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NCT03941483 · ClinicalTrials.gov registry record · Phase 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

A Phase 2 study of Acute Kidney Injury (AKI), sponsored by Astellas Pharma.

Completed
Registry status
Phase 2
Development phase
351
Enrollment target
20
Study locations

NCT03941483 is a Phase 2 study of Acute Kidney Injury (AKI) that has completed, run by Astellas Pharma. The registered enrollment target is 351 participants, below the 4,550-participant average among 4 other Acute Kidney Injury (AKI) trials with a reported enrollment target (92% lower). The trial reports 20 study locations across 13 states.

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The verdict

NCT03941483, a Phase 2 study of Acute Kidney Injury (AKI), has completed, sponsored by Astellas Pharma.

COMPLETED
Registry status
Phase 2
Development phase
351 participants
Enrollment target
20
Study locations

Study 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.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG ASP1128

Study Locations (20)

Florida

  • Morton Plant Hospital - Clearwater
  • Health Park Medical Center - Fort Myers
  • Shands Hospital - Gainesville
  • Florida Hospital Pepin Heart Institute - Tampa

Indiana

  • Luthern Medical Group - Fort Wayne
  • IU Health - Methodist - Indianapolis
  • St. Vincent Heart Center - Indianapolis
  • Indiana University Health Ball Memorial Hospital - Muncie

Michigan

  • Ascension Genesys Hospital - Grand Blanc
  • Mid Michigan Medical Center - Midland

Alabama

  • Heart Center Research, LLC - Huntsville

Arizona

  • Sarver Heart Center - Tucson

Illinois

  • Southern Illinois University - Springfield

Iowa

  • MercyOne Iowa Heart Center - Des Moines

Maryland

  • Delmarva Heart, LLC - Salisbury

Trial Details

FieldValue
Enrollment Target 351 participants
Start Date 2019-11-01
Est. Completion 2021-10-20
Phase Phase 2

Sponsor

Astellas Pharma

165 total trials

What the Registry Record Tells You About NCT03941483

The ClinicalTrials.gov registry entry for NCT03941483 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 351 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,550-participant average among 4 other Acute Kidney Injury (AKI) trials with a reported enrollment target (92% lower). The listed sponsor is Astellas Pharma, which has 165 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Acute Kidney Injury (AKI) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT03941483 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Florida, Indiana, Michigan.

Frequently Asked Questions

What is clinical trial NCT03941483 about?

NCT03941483 is a clinical study titled "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". 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 ASP112...

What is the current status of trial NCT03941483?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 351 participants. The study started on 2019-11-01. Estimated completion is 2021-10-20.

What conditions does trial NCT03941483 study?

This clinical trial studies the following conditions: Acute Kidney Injury (AKI).

What interventions are being tested in trial NCT03941483?

The interventions under investigation include: Placebo (DRUG), ASP1128 (DRUG).

Who is sponsoring clinical trial NCT03941483?

This trial is sponsored by Astellas Pharma, which has 165 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03941483 being conducted?

This trial has 20 study locations across Alabama, Arizona, Florida, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.