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Patients With Renal Impairment Undergoing CT

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00292487
First Posted: February 16, 2006
Last Update Posted: February 8, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bracco Diagnostics, Inc
  Purpose
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.

Condition Intervention Phase
Contrast Induced Nephropathy Drug: Iopamidol 370 mgI/mL Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Diagnostic
Official Title: Isovue and Visipaque in Renally Impaired Patients Undergoing CT

Resource links provided by NLM:


Further study details as provided by Bracco Diagnostics, Inc:

Primary Outcome Measures:
  • Increase in SCr at 48-72 hours post dose

Secondary Outcome Measures:
  • Compare incidence of delayed hypersensitivity type reactions
  • Compare changes in heart rate
  • Compare efficacy of key vessels

Estimated Enrollment: 150
Study Start Date: November 2004
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00292487


Locations
United States, New Jersey
Bracco Diagnostics, Inc
Princeton, New Jersey, United States, 08543
Sponsors and Collaborators
Bracco Diagnostics, Inc
Investigators
Study Director: Marie Morris Bracco Diagnostics, Inc
  More Information

ClinicalTrials.gov Identifier: NCT00292487     History of Changes
Other Study ID Numbers: IOP107
First Submitted: February 14, 2006
First Posted: February 16, 2006
Last Update Posted: February 8, 2012
Last Verified: August 2006