Back to resultsPatients With Renal Impairment Undergoing CT
Primary Purpose
Contrast Induced Nephropathy
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Iopamidol 370 mgI/mL
Sponsored by
About this trial
This is an interventional diagnostic trial for Contrast Induced Nephropathy
Eligibility Criteria
Inclusion Criteria: referred for MDCT of liver or peripheral CTA stable baseline SCr of 1.5 - 2.5 mg/dL and/or calculated CrCl of 10-60 mL/min Exclusion Criteria: unstable renal function required prophylactic drugs to receive contrast (other than hydration) uncontrolled diabetes currently on dialysis
Sites / Locations
- Bracco Diagnostics, Inc
Outcomes
Primary Outcome Measures
Increase in SCr at 48-72 hours post dose
Secondary Outcome Measures
Compare incidence of delayed hypersensitivity type reactions
Compare changes in heart rate
Compare efficacy of key vessels
Full Information
NCT ID
NCT00292487
First Posted
February 14, 2006
Last Updated
February 7, 2012
Sponsor
Bracco Diagnostics, Inc
1. Study Identification
Unique Protocol Identification Number
NCT00292487
Brief Title
Patients With Renal Impairment Undergoing CT
Official Title
Isovue and Visipaque in Renally Impaired Patients Undergoing CT
Study Type
Interventional
2. Study Status
Record Verification Date
August 2006
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
February 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bracco Diagnostics, Inc
4. Oversight
5. Study Description
Brief Summary
The purpose of the study is to compare the incidence of contrast induced nephrotoxicity following the administration of Isovue or Visipaque in patients with mild to moderate renal impairment who undergo a clinically indicated IV contrast-enhanced (multidetector computed tomography) MDCT of the liver or MDCT angiography of the lower extremities. Serum Creatinine (SCr) will be measured before and up to 48-72 hours post dose.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contrast Induced Nephropathy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
150 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Iopamidol 370 mgI/mL
Primary Outcome Measure Information:
Title
Increase in SCr at 48-72 hours post dose
Secondary Outcome Measure Information:
Title
Compare incidence of delayed hypersensitivity type reactions
Title
Compare changes in heart rate
Title
Compare efficacy of key vessels
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
referred for MDCT of liver or peripheral CTA
stable baseline SCr of 1.5 - 2.5 mg/dL and/or calculated CrCl of 10-60 mL/min
Exclusion Criteria:
unstable renal function
required prophylactic drugs to receive contrast (other than hydration)
uncontrolled diabetes
currently on dialysis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie Morris
Organizational Affiliation
Bracco Diagnostics, Inc
Official's Role
Study Director
Facility Information:
Facility Name
Bracco Diagnostics, Inc
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08543
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Patients With Renal Impairment Undergoing CT
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