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Patients With Renal Impairment and Diabetes Undergoing Computed Tomography (CT)

This study has been completed.
Information provided by:
Bracco Diagnostics, Inc Identifier:
First received: February 8, 2006
Last updated: January 3, 2008
Last verified: January 2008
The main purpose of this study is to compare the incidence of contrast induced nephrotoxicity following the administration of Isovue (iopamidol) or Visipaque in diabetic patients with moderate to severe chronic renal impairment undergoing clinically indicated contrast enhanced multidetector computed tomography (MDCT). Serum creatinine will be measured before and up to 48-72 hours post dose.

Condition Intervention Phase
Kidney Diseases Drug: Iopamidol 370 mgI/dL Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Official Title: Patients With Renal Impairment and Diabetes Undergoing Computed Tomography

Resource links provided by NLM:

Further study details as provided by Bracco Diagnostics, Inc:

Primary Outcome Measures:
  • Increase in serum creatinine (SCr) at 48-72 hours post dose

Secondary Outcome Measures:
  • Decrease in estimated glomerular filtration rate (eGFR) at 48-72 hours post dose; occurrence of adverse events

Estimated Enrollment: 350
Study Start Date: January 2006
Study Completion Date: April 2007

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

Inclusion Criteria:

  • Referred for contrast enhanced MDCT
  • Documented predose eGFR of greater than or equal to 20 and less than 60 mL/min/1.73m2
  • Diagnosed as having diabetes mellitus

Exclusion Criteria:

  • Unstable renal function
  • Unstable diabetes
  • Concurrent administration of nephrotoxic drugs
  • Undergoing dialysis
  Contacts and Locations
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Please refer to this study by its identifier: NCT00289614

United States, New Jersey
Bracco Diagnostics, Inc.
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
Bracco Diagnostics, Inc
Study Director: Kathleen S Bensel, CNMT Bracco Diagnostics, Inc
  More Information Identifier: NCT00289614     History of Changes
Other Study ID Numbers: IOP 105
Study First Received: February 8, 2006
Last Updated: January 3, 2008

Keywords provided by Bracco Diagnostics, Inc:
contrast induced nephropathy

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency
Urologic Diseases processed this record on August 21, 2017