Clinical trial NCT00793182: Effects of Contrast Media on Subjects With Stable Reduced Renal Function Undergoing Contrast-Enhanced Computed Tomography
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Renal Impairment
Keywords: Renal
Kidney
Contrast Induced Nephropathy
Lead sponsor: Guerbet
Sponsor class: INDUSTRY
First posted: 2008-11-19
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

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 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)

Primary outcomes:
measure: Percentage of Patients With Contrast-induced Nephropathy (CIN)
timeFrame: Based on the SCr values of each patient measured from 2 to 24 hours before and from 48 to 72 hours after contrast medium administration
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Hospital
state: Alabama
city: Tucson
country: United States
facility: Radiology LTD
state: Arizona
city: Washington
country: United States
facility: Providence Hospital
state: District of Columbia
city: Peoria
country: United States
facility: Methodist Medical Center of Illinois
state: Illinois
city: Auburn
country: United States
facility: Maine Research Associates
state: Maine
city: Grand Blanc
country: United States
facility: Genesys Regional Medical Center
state: Michigan
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Raleigh
country: United States
facility: Wake Research Associates
state: North Carolina
city: Youngstown
country: United States
facility: Radiology Consultants, Inc.
state: Ohio
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Albert Einstein Medical Center
state: Pennsylvania
city: Tyler
country: United States
facility: Trinity Clinic
state: Texas
Study officials:
affiliation: Mallinckrodt
name: Eddie Darton, MD
role: STUDY_DIRECTOR
References: