Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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:
Collaborators:
ABX-CRO
Examination Management Services Inc. (EMSI)
Covance
Quintiles
Averion International Corporation
Information provided by (Responsible Party):
GE Healthcare
ClinicalTrials.gov Identifier:
NCT00209417
First received: August 24, 2005
Last updated: October 9, 2014
Last verified: October 2014
Results First Received: October 2, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, 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  
Number of Participants  
[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


No publications provided


Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT00209417     History of Changes
Other Study ID Numbers: DXV406
Study First Received: August 24, 2005
Results First Received: October 2, 2014
Last Updated: October 9, 2014
Health Authority: United States: Food and Drug Administration
Austria: Federal Ministry for Health and Women
Belgium: Ministry of Social Affairs, Public Health and the Environment
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Italy: Ministry of Health
Norway: Norwegian Medicines Agency
Spain: Ministry of Health and Consumption
Sweden: Medical Products Agency
Switzerland: Swissmedic
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Czech Republic: State Institute for Drug Control
Hungary: National Institute of Pharmacy
Poland: Ministry of Health