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Clinical Trials/NCT00289614
NCT00289614
Completed
Phase 4

Patients With Renal Impairment and Diabetes Undergoing Computed Tomography

Bracco Diagnostics, Inc1 site in 1 country350 target enrollmentJanuary 2006

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Kidney Diseases
Sponsor
Bracco Diagnostics, Inc
Enrollment
350
Locations
1
Primary Endpoint
Increase in serum creatinine (SCr) at 48-72 hours post dose
Status
Completed
Last Updated
18 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2006
End Date
April 2007
Last Updated
18 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility 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

Outcomes

Primary Outcomes

Increase in serum creatinine (SCr) at 48-72 hours post dose

Secondary Outcomes

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

Study Sites (1)

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