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

February 13, 2019 updated by: Guerbet

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • UAB Hospital
    • Arizona
      • Tucson, Arizona, United States, 85711
        • Radiology Ltd
    • District of Columbia
      • Washington, District of Columbia, United States, 20017
        • Providence Hospital
    • Illinois
      • Peoria, Illinois, United States, 61602
        • Methodist Medical Center of Illinois
    • Maine
      • Auburn, Maine, United States, 04210
        • Maine Research Associates
    • Michigan
      • Grand Blanc, Michigan, United States, 48439
        • Genesys Regional Medical Center
    • New York
      • Rochester, New York, United States, 114642
        • University of Rochester Medical Center
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
        • Wake Research Associates
    • Ohio
      • Youngstown, Ohio, United States, 44512
        • Radiology Consultants, Inc.
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Medical Center
      • Philadelphia, Pennsylvania, United States, 19141
        • Albert Einstein Medical Center
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University Hospital
    • Texas
      • Tyler, Texas, United States, 75701
        • Trinity Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Ioversol 320 mgI/mL
Drug: Ioversol 320 mgI/mL
125 mL of Ioversol administered in the vein
Other Names:
  • Optiray
Active Comparator: 2
Iodixanol 320 mgI/mL
Drug: Iodixanol 320 mgI/mL
125 mL of Iodixanol administered in the vein
Other Names:
  • Visipaque

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Patients With Contrast-induced Nephropathy (CIN)
Time Frame: 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

Contrast-induced nephropathy (CIN) is 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 medium administration.

For each patient, SCr values were measured from 2 to 24 hours before and from 48 to 72 hours after contrast medium administration.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guerbet

Investigators

  • Study Director: Eddie Darton, MD, Mallinckrodt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

November 17, 2008

First Submitted That Met QC Criteria

November 17, 2008

First Posted (Estimate)

November 19, 2008

Study Record Updates

Last Update Posted (Actual)

March 6, 2019

Last Update Submitted That Met QC Criteria

February 13, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1323-07-872

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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