Trial Outcomes & Findings for Renal Safety Evaluation After Dotarem®-Enhanced MRI (NCT NCT00650845)
NCT ID: NCT00650845
Last Updated: 2015-06-09
Results Overview
Comparing the number of patients experiencing an increase of creatinine of at least 25% over baseline levels after Dotarem®-enhanced MRI and after non-enhanced MRI in patients with at least a moderate renal insufficiency.
COMPLETED
PHASE4
135 participants
baseline pre MRI and 3 days post MRI
2015-06-09
Participant Flow
This study did not use randomization. Eligible patients who provided written consent were enrolled chronologically in each investigational center. A total of 142 patients were screened between 29 January 2008 and 05 May 2011, 135 of whom were included in 15 European centers, eight centers in France, three in Belgium, two in Spain and two in Italy.
10 patients were screened but did not undergo the planned procedure: 7 were screen failures and 3 were included but dropped out prior to undergoing the planned procedure. Hence the total number of patients who were assigned to both groups is 132.
Participant milestones
| Measure |
Dotarem®-Enhanced MRI
Dotarem®: Single IV administration
|
Non-enhanced MRI
non-enhanced MRI: non injected MRI
|
|---|---|---|
|
Overall Study
STARTED
|
75
|
57
|
|
Overall Study
COMPLETED
|
70
|
44
|
|
Overall Study
NOT COMPLETED
|
5
|
13
|
Reasons for withdrawal
| Measure |
Dotarem®-Enhanced MRI
Dotarem®: Single IV administration
|
Non-enhanced MRI
non-enhanced MRI: non injected MRI
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
0
|
|
Overall Study
Protocol Violation
|
0
|
13
|
Baseline Characteristics
Renal Safety Evaluation After Dotarem®-Enhanced MRI
Baseline characteristics by cohort
| Measure |
Dotarem®-Enhanced MRI
n=75 Participants
Dotarem®: Single IV administration before the MRI
|
Non-enhanced MRI
n=57 Participants
non-enhanced MRI: non injected MRI
|
Total
n=132 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.6 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
66.2 years
STANDARD_DEVIATION 12.2 • n=7 Participants
|
67.9 years
STANDARD_DEVIATION 12.0 • 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
|
24 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
51 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
44 participants
n=5 Participants
|
11 participants
n=7 Participants
|
55 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
14 participants
n=5 Participants
|
7 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
17 participants
n=5 Participants
|
23 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
0 participants
n=5 Participants
|
16 participants
n=7 Participants
|
16 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline pre MRI and 3 days post MRIPopulation: Full analysis set population: all included patients with a pre and post-procedure blood sample for creatinine measures.
Comparing the number of patients experiencing an increase of creatinine of at least 25% over baseline levels after Dotarem®-enhanced MRI and after non-enhanced MRI in patients with at least a moderate renal insufficiency.
Outcome measures
| Measure |
Dotarem®-Enhanced MRI
n=70 Participants
Dotarem®: Single IV administration before the MRI
|
Non-enhanced MRI
n=44 Participants
non-enhanced MRI: non injected MRI
|
|---|---|---|
|
Number of Patients Presenting Contrast-induced Nephropathy as Defined by an Increase in Serum Creatinine Levels of a Least 25% Over Baseline Levels, in the Full Analysis Set Population.
|
1 Number of patients
|
0 Number of patients
|
PRIMARY outcome
Timeframe: Baseline pre MRI and 3 days post MRIPopulation: Per protocol population: This population is comprised of the full analysis set population (i.e. all included patients with a pre and post-procedure blood sample for creatinine measurement) deprived of patients with protocol deviations/violations.
Comparing the number of patients experiencing an increase of creatinine of at least 25% over baseline levels after Dotarem®-enhanced MRI and after non-enhanced MRI in patients with at least a moderate renal insufficiency.
Outcome measures
| Measure |
Dotarem®-Enhanced MRI
n=37 Participants
Dotarem®: Single IV administration before the MRI
|
Non-enhanced MRI
n=30 Participants
non-enhanced MRI: non injected MRI
|
|---|---|---|
|
Number of Patients Presenting Contrast-induced Nephropathy as Defined by an Increase in Serum Creatinine Levels of at Least 25% Over Baseline Levels, in the Per Protocol Population.
|
1 Number of patients
|
0 Number of patients
|
SECONDARY outcome
Timeframe: Baseline pre MRI and 3 days post MRIPopulation: Full analysis set population:all included patients with a pre and post-procedure blood sample for creatinine measurement.
