CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 135 enrolled
Drug / intervention
Dotarem®-enhanced MRI +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00650845
NCT00650845Phase 4Completed
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Renal Safety Evaluation After Dotarem®-Enhanced MRI Compared With Non-enhanced MRI in Patients at High Risk of Developing Contrast Medium Induced Nephropathy

Guerbet·interventional·Posted Apr 2, 2008·Updated Jun 9, 2015

In Brief

A Phase 4 clinical trial evaluating Dotarem®-enhanced MRI and non-enhanced MRI for Renal Insufficiency. Completed, enrolled 135 participants across 15 sites in 4 countries.

Detailed Summary

Although there is a well documented risk of acute renal failure with the iodinated contrast agents, the implication of intravenous gadolinium-based contrast agents in nephrotoxicity remains controversial. The aim of this study was to evaluate the safety profile of gadoterate meglumine (Dotarem®) in patients with chronic renal insufficiency by evaluating the rate of patients experiencing contrast-induced nephrotoxicity following the injection of gadoterate meglumine.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRenal Insufficiency
CountriesBelgium, France, Italy, Spain
Collaborators--

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 2, 2008
Enrollment StartJan 1, 2008
Primary CompletionMay 1, 2011
Study CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 18.3 years ago

Interventions

Dotarem®-enhanced MRIdrug

Single IV administration before MRI exam

non-enhanced MRIother

non injected MRI