drugset / Trial / NCT00650845

Renal Safety Evaluation After Dotarem®-Enhanced MRI

NCT00650845

Phase 4 Completed 135 enrolled Guerbet
Non-randomizedParallel-groupOpen-labelDiagnostic

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.

Timeline

Start
2008-01
Primary completion
2011-05
Completion
2011-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Gadoterate meglumine Diagnostic / imaging agent Intravenous