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临床试验/jRCT2080223905
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

AstraZeneca KK1 个研究点目标入组 240 人开始时间: 待定最近更新:
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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