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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
Last Update Posted : October 9, 2018
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

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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 13, 2018
Actual Primary Completion Date : September 13, 2018
Actual Study Completion Date : September 13, 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
100 mL iodixanol (Visipaque Injection 320 mg I/mL)
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: Placebo
Placebo (100 mL saline)
Drug: Placebos
100 mL saline, followed by a 10 mL saline flush.




Primary Outcome Measures :
  1. Incidence of AKI stage ≥1 (AKIN SCr criteria) [ Time Frame: Approximately 48 hours ]
    Incidence of AKI stage ≥1 (AKIN SCr criteria) following an i.v. injection of iodinated iso- osmolar contrast material iodixanol (Visipaque Injection 320 mgI/mL) or saline.


Secondary Outcome Measures :
  1. Incidence of AKI stage ≥2 (by AKIN SCr criteria) [ Time Frame: Approximately 48 hours ]

    Incidence of AKI stage ≥2 (by AKIN SCr criteria) following an i.v. injection of iodinated iso-

    osmolar contrast material iodixanol (Visipaque Injection 320 mgI/mL) or saline.


  2. Incidence of AKI (by standard definition of CIN [Mehran and Nikolsky 2006]) [ Time Frame: Approximately 48 hours ]
    Incidence of AKI (by standard definition of CIN [Mehran and Nikolsky 2006]) following an i.v. injection of iodinated iso-osmolar contrast material iodixanol (Visipaque Injection 320 mgI/mL) or saline.

  3. Incidence of AKI stage ≥2 (by Waikar criteria [Waikar and Bonventre 2009]) [ Time Frame: Approximately 48 hours ]
    Incidence of AKI stage ≥2 (by Waikar criteria [Waikar and Bonventre 2009]) following i.v. administration of iodinated iso-osmolar contrast material iodixanol (Visipaque Injection 320 mgI/mL) or saline.

  4. Mortality [ Time Frame: 6 months ]
    All-cause death.

  5. Blinded independent assessment of image quality/diagnostic confidence using a 5-point scale. [ Time Frame: < 1 hour ]
    Blinded independent assessment of image quality/diagnostic confidence using a 5-point scale.

  6. Morbidity [ Time Frame: 6 months ]
    Incidence rate of hospitalization due to renal failure.

  7. Morbidity [ Time Frame: 6 months ]
    Incidence rate of requirement for renal replacement therapy.

  8. Morbidity [ Time Frame: 6 months ]
    Incidence of the composite of death and hospitalization events due to renal failure.

  9. Morbidity [ Time Frame: 6 months ]
    Hospital length of stay in days.

  10. Morbidity [ Time Frame: Approximately 48 hours ]
    Incidence rate of patients with ≥30% reduction in estimated glomerular filtration rate.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Is ≥18 years of age at the time that written informed consent is obtained.
  • Is 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.

-Is an outpatient who has undergone successful EVAR and is scheduled for his/her next post- procedural imaging follow-up examination.

  • Has previously completed one or more of his or her post-EVAR surveillance imaging examination(s) that provided evidence on stable post-EVAR status.
  • Has a documented diagnosis of stage III or IV CKD and stable renal function.
  • Is able to provide written informed consent.
  • Is able and willing to comply with all study procedures as described in the protocol.

Exclusion Criteria:

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


  Show 29 Study Locations
Sponsors and Collaborators
GE Healthcare
Syneos Health

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Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT03119662     History of Changes
Other Study ID Numbers: GE-012-106
2016-001668-13 ( EudraCT Number )
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018

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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:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency