Effects of Contrast Media on Subjects With Stable Reduced Renal Function Undergoing Contrast-Enhanced Computed Tomography (CINOPSIS CT)

This study has been terminated.
(Slow enrollment)
Sponsor:
Information provided by:
Mallinckrodt
ClinicalTrials.gov Identifier:
NCT00793182
First received: November 17, 2008
Last updated: June 16, 2009
Last verified: June 2009
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
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

Resource links provided by NLM:


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 ]

Enrollment: 10
Study Start Date: January 2009
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Ioversol 320 mgI/mL
Drug: Ioversol 320 mgI/mL
125 mL of Ioversol administered in the vein
Other Name: Optiray
Active Comparator: 2
Iodixanol 320 mgI/mL
Drug: Iodixanol 320 mgI/mL
125 mL of Iodixanol administered in the vein
Other Name: Visipaque

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Alabama
UAB Hospital
Birmingham, Alabama, United States, 35233
United States, Arizona
Radiology LTD
Tucson, Arizona, United States, 85711
United States, District of Columbia
Providence Hospital
Washington, District of Columbia, United States, 20017
United States, Illinois
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61602
United States, Maine
Maine Research Associates
Auburn, Maine, United States, 04210
United States, Michigan
Genesys Regional Medical Center
Grand Blanc, Michigan, United States, 48439
United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 114642
United States, North Carolina
Wake Research Associates
Raleigh, North Carolina, United States, 27612
United States, Ohio
Radiology Consultants, Inc.
Youngstown, Ohio, United States, 44512
United States, Pennsylvania
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
Albert Einstein Medical Center
Philadelphia, Pennsylvania, United States, 19141
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
United States, Texas
Trinity Clinic
Tyler, Texas, United States, 75701
Sponsors and Collaborators
Mallinckrodt
Investigators
Study Director: Eddie Darton, MD Mallinckrodt
  More Information

No publications provided

Responsible Party: Eddie Darton, Jr., MD, Mallinckrodt
ClinicalTrials.gov Identifier: NCT00793182     History of Changes
Other Study ID Numbers: 1323-07-872
Study First Received: November 17, 2008
Last Updated: June 16, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Mallinckrodt:
Renal
Kidney
Contrast Induced Nephropathy

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Iodixanol
Ioversol
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014