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
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 943
- 试验地点
- 198
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 12 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
1
300 mg (three 2 mL vials of abetimus sodium plus six 2 mL vials of normal saline) administered i.v (in the vien) weekly
干预措施: abetimus sodium (LJP 394) and/or placebo solution (Drug)
2
900 mg (nine 2 mL vials of abetimus sodium) administered i.v. (in the vein) weekly
干预措施: abetimus sodium (LJP 394) (Drug)
3
A volume of 18 mL (Nine 2 mL vials) of identically appearing placebo (phosphate-buffered saline) administered i.v. (in the vien) weekly
干预措施: Phosphate-buffered saline (Drug)
结局指标
主要结局
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.
时间窗: Time to event (12 months fixed treatment duration)
次要结局
- 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)