Replication of the DAPA-CKD (Chronic Kidney Disease) Trial in Healthcare Claims Data
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 87,727
- 试验地点
- 1
- 主要终点
- Relative hazard of the composite of end-stage renal disease or all-cause mortality
研究概览
简要总结
Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.
详细描述
This is a non-randomized, non-interventional study that is part of the RCT DUPLICATE initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical School. It is intended to replicate, as closely as possible in healthcare insurance claims data, the trial listed below/above. Although many features of the trial cannot be directly replicated in healthcare claims, key design features, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the trial. Randomization is also not replicable in healthcare claims data but was proxied through a statistical balancing of measured covariates through standard practice. Investigators assume that the RCT provides the reference standard treatment effect estimate and that failure to replicate RCT findings is indicative of the inadequacy of the healthcare claims data for replication for a range of possible reasons and does not provide information on the validity of the original RCT finding.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age [Day 0, Day 0]
- •eGFR ≥25 and ≤75 mL/min/1.73 m2 (CKD-EPI formula) at visit 1 (- All Time, Day 0]
- •Evidence of increased albuminuria for 3 months or more before visit 1 and UACR ≥200 and ≤5000 mg/g at visit 1(- All Time, Day 0]
- •Stable, and for the patient maximum tolerated labelled daily dose, treatment with ACEi or ARB for at least 4 weeks before visit 1, if not medically contraindicated (-All Time, Day -45]
排除标准
- •Type I diabetes mellitus (-All Time, Day 0]
- •Autosomal dominant or autosomal recessive polycystic kidney disease, lupus nephritis or Antineutrophil cytoplasmic antibody (ANCA) - associated vasculitis (-All Time, Day 0]
- •Receiving cytotoxic therapy, immunosuppressive therapy or other immunotherapy for primary or secondary renal disease within 6 months prior to enrollment [Day -180, Day 0]
- •NYHA class IV congestive heart failure at the time of enrollment [Day -180, Day 0]
- •MI, unstable angina, stroke, transient ischemic attack within 8 weeks prior to enrollment [ Day -56, Day 0]
- •Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 8 weeks prior to enrollment [Day -56, Day 0]
- •Any condition outside the renal and cardiovascular study area with a life expectancy of <2 years based on investigator's clinical judgement [Day 0, Day 0]
- •Hepatic impairment [aspartate transaminase or alanine transaminase >3 times the upper limit of normal (ULN) or total bilirubin >2 times the ULN at the time of enrollment] (- All Time, Day 0]
- •History of organ transplantation (- All Time, Day 0]
- •Receiving therapy with SGLT2 inhibitor within 8 weeks prior to enrollment or previous intolerance of an SGLT2 inhibitor [Day -56, Day -1]
- •Exclude patients that have AKI, CKD V, ESRD and are on HD/PD during the baseline period [Day -14, Day 0] for AKI and [Day -180, Day 0] for CKD, ESRD, or Hemodialysis/Peritoneal Dialysis
研究组 & 干预措施
Dapagliflozin
Exposure group
干预措施: Dapagliflozin (Drug)
Sitagliptin
Reference group
干预措施: Sitagliptin (Drug)
结局指标
主要结局
Relative hazard of the composite of end-stage renal disease or all-cause mortality
时间窗: To study completion or censoring, up to 32 months
Claims-based algorithm: see attached protocol for full definition
次要结局
- Relative hazard of end-stage renal disease(To study completion or censoring event, up to 32 months)
- Relative hazard of all-cause mortality(To study completion or censoring event, up to 32 months)
研究者
Shirley Vichy Wang
Associate Professor of Medicine
Brigham and Women's Hospital