Serum creatinine levels were measured at baseline and at 72±24 hours after examination. The percentage of change in creatinemia from baseline was calculated for both the Dotarem® and the non-enhanced groups.
Outcome measures
| Measure |
Dotarem®-Enhanced MRI
n=70 Participants
Dotarem®: Single IV administration before the MRI
|
Non-enhanced MRI
n=44 Participants
non-enhanced MRI: non injected MRI
|
|---|---|---|
|
Percent Change of Serum Creatinine Level From Baseline to 72±24 Hours After Examination, in the Full Analysis Set Population.
|
-1.40 Percentage of change from baseline
Standard Deviation 10.36
|
-3.48 Percentage of change from baseline
Standard Deviation 9.92
|
SECONDARY outcome
Timeframe: Baseline pre MRI and 3 days post MRIPopulation: Per protocol population. This population is comprised of the full analysis set population (i.e. all included patients with a pre and post-procedure blood sample for creatinine measurement) deprived of patients with protocol deviations/violations.
Serum creatinine levels were measured at baseline and at 72±24 hours after examination. The percentage of change in creatinemia from baseline was calculated for both the Dotarem® and the non-enhanced groups.
Outcome measures
| Measure |
Dotarem®-Enhanced MRI
n=37 Participants
Dotarem®: Single IV administration before the MRI
|
Non-enhanced MRI
n=30 Participants
non-enhanced MRI: non injected MRI
|
|---|---|---|
|
Percent Change of Serum Creatinine Level Variation From Baseline to 72±24 Hours After Examination, in the Per Protocol Population
|
0.05 Percentage of change from baseline
Standard Deviation 10.84
|
-5.17 Percentage of change from baseline
Standard Deviation 9.16
|
SECONDARY outcome
Timeframe: Baseline pre MRI and 3 days post MRIPopulation: Full analysis set population: all included patients with a pre and a post-procedure blood sample for creatinine measurements.
eGFR was assessed using creatinemia and the Modification of Diet in Renal Disease (MDRD) study equation. eGFR were evaluated in terms of mean difference between the pre- and post-MRI procedure. The eGFR variation was expressed as a percentage of change from baseline values.
Outcome measures
| Measure |
Dotarem®-Enhanced MRI
n=70 Participants
Dotarem®: Single IV administration before the MRI
|
Non-enhanced MRI
n=44 Participants
non-enhanced MRI: non injected MRI
|
|---|---|---|
|
Percent Change of Estimated Glomerular Filtration Rate (eGFR) Values From Baseline to 72±24 Hours After Examination, in the Full Analysis Set Population
|
3.02 Percentage of change from baseline
Standard Deviation 12.51
|
5.55 Percentage of change from baseline
Standard Deviation 12.94
|
SECONDARY outcome
Timeframe: Baseline pre MRI and 3 days post MRIPopulation: Per protocol population: This population is comprised of the full analysis set population (i.e. all included patients with a pre and a post- procedure blood sample for creatinine measurements) deprived of patients with protocol deviations/violations.
eGFR (estimated Glomerular Filtration Rate) was assessed using creatinemia and the Modification of Diet in Renal Disease (MDRD) study equation. eGFR were evaluated in terms of mean difference between the pre- and post-MRI procedure. The eGFR variation was expressed as a percentage of change from baseline values.
