Trial Outcomes & Findings for Renal Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time Of Flight (TOF) (NCT NCT00845702)

Results Overview

For each examination (TOF and Dotarem MRA) the percent of non-assessable segment will be compared

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

33 participants

Primary outcome timeframe

1 to 7 days

Results posted on

2016-05-20

Participant Flow

First Patient First Visit: Apr 2009 Last Patient Last Visit: Feb 2010 Location: Radiology centers

Out of the 33 enrolled patients, one patient did not undergo any of the planned procedures due to an inability to obtain an intravenous access with the initial planned procedure.

Participant milestones

Participant milestones
Measure	TOF Followed by Dotarem-enhanced MRA Each patient will undergo a Time-Of-Flight Magnetic Resonance Angiography followed by an Dotarem-enhanced Magnetic Resonance Angiography(with an injection of Dotarem 0.2 ml/kg).
TOF MRA STARTED	33
TOF MRA COMPLETED	32
TOF MRA NOT COMPLETED	1
Dotarem MRA STARTED	32
Dotarem MRA COMPLETED	32
Dotarem MRA NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Renal Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time Of Flight (TOF)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TOF and Dotarem Enhanced MRA n=33 Participants Each subject will undergo a Time of Flight Magnetic Resonance Angiography followed by a Dotarem-enhanced Magnetic Resonance Angiography (with injection of Dotarem 0.2 ml/kg).
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants
Age, Categorical >=65 years	16 Participants n=5 Participants
Age, Continuous	62 years STANDARD_DEVIATION 15 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Region of Enrollment United States	33 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 to 7 days

Population: The study has been prematurely terminated, and the planned analyses were not done

For each examination (TOF and Dotarem MRA) the percent of non-assessable segment will be compared

Outcome measures

Outcome data not reported

Adverse Events

Dotarem Magnetic Resonance Angiography

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Time Of Flight MRA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Dotarem Magnetic Resonance Angiography n=32 participants at risk Each subject will receive one injection of Dotarem 0.2 ml/kg.	Time Of Flight MRA n=32 participants at risk Subjects undergo a TOF MRA
Psychiatric disorders Mental status changed	3.1% 1/32 • Number of events 1	0.00% 0/32

Other adverse events

Other adverse events
Measure	Dotarem Magnetic Resonance Angiography n=32 participants at risk Each subject will receive one injection of Dotarem 0.2 ml/kg.	Time Of Flight MRA n=32 participants at risk Subjects undergo a TOF MRA
Investigations Investigation	9.4% 3/32 • Number of events 3	0.00% 0/32
General disorders General disorders	6.2% 2/32 • Number of events 2	0.00% 0/32
Infections and infestations Infection	3.1% 1/32 • Number of events 1	0.00% 0/32

Additional Information

Pierre Desche, MD, Head of Clinical and Regulatory Affairs

Guerbet

Phone: +33 1 45 91 50 00

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60