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

General Electric (GE)

Status and phase: Terminated; Phase 4

Conditions: Chronic Kidney Diseases

Treatments: Drug: Placebos; Drug: Visipaque

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03119662

2016-001668-13 (EudraCT Number)

GE-012-106

Details and patient eligibility

About

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.

Full description

GEHC has decided not to provide this detail

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4 participants in 2 patient groups, including a placebo group

Visipaque™: Contrast-Enhanced Computed Tomography (CECT)

Experimental group

Description:

Participants received 1 intravenous injection of Visipaque™ 320 mg I/ml injection (100 mL iodixanol) and underwent computed tomography (CT) examination.

Treatment:

Drug: Visipaque

Saline: Non-Enhanced Computed Tomography (NECT)

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebos