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=5 Participants	64.2 years n=7 Participants	59.5 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	16 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	17 Participants n=7 Participants	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants	28 Participants n=7 Participants	40 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	23 Participants n=7 Participants	30 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	13 Participants n=5 Participants	33 Participants n=7 Participants	46 Participants n=5 Participants
Body Mass Index	30.5 kg/m^2 n=5 Participants	28.6 kg/m^2 n=7 Participants	29.6 kg/m^2 n=5 Participants

PRIMARY outcome

Timeframe: 72 hours

Population: 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

Ari Goldberg, M.D.

Loyola University Medical Center

Phone: 708-216-2229

Email: argoldberg@lumc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place