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

Primary Purpose

Renal Impairment

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ioversol 320 mgI/mL
Iodixanol 320 mgI/mL
Sponsored by
Guerbet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Renal Impairment focused on measuring Renal, Kidney, Contrast Induced Nephropathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • UAB Hospital
  • Radiology LTD
  • Providence Hospital
  • Methodist Medical Center of Illinois
  • Maine Research Associates
  • Genesys Regional Medical Center
  • University of Rochester Medical Center
  • Wake Research Associates
  • Radiology Consultants, Inc.
  • Geisinger Medical Center
  • Temple University Hospital
  • Albert Einstein Medical Center
  • Trinity Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Ioversol 320 mgI/mL

Iodixanol 320 mgI/mL

Outcomes

Primary Outcome Measures

Percentage of Patients With Contrast-induced Nephropathy (CIN)
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.

Secondary Outcome Measures

Full Information

First Posted
November 17, 2008
Last Updated
February 13, 2019
Sponsor
Guerbet
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1. Study Identification

Unique Protocol Identification Number
NCT00793182
Brief Title
Effects of Contrast Media on Subjects With Stable Reduced Renal Function Undergoing Contrast-Enhanced Computed Tomography
Acronym
CINOPSIS CT
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

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Terminated
Why Stopped
Slow enrollment
Study Start Date
January 2009 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guerbet

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Impairment
Keywords
Renal, Kidney, Contrast Induced Nephropathy

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Ioversol 320 mgI/mL
Arm Title
2
Arm Type
Active Comparator
Arm Description
Iodixanol 320 mgI/mL
Intervention Type
Drug
Intervention Name(s)
Ioversol 320 mgI/mL
Other Intervention Name(s)
Optiray
Intervention Description
125 mL of Ioversol administered in the vein
Intervention Type
Drug
Intervention Name(s)
Iodixanol 320 mgI/mL
Other Intervention Name(s)
Visipaque
Intervention Description
125 mL of Iodixanol administered in the vein
Primary Outcome Measure Information:
Title
Percentage of Patients With Contrast-induced Nephropathy (CIN)
Description
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.
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eddie Darton, MD
Organizational Affiliation
Mallinckrodt
Official's Role
Study Director
Facility Information:
Facility Name
UAB Hospital
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Radiology LTD
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85711
Country
United States
Facility Name
Providence Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20017
Country
United States
Facility Name
Methodist Medical Center of Illinois
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61602
Country
United States
Facility Name
Maine Research Associates
City
Auburn
State/Province
Maine
ZIP/Postal Code
04210
Country
United States
Facility Name
Genesys Regional Medical Center
City
Grand Blanc
State/Province
Michigan
ZIP/Postal Code
48439
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
114642
Country
United States
Facility Name
Wake Research Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Radiology Consultants, Inc.
City
Youngstown
State/Province
Ohio
ZIP/Postal Code
44512
Country
United States
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Albert Einstein Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
Facility Name
Trinity Clinic
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States

12. IPD Sharing Statement

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

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