Status:
TERMINATED
Study of LJP 394 in Lupus Patients With History of Renal Disease
Lead Sponsor:
La Jolla Pharmaceutical Company
Conditions:
Lupus Erythematosus, Systemic
Lupus Nephritis
Eligibility:
All Genders
12-70 years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
943 Patients enrolled
Trial Details
Trial ID
NCT00089804
Start Date
October 1 2004
End Date
February 1 2009
Last Update
April 1 2009
Active Locations (201)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Wallace Rheumatic Study Center
Los Angeles, California, United States, 90048
3
East Bay Rheumatology Medical Group
San Leandro, California, United States, 94578
4
Private Practice
San Mateo, California, United States, 94401