Effects of Contrast Media on Subjects With Stable Reduced Renal Function Undergoing Contrast-Enhanced Computed Tomography - Full Text View

Sponsored by:	Mallinckrodt
Information provided by:	Mallinckrodt
ClinicalTrials.gov Identifier:	NCT00793182

Purpose

The purpose of this study is to evaluate the contrast-induced nephropathy (CIN) rate in subjects randomized to receive either Ioversol or Iodixanol for contrast-enhanced computed tomography.

Condition	Intervention	Phase
Renal Impairment	Drug: Ioversol 320 mgI/mL Drug: Iodixanol 320 mgI/mL	Phase IV

MedlinePlus related topics: CT Scans

Drug Information available for: Iodixanol Ioversol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety Study
Official Title:	A Multicenter, Double-Blind, Randomized Study to Evaluate the Effects of Optiray 320 mgI/mL and Visipaque 320 mgI/mL on Renal Function in Subjects With Stable Reduced Renal Function Undergoing Contrast-Enhanced Computed Tomography

Further study details as provided by Mallinckrodt:

Primary Outcome Measures:

Evaluate the incidence of contrast-induced nephropathy (CIN), defined as an increase of ≥ 25% or an increase of ≥ 0.5 mg/dL from baseline serum creatinine (SCr), within 48 - 72 hours after contrast administration. [ Time Frame: Labs obtained 2-24 hours before and 48-72 hours after contrast administration, with a 7-day follow-up if indicated ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	300
Study Start Date:	January 2009
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Ioversol 320 mgI/mL	Drug: Ioversol 320 mgI/mL 125 mL of Ioversol administered in the vein
2: Active Comparator Iodixanol 320 mgI/mL	Drug: Iodixanol 320 mgI/mL 125 mL of Iodixanol administered in the vein

Detailed Description:

Contrast-induced nephropathy (CIN) is an acute decline in renal function after the administration of iodinated contrast agents. CIN is commonly defined as an increase in post contrast serum creatinine (SCr) greater than or equal to 25% or an absolute increase greater than or equal to 0.5 mg/dL from pre contrast baseline values. Study will evaluate and compare the effects of two (2) contrast media products on renal function in subjects with stable reduced renal function while undergoing contrast-enhanced computed tomography.

Eligibility

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

Criteria

Inclusion Criteria:

Males and females 18 years of age or older
Subjects scheduled for a clinically indicated CECT requiring 40 grams of iodine (125 mL)
Subjects have an abnormal screening SCr that results in a calculated eGFR of < 60 mL/min/1.73 m2 using the MDRD formula and acute causes for an elevation in SCr have been excluded
Subjects have stable reduced renal function which is defined as an abnormal screening SCr measurement with a < 15% difference from the oldest historical SCr measurement obtained within the proceeding 1 week to 12 weeks
Subjects must provide written consent and agree to abide by the site and study requirements

Exclusion Criteria:

Subjects previously entered into this study
Subjects on dialysis
Subjects received any investigational drug within 30 days of contrast administration or participated in an investigational study within 30 days prior to study enrollment
Subjects have undergone a procedure using iodinated or gadolinium contrast agent within 7 days prior to contrast administration, or is scheduled to receive additional doses of contrast agents during the 48-72 hour post-study contrast administration
Subjects in acute renal failure or have one or more known causes of acute renal failure
Subjects have known or suspected unstable renal function
Subjects scheduled for a surgical intervention or other procedure within 72 hours after the contrast administration
Subjects taking NSAIDs (with the exception of ASA) and/or any type of diuretics who cannot discontinue these drugs post contrast administration and hold all subsequent doses until the 48-72 hour post contrast SCr has been drawn
Subjects taking aminoglycosides
Subjects known to have an organ transplantation
Subjects have severe congestive heart failure (Class III-IV)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00793182

Contacts

Contact: Lisa Sisk, RN	314-654-3524	lisa.sisk@covidien.com
Contact: Nancy Denney, RN	314-654-3269	nancy.denney@covidien.com

Locations

United States, Alabama
UAB Hospital	Not yet recruiting
Birmingham, Alabama, United States, 35233
Principal Investigator: Mark Lockhart, MD, MPH
United States, Arizona
Radiology LTD	Not yet recruiting
Tucson, Arizona, United States, 85711
Principal Investigator: Jae K. Kim, MD, PhD
United States, District of Columbia
Providence Hospital	Not yet recruiting
Washington, District of Columbia, United States, 20017
Principal Investigator: Ana Ibrado, MD, PhD
United States, Michigan
Genesys Regional Medical Center	Not yet recruiting
Grand Blanc, Michigan, United States, 48439
Principal Investigator: John Morrison, D.O.
United States, North Carolina
Wake Research Associates	Not yet recruiting
Raleigh, North Carolina, United States, 27612
Principal Investigator: Wayne L. Harper, MD
United States, Ohio
Radiology Consultants, Inc.	Recruiting
Youngstown, Ohio, United States, 44512
Principal Investigator: Richard Barr, MD
United States, Pennsylvania
Temple University Hospital	Not yet recruiting
Philadelphia, Pennsylvania, United States, 19140
Principal Investigator: Dina Caroline, MD
Geisinger Medical Center	Not yet recruiting
Danville, Pennsylvania, United States, 17822
Principal Investigator: Taher Yahya, MD
United States, Texas
Trinity Clinic	Not yet recruiting
Tyler, Texas, United States, 75701
Principal Investigator: Ted Willis, M.D.

Sponsors and Collaborators

Mallinckrodt

Investigators

Study Director:

Eddie Darton, MD

Mallinckrodt

More Information

Responsible Party:	Mallinckrodt ( Eddie Darton, Jr., MD )
Study ID Numbers:	1323-07-872
Study First Received:	November 17, 2008
Last Updated:	January 6, 2009
ClinicalTrials.gov Identifier:	NCT00793182
Health Authority:	United States: Food and Drug Administration

Keywords provided by Mallinckrodt:

Renal
Kidney
Contrast Induced Nephropathy

Study placed in the following topic categories:

Kidney Diseases

ClinicalTrials.gov processed this record on January 15, 2009