Primovist in renally impaired patients

• Research type

  Research Study

• Full title

  Prospective non-randomized (pharmacoepidemiologic) cohort study (open-label, multicenter) to assess the magnitude of potential risk with the administration of Primovist/Eovist in patients with moderate to severe renal impairment for the development of nephrogenic systemic fibrosis (NSF) based on diagnostically specific clinical and histopathologic information.

• IRAS ID

  14778

• Contact name

  Eric Loveday

• Sponsor organisation

  Bayer HealthCare AG

• Eudract number

  2008-005867-33

• Research summary

  Primovist is licensed as a contrast agent for use with magnetic resonance imaging (MRI) of the liver. It helps detect and diagnose changes that may be found in the liver. Primovist is given as a single intravenous injection immediately before an MRI scan. Primovist has only been licensed in the UK since May 2008 so, as with all new drugs, it is important to collect data on the risks and benefits when it is used in clinical practice. Primovist and other, similar contrast agents may increase the risk of developing a condition called nephrogenic systemic fibrosis (NSF) in patients who have kidney disease. NSF is a rare and serious condition that involves fibrosis of skin, joints, eyes, and internal organs. The Regulatory Authorities in the US have asked for further research in to the link between the use of some contrast agents and NSF. This study therefore aims to collect data to determine if patients with moderate or severe kidney disease might develop NSF up to 2 years after receiving a Primovist injection.

• REC name

  South West - Central Bristol Research Ethics Committee

• REC reference

  09/H0106/54

• Date of REC Opinion

  16 Jul 2009

• REC opinion

  Further Information Favourable Opinion