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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00089804 |
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Date of registration:
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13/08/2004 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Study of LJP 394 in Lupus Patients With History of Renal Disease
ASPEN |
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Scientific title:
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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 |
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Date of first enrolment:
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October 2004 |
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Target sample size:
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943 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00089804 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Argentina
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Australia
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Belarus
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Brazil
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Bulgaria
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Czech Republic
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Former Serbia and Montenegro
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Georgia
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Germany
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Hong Kong
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Hungary
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India
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Indonesia
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Italy
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Korea, Republic of
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Lebanon
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Malaysia
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Mexico
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Philippines
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Poland
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Portugal
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Puerto Rico
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Romania
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Serbia
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Slovakia
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Spain
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Sri Lanka
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Taiwan
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Thailand
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Ukraine
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United States
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Contacts
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Name:
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Michael J Tansey, MD, Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Chief Medical Officer, La Jolla Pharmaceutical Company |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of Systemic Lupus Erythematosus (SLE)
- Active SLE renal disease within past 4 years.
- Males or females between 12 and 70 years old.
- Females must be non-pregnant and non-lactating. Females and males must use adequate
birth control methods during course of study.
- Ability to have weekly intravenous (IV) administration of study treatment.
Exclusion Criteria:
- Active SLE renal disease within past 3 months prior to entering study.
- Use of the following therapies within 3 months prior to entering the study:
alkylating agents, e.g., cyclophosphamide, TNF inhibitors, cyclosporine.
- 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.
- Use of rituximab within 6 months prior to entering study.
- Current abuse of drugs or alcohol.
Age minimum:
12 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Lupus Erythematosus, Systemic
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Lupus Nephritis
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Intervention(s)
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Drug: abetimus sodium (LJP 394)
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Drug: Phosphate-buffered saline
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Drug: abetimus sodium (LJP 394) and/or placebo solution
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Primary Outcome(s)
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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.
[Time Frame: Time to event (12 months fixed treatment duration)]
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Secondary Outcome(s)
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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.
[Time Frame: 12 month fixed treatment duration]
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Secondary ID(s)
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LJP 394-90-14
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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