A Study to Explore the Renal Safety of Visipaque Injection 320 mgI/mL in Patients With Chronic Kidney Disease

ID#: NCT03119662

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 4

Recruitment Status: Recruiting

Start Date: April 01, 2018

End Date: August 01, 2020

Contact Information:
Thomas M. Koperniak, Ph.D.
(774) 843-3908
Aleksandar Sarac
+44 (0) 1494 546 138
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.

Inclusion Criteria:

- Is ≥18 years of age at the time that written informed consent is obtained.

- Is 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. -Is an outpatient who has undergone successful EVAR and is scheduled for his/her next post- procedural imaging follow-up examination.

- Has previously completed one or more of his or her post-EVAR surveillance imaging examination(s) that provided evidence on stable post-EVAR status.

- Has a documented diagnosis of stage III or IV CKD and stable renal function.

- Is able to provide written informed consent.

- Is able and willing to comply with all study procedures as described in the protocol.

Exclusion Criteria:

- Is pregnant, lactating, is possibly pregnant, or is actively trying to conceive during the study period.

- Is a patient for whom an endoleak or other clinically meaningful EVAR-related complication (as judged by the investigator) has already been discovered.

- Is undergoing surveillance following a Thoracic Endovascular Repair (TEVAR).

- Has a known or suspected history of immediate or delayed hypersensitivity to iodine or any iodinated contrast medium.

- Is using metformin (e.g., Glucophage®) that cannot be discontinued for the period of 24 hours prior to the Baseline Visit and for at least 48 hours after the imaging procedure.

- Has been exposed to any intravascular iodinated contrast medium in the 7 days prior to the Baseline Visit.

- Has congestive heart failure (New York Heart Association [NYHA] Class IV) or hepatic failure/liver cirrhosis.

- Has Stage V CKD.

- Has a pre-existing requirement for renal dialysis.

- Has undergone percutaneous transluminal renal angioplasty (PTRA) within 12 months before the index EVAR procedure or is scheduled to undergo PTRA during the study period.

- Has any clinically active, serious, life-threatening disease, medical, or significant psychiatric condition; has a life expectancy of less than 6 months; or is, in the Investigator's opinion, unsuitable for participation in the study for any reason.

- Has been enrolled in another clinical study within the 30 days prior to the Screening Visit or is planned to enroll in another clinical study within the duration of this study.

- Has been previously enrolled in this study.

- Is using i.v. vasopressor or inotropic medications.

- Has used nonsteroidal anti-inflammatory drugs (NSAIDs) or any nephrotoxic medication within 48 hours of the Baseline Visit or will do so within 72 hours after the CT procedure-with the exception of acetylsalicylic acid (Aspirin) at a dose of ≤100 mg daily (QD).

- Has been hospitalized within 30 days prior to Screening Visit for any reason other than practical purposes for management of tests or diagnostic assessments.