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

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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 (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).
  • Is able to provide written informed consent.
  • Is able and willing to comply with all study procedures as described in the protocol.

* Adequate contraception is based on those methods identified in the Clinical Trial Facilitation Group document [CTFG Guidance 2014] for clarification of effective contraception. Such methods include:

  • Combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, or  implantable); intrauterine device; intrauterine hormone-releasing system; bilateral tubal occlusion; vasectomized partner; sexual abstinence, progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action, male or female condom with or without spermicide cap, diaphragm or sponge with spermicide.

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 a patient who is undergoing surveillance following a Thoracic Endovascular Repair (TEVAR).
  • 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.
  • Is using metformin (e.g., Glucophage®) that cannot be discontinued for the period of 48 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).
  • Has been exposed to any intravascular iodinated contrast medium in the 7 14 days prior to the Baseline Visit.
  • Has congestive heart failure (New York Heart Association [NYHA] Class IV) or hepatic failure/liver cirrhosis according to the investigator’s judgement.
  • Has stage V CKD, defined as eGFR <15 mL/min/1.73 m² according to the MDRD equation.
  • 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 (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).
  • Has been hospitalized within 30 days prior to Screening Visit for any reason other than practical purposes for management of tests or diagnostic assessments.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Gustavo Oderich, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

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CLS-20426140

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