Status: No Longer Actively Enrolling
Do you have chronic kidney disease?
If you have chronic kidney disease, this study may be an option for you.
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.
Candidates for Chronic Kidney Disease Study
You may qualify for this study if you:
- Was ≥18 years of age at the time that written informed consent is obtained.
- Was male or is a nonpregnant, nonlactating female who is either surgically sterile or is postmenopausal. Women of childbearing potential must use adequate contraception from Screening until 30 days after the Baseline Visit and must have a negative pregnancy test at the Baseline Visit.
- Was an outpatient who has undergone successful EVAR and is scheduled for his/her next post-procedural imaging follow-up examination.
- Had previously completed one or more of his or her post-EVAR surveillance imaging examination(s) that provided evidence on stable post-EVAR status.
- Had a documented diagnosis of stage III or IV CKD and stable renal function.
- Was able to provide written informed consent.
- Was able and willing to comply with all study procedures as described in the protocol.
Study Length & Information: 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.
Principal Investigator: Jeffrey M. Slaiby, MD, FACS, RPVI
Research Nurse Contact: Melanie Salerno (401) 228-0646 or melanie.salerno@brownphysicians.org