Roxadustat Reduces the Incidence of Acute Kidney Injury After Coronary Artery Bypass Grafting: a Multicenter, Randomized, Double-blind, Placebo-controlled Study
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Enrollment
- 98
- Locations
- 2
- Primary Endpoint
- acute kidney injury
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18-80 years old
- •non-emergent CABG and planned cardiopulmonary bypass (CPB)
- •eGFR>15ml/min/1.73m2
Exclusion Criteria
- •pregnancy or breast feeding
- •malignancy
- •severe liver dysfunction
- •acute kidney injury before randomization
- •uncontrolled hypertension
Arms & Interventions
Roxadustat
Roxadustat
Intervention: Roxadustat (Drug)
placebo
Placebo has the same appearance with the experimental drug (Roxadustat).
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
acute kidney injury
Time Frame: 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
Secondary Outcomes
- 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)