JPRN-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
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 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
研究者
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