A Study to Explore the Renal Safety of Visipaque Injection 320 mgI/mL in Patients With Chronic Kidney Disease
Chronic Kidney Diseases
About this trial
This is an interventional other trial for Chronic Kidney Diseases focused on measuring 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)
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.
Sites / Locations
- University Hospital
- : Aventiv Research Inc.
- Central Arkansas Veteran's Healthcare System
- Alliance Research Centers
- Universal Axon Clinical Research, LLC
- Jacksonville Center for Clinical Research
- University of South Florida - South Tampa Campus
- University of Iowa Hospitals and Clinics
- Norton Hospital
- Boston University Medical Center/Boston Medical Center
- The Duluth Clinic, Ltd.
- Mount Sinai West
- University of North Carolina at Chapel Hill Clinical Translational Research Center
- Wake Forest Baptist Health
- Rhode Island Hospital
- UT Southwestern Medical Center
- University of Vermont Medical Center
- UZ Leuven
- CRCHUM- CHUM Research Center
- St. Boniface General Hospital
- Oddzial Chirurgii Naczyniowej i Ogolnej, Wojewodzki Szpital Specjalistyczny Nr 4 w Bytomiu
- Klinika Kardiochirurgii i Chirurgii Naczyniowej, Uniwersyteckie Centrum Kliniczne
- Klinika Chirurgii Naczyniowej i Angiologii, Samodzielny Publiczny Szpital Kliniczny nr 1
- Oddzial Chirurgii Ogolnej i Naczyn, Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego
- Hospital Clinic de Barcelona
- Hospital Universitario Puerta del Mar
- Hospital Universitario Son Espases
- St. George's Healthcare NHS Trust, St. George's Hospital
- Royal Stoke University Hospital, Radiology Department
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Visipaque™: Contrast-Enhanced Computed Tomography (CECT)
Saline: Non-Enhanced Computed Tomography (NECT)
Participants received 1 intravenous injection of Visipaque™ 320 mg I/ml injection (100 mL iodixanol) and underwent computed tomography (CT) examination.
Participants received 1 intravenous injection of saline placebo (matched to Visipaque™ 320 mg I/ml injection) and underwent computed tomography (CT) examination and supplemental non-contrast duplex ultrasonography imaging examination.