Trial Outcomes & Findings for Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed Tomography (NCT NCT00209417)
NCT ID: NCT00209417
Last Updated: 2014-10-17
Results Overview
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.
TERMINATED
PHASE4
656 participants
From baseline up to 3 days post contrast administration.
2014-10-17
Participant Flow
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.
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
321
|
327
|
|
Overall Study
COMPLETED
|
321
|
327
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed Tomography
Baseline characteristics by cohort
| Measure |
Iodixanol 320-Arm 1
n=321 Participants
Iodixanol 320 mg I/mL
Iodixanol 320-Arm 1
|
Iopamidol 300-Arm 2
n=327 Participants
Iopamidol 300 mg I/mL
Iopamidol 300-Arm 2
|
Total
n=648 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.4 years
STANDARD_DEVIATION 12.02 • n=5 Participants
|
66.5 years
STANDARD_DEVIATION 12.01 • n=7 Participants
|
66.4 years
STANDARD_DEVIATION 12.01 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
133 Participants
n=5 Participants
|
136 Participants
n=7 Participants
|
269 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
188 Participants
n=5 Participants
|
191 Participants
n=7 Participants
|
379 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
147 Participants
n=5 Participants
|
170 Participants
n=7 Participants
|
317 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
174 Participants
n=5 Participants
|
157 Participants
n=7 Participants
|
331 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
71 participants
n=5 Participants
|
70 participants
n=7 Participants
|
141 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
10 participants
n=5 Participants
|
14 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
11 participants
n=5 Participants
|
12 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Region of Enrollment
China
|
45 participants
n=5 Participants
|
48 participants
n=7 Participants
|
93 participants
n=5 Participants
|
|
Region of Enrollment
Czech Republic
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
France
|
8 participants
n=5 Participants
|
9 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
34 participants
n=5 Participants
|
38 participants
n=7 Participants
|
72 participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
6 participants
n=5 Participants
|
8 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
60 participants
n=5 Participants
|
55 participants
n=7 Participants
|
115 participants
n=5 Participants
|
|
Region of Enrollment
Russian Federation
|
57 participants
n=5 Participants
|
56 participants
n=7 Participants
|
113 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
5 participants
n=5 Participants
|
1 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
6 participants
n=5 Participants
|
8 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Region of Enrollment
Switzerland
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline up to 3 days post contrast administration.Population: To calculate the incidence rate of CIN, divide the number of subjects affected by the total number of subjects dosed in each treatment group.
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.
Outcome measures
| Measure |
Iodixanol 320-Arm 1
n=192 Participants
Iodixanol 320 mg I/mL
Iodixanol 320-Arm 1
|
Iopamidol 300-Arm 2
n=207 Participants
Iopamidol 300 mg I/mL
Iopamidol 300-Arm 2
|
|---|---|---|
|
Assessment of the Incidence Rate of Contrast Medium-Induced Nephropathy (CIN) Between Iodixanol and Iopamidol in Patients With Impaired Renal Function.
|
9.90 percentage of subjects
Interval 5.67 to 14.12
|
10.63 percentage of subjects
Interval 6.43 to 14.83
|
SECONDARY outcome
Timeframe: Within 2, 3 and 7 days post contrast administration.Overall Image Quality rated as "Excellent, Good, Sufficient or Insufficient Poor" by radiologists blinded to the contrast administration.
Outcome measures
| Measure |
Iodixanol 320-Arm 1
n=321 Images Analyzed
Iodixanol 320 mg I/mL
Iodixanol 320-Arm 1
|
Iopamidol 300-Arm 2
n=327 Images Analyzed
Iopamidol 300 mg I/mL
Iopamidol 300-Arm 2
|
|---|---|---|
|
Assessment of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Contrast-enhanced Multi-detector-row Helical Computed Tomography (MDCT) Examination.
Image Quality-Excellent
|
220 Number of images
|
207 Number of images
|
|
Assessment of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Contrast-enhanced Multi-detector-row Helical Computed Tomography (MDCT) Examination.
Image Quality-Good
|
81 Number of images
|
103 Number of images
|
|
Assessment of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Contrast-enhanced Multi-detector-row Helical Computed Tomography (MDCT) Examination.
Image Quality-Sufficient
|
13 Number of images
|
9 Number of images
|
|
Assessment of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Contrast-enhanced Multi-detector-row Helical Computed Tomography (MDCT) Examination.
Image Quality-Insufficient
|
7 Number of images
|
8 Number of images
|
Adverse Events
Iodixanol 320-Arm 1
Iopamidol 300-Arm 2
Serious adverse events
| Measure |
Iodixanol 320-Arm 1
n=321 participants at risk
Iodixanol 320 mg I/mL
Iodixanol 320-Arm 1
|
Iopamidol 300-Arm 2
n=327 participants at risk
Iopamidol 300 mg I/mL
Iopamidol 300-Arm 2
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic Carcinoma
|
0.31%
1/321 • Number of events 1
|
0.00%
0/327
|
|
Cardiac disorders
Cardiac Failure
|
0.31%
1/321 • Number of events 1
|
0.00%
0/327
|
|
Cardiac disorders
Cardiac Failure congestive
|
0.31%
1/321 • Number of events 1
|
0.00%
0/327
|
|
Renal and urinary disorders
Renal failure Acute
|
0.31%
1/321 • Number of events 1
|
0.31%
1/327 • Number of events 1
|
|
Renal and urinary disorders
Renal Impairment
|
0.31%
1/321 • Number of events 1
|
0.00%
0/327
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.31%
1/321 • Number of events 1
|
0.00%
0/327
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.31%
1/321 • Number of events 1
|
0.00%
0/327
|
|
Cardiac disorders
Sudden Death
|
0.00%
0/321
|
0.31%
1/327 • Number of events 1
|
|
Cardiac disorders
Aortic Dissection
|
0.00%
0/321
|
0.31%
1/327 • Number of events 1
|
|
Hepatobiliary disorders
Hepatic Failure
|
0.00%
0/321
|
0.31%
1/327 • Number of events 1
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/321
|
0.31%
1/327 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.00%
0/321
|
0.31%
1/327 • Number of events 1
|
|
Metabolism and nutrition disorders
Blood Lactic Acid Increase
|
0.00%
0/321
|
0.31%
1/327 • Number of events 1
|
|
Vascular disorders
Coma
|
0.00%
0/321
|
0.31%
1/327 • Number of events 1
|
|
Vascular disorders
Sepsis
|
0.00%
0/321
|
0.31%
1/327 • Number of events 1
|
|
Vascular disorders
Shock
|
0.00%
0/321
|
0.31%
1/327 • Number of events 1
|
|
Vascular disorders
Cerebrovascular Accident
|
0.00%
0/321
|
0.31%
1/327 • Number of events 1
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place