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

NCT ID: NCT00289614

Last Updated: 2008-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2007-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Kidney Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Interventions

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Iopamidol 370 mgI/dL

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bracco Diagnostics, Inc

INDUSTRY

Sponsor Role lead

Principal Investigators

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Kathleen S Bensel, CNMT

Role: STUDY_DIRECTOR

Bracco Diagnostics, Inc

Locations

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Bracco Diagnostics, Inc.

Princeton, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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IOP 105

Identifier Type: -

Identifier Source: org_study_id

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