Roxadustat Reduces the Incidence of Acute Kidney Injury After Coronary Artery Bypass Grafting: a Multicenter, Randomized, Double-blind, Placebo-controlled Study
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 98
- 试验地点
- 2
- 主要终点
- acute kidney injury
研究概览
简要总结
Acute kidney injury is a frequent complication after coronary artery bypass grafting (CABG). Roxadustat is a prolyl hydroxylase inhibitor (PHI) which can stabilize hypoxia-inducible factor (HIF) and improve the hypoxic tolerance of tissues. Roxadustat has shown effect in reducing acute kidney injury in animal studies.
This study aims to evaluate the efficacy of administration of Roxadustat before surgery in the prevention of acute kidney injury after CABG.
详细描述
Acute kidney injury is a frequent complication after coronary artery bypass grafting (CABG), with a incidence of 28-38%. Renal ischemia-reperfusion injury is the main mechanism for acute kidney injury after CABG.
Roxadustat is a kind of prolyl hydroxylase inhibitor (PHI) which can stabilize hypoxia-inducible factor (HIF) and improve the hypoxic tolerance of tissues. Roxadustat has shown effect in reducing acute kidney injury in animal studies.
This study aims to evaluate the efficacy of administration of Roxadustat (before surgery) in the prevention of acute kidney injury after CABG. This is a multicenter, randomized, double-blind, placebo-controlled study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-80 years old
- •non-emergent CABG and planned cardiopulmonary bypass (CPB)
- •eGFR>15ml/min/1.73m2
排除标准
- •pregnancy or breast feeding
- •malignancy
- •severe liver dysfunction
- •acute kidney injury before randomization
- •uncontrolled hypertension
研究组 & 干预措施
Roxadustat
Roxadustat
干预措施: Roxadustat (Drug)
placebo
Placebo has the same appearance with the experimental drug (Roxadustat).
干预措施: Placebo (Drug)
结局指标
主要结局
acute kidney injury
时间窗: 0-48 hours after surgery
elevation of serum creatinine ≥0.3mg/dl（26.5μmol/L）or ≥ 1.5 times baseline levels within 48 hours post surgery
次要结局
- classification of acute kidney injury(0-3 days after surgery)
- renal function(0-3 days after surgery)
- new biomarkers of renal injury(immediately after surgery and the first morning after surgery)
- Cardiac Troponin Subunit I (cTnI)(0-3 days after surgery)
- brain natriuretic peptide (BNP) or N-terminal pro-BNP (NT-proBNP)(0-3 days after surgery)
- death(through study completion, an average of one month)
- length of hospital stay and ICU stay(through study completion, an average of one month)
- Blood infusion(0-3 days after surgery)
- adverse events(through study completion, an average of one month)