Study of LJP 394 in Lupus Patients With History of Renal Disease

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Lupus Erythematosus, Systemic, Lupus Nephritis

In brief

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.

Key facts

Study ID

NCT00089804

Run by

La Jolla Pharmaceutical Company

People needed

943

Starts

2004-10-01

Expected to finish

2009-02-01

Last updated by the study team

2009-04-01

Who can join

Age: 12 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Wallace Rheumatic Study Center — Los Angeles, California, United States
• East Bay Rheumatology Medical Group — San Leandro, California, United States
• Private Practice — San Mateo, California, United States
• CRIA Research — Fort Lauderdale, Florida, United States
• Miami Children's Hospital — Miami, Florida, United States
• Emory University School of Medicine, Renal Division — Atlanta, Georgia, United States
• Private Practice — Augusta, Georgia, United States
• Southeast Regional Research Group — Savannah, Georgia, United States
• Intermountain Orthopedics — Boise, Idaho, United States
• Rheumatology Associates — Chicago, Illinois, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• SOMARC Trials, LLC — Greenbelt, Maryland, United States
• Nephrology Associates, PC — Flushing, New York, United States
• North Shore - LIJ Health System — Lake Success, New York, United States
• Feinstein Institute for Medical Research — Manhasset, New York, United States
• Seligman Center for Advanced Therapeutics, NYU Hospital for Joint Diseases — New York, New York, United States
• AAIR Research Center — Rochester, New York, United States
• Suny Upstate Medical University — Syracuse, New York, United States
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
• Ohio State University Medical Center — Columbus, Ohio, United States
• Healthcare Research Consultants — Tulsa, Oklahoma, United States
• Private Practice — Camp Hill, Pennsylvania, United States
• Altoona Center for Clinical Research — Duncansville, Pennsylvania, United States
• Arthritis Clinic, 371 North Parkway, Suite 400 — Jackson, Tennessee, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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