Trial Outcomes & Findings for Evaluation of Gadoterate in Patients With Renal Dysfunction (NCT NCT02382380)
NCT ID: NCT02382380
Last Updated: 2025-08-13
Results Overview
Change in GFR from 0 to 72 hours
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
46 participants
Primary outcome timeframe
72 hours
Results posted on
2025-08-13
Participant Flow
Recruitment began on November 5, 2014 and ended on May 15, 2019
Participant milestones
| Measure |
Gadoterate
Gadoterate: Patients who choose to receive Gadoterate will receive an MRI exam with standard pre-contrast and Gadoterate-enhanced acquisitions (0.2 mL/kg). The MRI protocol utilized in the study will be comprised of the standard Body protocols (routine abdomen, liver-pancreas, renal, prostate, angiography) as well as the standard Neurologic exam protocols (routine brain, orbital, brainstem, neck, angiography).
|
No Gadoterate
No Gadoterate: Patients who choose not to receive Gadoterate will receive an MRI exam with no Gadolinium contrast. The MRI protocol utilized in the study will be comprised of the standard Body protocols (routine abdomen, liver-pancreas, renal, prostate, angiography) as well as the standard Neurologic exam protocols (routine brain, orbital, brainstem, neck, angiography).
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
13
|
|
Overall Study
COMPLETED
|
31
|
10
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
Gadoterate
Gadoterate: Patients who choose to receive Gadoterate will receive an MRI exam with standard pre-contrast and Gadoterate-enhanced acquisitions (0.2 mL/kg). The MRI protocol utilized in the study will be comprised of the standard Body protocols (routine abdomen, liver-pancreas, renal, prostate, angiography) as well as the standard Neurologic exam protocols (routine brain, orbital, brainstem, neck, angiography).
|
No Gadoterate
No Gadoterate: Patients who choose not to receive Gadoterate will receive an MRI exam with no Gadolinium contrast. The MRI protocol utilized in the study will be comprised of the standard Body protocols (routine abdomen, liver-pancreas, renal, prostate, angiography) as well as the standard Neurologic exam protocols (routine brain, orbital, brainstem, neck, angiography).
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Evaluation of Gadoterate in Patients With Renal Dysfunction
Baseline characteristics by cohort
| Measure |
No Gadoterate
n=13 Participants
No Gadoterate: Patients who choose not to receive Gadoterate will receive an MRI exam with no Gadolinium contrast. The MRI protocol utilized in the study will be comprised of the standard Body protocols (routine abdomen, liver-pancreas, renal, prostate, angiography) as well as the standard Neurologic exam protocols (routine brain, orbital, brainstem, neck, angiography).
|
Gadoterate
n=33 Participants
Gadoterate: Patients who choose to receive Gadoterate will receive an MRI exam with standard pre-contrast and Gadoterate-enhanced acquisitions (0.2 mL/kg). The MRI protocol utilized in the study will be comprised of the standard Body protocols (routine abdomen, liver-pancreas, renal, prostate, angiography) as well as the standard Neurologic exam protocols (routine brain, orbital, brainstem, neck, angiography).
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.2 years
n=99 Participants
|
64.2 years
n=107 Participants
|
59.5 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
13 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
|
Body Mass Index
|
30.5 kg/m^2
n=99 Participants
|
28.6 kg/m^2
n=107 Participants
|
29.6 kg/m^2
n=206 Participants
|
PRIMARY outcome
Timeframe: 72 hoursPopulation: The analysis population includes all participants with a baseline and 72-hour follow-up GFR assessment
Change in GFR from 0 to 72 hours
Outcome measures
| Measure |
No Gadoterate
n=10 Participants
No Gadoterate: Patients who choose not to receive Gadoterate will receive an MRI exam with no Gadolinium contrast. The MRI protocol utilized in the study will be comprised of the standard Body protocols (routine abdomen, liver-pancreas, renal, prostate, angiography) as well as the standard Neurologic exam protocols (routine brain, orbital, brainstem, neck, angiography).
|
Gadoterate
n=31 Participants
Gadoterate: Patients who choose to receive Gadoterate will receive an MRI exam with standard pre-contrast and Gadoterate-enhanced acquisitions (0.2 mL/kg). The MRI protocol utilized in the study will be comprised of the standard Body protocols (routine abdomen, liver-pancreas, renal, prostate, angiography) as well as the standard Neurologic exam protocols (routine brain, orbital, brainstem, neck, angiography).
|
|---|---|---|
|
Change in Glomerular Filtration Rate (GFR)
|
1.5 ml/minute
Interval 1.0 to 5.0
|
1.0 ml/minute
Interval -2.0 to 3.0
|
Adverse Events
No Gadoterate
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Gadoterate
Serious events: 5 serious events
Other events: 0 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
No Gadoterate
n=13 participants at risk
No Gadoterate: Patients who choose not to receive Gadoterate will receive an MRI exam with no Gadolinium contrast. The MRI protocol utilized in the study will be comprised of the standard Body protocols (routine abdomen, liver-pancreas, renal, prostate, angiography) as well as the standard Neurologic exam protocols (routine brain, orbital, brainstem, neck, angiography).
|
Gadoterate
n=33 participants at risk
Gadoterate: Patients who choose to receive Gadoterate will receive an MRI exam with standard pre-contrast and Gadoterate-enhanced acquisitions (0.2 mL/kg). The MRI protocol utilized in the study will be comprised of the standard Body protocols (routine abdomen, liver-pancreas, renal, prostate, angiography) as well as the standard Neurologic exam protocols (routine brain, orbital, brainstem, neck, angiography).
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer exacerbation leading to death
|
0.00%
0/13 • Adverse event data were collected for 3 years
|
15.2%
5/33 • Number of events 5 • Adverse event data were collected for 3 years
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place