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

Kidney Diseases Clinical Trial

Official title:

Patients With Renal Impairment and Diabetes Undergoing Computed Tomography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00289614
• Other study ID #: IOP 105
• Status: Completed
• Phase: Phase 4
• First received: February 8, 2006
• Last updated: January 3, 2008
• Start date: January 2006
• Est. completion date: April 2007

Study information

• Verified date: January 2008
• Source: Bracco Diagnostics, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

• Kidney Diseases
• Renal Insufficiency

Intervention

Drug:
• Iopamidol 370 mgI/dL

Locations

Country	Name	City	State
United States	Bracco Diagnostics, Inc.	Princeton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Bracco Diagnostics, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase in serum creatinine (SCr) at 48-72 hours post dose
Secondary	Decrease in estimated glomerular filtration rate (eGFR) at 48-72 hours post dose; occurrence of adverse events