ACTRN12622001467729招募中3 期
carDIovaScular and renal outCOmes in patients recoVERed from acute kidney injury
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1) Adult participants at least 18 years of age
- •2) Pre-existing diagnosis of albuminuria (defined as urine albumin-creatinine ratio (UACR) greater than or equal to 30 mg/g)
- •3) Recovered from the previous acute kidney injury (AKI) within the last 30 days. AKI recovery is defined as:
- •Complete if the estimated glomerular filtration rate (eGFR) level, at the time of screening for the DISCOVER trial, has returned to within 20% of baseline levels as assessed by the median eGFR level during the 12 months prior to the recent AKI episode, and excluding eGFR values during other instances of AKI
- •Complete if the serum creatinine (SCr) level, at the time of screening for the DISCOVER trial, has returned to within 20% of baseline levels as assessed by the median SCr level during the 12 months prior to the recent AKI episode, and excluding SCr values during other instances of AKI
- •Partial if there is a fall in the Kidney Disease Improving Global Outcomes (KDIGO) AKI stage classification by at least one stage (e.g., from stage 3 to stage 2 AKI, or from stage 2 to stage 1 AKI) when a baseline eGFR and/or SCr value is not available during the 12 months prior to the recent AKI episode
- •4) Recently discharged from hospital or seen in the renal outpatient clinic
- •5) Stable eGFR defined as within 20% of the hospital discharge level or increasing (greater than 20% of discharge levels)
- •6) Expected to be under the care of the participating renal unit for the next 6 months
- •7) The treating physician has equipoise on the balance of risk and benefit for the participant in either arm of the study and is willing to randomise participants
排除标准
- •1) Diagnosis of type-1 diabetes mellitus (T1DM)
- •2) Current use of a sodium glucose cotransporter 2 (SGLT2) inhibitor at the time of screening for the DISCOVER trial
- •3) Documented SGLT2 inhibitor intolerance
- •4) Current or ongoing use of contraindicated concomitant medications
- •5) Severe hepatic impairment, defined as Child-Pugh class C hepatic failure
- •6) Pregnancy, including breast feeding
- •7) Patients with diabetic ketoacidosis
- •8) Advanced CKD with an estimated glomerular filtration rate (eGFR) of less than 25 ml/min/1.73m2
- •9) Solid organ transplant recipients
- •10) Participants with cognitive impairment
研究者
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