Effects of Contrast Media on Subjects With Stable Reduced Renal Function Undergoing Contrast-Enhanced Computed Tomography

Stopped early · Phase 4

Conditions studied: Renal Impairment

In brief

The purpose of this study is to evaluate the contrast-induced nephropathy (CIN) rate in subjects randomized to receive either Ioversol or Iodixanol for contrast-enhanced computed tomography.

Key facts

Study ID

NCT00793182

Run by

Guerbet

People needed

6

Starts

2009-01-01

Expected to finish

2009-06-01

Last updated by the study team

2019-03-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and females 18 years of age or older
• Subjects scheduled for a clinically indicated CECT requiring 40 grams of iodine (125 mL)
• Subjects have an abnormal screening SCr that results in a calculated eGFR of < 60 mL/min/1.73 m2 using the MDRD formula and acute causes for an elevation in SCr have been excluded
• Subjects have stable reduced renal function which is defined as an abnormal screening SCr measurement with a < 15% difference from the oldest historical SCr measurement obtained within the proceeding 1 week to 12 weeks
• Subjects must provide written consent and agree to abide by the site and study requirements

You may not qualify if…

• Subjects previously entered into this study
• Subjects on dialysis
• Subjects received any investigational drug within 30 days of contrast administration or participated in an investigational study within 30 days prior to study enrollment
• Subjects have undergone a procedure using iodinated or gadolinium contrast agent within 7 days prior to contrast administration, or is scheduled to receive additional doses of contrast agents during the 48-72 hour post-study contrast administration
• Subjects in acute renal failure or have one or more known causes of acute renal failure
• Subjects have known or suspected unstable renal function
• Subjects scheduled for a surgical intervention or other procedure within 72 hours after the contrast administration
• Subjects taking NSAIDs (with the exception of ASA) and/or any type of diuretics who cannot discontinue these drugs post contrast administration and hold all subsequent doses until the 48-72 hour post contrast SCr has been drawn
• Subjects taking aminoglycosides
• Subjects known to have an organ transplantation
• Subjects have severe congestive heart failure (Class III-IV)

Where it is running

• UAB Hospital — Birmingham, Alabama, United States
• Radiology LTD — Tucson, Arizona, United States
• Providence Hospital — Washington D.C., District of Columbia, United States
• Methodist Medical Center of Illinois — Peoria, Illinois, United States
• Maine Research Associates — Auburn, Maine, United States
• Genesys Regional Medical Center — Grand Blanc, Michigan, United States
• University of Rochester Medical Center — Rochester, New York, United States
• Wake Research Associates — Raleigh, North Carolina, United States
• Radiology Consultants, Inc. — Youngstown, Ohio, United States
• Geisinger Medical Center — Danville, Pennsylvania, United States
• Temple University Hospital — Philadelphia, Pennsylvania, United States
• Albert Einstein Medical Center — Philadelphia, Pennsylvania, United States
• Trinity Clinic — Tyler, Texas, United States

Full record on ClinicalTrials.gov

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