A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients With Chronic Kidney Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 4,304
- 试验地点
- 1
- 主要终点
- Time to the First Occurrence of Any of the Components of the Composite: ≥50% Sustained Decline in eGFR or Reaching ESRD or CV Death or Renal Death.
研究概览
简要总结
The purpose of this study is to evaluate the effect of dapagliflozin on renal outcomes and cardiovascular mortality in patients with chronic kidney disease.
详细描述
This is an international, multicentre, event-driven, randomized, double-blind, parallel group, placebo-controlled study, evaluating the effect of dapagliflozin versus placebo, given once daily in addition to standard of care, to prevent the progression of chronic kidney disease (CKD) or cardiovascular (CV)/renal death.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 130 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed informed consent prior to any study specific procedures
- •Female or male aged ≥18 years at the time of consent
- •eGFR ≥25 and ≤75 mL/min/1.73m2 (CKD-EPI Formula) at visit 1
- •Evidence of increased albuminuria 3 months or more before visit 1 and UACR ≥200 and ≤5000 mg/g 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
研究组 & 干预措施
Dapagliflozin
Patients will be randomized 1:1 to either dapagliflozin or placebo.
干预措施: Dapagliflozin (Drug)
Placebo
Placebo matching dapagliflozin.
干预措施: Placebo (Drug)
结局指标
主要结局
Time to the First Occurrence of Any of the Components of the Composite: ≥50% Sustained Decline in eGFR or Reaching ESRD or CV Death or Renal Death.
时间窗: Up to 38.2 months
End Stage Renal Disease (ESRD) is defined as: * Sustained eGFR \<15 mL/min/1.73m2 or, * Chronic dialysis treatment or, * Receiving a renal transplant The proportional hazards Cox regression model takes into account the time to the event. Data is reported as the numbers of subjects with the event and the Hazard ratio is included in the Statistical Analysis section attached to the Outcome Measure data table.
次要结局
- Time to the First Occurrence of Any of the Components of the Composite: ≥50% Sustained Decline in eGFR or Reaching ESRD or Renal Death.(Up to 38.2 months)
- Time to the First Occurrence of Either of the Components of the Composite: CV Death or Hospitalization for Heart Failure.(Up to 38.2 months)
- Time to Death From Any Cause.(Up to 38.2 months)