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

Completed · Phase 2 · Has a placebo group

Conditions studied: Acute Kidney Injury (AKI)

In brief

The purpose of this study was to evaluate the efficacy of postsurgery treatment with ASP1128 in subjects at risk for AKI following CABG and/or valve surgery. This study also investigated the safety and tolerability of postsurgery treatment with ASP1128, and pharmacokinetic characteristics of ASP1128 in subjects at risk for AKI following CABG and/or valve surgery.

Key facts

Study ID

NCT03941483

Run by

Astellas Pharma Inc

People needed

351

Starts

2019-11-01

Expected to finish

2021-10-20

Last updated by the study team

2024-12-04

Who can join

Age: 35 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• At Screening:
• Subject has received investigational drug within 30 days or 5 half-lives, whichever is longer, prior to screening.
• Subject has received RRT within 30 days prior to screening.
• Subject has CKD stage 4 or 5, or stage 3 (i.e., eGFR 30-59 mL/min per 1.73m\^2) with a known history of eGFR < 30 mL/min per 1.73 m\^2 as per CKD-EPI or MDRD equation within 6 months prior to screening.
• Subject has a prior kidney transplantation.
• Subject has a known or suspected glomerulonephritis (other than Diabetic Kidney Disease).
• Subject has confirmed or treated endocarditis or other current active infection requiring antibiotic treatment within 30 days prior to screening.
• Subject is using prohibited.
• Subject has a prior history of intravenous drug abuse within 1 year prior to screening.
• Subject has a known chronic liver disorder with Child-Pugh B or C classification.
• Subject has any of the following abnormal liver or kidney function parameters:
• Alanine aminotransferase (ALT), aspartate aminotransferase (AST) > 2 times the upper limit of normal (ULN) or bilirubin increased to > 1.5 times the ULN.
• eGFR < 30 mL/min per 1.73 m\^2 as per CKD-EPI equation.
• Subject has use of left ventricular assist device, intra-aortic balloon pump or other cardiac devices, or catecholamines within 7 days prior to screening.
• Subject has surgery scheduled to be performed without CPB (i.e., "Off-Pump" surgery).
• Subject has surgery scheduled to be performed under conditions of circulatory arrest, including planned deep hypothermic circulatory arrest.
• Subject has surgery scheduled for aortic dissection.
• Subject has surgery for a condition that is immediately life-threatening.
• Subject has surgery scheduled to correct major congenital heart defect.
• Subject has current or previous malignant disease. Subjects with a history of cancer are considered eligible if the subject has undergone therapy and the subject has been considered disease free or progression free for at least 5 years. Subject with completely excised basal cell carcinoma or squamous cell carcinoma of the skin and completely excised cervical cancer in situ are also considered eligible.
• Preoperatively on the Day of Surgery:
• Exclusion criteria 1 to 17 are applicable at this time.
• Subject has AKI (any stage) present at presurgery baseline.
• Subject has known or suspected infection/sepsis at time of presurgery baseline.
• Perioperative Exclusion Criteria:

Where it is running

• Heart Center Research, LLC — Huntsville, Alabama, United States
• Sarver Heart Center — Tucson, Arizona, United States
• Morton Plant Hospital — Clearwater, Florida, United States
• Health Park Medical Center — Fort Myers, Florida, United States
• Shands Hospital — Gainesville, Florida, United States
• Florida Hospital Pepin Heart Institute — Tampa, Florida, United States
• Southern Illinois University — Springfield, Illinois, United States
• Luthern Medical Group — Fort Wayne, Indiana, United States
• IU Health - Methodist — Indianapolis, Indiana, United States
• St. Vincent Heart Center — Indianapolis, Indiana, United States
• Indiana University Health Ball Memorial Hospital — Muncie, Indiana, United States
• MercyOne Iowa Heart Center — Des Moines, Iowa, United States
• Delmarva Heart, LLC — Salisbury, Maryland, United States
• Ascension Genesys Hospital — Grand Blanc, Michigan, United States
• Mid Michigan Medical Center — Midland, Michigan, United States
• Minneapolis Heart Institute — Minneapolis, Minnesota, United States
• Baptist Medical Center — Jackson, Mississippi, United States
• St. Luke's Hospital of Kansas City — Kansas City, Missouri, United States
• Lourdes Cardiology Services — Voorhees Township, New Jersey, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Moses H. Cone Memorial Hospital — Greensboro, North Carolina, United States
• Fairview Hospital - Cleveland Clinic — Cleveland, Ohio, United States
• ProMedica Toledo Hospital — Toledo, Ohio, United States
• Vanderbilt University — Nashville, Tennessee, United States
• Baylor Scott & White Heart Hospital — Plano, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.