NCT00793182

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

A Multicenter, Double-blind, Randomized Study to Evaluate the Effects of Optiray 320 mgI/mL and Visipaque 320 mgI/mL on Renal Function in Subjects With Stable Reduced Renal Function Undergoing Contrast-enhanced Computed Tomography

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Guerbet · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Contrast-induced nephropathy (CIN) is an acute decline in renal function after the administration of iodinated contrast agents. CIN is commonly defined as an increase in post contrast serum creatinine (SCr) greater than or equal to 25% or an absolute increase greater than or equal to 0.5 mg/dL from pre contrast baseline values. Study will evaluate and compare the effects of two (2) contrast media products on renal function in subjects with stable reduced renal function while undergoing contrast-enhanced computed tomography.

Conditions

• Renal Impairment

Interventions

Type	Name	Description
DRUG	Ioversol 320 mgI/mL	125 mL of Ioversol administered in the vein
DRUG	Iodixanol 320 mgI/mL	125 mL of Iodixanol administered in the vein

Timeline

• Start date: 2009-01-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2008-11-19
• Last updated: 2019-03-06
• Results posted: 2017-09-29

Locations

13 sites across 1 country: United States