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

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. Identifier: NCT00289614
Recruitment Status : Completed
First Posted : February 10, 2006
Last Update Posted : January 7, 2008
Information provided by:
Bracco Diagnostics, Inc

Brief Summary:
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 or disease Intervention/treatment Phase
Kidney Diseases Drug: Iopamidol 370 mgI/dL Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Official Title: Patients With Renal Impairment and Diabetes Undergoing Computed Tomography
Study Start Date : January 2006
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Iopamidol

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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 identifier (NCT number): NCT00289614

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United States, New Jersey
Bracco Diagnostics, Inc.
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
Bracco Diagnostics, Inc
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Study Director: Kathleen S Bensel, CNMT Bracco Diagnostics, Inc
Layout table for additonal information Identifier: NCT00289614    
Other Study ID Numbers: IOP 105
First Posted: February 10, 2006    Key Record Dates
Last Update Posted: January 7, 2008
Last Verified: January 2008
Keywords provided by Bracco Diagnostics, Inc:
contrast induced nephropathy
Additional relevant MeSH terms:
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Kidney Diseases
Urologic Diseases