jRCT2080223905已完成3 期
A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients With Chronic Kidney Disease
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Randomized, Parallel Assignment
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 18age old over 至 No limit(—)
- 性别
- All
入选标准
- •Provision of signed informed consent prior to any study specific procedures
- •Female or male aged 18 years or more at the time of consent
- •eGFR 25 or more and 75 mL/min/1.73 m2 (CKD-EPI Formula) or less at visit 1
- •Evidence of increased albuminuria 3 months or more before visit 1 and UACR 200 or more and 5000 mg/g or less at visit 1
- •Stable, and for the patient maximum tolerated labelled daily dose, treatment with ACE-I or ARB for at least 4 weeks before visit 1, if not medically contraindicated
排除标准
- •Autosomal dominant or autosomal recessive polycystic kidney disease, lupus nephritis or ANCA-associated vasculitis
- •Receiving cytotoxic therapy, immunosuppressive therapy or other immunotherapy for primary or secondary renal disease within 6 months prior to enrolment
- •History of organ transplantation
- •Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
- •Type 1 diabetes mellitus
- •New York Heart Association (NYHA) class IV Congestive Heart Failure at the time of enrolment
- •MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
结局指标
主要结局
-
efficacy -
次要结局
未报告次要终点
研究者
研究点 (1)
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