NCT02433236撤回2 期
A Phase 2, Multi-Centre, Open Label Extension Study of Fostamatinib in the Treatment of IgA Nephropathy for Patients Who Participated in Study C-935788-050
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Number of Participants with mean change of Proteinuria as measured by spot urine protein/creatinine ratio (sPCR)
研究概览
简要总结
Phase 2, multi-center, open label extension study to evaluate 2 dose regimens of fostamatinib in approximately 25 subjects. The study will consist of 11 visits over 15 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 72 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completed Study C-938788-050, including having received a post-treatment renal biopsy, and having had a clinically meaningful response (i.e. decreased proteinuria or improved renal histology)
- •Able and willing to give written informed consent
排除标准
- •Unresolved Grade 2 or greater toxicity in Study C-935788-050
研究组 & 干预措施
Fostamatinib Disodium tablet 100 mg
Experimental
Fostamatinib Disodium tablet 100 milligram (mg) by mouth twice a day for 15 months
干预措施: Fostamatinib Disodium tablet 100 mg (Drug)
Fostamatinib Disodium tablet 150 mg
Experimental
Fostamatinib Disodium tablet 150 milligram (mg) by mouth twice a day for 15 months
干预措施: Fostamatinib Disodium tablet 150 mg (Drug)
结局指标
主要结局
Number of Participants with mean change of Proteinuria as measured by spot urine protein/creatinine ratio (sPCR)
时间窗: 15 months
次要结局
未报告次要终点
研究者
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终止
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