title: Gadobutrol in Renally Impaired Patients: Results of the GRIP Study.
abstract: OBJECTIVE
  The aim of this study was to assess the potential risk of gadobutrol-enhanced magnetic resonance imaging (MRI) in patients with moderate to severe renal impairment for the development of nephrogenic systemic fibrosis (NSF).
  
  
  METHODS
  We performed a prospective, international, multicenter, open-label study in 55 centers. Patients with moderate to severe renal impairment scheduled for any gadobutrol-enhanced MRI were included. All patients received a single intravenous bolus injection of gadobutrol at a dose of 0.1 mmol/kg body weight. The primary target variable was the number of patients who develop NSF within a 2-year follow-up period.
  
  
  RESULTS
  A total of 908 patients were enrolled, including 586 with moderate and 284 with severe renal impairment who are at highest risk for developing NSF. The mean time since renal disease diagnosis was 1.83 and 5.49 years in the moderate and severe renal impairment cohort, respectively. Overall, 184 patients (20.3%) underwent further contrast-enhanced MRI with other gadolinium-based contrast agents within the 2-year follow-up. No patient developed symptoms conclusive of NSF.
  
  
  CONCLUSIONS
  No safety concerns with gadobutrol in patients with moderate to severe renal impairment were identified. There were no NSF cases.
authors.affiliation: From the *Institute of Clinical Radiology and Nuclear Medicine, University Hospital Mannheim, Mannheim, Germany; †Clinical Division of Neuroradiology, Vascular and Interventional Radiology, Department of Radiology, Medical University Graz, Graz, Austria; ‡Department of Radiology and Nuclear Medicine, University of Basel Hospital, Basel, Switzerland; §Department of Diagnostic and Interventional Radiology, University Leipzig-Heart Center, Leipzig, Germany; ∥Department of Biomedical Imaging and Image-guided Therapy, Medical University of Vienna, Vienna, Austria; ¶Institute for Clinical Radiology, Ludwig-Maximilian University of Munich-Grosshadern Hospital, Munich, Germany; #Department of Medical Imaging, University Health Network and University of Toronto, Toronto, Ontario, Canada; **Department of Diagnostic and Interventional Radiology, University Hospital Frankfurt, Frankfurt am Main, Germany; ††Department of Radiology Experimental Imaging Center, San Raffaele Hospital, Vita-Salute University, Milan, Italy; ‡‡Bayer Pharmaceuticals, Radiology, Whippany, NJ; §§Bayer Pharma AG, Radiology, Berlin, Germany; and ∥∥Department of Gynecology, Obstetrics, and Reproductive Medicine, University Medical School of Saarland, Homburg/Saar, Germany.
authors.forename: Henrik J
authors.initials: HJ
authors.lastname: Michaely
authors.forename: Manuela
authors.initials: M
authors.lastname: Aschauer
authors.forename: Hannes
authors.initials: H
authors.lastname: Deutschmann
authors.forename: Georg
authors.initials: G
authors.lastname: Bongartz
authors.forename: Matthias
authors.initials: M
authors.lastname: Gutberlet
authors.forename: Ramona
authors.initials: R
authors.lastname: Woitek
authors.forename: Birgit
authors.initials: B
authors.lastname: Ertl-Wagner
authors.forename: Walter
authors.initials: W
authors.lastname: Kucharczyk
authors.forename: Renate
authors.initials: R
authors.lastname: Hammerstingl
authors.forename: Francesco
authors.initials: F
authors.lastname: De Cobelli
authors.forename: Martin
authors.initials: M
authors.lastname: Rosenberg
authors.forename: Thomas
authors.initials: T
authors.lastname: Balzer
authors.forename: Jan
authors.initials: J
authors.lastname: Endrikat
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003287:Contrast Media / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D006801:Humans; D007275:Injections, Intravenous; D008279:Magnetic Resonance Imaging / Q000009:adverse effects / Q000379:methods; D008297:Male; D008875:Middle Aged; D054989:Nephrogenic Fibrosing Dermopathy / Q000000981:diagnostic imaging* / Q000209:etiology; D009942:Organometallic Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D051437:Renal Insufficiency / Q000150:complications / Q000000981:diagnostic imaging*; D055815:Young Adult
chemical_list: D003287:Contrast Media; D009942:Organometallic Compounds; C090600:gadobutrol