NCT00292487

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

February 14, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 16, 2006

Completed
Last Updated

February 8, 2012

Status Verified

August 1, 2006

Enrollment Period

1.3 years

First QC Date

February 14, 2006

Last Update Submit

February 7, 2012

Conditions

Contrast Induced Nephropathy

Outcome Measures

Primary Outcomes (1)

  • Increase in SCr at 48-72 hours post dose

Secondary Outcomes (3)

  • Compare incidence of delayed hypersensitivity type reactions

  • Compare changes in heart rate

  • Compare efficacy of key vessels

Interventions

Iopamidol 370 mgI/mLDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • unstable renal function
  • required prophylactic drugs to receive contrast (other than hydration)
  • uncontrolled diabetes
  • currently on dialysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bracco Diagnostics, Inc

Princeton, New Jersey, 08543, United States

Location

Study Officials

  • Marie Morris

    Bracco Diagnostics, Inc

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 14, 2006

First Posted

February 16, 2006

Study Start

November 1, 2004

Primary Completion

February 1, 2006

Study Completion

February 1, 2006

Last Updated

February 8, 2012

Record last verified: 2006-08

Locations

US(1)