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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Lupus Erythematosus, Systemic, Lupus Nephritis

Intervention / Treatment
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* Drug: abetimus sodium (LJP 394) and/or placebo solution
* Drug: abetimus sodium (LJP 394)
* Drug: Phosphate-buffered saline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>300 mg (three 2 mL vials of abetimus sodium plus six 2 mL vials of normal saline) administered i.v (in the vien) weekly | Drug: abetimus sodium (LJP 394) and/or placebo solution<br>* 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<br>|
| Active Comparator: 2<br>900 mg (nine 2 mL vials of abetimus sodium) administered i.v. (in the vein) weekly | Drug: abetimus sodium (LJP 394)<br>* 900 mg (50 mg/mL) abetimus sodium (nine 2 mL vials) administered i.v. (in the vien) weekly for 52 weeks.<br>|
| Placebo Comparator: 3<br>A volume of 18 mL (Nine 2 mL vials) of identically appearing placebo (phosphate-buffered saline) administered i.v. (in the vien) weekly | Drug: Phosphate-buffered saline<br>* 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<br>* Other names: Placebo, normal saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lupus, Nephritis, Kidney, SLE, Systemic Lupus Erythematosus, Nephritis, Lupus