NCT06527846进行中（未招募）不适用
Post Marketing Surveillance on Long Term Use of JARDIANCE® Tablets in Patients With Chronic Kidney Disease in Japan
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,027
- 试验地点
- 1
- 主要终点
- Incidence of Adverse Drug Reactions (ADRs)
研究概览
简要总结
Study objective is to investigate the safety and effectiveness of long-term daily use of JARDIANCE® Tablets in patients with chronic kidney disease under real-world use.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with CKD who are prescribed JARDIANCE® Tablets for CKD according to the current Japanese package insert and who provided written informed consent prior to enrolment in this study.
- •Patients who have never been treated with JARDIANCE® Tablets (including treatment for Type 2 diabetes mellitus (T2DM) and/or chronic heart failure (CHF)) before enrolment.
排除标准
- 未提供
研究组 & 干预措施
Patients with chronic kidney disease (CKD)
干预措施: JARDIANCE® (Drug)
结局指标
主要结局
Incidence of Adverse Drug Reactions (ADRs)
时间窗: Up to 52 weeks
次要结局
- Kidney disease progression(Up to 52 weeks)
- Incidence of hospitalization for heart failure(Up to 52 weeks)
- Incidence of cardiovascular death(Up to 52 weeks)
- Incidence of all cause death(Up to 52 weeks)
- Change from baseline in eGFR to the last observation on treatment(at baseline, at last observation on treatment (Up to 52 weeks))
研究者
研究点 (1)
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