Related Experiment Video
Updated: Mar 16, 2026
A Murine Model of Hemodialysis Access-Related Hand Dysfunction
Published on: May 31, 2022
Gadobutrol in Renally Impaired Patients: Results of the GRIP Study
Henrik J Michaely1, Manuela Aschauer, Hannes Deutschmann
1From 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.
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).
Materials And 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.
Related Concept Videos
01:25Drug Dosing in Renal Diseases: Measurement of Glomerular Filtration Rate
01:18Pharmacokinetics in Geriatric Patients: Effect of Age on Drug Excretion
01:28Drug Dosing in Renal Diseases: Estimation of Glomerular Filtration Rate Based on Serum Creatinine Concentration
01:15Drug Dosing: Geriatric Patients
01:25Drug Dosing in Renal Diseases: Dose Adjustments Based on Drug Clearance and Elimination Rate Constant
01:11Renal Failure: Dose Adjustments
Reduced renal clearance and elimination rate are common outcomes of renal impairment. These alterations lead to a prolonged elimination half-life and an altered apparent volume of distribution for drugs. As a result, dosage adjustments are typically necessary to maintain optimal drug levels in the body.
However, dosage adjustments...