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.
The study comprised of a screening visit, followed by CABG and/or valve surgery on Day 1, double-blind treatment period and a follow-up period up to Day 90 in subjects with moderate/severe risk of AKI at 2-22 hours post-surgery. Subjects with low risk of AKI at 2-22 hours post-surgery assessment were enrolled in the observational cohort to evaluate subject characteristics and biomarkers for exploratory objectives.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
351
Percentage of Participants Developing AKI Based on Serum Creatinine (SCr) Criteria Within 72 Hrs From End of Surgery (AKI-SCr72h)
Development of AKI was based on SCr criteria from the kidney disease improving global outcomes (KDIGO) guideline (i.e., increase in SCr ≥ 0.3 milligram per deciliter (mg/dL) \[≥ 26.5 micromoles per liter {μmol/L}\] within any 48 hours or increase in SCr to ≥ 1.5 times baseline within 72 hours after end of surgery \[T0\]). Percentage of participants who developed AKI-SCr72h were reported.
Time frame: From end of surgery up to 72 hrs
Percentage of Participants Developing AKI Based on Serum Creatinine (SCr) Criteria Within 7 Days From End of Surgery (AKI-SCr7d)
Development of AKI was based on SCr criteria from the KDIGO guideline (i.e., increase in SCr ≥ 0.3 mg/dL \[≥ 26.5 μmol/L\] within any 48 hours or increase in SCr to ≥ 1.5 times baseline within 7 days after T0). Percentage of participants who developed AKI-SCr7d were reported.
Time frame: From end of surgery up to 7 days
Percentage of Participants Developing AKI Based on All Captured Criteria Within 72 Hrs From End of Surgery (AKI-KDIGO72h)
Development of AKI was based on all captured criteria from KDIGO guideline (i.e., AKI-SCr stage 1 to 3: increase in SCr ≥ 0.3 mg/dL \[≥ 26.5 μmol/L\] within any 48 hours, increase in SCr to ≥ 1.5 times baseline, and/or AKI-urinary output (UO) stage 2 and 3: urine volume \< 0.5 mL/kg per hour for 12 consecutive hours) within 72 hours after T0. Percentage of participants who developed AKI-KDIGO72h were reported.
Time frame: From end of surgery up to 72 hrs
Percentage of Participants Developing AKI Based on All Captured Criteria Within 7 Days From End of Surgery (AKI-KDIGO7d)
Development of AKI was based on all captured criteria from KDIGO guideline (i.e., AKI-SCr stage 1 to 3: increase in SCr ≥ 0.3 mg/dL \[≥ 26.5 μmol/L\] within any 48 hours, increase in SCr to ≥ 1.5 times baseline, and/or AKI-urinary output (UO) stage 2 and 3: urine volume \< 0.5 milliliter per kilogram (mL/kg) per hour for 12 consecutive hours) within 7 days after T0. Percentage of participants who developed AKI-KDIGO7d were reported.
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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
...and 17 more locations
Time frame: From end of surgery up to 7 days
Percentage of Participants With Major Adverse Kidney Events (MAKE) Within 30 Days After Day of Surgery (MAKE30)
MAKE30 was defined as all-cause mortality, renal replacement therapy (RRT) and/or ≥ 25% sustained reduction in estimated glomerular filtration rate (eGFR) based on SCr within 30 days after day of surgery. Percentage of participants with MAKE30 were reported.
Time frame: From day of surgery up to 30 days
Percentage of Participants With MAKE Within 90 Days After Day of Surgery (MAKE90)
MAKE90 was defined as all-cause mortality, renal replacement therapy (RRT) and/or ≥ 25% sustained reduction in estimated glomerular filtration rate (eGFR) based on SCr within 90 days after day of surgery. Percentage of participants with MAKE90 were reported.
Time frame: From day of surgery up to 90 days