Patients With Renal Impairment Undergoing CT

This study has been completed.
Sponsor:
Information provided by:
Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier:
NCT00292487
First received: February 14, 2006
Last updated: February 7, 2012
Last verified: August 2006

February 14, 2006
February 7, 2012
November 2004
February 2006   (final data collection date for primary outcome measure)
Increase in SCr at 48-72 hours post dose
Same as current
Complete list of historical versions of study NCT00292487 on ClinicalTrials.gov Archive Site
  • Compare incidence of delayed hypersensitivity type reactions
  • Compare changes in heart rate
  • Compare efficacy of key vessels
Same as current
Not Provided
Not Provided
 
Patients With Renal Impairment Undergoing CT
Isovue and Visipaque in Renally Impaired Patients Undergoing CT

The purpose of the study is to compare the incidence of contrast induced nephrotoxicity following the administration of Isovue or Visipaque in patients with mild to moderate renal impairment who undergo a clinically indicated IV contrast-enhanced (multidetector computed tomography) MDCT of the liver or MDCT angiography of the lower extremities. Serum Creatinine (SCr) will be measured before and up to 48-72 hours post dose.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Diagnostic
Contrast Induced Nephropathy
Drug: Iopamidol 370 mgI/mL
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
February 2006
February 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • referred for MDCT of liver or peripheral CTA
  • stable baseline SCr of 1.5 - 2.5 mg/dL and/or calculated CrCl of 10-60 mL/min

Exclusion Criteria:

  • unstable renal function
  • required prophylactic drugs to receive contrast (other than hydration)
  • uncontrolled diabetes
  • currently on dialysis
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00292487
IOP107
Not Provided
Not Provided
Bracco Diagnostics, Inc
Not Provided
Study Director: Marie Morris Bracco Diagnostics, Inc
Bracco Diagnostics, Inc
August 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP