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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
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Diagnostic
Official Title: Isovue and Visipaque in Renally Impaired Patients Undergoing CT

Resource links provided by NLM:

Drug Information available for: Iopamidol
U.S. FDA Resources

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00292487     History of Changes
Other Study ID Numbers: IOP107
Study First Received: February 14, 2006
Last Updated: February 7, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on June 18, 2013