Patients With Renal Impairment and Diabetes Undergoing Computed Tomography (CT)
Phase 4
Completed
- Conditions
- Kidney Diseases
- Registration Number
- NCT00289614
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 350
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Increase in serum creatinine (SCr) at 48-72 hours post dose
- Secondary Outcome Measures
Name Time Method Decrease in estimated glomerular filtration rate (eGFR) at 48-72 hours post dose; occurrence of adverse events
Trial Locations
- Locations (1)
Bracco Diagnostics, Inc.
🇺🇸Princeton, New Jersey, United States