Patients With Renal Impairment Undergoing CT

Contrast Induced Nephropathy Clinical Trial

Official title:

Isovue and Visipaque in Renally Impaired Patients Undergoing CT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00292487
• Other study ID #: IOP107
• Status: Completed
• Phase: Phase 4
• First received: February 14, 2006
• Last updated: February 7, 2012
• Start date: November 2004
• Est. completion date: February 2006

Study information

• Verified date: August 2006
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: February 2006
• Est. primary completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Contrast Induced Nephropathy

Intervention

Drug:
• Iopamidol 370 mgI/mL

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 SCr at 48-72 hours post dose
Secondary	Compare incidence of delayed hypersensitivity type reactions
Secondary	Compare changes in heart rate
Secondary	Compare efficacy of key vessels