Trials / Terminated
TerminatedNCT03119662
A Study to Explore the Renal Safety of Visipaque Injection 320 mgI/mL in Patients With Chronic Kidney Disease
Parallel-Group, Placebo-Controlled Randomized Study Investigating the Effect of Intravenous Iso-osmolar Iodinated Contrast Material Iodixanol (Visipaque™ Injection 320 mgI/mL) on Renal Function in Adults With Chronic Kidney Disease (CKD) Stage III or Stage IV Who Have Undergone Endovascular Aneurysm Repair (EVAR)
- Status
- Terminated
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 4 (actual)
- Sponsor
- GE Healthcare · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
GEHC has decided not to provide this detail
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Visipaque | 100 mL iodixanol (Visipaque Injection 320 mg I/mL), followed by a 10 mL saline flush to ensure delivery of the full dose of Visipaque. |
| DRUG | Placebos | 100 mL saline, followed by a 10 mL saline flush. |
Timeline
- Start date
- 2018-02-08
- Primary completion
- 2018-09-13
- Completion
- 2018-10-19
- First posted
- 2017-04-18
- Last updated
- 2019-12-17
- Results posted
- 2019-12-17
Locations
29 sites across 6 countries: United States, Belgium, Canada, Poland, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03119662. Inclusion in this directory is not an endorsement.