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NCT03119662 · ClinicalTrials.gov registry record · Phase 4
A Study to Explore the Renal Safety of Visipaque Injection 320 mgI/mL in Patients With Chronic Kidney Disease
A Phase 4 study, sponsored by GE Healthcare.
- Terminated
- Registry status
- Phase 4
- Development phase
- 4
- Enrollment target
NCT03119662: Clinical Trial Phase 4 study, sponsored by GE Healthcare.
NCT03119662 is a Phase 4 study that was terminated before completion, run by GE Healthcare. The registered enrollment target is 4 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03119662, a Phase 4 study, was terminated before completion, sponsored by GE Healthcare.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 4 participants
- Enrollment target
Study Summary
This parallel-group, randomized, placebo-controlled study will examine the incidence and severity of acute kidney injury (AKI) in patients with chronic kidney disease (CKD) stage III/IV following an i.v. injection of iso-osmolar iodinated contrast material iodixanol (Visipaque™ Injection 320 mgI/mL), as compared with patients who received saline and underwent a non-enhanced CT (NECT) and duplex ultrasound (US) during their scheduled post-EVAR surveillance imaging.
Primary Outcome
AKIN Serum Creatinine Criteria for AKI- Stage 1: a SCr increase of \>=0.3 mg/dL (\>=26.4 μmol/L) or increase to \>=150% to 200% (\>=1.5- to 2.0-fold) from baseline within 48 hours. Stage 2: a SCr increase to \>200% to 300% (\>2.0- to 3-fold) from baseline within 48 hours. Stage 3: a SCr increase to \>300% (\>3.0-fold) from baseline or SCr \>=4.0 mg/dL (\>=354 μmol/L) with an acute increase of \>=0.5 mg/dL (\>=44 μmol/L) within 48 hours.
Interventions
- DRUG Placebos
- DRUG Visipaque
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2018-02-08 |
| Est. Completion | 2018-10-19 |
| Phase | Phase 4 |
Why NCT03119662 stopped before completion
NCT03119662 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebos is the first listed.
NCT03119662 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03119662 about?
NCT03119662 is a clinical study titled "A Study to Explore the Renal Safety of Visipaque Injection 320 mgI/mL in Patients With Chronic Kidney Disease". This parallel-group, randomized, placebo-controlled study will examine the incidence and severity of acute kidney injury (AKI) in patients with chronic kidney disease (CKD) stage III/IV following an i.v. injection of iso-osmolar iodinated contrast material iodixanol (Visipaque™ Injection 320 mgI/mL)...
What is the current status of trial NCT03119662?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 4 participants. The study started on 2018-02-08. Estimated completion is 2018-10-19.
What interventions are being tested in trial NCT03119662?
The interventions under investigation include: Placebos (DRUG), Visipaque (DRUG).
Who is sponsoring clinical trial NCT03119662?
This trial is sponsored by GE Healthcare, which has 99 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03119662's enrollment target sits among peer trials
4 1994th of 2000 higher than 6 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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