Ignite Creation Date:
2025-12-24 @ 6:58 PM
Ignite Modification Date:
2025-12-29 @ 7:30 PM
Study NCT ID:
NCT01169857
Status:
WITHDRAWN
Last Update Posted:
2012-04-24
First Post:
2010-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Velcade for Proliferative Lupus Nephritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008181', 'term': 'Lupus Nephritis'}, {'id': 'D011507', 'term': 'Proteinuria'}, {'id': 'D006417', 'term': 'Hematuria'}], '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': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069286', 'term': 'Bortezomib'}, {'id': 'D061988', 'term': 'Proteasome Inhibitors'}], 'ancestors': [{'id': 'D001897', 'term': 'Boronic Acids'}, {'id': 'D000148', 'term': 'Acids, Noncarboxylic'}, {'id': 'D000143', 'term': 'Acids'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D001896', 'term': 'Boron Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011719', 'term': 'Pyrazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011480', 'term': 'Protease Inhibitors'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No participants were enrolled.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-04-23', 'studyFirstSubmitDate': '2010-07-23', 'studyFirstSubmitQcDate': '2010-07-23', 'lastUpdatePostDateStruct': {'date': '2012-04-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proteinuria', 'timeFrame': '1 year', 'description': 'Quantification of 24 hr urinary protein.'}], 'secondaryOutcomes': [{'measure': 'Renal function', 'timeFrame': '1 year', 'description': 'Serum creatinine and GFR'}, {'measure': 'Lupus activity score', 'timeFrame': '1 year', 'description': 'Assessment of SELENA-SLEDAI'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Proliferative lupus nephritis', 'WHO class III/IV/V lupus nephritis', 'Proteinuria', 'Hematuria', 'Velcade', 'SLE', 'Bortezomib', 'Proteasome inhibitor'], 'conditions': ['Lupus Nephritis', 'Proteinuria', 'Hematuria']}, 'descriptionModule': {'briefSummary': 'The primary objective is to test the safety and efficacy of Velcade to induce remission in WHO class III/IV/V lupus nephritis that are refractory to standard medications.', 'detailedDescription': 'This exploratory single center, open-label, single treatment group assignment, safety, and efficacy study will enroll 14 patients with WHO class III/IV/V lupus nephritis. Subjects will receive 12 doses of Velcade to induce clinical remission.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. ACR criteria for lupus (minimum 4 out of 11).\n2. Biopsy proven WHO class III or IV or V lupus nephritis with clinical activity.\n3. GFR must be greater or equal to 30 cc/min/1.73 m2.\n4. Proteinuria must exceed 1000 mg per day except for WHO class V lupus nephritis, daily proteinuria must be greater or equal to 2000 mg.\n5. Primary therapy for active disease must have been given at least 6 months prior to protocol enrollment for WHO lupus III/IV.\n\nExclusion Criteria:\n\n1. Serum creatinine of more than 3.0 mg/dL on repeated testing.\n2. Greater than 50% fibrosis on renal biopsy.\n3. Platelet count of less than 30× 109/L.\n4. Absolute neutrophil count of less than 1.0 × 109/L.\n5. Greater than or equal to Grade 1 peripheral neuropathy.\n6. Myocardial infarction within 6 months prior to enrollment or New York Heart Association (NYHA) Class III or IV heart failure.\n7. Hypersensitivity to Velcade, boron or mannitol.\n8. Serious medical conditions and infections (including HIV, HCV, HBV) or psychiatric illness.\n9. Known history of untreated positive PPD.\n10. Serious complications from systemic lupus such as cerebral lupus and severe active infections.\n11. Diagnosed or treated for another malignancy within 3 years of enrollment.\n12. Greater than 1.5x upper limit of normal total bilirubin.'}, 'identificationModule': {'nctId': 'NCT01169857', 'briefTitle': 'Velcade for Proliferative Lupus Nephritis', 'organization': {'class': 'OTHER', 'fullName': 'The Rogosin Institute'}, 'officialTitle': 'Velcade for Proliferative Lupus Nephritis', 'orgStudyIdInfo': {'id': 'X05321'}, 'secondaryIdInfos': [{'id': '1003010960', 'type': 'OTHER', 'domain': 'Weill Cornell Medical College IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Velcade Therapy', 'interventionNames': ['Drug: Velcade']}], 'interventions': [{'name': 'Velcade', 'type': 'DRUG', 'otherNames': ['Bortezomib', 'Proteasome inhibitor'], 'description': 'Velcade at 1.3 mg/m2, on days 1, 4, 8 and 11 (=1 cycle). The study will involve 3 cycles of Velcade therapy.', 'armGroupLabels': ['Velcade Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'The Rogosin Institute', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Choli Hartono, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Rogosin Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Rogosin Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Weill Medical College of Cornell University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}