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

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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00089804

Acronym

ASPEN

Enrollment

943

Registered

2004-08-17

Start date

2004-10-31

Completion date

2009-02-28

Last updated

2009-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lupus Erythematosus, Systemic, Lupus Nephritis

Keywords

Lupus, Nephritis, Kidney, SLE, Systemic Lupus Erythematosus, Nephritis, Lupus

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.

Interventions

DRUGabetimus sodium (LJP 394) and/or placebo solution

300 mg (50 mg/mL)abetimus sodium (three 2 mL vials of of abetimus sodium plus six 2 mL vials of normal saline) administered i.v. (in the vien) weekly for 52 weeks

DRUGabetimus sodium (LJP 394)

900 mg (50 mg/mL) abetimus sodium (nine 2 mL vials) administered i.v. (in the vien) weekly for 52 weeks.

DRUGPhosphate-buffered saline

A volume of 18 mL (nine 2 mL vials of normal saline) of identically appearing placebo (phosphate-buffered saline) administered i.v. (in the vien) weekly for 52 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

12 Years to 70 Years

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Argentina, Australia, Belarus, Brazil, Bulgaria, Czechia, Georgia, Germany, Hong Kong, Hungary, India, Indonesia, Italy, Lebanon, Malaysia, Mexico, Philippines, Poland, Portugal, Puerto Rico, Romania, Serbia, Slovakia, South Korea, Spain, Sri Lanka, Taiwan, Thailand, Ukraine, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026