A Study to Explore the Renal Safety of Visipaque Injection 320 mgI/mL in Patients With Chronic Kidney Disease
NCT ID: NCT03119662
Last Updated: 2019-12-17
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
4 participants
INTERVENTIONAL
2018-02-08
2018-10-19
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Visipaque™: Contrast-Enhanced Computed Tomography (CECT)
Participants received 1 intravenous injection of Visipaque™ 320 mg I/ml injection (100 mL iodixanol) and underwent computed tomography (CT) examination.
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.
Saline: Non-Enhanced Computed Tomography (NECT)
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.
Placebos
100 mL saline, followed by a 10 mL saline flush.
Interventions
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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.
Placebos
100 mL saline, followed by a 10 mL saline flush.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Syneos Health
OTHER
GE Healthcare
INDUSTRY
Responsible Party
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Locations
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University Hospital
Birmingham, Alabama, United States
: Aventiv Research Inc.
Mesa, Arizona, United States
Central Arkansas Veteran's Healthcare System
Little Rock, Arkansas, United States
Alliance Research Centers
Laguna Hills, California, United States
Universal Axon Clinical Research, LLC
Doral, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
University of South Florida - South Tampa Campus
Tampa, Florida, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Norton Hospital
Louisville, Kentucky, United States
Boston University Medical Center/Boston Medical Center
Boston, Massachusetts, United States
The Duluth Clinic, Ltd.
Duluth, Minnesota, United States
Mount Sinai West
New York, New York, United States
University of North Carolina at Chapel Hill Clinical Translational Research Center
Chapel Hill, North Carolina, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States
Rhode Island Hospital
Providence, Rhode Island, United States
UT Southwestern Medical Center
Dallas, Texas, United States
University of Vermont Medical Center
Burlington, Vermont, United States
UZ Leuven
Leuven, , Belgium
CRCHUM- CHUM Research Center
Montreal, , Canada
St. Boniface General Hospital
Winnipeg, , Canada
Oddzial Chirurgii Naczyniowej i Ogolnej, Wojewodzki Szpital Specjalistyczny Nr 4 w Bytomiu
Bytom, , Poland
Klinika Kardiochirurgii i Chirurgii Naczyniowej, Uniwersyteckie Centrum Kliniczne
Gdansk, , Poland
Klinika Chirurgii Naczyniowej i Angiologii, Samodzielny Publiczny Szpital Kliniczny nr 1
Lublin, , Poland
Oddzial Chirurgii Ogolnej i Naczyn, Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego
Poznan, , Poland
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital Universitario Puerta del Mar
Cadiz, , Spain
Hospital Universitario Son Espases
Palma, , Spain
St. George's Healthcare NHS Trust, St. George's Hospital
London, , United Kingdom
Royal Stoke University Hospital, Radiology Department
Stoke-on-Trent, , United Kingdom
Countries
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References
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Solomon R. PRESERVE: The End or the Beginning of a New Era in Prevention of Contrast-Associated Acute Kidney Injury? Am J Kidney Dis. 2018 Sep;72(3):322-324. doi: 10.1053/j.ajkd.2018.03.013. Epub 2018 May 8. No abstract available.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2016-001668-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GE-012-106
Identifier Type: -
Identifier Source: org_study_id