We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed Tomography

This study has been terminated.
(Supported by preliminary interim analysis. Not based on any safety signals in study or any quality issues that could affect efficacy of the product.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00209417
First Posted: September 21, 2005
Last Update Posted: October 17, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
ABX CRO
Examination Management Services Inc.
Covance
Quintiles, Inc.
Averion International Corporation
Information provided by (Responsible Party):
GE Healthcare
Results First Submitted: October 2, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Diagnostic
Conditions: Renal Insufficiency
Diabetes Mellitus
Interventions: Drug: Iodixanol 320-Arm 1
Drug: Iopamidol 300-Arm 2

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

656 subjects enrolled. 8 subjects did not continue on in the study. 7 of the 8 subjects discontinued the study prior to contrast media administration and 1 of the 8 subjects received a contrast media of unknown type and was excluded from the study.

Subtracting 8 subjects from the total 656, a total of 648 subjects actually completed the study.


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Iodixanol 320-Arm 1

Iodixanol 320 mg I/mL

Iodixanol 320-Arm 1

Iopamidol 300-Arm 2

Iopamidol 300 mg I/mL

Iopamidol 300-Arm 2


Participant Flow:   Overall Study
    Iodixanol 320-Arm 1   Iopamidol 300-Arm 2
STARTED   321   327 
COMPLETED   321   327 
NOT COMPLETED   0   0 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Iodixanol 320-Arm 1

Iodixanol 320 mg I/mL

Iodixanol 320-Arm 1

Iopamidol 300-Arm 2

Iopamidol 300 mg I/mL

Iopamidol 300-Arm 2

Total Total of all reporting groups

Baseline Measures
   Iodixanol 320-Arm 1   Iopamidol 300-Arm 2   Total 
Overall Participants Analyzed 
[Units: Participants]
 321   327   648 
Age 
[Units: Years]
Mean (Standard Deviation)
 66.4  (12.02)   66.5  (12.01)   66.4  (12.01) 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   133   136   269 
>=65 years   188   191   379 
Gender 
[Units: Participants]
     
Female   147   170   317 
Male   174   157   331 
Region of Enrollment 
[Units: Participants]
     
United States   71   70   141 
United Kingdom   10   14   24 
Austria   11   12   23 
China   45   48   93 
Czech Republic   1   1   2 
France   8   9   17 
Germany   34   38   72 
Hungary   6   8   14 
Italy   4   5   9 
Poland   60   55   115 
Russian Federation   57   56   113 
Spain   5   1   6 
Sweden   6   8   14 
Switzerland   3   2   5 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Assessment of the Incidence Rate of Contrast Medium-Induced Nephropathy (CIN) Between Iodixanol and Iopamidol in Patients With Impaired Renal Function.   [ Time Frame: From baseline up to 3 days post contrast administration. ]

2.  Secondary:   Assessment of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Contrast-enhanced Multi-detector-row Helical Computed Tomography (MDCT) Examination.   [ Time Frame: Within 2, 3 and 7 days post contrast administration. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Paul Gordon, PhD
Organization: GE Healthcare
phone: 011-47-2318-5822
e-mail: Paul.Gordon@ge.com



Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT00209417     History of Changes
Other Study ID Numbers: DXV406
First Submitted: August 24, 2005
First Posted: September 21, 2005
Results First Submitted: October 2, 2014
Results First Posted: October 10, 2014
Last Update Posted: October 17, 2014