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

This study has been completed.
Sponsor:
Information provided by:
Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier:
NCT00289614
First received: February 8, 2006
Last updated: January 3, 2008
Last verified: January 2008
History of Changes
  Purpose

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-Blind
Official Title: Patients With Renal Impairment and Diabetes Undergoing Computed Tomography

Resource links provided by NLM:

MedlinePlus related topics: CT Scans Diabetes
Drug Information available for: Iopamidol
U.S. FDA Resources

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00289614

Locations
United States, New Jersey
Bracco Diagnostics, Inc.
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
Bracco Diagnostics, Inc
Investigators
Study Director: Kathleen S Bensel, CNMT Bracco Diagnostics, Inc
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00289614     History of Changes
Other Study ID Numbers: IOP 105
Study First Received: February 8, 2006
Last Updated: January 3, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Bracco Diagnostics, Inc:
contrast induced nephropathy

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 19, 2013