title: Nephrogenic systemic fibrosis risk after liver magnetic resonance imaging with gadoxetate disodium in patients with moderate to severe renal impairment: results of a prospective, open-label, multicenter study.
abstract: OBJECTIVE
  The objective of this study was to assess the risk of gadoxetate disodium in liver imaging for the development of nephrogenic systemic fibrosis (NSF) in patients with moderate to severe renal impairment.
  
  
  METHODS
  We performed a prospective, multicenter, nonrandomized, open-label phase 4 study in 35 centers from May 2009 to July 2013. The study population consisted of patients with moderate to severe renal impairment scheduled for liver imaging with gadoxetate disodium. All patients received a single intravenous bolus injection of 0.025-mmol/kg body weight of liver-specific gadoxetate disodium. The primary target variable was the number of patients who develop NSF within a 2-year follow-up period.
  
  
  RESULTS
  A total of 357 patients were included, with 85 patients with severe and 193 patients with moderate renal impairment, which were the clinically most relevant groups. The mean time period from diagnosis of renal disease to liver magnetic resonance imaging (MRI) was 1.53 and 5.46 years in the moderate and severe renal impairment cohort, respectively. Overall, 101 patients (28%) underwent additional contrast-enhanced MRI with other gadolinium-based MRI contrast agents within 12 months before the start of the study or in the follow-up. No patient developed symptoms conclusive of NSF within the 2-year follow-up.
  
  
  CONCLUSIONS
  Gadoxetate disodium in patients with moderate to severe renal impairment did not raise any clinically significant safety concern. No NSF cases were observed.
authors.affiliation: From the *Department of Diagnostic and Interventional Radiology and Neuroradiology, University Hospital Essen, Essen, Germany; †Departmento de Radiologia Hospital Universitario San Cecili Granada, Granada, Spain; ‡Department of Radiology and Research Institute of Radiology, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Bundang; §Department of Radiology, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea; ∥Klinik für Radiologie und Nuklearmedizin Universitätsklinikum Magdeburg, Magdeburg, Germany; ¶Department of Radiology, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; #Institut für Diagnostische und Interventionelle Radiologie, SRH Wald-Klinikum Gera, Gera, Germany; **Department of Radiology, Duke University Medical Center, Durham, NC; ††Department of Radiology, Faculty of Medicine, Mahidol University Siriraj Hospital, Bangkok; ‡‡Department of Radiology, Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand; §§Department of Biomedical Imaging und Image-Guided Therapy, Medical University of Vienna, Austria; ∥∥Department of Radiology, Division of Magnetic Resonance Imaging, University of Michigan Health System, Ann Arbor, MI; ¶¶Bayer HealthCare Pharmaceuticals, Berlin, Germany; and ##Department of Gynecology, Obstetrics and Reproductive Medicine, University Medical School of Saarland, Homburg/Saar, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Lauenstein
authors.forename: Francisco
authors.initials: F
authors.lastname: Ramirez-Garrido
authors.forename: Young Hoon
authors.initials: YH
authors.lastname: Kim
authors.forename: Sung Eun
authors.initials: SE
authors.lastname: Rha
authors.forename: Jens
authors.initials: J
authors.lastname: Ricke
authors.forename: Sith
authors.initials: S
authors.lastname: Phongkitkarun
authors.forename: Joachim
authors.initials: J
authors.lastname: Boettcher
authors.forename: Rajan T
authors.initials: RT
authors.lastname: Gupta
authors.forename: Pornpim
authors.initials: P
authors.lastname: Korpraphong
authors.forename: Wiwatana
authors.initials: W
authors.lastname: Tanomkiat
authors.forename: Julia
authors.initials: J
authors.lastname: Furtner
authors.forename: Peter S
authors.initials: PS
authors.lastname: Liu
authors.forename: Maren
authors.initials: M
authors.lastname: Henry
authors.forename: Jan
authors.initials: J
authors.lastname: Endrikat
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003287:Contrast Media / Q000009:adverse effects*; D005260:Female; D005500:Follow-Up Studies; D019786:Gadolinium DTPA / Q000009:adverse effects*; D006801:Humans; D007674:Kidney Diseases / Q000150:complications*; D008099:Liver / Q000473:pathology; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D054989:Nephrogenic Fibrosing Dermopathy / Q000139:chemically induced* / Q000150:complications*; D011446:Prospective Studies; D012306:Risk; D012720:Severity of Illness Index; D055815:Young Adult
chemical_list: D003287:Contrast Media; C073590:gadolinium ethoxybenzyl DTPA; D019786:Gadolinium DTPA