COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03119662
Recruitment Status : Terminated (The trial was discontinued due to a lower than anticipated recruitment rate. The decision has not been made due to any safety reasons.)
First Posted : April 18, 2017
Results First Posted : December 17, 2019
Last Update Posted : December 17, 2019
Sponsor:
Collaborator:
Syneos Health
Information provided by (Responsible Party):
GE Healthcare

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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Diseases Drug: Visipaque Drug: Placebos Phase 4

Detailed Description:
GEHC has decided not to provide this detail

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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)
Actual Study Start Date : February 8, 2018
Actual Primary Completion Date : September 13, 2018
Actual Study Completion Date : October 19, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
Drug Information available for: Iodixanol

Arm Intervention/treatment
Experimental: 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.
Drug: 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.

Placebo Comparator: 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.
Drug: Placebos
100 mL saline, followed by a 10 mL saline flush.




Primary Outcome Measures :
  1. Assessment of the Incidence of Acute Kidney Injury (AKI) Stage >=1 Per Acute Kidney Injury Network (AKIN) Serum Creatinine (SCr) Criteria [ Time Frame: 48 hours post-baseline (Follow-up 1) ]
    AKIN Serum Creatinine Criteria for AKI- Stage 1: a SCr increase of >=0.3 mg/dL (>=26.4 μmol/L) or increase to >=150% to 200% (>=1.5- to 2.0-fold) from baseline within 48 hours. Stage 2: a SCr increase to >200% to 300% (>2.0- to 3-fold) from baseline within 48 hours. Stage 3: a SCr increase to >300% (>3.0-fold) from baseline or SCr >=4.0 mg/dL (>=354 μmol/L) with an acute increase of >=0.5 mg/dL (>=44 μmol/L) within 48 hours.


Secondary Outcome Measures :
  1. Assessment of the Incidence of Acute Kidney Injury (AKI) Stage >=2 Per Acute Kidney Injury Network (AKIN) Serum Creatinine (SCr) Criteria [ Time Frame: 48 hours post-baseline (Follow-up 1) ]
    AKIN Serum Creatinine Criteria for AKI- Stage 1: a SCr increase of >=0.3 mg/dL (>=26.4 μmol/L) or increase to >=150% to 200% (>=1.5- to 2.0-fold) from baseline within 48 hours. Stage 2: a SCr increase to >200% to 300% (>2.0- to 3-fold) from baseline within 48 hours. Stage 3: a SCr increase to >300% (>3.0-fold) from baseline or SCr >=4.0 mg/dL (>=354 μmol/L) with an acute increase of >=0.5 mg/dL (>=44 μmol/L) within 48 hours.

  2. Assessment of the Incidence of Acute Kidney Injury (AKI) by Contrast Induced Nephropathy (CIN) [ Time Frame: 48 hours post-baseline (Follow-up 1) ]
    Standard definition of CIN: Increase in SCr of 0.5 mg/dL or more in the 24 to 72 hours after the CT scan.

  3. Assessment of the Incidence of Acute Kidney Injury (AKI) Stage >=2 By Waikar Criteria [ Time Frame: 48 hours post-baseline (Follow-up 1) ]
    Waikar's definitions of AKI: Stage 1: 0.3 mg/dL increase in SCr over 24 hours or a 0.5 mg/dL increase in SCr over 48 hours. Stage 2: 0.5 mg/dL increase in SCr over 24 hours or a 1.0 mg/dL increase in SCr over 48 hours. Stage 3: 1.0 mg/dL increase in SCr over 24 hours or a 1.5 mg/dL increase in SCr over 48 hours.

  4. All Cause Mortality and Morbidity [ Time Frame: From Baseline to Month 6 ]
    Mortality (all cause death) and morbidity i.e. critical events.

  5. Blinded Independent Assessment of Image Quality/Diagnostic Confidence Using a 5-Point Scale [ Time Frame: Month 6 ]
    Blinded independent assessment of image quality/diagnostic confidence using a 5-point scale. Image quality/diagnostic confidence for all imaging studies was rated on a 5-point scale from 1 (poor) to 5 (excellent).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03119662


Locations
Show Show 29 study locations
Sponsors and Collaborators
GE Healthcare
Syneos Health
  Study Documents (Full-Text)

Documents provided by GE Healthcare:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT03119662    
Other Study ID Numbers: GE-012-106
2016-001668-13 ( EudraCT Number )
First Posted: April 18, 2017    Key Record Dates
Results First Posted: December 17, 2019
Last Update Posted: December 17, 2019
Last Verified: November 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GE Healthcare:
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)
Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency