NCT00289614
Completed
Phase 4
Patients With Renal Impairment and Diabetes Undergoing Computed Tomography
ConditionsKidney Diseases
DrugsIopamidol 370 mgI/dL
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.
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)
Loading locations...
Similar Trials
Completed
Phase 4
Patients With Renal Impairment Undergoing CTContrast Induced NephropathyNCT00292487Bracco Diagnostics, Inc150
Completed
Phase 4
Comparison Between Iso-Osmolar and Ipo-Osmolar Contrast Agents in Patients With Acute Myocardial Infarction (AMI) Undergoing Primary Percutaneous Coronary Intervention (PCI)Contrast Induced NephropathyAcute Myocardial InfarctionNCT00827788Ospedale San Donato432
Completed
Phase 3
Effect of Red Wine, White Wine and Beer on Contrast-Medium Induced Acute Kidney InjuryChronic Renal Failure/ Kidney DiseaseContrast-medium Induced Acute Kidney InjuryNCT01562925University of Cologne260
Terminated
Phase 4
Effects of Contrast Media on Subjects With Stable Reduced Renal Function Undergoing Contrast-Enhanced Computed TomographyRenal ImpairmentNCT00793182Guerbet6
Completed
Not Applicable
Combined Diabetes-Renal Multifactorial Intervention In Patients With Advanced Diabetic Nephropathy (ADN)Diabetic NephropathyNCT00708981Cook County Health120