Study to Evaluate the Efficacy of ASP1128 (MA-0217) in Subjects at Risk for Acute Kidney Injury (AKI) Following Coronary Artery Bypass Graft (CABG) and/or Valve Surgery

Subject agrees not to participate in another interventional study after signing the informed consent form and until the end of study (EoS) visit has been completed.

Subject is ≥ 35 years of age at the time of screening (visit 1).

Subject undergoing non-emergent open chest cardiovascular surgery with the use of cardiopulmonary bypass pump (CPB) (i.e., coronary artery bypass graft (CABG) and/or valve surgery \[including aortic root and ascending aorta surgery without circulatory arrest\]) within 4 weeks of screening (visit 1).

Subject is at risk of developing acute kidney injury (AKI) following cardiovascular surgery, i.e., has 1 or more of the following AKI risk factors:

* Age at screening of ≥ 70 years

* Documented history of eGFR \< 60 mL/min per 1.73 m\^2 as per Modification of Diet in Renal Disease Study (MDRD) or Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation (or documented measured glomerular filtration rate assessment) (history needs to be present for at least 90 days prior to screening, and eGFR at screening or baseline needs to be \< 60 mL/min per 1.73 m\^2, as well as per CKD-EPI equation.)

* Documented history of congestive heart failure requiring hospitalization. This condition should exist for ≥ 90 days prior to screening.

* Documented history of diabetes mellitus (type 1 or 2) of ≥ 90 days prior to screening, and subject is on active antidiabetic medication treatment for ≥ 90 days.

* Documented history of proteinuria/albuminuria at any time point before screening (urinary dipstick result of ≥ 2+, documented urinary albumin creatinine ratio measurement of ≥ 300 mg/g, or documented total quantity of protein in a 24-hour urine collection test ≥ 0.3 g/day)

Subject must have the ability and willingness to return for all scheduled visits and perform all assessments.

Female subject is eligible to participate if she is not pregnant and at least 1 of the following conditions applies:

* Not a woman of childbearing potential (WOCBP), OR

* WOCBP who agrees to follow the contraceptive guidance throughout the treatment period and for at least 30 days after the final study drug administration.

Female subject must agree not to breastfeed starting at screening and throughout the study period, and for 30 days after the final study drug administration.

Female subject must not donate ova starting at screening and throughout the study period, and for 30 days after the final study drug administration.

Male subject with female partner(s) of child-bearing potential must agree to use contraception during the treatment period and for at least 30 days after the final study drug administration.

Male subject must not donate sperm during the treatment period and for at least 30 days after the final study drug administration.

Male subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or time partner is breastfeeding throughout the study period and for 30 days after the final study drug administration.

Preoperatively on the Day of Surgery:

Study to Evaluate the Efficacy of ASP1128 (MA-0217) in Subjects at Risk for Acute Kidney Injury (AKI) Following Coronary Artery Bypass Graft (CABG) and/or Valve Surgery

What this study is about

Study to Evaluate the Efficacy of ASP1128 (MA-0217) in Subjects at Risk for Acute Kidney Injury (AKI) Following Coronary Artery Bypass Graft (CABG) and/or Valve Surgery

What this study is about