No incidence of nephrogenic systemic fibrosis after gadobenate dimeglumine administration in patients undergoing dialysis or those with severe chronic kidney disease

Purpose: To determine the incidence of nephrogenic systemic fibrosis (NSF) in patients with severe chronic kidney disease (CKD) who underwent a uniform protocol for contrast material-enhanced magnetic resonance (MR) imaging with a gadolinium-based contrast agent (GBCA). Materials and Methods: This retrospective, single-center, institutional review board-approved, HIPAA-compliant study included 3819 patients with severe (stage 4 or 5) CKD who underwent gadobenate dimeglumine-enhanced MR imaging as part of a preoperative evaluation for potential renal transplantation from January 2008 to February 2014. After undergoing contrast-enhanced MR imaging, patients were assessed for NSF by means of clinical follow-up, including a full integumentary examination, with a minimum of 6 months between administration of the GBCA and clinical skin examination. Suspicious skin lesions were sampled with deep punch biopsy, and results of pathologic examination were reviewed and categorized. In addition, a search of the institution's pathology database during the time of the study was performed to identify any additional patients with NSF. The proportion of subjects who developed NSF after the administration of gadobenate dimeglumine was calculated, and Clopper-Pearson 95% confidence intervals were determined by using binomial proportions. Results: The average length of follow-up for the patient population was 501 days (range, 186-2121 days). A total of 219 biopsies were performed, and none of the 3819 patients developed NSF after administration of gadobenate dimeglumine, resulting in a proportion of zero; the exact upper bound of 95% confidence interval was 0.000965 (0.0965%). Conclusion: None of the 3819 patients with severe CKD developed NSF after undergoing gadobenate dimeglumine-enhanced MR imaging, which suggests that this GBCA may be safely administered in patients with severe CKD, with an immeasurable risk for the subsequent development of NSF.