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

• Status: Terminated
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guerbet; Mallinckrodt

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)