Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2026-01-03 @ 7:32 PM
Study NCT ID:
NCT00089804
Status:
TERMINATED
Last Update Posted:
2009-04-01
First Post:
2004-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of LJP 394 in Lupus Patients With History of Renal Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Serbia and Montenegro']}, 'conditionBrowseModule': {'meshes': [{'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}, {'id': 'D008181', 'term': 'Lupus Nephritis'}, {'id': 'D009393', 'term': 'Nephritis'}], 'ancestors': [{'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': 'D005921', 'term': 'Glomerulonephritis'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C094104', 'term': 'abetimus'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 943}}, 'statusModule': {'whyStopped': 'Interim efficacy analysis indicated it would be futile to continue study.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2004-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-03-30', 'studyFirstSubmitDate': '2004-08-13', 'studyFirstSubmitQcDate': '2004-08-16', 'lastUpdatePostDateStruct': {'date': '2009-04-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-08-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine whether abetimus sodium is more effective than placebo in delaying the time to renal flare in SLE patients with a history of SLE renal disease. Weekly administration with a 52-week treatment duration.', 'timeFrame': 'Time to event (12 months fixed treatment duration)'}], 'secondaryOutcomes': [{'measure': 'To determine whether treatment with abetimus sodium is more effective than placebo in delaying the time to Major SLE flare; and to determine whether treatment with abetimus sodium (LJP 394) is more effective than placebo in reducing proteinuria.', 'timeFrame': '12 month fixed treatment duration'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Lupus', 'Nephritis', 'Kidney', 'SLE', 'Systemic Lupus Erythematosus', 'Nephritis, Lupus'], 'conditions': ['Lupus Erythematosus, Systemic', 'Lupus Nephritis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.ljpc.com', 'label': "Sponsor's website"}]}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to determine whether abetimus sodium is more effective than placebo in delaying time to renal flare in SLE patients with a history of renal disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of Systemic Lupus Erythematosus (SLE)\n* Active SLE renal disease within past 4 years.\n* Males or females between 12 and 70 years old.\n* Females must be non-pregnant and non-lactating. Females and males must use adequate birth control methods during course of study.\n* Ability to have weekly intravenous (IV) administration of study treatment.\n\nExclusion Criteria:\n\n* Active SLE renal disease within past 3 months prior to entering study.\n* Use of the following therapies within 3 months prior to entering the study: alkylating agents, e.g., cyclophosphamide, TNF inhibitors, cyclosporine.\n* Use of mycophenolate mofetil that exceeds 1000 mg/day, azathioprine that exceeds 100 mg/day, methotrexate that exceeds 10 mg/week, leflunomide that exceeds 10 mg/day within 2 months prior to entering study.\n* Use of rituximab within 6 months prior to entering study.\n* Current abuse of drugs or alcohol.'}, 'identificationModule': {'nctId': 'NCT00089804', 'acronym': 'ASPEN', 'briefTitle': 'Study of LJP 394 in Lupus Patients With History of Renal Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'La Jolla Pharmaceutical Company'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Three-Arm, Parallel-Group, Multicenter, Multinational Safety and Efficacy Trial of 300 mg and 900 mg of Abetimus Sodium in Systemic Lupus Erythematosus (SLE) Patients With a History of Renal Disease', 'orgStudyIdInfo': {'id': 'LJP 394-90-14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': '300 mg (three 2 mL vials of abetimus sodium plus six 2 mL vials of normal saline) administered i.v (in the vien) weekly', 'interventionNames': ['Drug: abetimus sodium (LJP 394) and/or placebo solution']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': '900 mg (nine 2 mL vials of abetimus sodium) administered i.v. (in the vein) weekly', 'interventionNames': ['Drug: abetimus sodium (LJP 394)']}, {'type': 'PLACEBO_COMPARATOR', 'label': '3', 'description': 'A volume of 18 mL (Nine 2 mL vials) of identically appearing placebo (phosphate-buffered saline) administered i.v. (in the vien) weekly', 'interventionNames': ['Drug: Phosphate-buffered saline']}], 'interventions': [{'name': 'abetimus sodium (LJP 394) and/or placebo solution', 'type': 'DRUG', 'description': '300 mg (50 mg/mL)abetimus sodium (three 2 mL vials of of abetimus sodium plus six 2 mL vials of normal saline) administered i.v. (in the vien) weekly for 52 weeks', 'armGroupLabels': ['1']}, {'name': 'abetimus sodium (LJP 394)', 'type': 'DRUG', 'description': '900 mg (50 mg/mL) abetimus sodium (nine 2 mL vials) administered i.v. (in the vien) weekly for 52 weeks.', 'armGroupLabels': ['2']}, {'name': 'Phosphate-buffered saline', 'type': 'DRUG', 'otherNames': ['Placebo, normal saline'], 'description': 'A volume of 18 mL (nine 2 mL vials of normal saline) of identically appearing placebo (phosphate-buffered saline) administered i.v. 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