NSsaFe study: Observational study on the incidence of nephrogenic systemic fibrosis in renal impaired patients following gadoterate meglumine administration.

Purpose: Nephrogenic Systemic Fibrosis (NSF) has been reported to occur in patients with impaired renal function after administration of gadolinium-based contrast agents (GBCAs) for Magnetic Resonance Imaging (MRI). The aim of this prospective study is to evaluate the occurrence of adverse reactions with special focus on NSF after administration of gadoterate meglumine (Dotarem) in a large series of patients with moderate, severe and end stage renal insufficiency and after renal transplantation. Conclusion: Interim analysis of the NSsaFe study showed no cases of NSF in patients with moderate to severe renal impairment. NSsaFe study confirms the excellent safety profile of gadoterate meglumine.

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