 'Rituximab'}], 'ancestors': [{'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-20', 'studyFirstSubmitDate': '2010-12-15', 'studyFirstSubmitQcDate': '2010-12-28', 'lastUpdatePostDateStruct': {'date': '2015-03-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proteinuria with relapse of nephrotic syndrome (Serum albumin < 30 g/L) within 5 months', 'timeFrame': '5 months', 'description': 'Proteinuria with relapse of nephrotic syndrome (Serum albumin \\< 30 g/L) within 5 months'}], 'secondaryOutcomes': [{'measure': '- dosing of rituximab for toxicity during and/or after infusion', 'timeFrame': '5 months', 'description': '\\- toxicity during and/or after infusion'}, {'measure': '- dosing of rituximab for pharmacokinetics', 'timeFrame': '5 months', 'description': '\\- dosing of rituximab for pharmacokinetics'}, {'measure': '- dosing of lymphocyte', 'timeFrame': '5 months', 'description': '\\- lymphocyte phenotyping'}, {'measure': 'Pediatric Quality of life inventory', 'timeFrame': '5 months', 'description': 'Pediatric Quality of life inventory'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['rituximab', 'idiopathic nephrotic syndrome', 'minimal change disease', 'focal and segmental glomerulosclerosis'], 'conditions': ['Childhood Idiopathic Nephrotic Syndrome']}, 'referencesModule': {'references': [{'pmid': '39513526', 'type': 'DERIVED', 'citation': 'Larkins NG, Hahn D, Liu ID, Willis NS, Craig JC, Hodson EM. Non-corticosteroid immunosuppressive medications for steroid-sensitive nephrotic syndrome in children. Cochrane Database Syst Rev. 2024 Nov 8;11(11):CD002290. doi: 10.1002/14651858.CD002290.pub6.'}]}, 'descriptionModule': {'briefSummary': 'Background\n\nIdiopathic nephrotic syndrome is a rare disease beginning during childhood and treated with immunosuppressants (i.e. steroids, mycophenolate mofetil, cyclophosphamide, cyclosporine).\n\nRenal function of patients suffering from severe, steroid-dependent nephrotic syndrome with failure or toxic side effects of other immunosuppressant treatments is a major matter of concern.\n\nCyclosporine endangers renal parenchyma (fibrosis) in these patients who must take this treatment for years. At the same time, low doses of cyclosporine allow proteinuria to reappear, which provokes degradation of renal function by focal segmental glomerulosclerosis. Some recent data lead to the conclusion that Rituximab may be effective in such a disease, with a cyclosporin sparing effect.\n\nPurpose\n\nThe aim of the study is to evaluate the efficacy of Rituximab versus placebo in the treatment of pediatric patients suffering from severe cyclosporine-dependent nephrotic syndrome.\n\nAbstract Patients will be included in the study in a period of remission of proteinuria. Two infusions of Rituximab - at the dose of 375 mg/m²- or placebo will be administered at one week of interval. Other immunosuppressant treatments will be gradually tapered off with the same tapering pattern in both groups. In case of relapse of nephrotic syndrome, the blinding code will be broken. Rituximab will then be infused to patients having received placebo.', 'detailedDescription': 'After infusions of Rituximab or placebo, patients will be examined by their nephrologist on a monthly basis during five months. Follow up will be focused on proteinuria, albuminemia, lymphocyte phenotyping and Rituximab pharmacokinetics'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or Female patients over 2 and under 18 years, with an idiopathic nephrotic syndrome (NS)\n* Steroid Sensitive Nephrotic Syndrome (according to the French pediatric protocol).\n\nNEPHRUTIX\n\n* Calcineurin inhibitor Dependent NS or NS for which anticalcineurin treatment has not been effective. Others immunosuppressive treatments (MMF) must have failed to control the disease activity.\n* Effective contraception for girls of childbearing age.\n* The patient is able to understand and has signed a written informed consent OR the parent or legal guardian is able to understand and has signed a written informed consent, which must be obtained prior to the initiation of any study procedure\n\nExclusion Criteria:\n\n* Terminal renal failure requiring dialysis/transplantation\n* Transcutaneous oxygen stauration \\< 97%\n* Clinical or Radiological brochopulmonar or pleural abnormality\n* Asymptomatic carrier of Hepatitis B virus our history of Hepatitis B\n* Contraindication to Rituximab (RTX)\n* Parents/patient refusing to participate in the study'}, 'identificationModule': {'nctId': 'NCT01268033', 'acronym': 'NEPHRUTIX', 'briefTitle': 'Efficacy of Rituximab For the Treatment of Calcineurin Inhibitors Dependent Nephrotic Syndrome During Childhood', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Limoges'}, 'officialTitle': 