NL-OMON37265撤回2 期
BEL114674: A 2 year study of efficacy and safety of intravenous belimumab versus placebo in subjects with idiopathic membranous nephropathy - BEL114674
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Subjects between 18 and 75 years of age (inclusive) with active IMN (confirmed with biopsy in last 3 y; biopsy should be available for independent evaluation) and proteinuria >400 mg/mmol. See protocol page 30 for details.
- •Capable of giving IC.
- •Females of childbearing potential: adequate method of contraception. See protocol page 39-40 for details.
排除标准
- •Non-Idiopathic MN or other condition affecting the kidney. See protocol page 40 for details.
- •Patients known to be negative for anti-PLA2R autoantibody.
- •Severely reduced or deteriorating kidney function (eGFR< 40mL/min/1.73m2). See protocol page 40 for details.
- •Uncontrolled hypertension (>150/90).
- •Defined prior therapies. See protocol page 41-42 for details.
- •Pregnancy or breastfeeding
研究者
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