At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 351 enrolled
Drug / intervention
ASP1128 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating ASP1128 and Placebo for Acute Kidney Injury (AKI). Completed, enrolled 351 participants across 27 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Kidney Injury (AKI)
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
First PostedMay 2019
Enrollment StartNov 2019
Primary CompletionJul 2021
Study CompletionOct 2021
TodayJul 2026
First PostedMay 8, 2019
Enrollment StartNov 1, 2019
Primary CompletionJul 26, 2021
Study CompletionOct 20, 2021
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 7.1 years ago
Interventions
ASP1128drug
Intravenous Infusion
Placebodrug
Intravenous Infusion