NCT05248659Enrolling By Invitation2 期
A Phase 2/3, Multicenter, Open-label Trial to Evaluate the Long-term Safety, Tolerability, and Efficacy of Sibeprenlimab Administered Subcutaneously in Subjects With Immunoglobulin A Nephropathy.
Otsuka Pharmaceutical Development & Commercialization, Inc.158 个研究点 分布在 9 个国家目标入组 600 人开始时间: 2022年4月5日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 入组人数
- 600
- 试验地点
- 158
- 主要终点
- Adverse Events
研究概览
简要总结
This is a phase 2/3 open-label trial to evaluate the long-term safety, tolerability, and efficacy of sibeprenlimab administered subcutaneously (SC) in subjects with IgAN.
详细描述
This is a phase 2/3, multicenter, open-label trial to evaluate the long-term safety, tolerability, and efficacy of sibeprenlimab administered subcutaneously (SC) to subjects with IgAN.
Eligible subjects will have participated in trials 417-201-00007 or VIS649-201 and, in the investigator's judgement, could benefit from continued treatment with sibeprenlimab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who completed Trial 417-201-00007 or VIS649-201 without safety concerns and who, in the opinion of the investigator, could potentially benefit from treatment with sibeprenlimab.
- •eGFR ≥ 20 mL/min/1.73 m2, calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.
排除标准
- •Subjects who have not completed participation in trials 417-201-00007 or VIS649-
- •Subjects who, following enrollment in trials 417-201-00007 or VIS649-201 developed a condition or characteristic that would have excluded them from participation in these trials.
研究组 & 干预措施
Sibeprenlimab 400 mg s.c. q 4 weeks
Experimental
干预措施: Sibeprenlimab 400 mg s.c. Q4weeks (Drug)
结局指标
主要结局
Adverse Events
时间窗: From baseline to the end-of-trial visit in Week 112.
次要结局
- Time to Progression of Chronic Kidney Disease, as defined in the protocol(Over 24 months)
- Proportion of Subjects with Clinical Remission as defined in the protocol(At 12 and 24 months)
- Annualized slope of Estimated Glomerular Filtration Rate (eGFR)(Over 12 and 24 months)
- Urine protein/creatinine ratio (uPCR) in a 24-hour collection(At 12 and 24 months)
研究者
研究点 (158)
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