NCT00650845

Renal Safety Evaluation After Dotarem®-Enhanced MRI

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 135 (actual)
• Sponsor: Guerbet · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients with renal insufficiency not requiring hemodialysis and scheduled to undergo a contrast enhanced MRI or unenhanced MRI examination to specify a diagnosis, were selected for inclusion. Two groups of patients were defined on the basis of the planned imaging procedure selected to obtain a diagnosis: those undergoing a Dotarem®-enhanced MRI and those undergoing an unenhanced MRI. A clinically significant increase in serum creatinine levels after the contrast-enhanced MRI exam was used as an indication of contrast induced nephrotoxicity. A blood test was performed 24h before the MRI in order to evaluate baseline creatinine values. 72h after the exam, a second blood test was performed. An increase in creatinemia above 25% from baseline levels was defined as a contrast-induced nephrotoxic reaction. The primary endpoint of the study assessed the percentage of patients presenting a contrast-induced nephrotoxic reaction in order to show a non inferiority of enhanced as compared to non-enhanced MRI exams.

Conditions

• Renal Insufficiency

Interventions

Type	Name	Description
DRUG	Dotarem®-enhanced MRI	Single IV administration before MRI exam
OTHER	non-enhanced MRI	non injected MRI

Timeline

• Start date: 2008-01-01
• Primary completion: 2011-05-01
• Completion: 2011-08-01
• First posted: 2008-04-02
• Last updated: 2015-06-09
• Results posted: 2015-06-09

Locations

15 sites across 4 countries: Belgium, France, Italy, Spain