Trial Outcomes & Findings for Post-marketing Safety Study in Patients With Moderate Renal Insufficiency Who Receive Omniscan for Contrast-enhanced Magnetic Resonance Imaging (MRI) (NCT NCT00908310)
NCT ID: NCT00908310
Last Updated: 2014-07-17
Results Overview
Capture of safety information in moderate renal insufficiency patients undergoing routine contrast-enhanced MRI with administration of OMNISCAN.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
213 participants
Primary outcome timeframe
Greater than or equal to 7 days post contrast administration.
Results posted on
2014-07-17
Participant Flow
There were 213 subjects enrolled in this study. Total of 202 subjects evaluated for safety purposes. Total of 153 subjects completed this study. Total of 11 subjects discontinued prior to contrast administration (no contrast media received).
Participant milestones
| Measure |
Omniscan
OMNISCAN 287mg/mL will be administered intravenously at the medical discretion of the prescribing physician.
|
|---|---|
|
Overall Study
STARTED
|
213
|
|
Overall Study
COMPLETED
|
153
|
|
Overall Study
NOT COMPLETED
|
60
|
Reasons for withdrawal
| Measure |
Omniscan
OMNISCAN 287mg/mL will be administered intravenously at the medical discretion of the prescribing physician.
|
|---|---|
|
Overall Study
Death
|
37
|
|
Overall Study
Withdrawal by Subject
|
7
|
|
Overall Study
Lost to Follow-up
|
7
|
|
Overall Study
Screening failure
|
5
|
|
Overall Study
Other reasons
|
4
|
Baseline Characteristics
Post-marketing Safety Study in Patients With Moderate Renal Insufficiency Who Receive Omniscan for Contrast-enhanced Magnetic Resonance Imaging (MRI)
Baseline characteristics by cohort
| Measure |
Omniscan
n=202 Participants
OMNISCAN 287mg/mL will be administered intravenously at the medical discretion of the prescribing physician.
|
|---|---|
|
Age, Continuous
|
67.2 years
STANDARD_DEVIATION 12.41 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
84 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
118 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
76 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
126 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
28 participants
n=5 Participants
|
|
Region of Enrollment
China
|
62 participants
n=5 Participants
|
|
Region of Enrollment
India
|
10 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
12 participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
77 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Greater than or equal to 7 days post contrast administration.Population: Incidence of Nephrogenic Systemic Fibrosis (NSF)
Capture of safety information in moderate renal insufficiency patients undergoing routine contrast-enhanced MRI with administration of OMNISCAN.
Outcome measures
| Measure |
Omniscan
n=202 Participants
OMNISCAN 287mg/mL will be administered intravenously at the medical discretion of the prescribing physician.
|
|---|---|
|
Capture of Post-marketing Safety Information in Patients With Moderate Renal Insufficiency Undergoing Routine Contrast-enhanced MRI With Administration of OMNISCAN in Order to Assess the Risk for Developing Nephrogenic Systemic Fibrosis (NSF).
Reporting of NSF and Symptoms
|
3.96 percentage of subjects
Interval 1.73 to 7.65
|
|
Capture of Post-marketing Safety Information in Patients With Moderate Renal Insufficiency Undergoing Routine Contrast-enhanced MRI With Administration of OMNISCAN in Order to Assess the Risk for Developing Nephrogenic Systemic Fibrosis (NSF).
Diagnosis of NSF
|
0.00 percentage of subjects
Interval 0.0 to 1.81
|
|
Capture of Post-marketing Safety Information in Patients With Moderate Renal Insufficiency Undergoing Routine Contrast-enhanced MRI With Administration of OMNISCAN in Order to Assess the Risk for Developing Nephrogenic Systemic Fibrosis (NSF).
Biopsy confirmed NSF
|
0.00 percentage of subjects
Interval 0.0 to 1.81
|
Adverse Events
Omniscan
Serious events: 7 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Omniscan
n=202 participants at risk
OMNISCAN 287mg/mL will be administered intravenously at the medical discretion of the prescribing physician.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Skin burning sensation
|
0.50%
1/202 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.50%
1/202 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.50%
1/202 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.99%
2/202 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Skin swelling
|
0.50%
1/202 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.99%
2/202 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness
|
0.50%
1/202 • Number of events 1
|
|
Eye disorders
Pterygium
|
0.50%
1/202 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.50%
1/202 • Number of events 1
|
|
Renal and urinary disorders
Azotemia
|
0.50%
1/202 • 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