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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: Completed Phase 2 study of Acute Kidney Injury (AKI), sponsored by Astellas Pharma.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Development of AKI was based on SCr criteria from the kidney disease improving global outcomes (KDIGO) guideline (i.e., increase in SCr ≥ 0.3 milligram per deciliter (mg/dL) \[≥ 26.5 micromoles per liter {μmol/L}\] within any 48 hours or increase in SCr to ≥ 1.5 times baseline within 72 hours after end of surgery \[T0\]). Percentage of participants who developed AKI-SCr72h were reported.
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
| Field | Value |
|---|---|
| Enrollment Target | 351 participants |
| Start Date | 2019-11-01 |
| Est. Completion | 2021-10-20 |
| Phase | Phase 2 |
What the finished NCT03941483 record still lists
NCT03941483 is an interventional study that assigns participants to a tested intervention. The registered 351 participants enrollment target is mid-sized for trials with a published cap, below the 4,550-participant average among 4 other Acute Kidney Injury (AKI) trials with a reported enrollment target (92% lower).
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 names 20 study sites across 13 states, led by 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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