NSsaFe Study: Observational Study on the Incidence of Nephrogenic Systemic Fibrosis in Renal Impaired Patients Following Gadoterate Meglumine Administration.

Byung Chul Kang¹

High doses of gadolinium-based contrast agents (GBCAs), and possibly use of linear nonionic GBCAs, contribute to increased risk of Nephrogenic Systemic Fibrosis (NSF). Patients with severely impaired kidney function have an increased risk to develop NSF. Therefore, the main purpose of this study is to prospectively estimate the incidence of NSF after injection of gadoterate meglumine not only in patients with severe renal impairment, but also in patients with moderate renal impairment. This interim safety analysis already confirms the very good safety profile of gadoterate meglumine in renal impaired patients.