Clinical trial NCT03119662: A Study to Explore the Renal Safety of Visipaque Injection 320 mgI/mL in Patients With Chronic Kidney Disease
Official title: Parallel-Group, Placebo-Controlled Randomized Study Investigating the Effect of Intravenous Iso-osmolar Iodinated Contrast Material Iodixanol (Visipaque™ Injection 320 mgI/mL) on Renal Function in Adults With Chronic Kidney Disease (CKD) Stage III or Stage IV Who Have Undergone Endovascular Aneurysm Repair (EVAR)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Chronic Kidney Diseases
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)
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
Collaborators: name: Syneos Health
First posted: 2017-04-18
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed description: GEHC has decided not to provide this detail

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.

Primary outcomes:
measure: Assessment of the Incidence of Acute Kidney Injury (AKI) Stage >=1 Per Acute Kidney Injury Network (AKIN) Serum Creatinine (SCr) Criteria
timeFrame: 48 hours post-baseline (Follow-up 1)
Secondary outcomes:
measure: Assessment of the Incidence of Acute Kidney Injury (AKI) Stage >=2 Per Acute Kidney Injury Network (AKIN) Serum Creatinine (SCr) Criteria
timeFrame: 48 hours post-baseline (Follow-up 1)
measure: Assessment of the Incidence of Acute Kidney Injury (AKI) by Contrast Induced Nephropathy (CIN)
timeFrame: 48 hours post-baseline (Follow-up 1)
measure: Assessment of the Incidence of Acute Kidney Injury (AKI) Stage >=2 By Waikar Criteria
timeFrame: 48 hours post-baseline (Follow-up 1)
measure: All Cause Mortality and Morbidity
timeFrame: From Baseline to Month 6
measure: Blinded Independent Assessment of Image Quality/Diagnostic Confidence Using a 5-Point Scale
timeFrame: Month 6
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University Hospital
state: Alabama
city: Mesa
country: United States
facility: : Aventiv Research Inc.
state: Arizona
city: Little Rock
country: United States
facility: Central Arkansas Veteran's Healthcare System
state: Arkansas
city: Laguna Hills
country: United States
facility: Alliance Research Centers
state: California
city: Doral
country: United States
facility: Universal Axon Clinical Research, LLC
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Tampa
country: United States
facility: University of South Florida - South Tampa Campus
state: Florida
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Louisville
country: United States
facility: Norton Hospital
state: Kentucky
city: Boston
country: United States
facility: Boston University Medical Center/Boston Medical Center
state: Massachusetts
city: Duluth
country: United States
facility: The Duluth Clinic, Ltd.
state: Minnesota
city: New York
country: United States
facility: Mount Sinai West
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill Clinical Translational Research Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Burlington
country: United States
facility: University of Vermont Medical Center
state: Vermont
city: Leuven
country: Belgium
facility: UZ Leuven
city: Montreal
country: Canada
facility: CRCHUM- CHUM Research Center
city: Winnipeg
country: Canada
facility: St. Boniface General Hospital
city: Bytom
country: Poland
facility: Oddzial Chirurgii Naczyniowej i Ogolnej, Wojewodzki Szpital Specjalistyczny Nr 4 w Bytomiu
city: Gdansk
country: Poland
facility: Klinika Kardiochirurgii i Chirurgii Naczyniowej, Uniwersyteckie Centrum Kliniczne
city: Lublin
country: Poland
facility: Klinika Chirurgii Naczyniowej i Angiologii, Samodzielny Publiczny Szpital Kliniczny nr 1
city: Poznan
country: Poland
facility: Oddzial Chirurgii Ogolnej i Naczyn, Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Cadiz
country: Spain
facility: Hospital Universitario Puerta del Mar
city: Palma
country: Spain
facility: Hospital Universitario Son Espases
city: London
country: United Kingdom
facility: St. George's Healthcare NHS Trust, St. George's Hospital
city: Stoke on Trent
country: United Kingdom
facility: Royal Stoke University Hospital, Radiology Department
Study officials:
References:
citation: 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.