A Study to Explore the Renal Safety of Visipaque Injection 320 mgI/mL in Patients With Chronic Kidney Disease
Condition: Chronic Kidney Diseases
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Intervention: Visipaque; Placebos
Intervention description: 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.; 100 mL saline, followed by a 10 mL saline flush.
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Acute kidney injury (AKI); Acute kidney injury network (AKIN); Chronic kidney disease (CKD); Contrast-enhanced computed tomography (CECT); Endovascular Aneurysm Repair (EVAR); Iodixanol; Non-enhanced computed tomography (NECT); Serum creatinine (SCr)

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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.

        Exclusion Criteria:

          -  Was pregnant, lactating, is possibly pregnant, or is actively trying to conceive
             during the study period.

          -  Was a patient for whom an endoleak or other clinically meaningful EVAR-related
             complication (as judged by the investigator) has already been discovered.

          -  Was undergoing surveillance following a Thoracic Endovascular Repair (TEVAR).

          -  Had a known or suspected history of immediate or delayed hypersensitivity to iodine or
             any iodinated contrast medium.

          -  Was 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.

          -  Had been exposed to any intravascular iodinated contrast medium in the 7 days prior to
             the Baseline Visit.

          -  Had congestive heart failure (New York Heart Association [NYHA] Class IV) or hepatic
             failure/liver cirrhosis.

          -  Had Stage V CKD.

          -  Had a pre-existing requirement for renal dialysis.

          -  Had undergone percutaneous transluminal renal angioplasty (PTRA) within 12 months
             before the index EVAR procedure or is scheduled to undergo PTRA during the study
             period.

          -  Had 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.

          -  Had 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.

          -  Had been previously enrolled in this study.

          -  Was using i.v. vasopressor or inotropic medications.

          -  Had 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).

          -  Had been hospitalized within 30 days prior to Screening Visit for any reason other
             than practical purposes for management of tests or diagnostic assessments.