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

Phase 3

Terminated

• Conditions: Lupus Erythematosus, Systemic; Lupus Nephritis
• Interventions: Drug: abetimus sodium (LJP 394) and/or placebo solution; Drug: abetimus sodium (LJP 394); Drug: Phosphate-buffered saline

• Registration Number: NCT00089804
• Lead Sponsor: La Jolla Pharmaceutical Company

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2004-08-13
• Study First Submitted QC: 2004-08-16
• Study First Posted: 2004-08-17
• Study Start: 2004-10
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-30
• Last Update Posted: 2009-04-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 943

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	abetimus sodium (LJP 394) and/or placebo solution	300 mg (three 2 mL vials of abetimus sodium plus six 2 mL vials of normal saline) administered i.v (in the vien) weekly
2	abetimus sodium (LJP 394)	900 mg (nine 2 mL vials of abetimus sodium) administered i.v. (in the vein) weekly
3	Phosphate-buffered saline	A volume of 18 mL (Nine 2 mL vials) of identically appearing placebo (phosphate-buffered saline) administered i.v. (in the vien) weekly

Primary Outcome Measures

Name	Time	Method
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 to event (12 months fixed treatment duration)

Secondary Outcome Measures

Name	Time	Method
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.	12 month fixed treatment duration

Trial Locations

Locations (198)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Wallace Rheumatic Study Center; 🇺🇸 Los Angeles, California, United States

East Bay Rheumatology Medical Group; 🇺🇸 San Leandro, California, United States

Private Practice; 🇺🇸 Camp Hill, Pennsylvania, 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

Southeast Regional Research Group; 🇺🇸 Savannah, Georgia, United States

Intermountain Orthopedics; 🇺🇸 Boise, Idaho, United States

Rheumatology Associates; 🇺🇸 Chicago, Illinois, United States

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