NCT03941483

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

A Phase 2 Proof of Concept, Double-blind, Randomized, Placebo-controlled 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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 351 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 35 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Acute Kidney Injury (AKI)

Interventions

Type	Name	Description
DRUG	ASP1128	Intravenous Infusion
DRUG	Placebo	Intravenous Infusion

Timeline

• Start date: 2019-11-01
• Primary completion: 2021-07-26
• Completion: 2021-10-20
• First posted: 2019-05-08
• Last updated: 2024-12-04
• Results posted: 2022-10-04

Locations

27 sites across 1 country: United States

Regulatory

• FDA-regulated drug study