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

This study has been completed.

First Received: February 8, 2006 Last Updated: January 3, 2008 History of Changes

Sponsored by:	Bracco Diagnostics, Inc
Information provided by:	Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier:	NCT00289614

Purpose

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.

Condition	Intervention	Phase
Kidney Diseases	Drug: Iopamidol 370 mgI/dL	Phase IV

MedlinePlus related topics: CT Scans Diabetes

Drug Information available for: Iopamidol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Active Control, Parallel Assignment
Official Title:	Patients With Renal Impairment and Diabetes Undergoing Computed Tomography

Further study details as provided by Bracco Diagnostics, Inc:

Primary Outcome Measures:

Increase in serum creatinine (SCr) at 48-72 hours post dose

Secondary Outcome Measures:

Decrease in estimated glomerular filtration rate (eGFR) at 48-72 hours post dose; occurrence of adverse events

Estimated Enrollment:	350
Study Start Date:	January 2006
Study Completion Date:	April 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00289614

Locations

United States, New Jersey
Bracco Diagnostics, Inc.
Princeton, New Jersey, United States, 08540

Sponsors and Collaborators

Bracco Diagnostics, Inc

Investigators

Study Director:

Kathleen S Bensel, CNMT

Bracco Diagnostics, Inc

More Information

No publications provided

Study ID Numbers:	IOP 105
Study First Received:	February 8, 2006
Last Updated:	January 3, 2008
ClinicalTrials.gov Identifier:	NCT00289614 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Bracco Diagnostics, Inc:

contrast induced nephropathy

Study placed in the following topic categories:

Urologic Diseases
Diabetes Mellitus
Kidney Diseases

Additional relevant MeSH terms:

Urologic Diseases
Kidney Diseases

ClinicalTrials.gov processed this record on May 07, 2009