Study to Evaluate the Efficacy of ASP1128 (MA-0217) in Subjects at Risk for Acute Kidney Injury (… (NCT03941483) | Clinical Trial Compass
CompletedPhase 2
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
United States351 participantsStarted 2019-11-01
Plain-language summary
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.
Who can participate
Age range35 Years
SexALL
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Inclusion Criteria:
* 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…
What they're measuring
1
Percentage of Participants Developing AKI Based on Serum Creatinine (SCr) Criteria Within 72 Hrs From End of Surgery (AKI-SCr72h)