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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00292487
Other study ID # IOP107
Secondary ID
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


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
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