A study to explore the renal safety of Visipaque Injection 320 mgI/mL in patients with chronic kidney disease.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1164

Inclusion Criteria

(1)Is =18 years of age at the time that written informed consent is obtained.
(2)Is male or is a nonpregnant, nonlactating female who is either surgically sterile (has a documented bilateral tubal ligation or oophorectomy and/or documented hysterectomy) or is postmenopausal (cessation of menses for more than 1 year). Women of childbearing potential must use adequate contraception from Screening until 30 days after the Baseline Visit and must have a negative result for a urine human chorionic gonadotropin pregnancy test at the Baseline Visit.
(3)Is an outpatient who has undergone successful EVAR and is scheduled for his/ her next post-procedural imaging follow-up examination.
(4)Has previously completed one or more of his or her first post-EVAR surveillance imaging examination(s) that provided evidence on stable
post-EVAR status.
(5)Has a documented diagnosis of stage III or IV (defined as 30= estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m² and
15 =eGFR <30 mL/min/1.73 m², respectively, according to the Modification of Diet in Renal Disease [MDRD] equation) CKD and stable renal function
(last 2 SCr values within ±0.5 mg/dL of each other, with the most recent value within 14 days prior to the scheduled CT examination and the preceding value within 1 to 12 months before that).
(6)Is able to provide written informed consent.
(7)Is able and willing to comply with all study procedures as described in the protocol.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 466
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 698

Exclusion Criteria

(1)Is pregnant, lactating, is possibly pregnant, or is actively trying to conceive during the study period.
(2)Is a patient for whom an endoleak or other clinically meaningful EVAR-related complication (as judged by the Investigator) has already been discovered.
(3)Is a patient who is undergoing surveillance following a Thoracic Endovascular Repair (TEVAR)
(4)Has a known or suspected history of immediate or delayed hypersensitivity (including but not limited to hives, anaphylactoid or cardiovascular reactions, laryngeal edema, and bronchospasm) to iodine or any iodinated contrast medium.
(5)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 (renal function must be evaluated before metformin is resumed).
(6)Has been exposed to any intravascular iodinated contrast medium in the 14 days prior to the Baseline Visit.
(7)Has congestive heart failure (New York Heart Association [NYHA] Class IV) or hepatic failure/liver cirrhosis according to the investigator’s judgement.
(8)Has stage V CKD, defined as eGFR <15 mL/min/1.73 m² according to the MDRD equation.
(9)Has a pre-existing requirement for renal dialysis.
(10)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.
(11)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.
(12)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.
(13)Has been previously enrolled in this study.
(14)Is using i.v. vasopressor or inotropic medications.
(15)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 (renal function must be evaluated before any nephrotoxic medication is resumed) – with the exception of acetylsalicylic acid (Aspirin) at a dose of =100 mg daily (QD).
(16)Has been hospitalized within 30 days prior to Screening Visit for any reason other than practical purposes for management of tests or diagnostic assessments.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method