Last updated on September 2020

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


Brief description of study

The purpose of this study is to evaluate the efficacy of postsurgery treatment with ASP1128 in subjects at risk for acute kidney injury (AKI) following CABG and/or valve surgery.

This study will also investigate 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.

Detailed Study Description

The study will comprise 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 (acute kidney injury) at 2-6 hours post-surgery.

Subjects with low risk of AKI at 2-6 hour post-surgery assessment will be enrolled in the observational cohort to evaluate subject characteristics and biomarkers for exploratory objectives.

Clinical Study Identifier: NCT03941483

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Inova Heart and Vascular Institute

Falls Church, VA United States
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Keck School of Medicine USC

Los Angeles, CA United States
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Springfield, IL United States
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Springfield, IL United States
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Fort Wayne, IN United States
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Minneapolis, MN United States
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Recruitment Status: Open


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