'A Prospective, Randomized, Double Blind, Placebo-controlled Phase II/III Study Evaluating the Efficacy of Rituximab in the Prevention of Relapse of Calcineurin Inhibitors Dependent Idiopathic Nephrotic Syndrome of Childhood', 'orgStudyIdInfo': {'id': 'I08013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rituximab', 'description': 'two infusions of Rituximab - at the dose of 375 mg/m²', 'interventionNames': ['Drug: Rituximab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'two infusions of placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Rituximab', 'type': 'DRUG', 'description': 'two infusions - at the dose of 375 mg/m²- will be administered at one week of interval', 'armGroupLabels': ['Rituximab']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'two infusions - at the dose of 375 mg/m² - will be administrered at one week of interval', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1020', 'city': 'Brussels', 'state': 'Brussels Capital', 'country': 'Belgium', 'facility': "Queen Fabiola Universitary Children's Hospital", 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '80054', 'city': 'Amiens', 'state': 'Amiens', 'country': 'France', 'facility': 'Chu Amiens', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'zip': '25030', 'city': 'Besançon', 'state': 'Besancon', 'country': 'France', 'facility': 'Chu Besancon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '33076', 'city': 'Bordeaux', 'state': 'Bordeaux', 'country': 'France', 'facility': 'Chu Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '29609', 'city': 'Brest', 'state': 'Brest', 'country': 'France', 'facility': 'Chu Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '14033', 'city': 'Caen', 'state': 'Caen', 'country': 'France', 'facility': 'CHU CAEN', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '63058', 'city': 'Clermont-Ferrand', 'state': 'Clermont Ferrand', 'country': 'France', 'facility': 'Chu Clermont Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '38043', 'city': 'Grenoble', 'state': 'Grenoble', 'country': 'France', 'facility': 'Chu Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '59800', 'city': 'Lille', 'state': 'Lille', 'country': 'France', 'facility': 'Chu Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '87042', 'city': 'Limoges', 'state': 'Limoges', 'country': 'France', 'facility': 'Chu Limoges', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '13385', 'city': 'Marseille', 'state': 'Marseille', 'country': 'France', 'facility': 'AP-HM - Hôpital La Timone', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '34295', 'city': 'Montpellier', 'state': 'Montpellier', 'country': 'France', 'facility': 'Chu Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '44033', 'city': 'Nantes', 'state': 'Nantes', 'country': 'France', 'facility': 'Chu Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '06202', 'city': 'Nice', 'state': 'Nice', 'country': 'France', 'facility': 'CHU NICE', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '75015', 'city': 'Paris', 'state': 'Paris', 'country': 'France', 'facility': 'AP-HP - Hôpital Necker', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75571', 'city': 'Paris', 'state': 'Paris', 'country': 'France', 'facility': 'AP-HP - Hôpital Trousseau', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '51092', 'city': 'Reims', 'state': 'Reims', 'country': 'France', 'facility': 'CHU REIMS - American Memorial Hospital', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'zip': '35000', 'city': 'Rennes', 'state': 'Rennes', 'country': 'France', 'facility': 'Chu Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '76031', 'city': 'Rouen', 'state': 'Rouen', 'country': 'France', 'facility': 'Chu Rouen', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '42055', 'city': 'Saint-Etienne', 'state': 'Saint Etienne', 'country': 'France', 'facility': 'Chu Saint Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}, {'zip': '67098', 'city': 'Strasbourg', 'state': 'Strasbourg', 'country': 'France', 'facility': 'Chu Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '31059', 'city': 'Toulouse', 'state': 'Toulouse', 'country': 'France', 'facility': 'Chu Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '37044', 'city': 'Tours', 'state': 'Tours', 'country': 'France', 'facility': 'Chu Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'zip': '54511', 'city': 'Vandœuvre-lès-Nancy', 'state': 'Vandoeuvre Les Nancy', 'country': 'France', 'facility': 'Chu Nancy', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}], 'overallOfficials': [{'name': 'Vincent GUIGONIS, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Limoges'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Limoges', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}