NCT00479622终止1 期
A Randomized, Two-Arm, Parallel Group Study of the Safety, Pharmacokinetics, and Pharmacodynamics of TRU-015 Added to Standard Therapy in Subjects With Membranous Nephropathy Secondary to Systemic Lupus Erythematosus
Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 20 人开始时间: 2007年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 20
- 主要终点
- To evaluate the pharmacokinetics of TRU-015 after a single administration in subjects with membranous nephropathy secondary to systemic lupus erythematosus.
研究概览
简要总结
The purpose of this study is to determine how the body absorbs and chemically changes a single infusion of TRU-015 in subjects with kidney disease caused by lupus.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Man or nonlactating and nonpregnant woman, aged 18 to 70 years, inclusive, at the screening visit.
- •Diagnosis of systemic lupus erythematosus more than 6 months before study day
- •History of positive antinuclear antibody titer of >1:160 or equivalent.
- •Biopsy-proven class V lupus nephritis within the last 2 years.
- •Have been on a stable dose of oral corticosteroids (<20 mg/day prednisone or equivalent) for 2 months before study day 1.
排除标准
- 未提供
研究组 & 干预措施
1
Experimental
干预措施: TRU-015 (Drug)
2
Experimental
干预措施: TRU-015 (Drug)
结局指标
主要结局
To evaluate the pharmacokinetics of TRU-015 after a single administration in subjects with membranous nephropathy secondary to systemic lupus erythematosus.
时间窗: 6 months
次要结局
- To evaluate the safety, immunogenicity, and pharmacokinetic/pharmacodynamic relationship of TRU-015 in subjects with membranous nephropathy secondary to systemic lupus erythematosus.(1 year)
研究者
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