Table 1.

Patient population

Inclusion criteria	Exclusion criteria
≥18 years of age undergoing CPB surgerya	Emergency cardiac surgery
eGFR ≥20 and <30 ml/min per 1.73 m2	AKI or significant renal impairment within 24 hours of surgery: a diagnosis of AKI as defined by KDIGO criteria or
eGFR ≥30 and <60 ml/min per 1.73 m2 and one additional risk factor from Table 2 (other than age ≥75 years) or	eGFR <20 ml/min per 1.73 m2 or
eGFR ≥60 ml/min per 1.73 m2 and two additional risk factors from Table 2	An acute rise in SCr >0.3 mg/dl or
	50% increase in SCr between the time of screening visit and pre-surgery
	Patients receiving iodinated contrast material within 24 hours of surgery
	Active sepsis or current active infection requiring antibiotic treatment
	Treatment with cytochrome P450 1A2 (CYP1A2) inhibitors;
	HIV seropositivity
	Active malignancy or history within the previous 5 years before screening visit
	Cardiogenic shock or hemodynamic instability within 24 hours before randomization
	Use of a pacemaker, mechanical ventilation, any form of mechanical circulatory support, or cardiopulmonary resuscitation 7 days before surgery
	Clinical or laboratory diagnosis of shock liver
	BMI >40 kg/m2 at screening

AKI, acute kidney injury; BMI, body mass index; CPB, cardiopulmonary bypass; eGFR, estimated glomerular filtration rate; KDIGO, Kidney Disease: Improving Global Outcomes; SCr, serum creatinine.

^aAge ≥75 years can be considered an additional risk factor only for patients with eGFR ≥60 ml/min per 1.73 m².