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

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ClinicalTrials.gov Identifier: NCT00209417
Recruitment Status : 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.)
First Posted : September 21, 2005
Results First Posted : October 10, 2014
Last Update Posted : October 17, 2014
Sponsor:
Collaborators:
ABX CRO
Examination Management Services Inc.
Covance
Quintiles, Inc.
Averion International Corporation
Information provided by (Responsible Party):
GE Healthcare

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
Enrollment 656
Recruitment Details

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  
Arm/Group Title Iodixanol 320-Arm 1 Iopamidol 300-Arm 2
Hide Arm/Group Description

Iodixanol 320 mg I/mL

Iodixanol 320-Arm 1

Iopamidol 300 mg I/mL

Iopamidol 300-Arm 2

Period Title: Overall Study
Started 321 327
Completed 321 327
Not Completed 0 0
Arm/Group Title Iodixanol 320-Arm 1 Iopamidol 300-Arm 2 Total
Hide Arm/Group Description

Iodixanol 320 mg I/mL

Iodixanol 320-Arm 1

Iopamidol 300 mg I/mL

Iopamidol 300-Arm 2

Total of all reporting groups
Overall Number of Baseline Participants 321 327 648
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 321 participants 327 participants 648 participants
66.4  (12.02) 66.5  (12.01) 66.4  (12.01)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 321 participants 327 participants 648 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
133
  41.4%
136
  41.6%
269
  41.5%
>=65 years
188
  58.6%
191
  58.4%
379
  58.5%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 321 participants 327 participants 648 participants
Female
147
  45.8%
170
  52.0%
317
  48.9%
Male
174
  54.2%
157
  48.0%
331
  51.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 321 participants 327 participants 648 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
1.Primary Outcome
Title Assessment of the Incidence Rate of Contrast Medium-Induced Nephropathy (CIN) Between Iodixanol and Iopamidol in Patients With Impaired Renal Function.
Hide Description

The primary endpoint was the incidence rate of CIN, defined as an intra-individual increase in serum creatinine (SCr) of greater than or equal to 44.2 µmol/L (greater than or equal to 0.5 mg/dL).

Subjects with a pre-contrast (baseline) serum creatinine value greater than or equal to 1.5 mg/dL for males and greater than or equal to 1.3 mg/dL for females or eGFR of less than or equal to 50 mL/min/1.73m squared, and a post-contrast serum creatinine value available on days 2 or 3, administered greater than or equal to100 mL or greater than or equal to 1.5 mL/kg bodyweight IMP, without presence of any major protocol violations, and without evidence of other causes inducing acute renal dysfunction.

Time Frame From baseline up to 3 days post contrast administration.
Hide Outcome Measure Data
Hide Analysis Population Description
To calculate the incidence rate of CIN, divide the number of subjects affected by the total number of subjects dosed in each treatment group.
Arm/Group Title Iodixanol 320-Arm 1 Iopamidol 300-Arm 2
Hide Arm/Group Description:

Iodixanol 320 mg I/mL

Iodixanol 320-Arm 1

Iopamidol 300 mg I/mL

Iopamidol 300-Arm 2

Overall Number of Participants Analyzed 192 207
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
9.90
(5.67 to 14.12)
10.63
(6.43 to 14.83)
2.Secondary Outcome
Title Assessment of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Contrast-enhanced Multi-detector-row Helical Computed Tomography (MDCT) Examination.
Hide Description Overall Image Quality rated as "Excellent, Good, Sufficient or Insufficient Poor" by radiologists blinded to the contrast administration.
Time Frame Within 2, 3 and 7 days post contrast administration.
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Iodixanol 320-Arm 1 Iopamidol 300-Arm 2
Hide Arm/Group Description:

Iodixanol 320 mg I/mL

Iodixanol 320-Arm 1

Iopamidol 300 mg I/mL

Iopamidol 300-Arm 2

Overall Number of Participants Analyzed 321 327
Overall Number of Units Analyzed
Type of Units Analyzed: Images Analyzed
321 327
Measure Type: Number
Unit of Measure: Number of images
Image Quality-Excellent 220 207
Image Quality-Good 81 103
Image Quality-Sufficient 13 9
Image Quality-Insufficient 7 8
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Iodixanol 320-Arm 1 Iopamidol 300-Arm 2
Hide Arm/Group Description

Iodixanol 320 mg I/mL

Iodixanol 320-Arm 1

Iopamidol 300 mg I/mL

Iopamidol 300-Arm 2

All-Cause Mortality
Iodixanol 320-Arm 1 Iopamidol 300-Arm 2
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Iodixanol 320-Arm 1 Iopamidol 300-Arm 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/321 (1.87%)      6/327 (1.83%)    
Cardiac disorders     
Cardiac Failure  1  1/321 (0.31%)  1 0/327 (0.00%)  0
Cardiac Failure congestive  1  1/321 (0.31%)  1 0/327 (0.00%)  0
Sudden Death  1 [1]  0/321 (0.00%)  0 1/327 (0.31%)  1
Aortic Dissection  1 [1]  0/321 (0.00%)  0 1/327 (0.31%)  1
Hepatobiliary disorders     
Hepatic Failure  1  0/321 (0.00%)  0 1/327 (0.31%)  1
Metabolism and nutrition disorders     
Blood Lactic Acid Increase  1  0/321 (0.00%)  0 1/327 (0.31%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Pancreatic Carcinoma  1  1/321 (0.31%)  1 0/327 (0.00%)  0
Renal and urinary disorders     
Renal failure Acute  1 [2]  1/321 (0.31%)  1 1/327 (0.31%)  1
Renal Impairment  1  1/321 (0.31%)  1 0/327 (0.00%)  0
Renal Failure  1  0/321 (0.00%)  0 1/327 (0.31%)  1
Respiratory, thoracic and mediastinal disorders     
Pleural Effusion  1 [3]  1/321 (0.31%)  1 0/327 (0.00%)  0
Pulmonary Embolism  1 [3]  1/321 (0.31%)  1 0/327 (0.00%)  0
Chronic Obstructive Pulmonary Disease  1  0/321 (0.00%)  0 1/327 (0.31%)  1
Vascular disorders     
Coma  1  0/321 (0.00%)  0 1/327 (0.31%)  1
Sepsis  1  0/321 (0.00%)  0 1/327 (0.31%)  1
Shock  1 [1]  0/321 (0.00%)  0 1/327 (0.31%)  1
Cerebrovascular Accident  1  0/321 (0.00%)  0 1/327 (0.31%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
[1]
Outcome was death for Iopamidol.
[2]
Outcome was death for both Iodixanol and Iopamidol.
[3]
Outcome was death for Iodixanol.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Iodixanol 320-Arm 1 Iopamidol 300-Arm 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/321 (0.00%)      0/327 (0.00%)    
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
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