Study of LJP 394 in Lupus Patients With History of Renal Disease (ASPEN)

La Jolla Pharmaceutical

Status and phase: Terminated; Phase 3

Conditions: Lupus Erythematosus, Systemic; Lupus Nephritis

Treatments: Drug: abetimus sodium (LJP 394) and/or placebo solution; Drug: abetimus sodium (LJP 394); Drug: Phosphate-buffered saline

Study type: Interventional

Funder types: Industry

Identifiers

NCT00089804

LJP 394-90-14

Details and patient eligibility

About

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.

Enrollment: 943 patients

Sex: All

Ages: 12 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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943 participants in 3 patient groups, including a placebo group

1

Active Comparator group

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

Treatment:

Drug: abetimus sodium (LJP 394) and/or placebo solution

2

Active Comparator group

Description:

900 mg (nine 2 mL vials of abetimus sodium) administered i.v. (in the vein) weekly

Treatment:

Drug: abetimus sodium (LJP 394)

3

Placebo Comparator group

Description:

A volume of 18 mL (Nine 2 mL vials) of identically appearing placebo (phosphate-buffered saline) administered i.v. (in the vien) weekly

Treatment:

Drug: Phosphate-buffered saline