Outcome measures
| Measure |
Dotarem®-Enhanced MRI
n=37 Participants
Dotarem®: Single IV administration before the MRI
|
Non-enhanced MRI
n=30 Participants
non-enhanced MRI: non injected MRI
|
|---|---|---|
|
eGFR Values Variation Between Baseline and 72±24 Hours After Examination, in the Per Protocol Population
|
1.37 Percentage of change from baseline
Standard Deviation 12.65
|
7.58 Percentage of change from baseline
Standard Deviation 12.82
|
Adverse Events
Dotarem®-Enhanced MRI
Non-enhanced MRI
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dotarem®-Enhanced MRI
n=70 participants at risk
Dotarem®: Single IV administration before the MRI
|
Non-enhanced MRI
n=44 participants at risk
non-enhanced MRI: non injected MRI
|
|---|---|---|
|
Vascular disorders
Hematoma
|
1.4%
1/70 • Number of events 1 • The period of observation for Adverse Events (AEs) collection extended from the time of patient informed consent until the end of his/her follow-up (i.e. 72 ±24hrs or 14 days after the imaging procedure) or until patient early withdrawal from the trial.
|
0.00%
0/44 • The period of observation for Adverse Events (AEs) collection extended from the time of patient informed consent until the end of his/her follow-up (i.e. 72 ±24hrs or 14 days after the imaging procedure) or until patient early withdrawal from the trial.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.4%
1/70 • Number of events 1 • The period of observation for Adverse Events (AEs) collection extended from the time of patient informed consent until the end of his/her follow-up (i.e. 72 ±24hrs or 14 days after the imaging procedure) or until patient early withdrawal from the trial.
|
0.00%
0/44 • The period of observation for Adverse Events (AEs) collection extended from the time of patient informed consent until the end of his/her follow-up (i.e. 72 ±24hrs or 14 days after the imaging procedure) or until patient early withdrawal from the trial.
|
|
Vascular disorders
Hypotension
|
1.4%
1/70 • Number of events 1 • The period of observation for Adverse Events (AEs) collection extended from the time of patient informed consent until the end of his/her follow-up (i.e. 72 ±24hrs or 14 days after the imaging procedure) or until patient early withdrawal from the trial.
|
0.00%
0/44 • The period of observation for Adverse Events (AEs) collection extended from the time of patient informed consent until the end of his/her follow-up (i.e. 72 ±24hrs or 14 days after the imaging procedure) or until patient early withdrawal from the trial.
|
|
Investigations
Blood creatinin increased
|
1.4%
1/70 • Number of events 1 • The period of observation for Adverse Events (AEs) collection extended from the time of patient informed consent until the end of his/her follow-up (i.e. 72 ±24hrs or 14 days after the imaging procedure) or until patient early withdrawal from the trial.
|
0.00%
0/44 • The period of observation for Adverse Events (AEs) collection extended from the time of patient informed consent until the end of his/her follow-up (i.e. 72 ±24hrs or 14 days after the imaging procedure) or until patient early withdrawal from the trial.
|
|
Gastrointestinal disorders
toothache
|
1.4%
1/70 • Number of events 1 • The period of observation for Adverse Events (AEs) collection extended from the time of patient informed consent until the end of his/her follow-up (i.e. 72 ±24hrs or 14 days after the imaging procedure) or until patient early withdrawal from the trial.
|
0.00%
0/44 • The period of observation for Adverse Events (AEs) collection extended from the time of patient informed consent until the end of his/her follow-up (i.e. 72 ±24hrs or 14 days after the imaging procedure) or until patient early withdrawal from the trial.
|
|
Gastrointestinal disorders
Constipation
|
1.4%
1/70 • Number of events 1 • The period of observation for Adverse Events (AEs) collection extended from the time of patient informed consent until the end of his/her follow-up (i.e. 72 ±24hrs or 14 days after the imaging procedure) or until patient early withdrawal from the trial.
|
0.00%
0/44 • The period of observation for Adverse Events (AEs) collection extended from the time of patient informed consent until the end of his/her follow-up (i.e. 72 ±24hrs or 14 days after the imaging procedure) or until patient early withdrawal from the trial.
|
Additional Information
Pierre Desché, MD - VP Development, Medical and Regulatory Affairs.
Guerbet
Results disclosure agreements
- Principal investigator is a sponsor employee No unpublished data given to the investigator may be transmitted to a third party without prior approval of the sponsor in writing. The data are the exclusive property of Guerbet. The investigator undertakes to submit to Guerbet any draft articles or papers related to this study within 30 days of their submission to the scientific review or the congress scientific committee. All written or oral papers and publications must have the joint agreement of the investigator and the sponsor.
- Publication restrictions are in place
Restriction type: OTHER