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

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.

Timeline

Start

2019-11-01

Primary completion

2021-07-26

Completion

2021-10-20

Outcome

Missed primary endpoint

registry NUMBER ASP1128: 24.6 percentage of participants NUMBER Placebo: 21.0 percentage of participants NCT03941483 ↗

registry analysis (superiority test); ASP1128 vs Placebo; p = 0.595; Risk Ratio (RR) 1.174 (90% CI 0.715 to 1.927); Chi-squared NCT03941483 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ASP1128	Unknown	—	Intravenous

Indications