NCT03146793Unknown不适用
National Follow-up of Dialysis Patients With Sodium Thiosufate-treated Calciphylaxis Under Temporary Use Authorization
Centre Hospitalier St Esprit1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2017年5月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
The national drug safety agency authorizes nominatively the use of sodium thiosulfate in dialysis patients with calciphylaxis. To date, it is the largest global cohort (more 600 patients from 2012 to 2016). We wanted to study retrospectively the fate of these patients at 6 months including mortality. Early use improves effectiveness.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •All dialysis patients with calciphylaxis in France who have obtained a temporary use authorization for sodium thiosulfate by National Agency for the Safety of Medicines
排除标准
- 未提供
结局指标
主要结局
Mortality
时间窗: 6 months
次要结局
- time factor on mortality(6 months)
研究者
Albert TRINH-DUC
Principal investigator
Centre Hospitalier St Esprit
研究点 (1)
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