Renal tolerance of a neutral gadolinium chelate (gadobutrol) in patients with chronic renal failure: Results of a randomized study

PURPOSE: To assess the renal tolerance of 1.0 mol/L gadobutrol as an electr ically neutral contrast agent at magnetic resonance (MR) imaging in patient s with impaired renal function. MATERIALS AND METHODS: Twenty-one patients with impaired renal function wer e enrolled in this prospective randomized study and classified into two sub groups according to their creatinine clearance: group 1 (n = 12), less than 80 mL/min (<1.33 mL/sec) and greater than 30 mL/min (>0.50 mL/sec); group 2 (n = 9), less than 30 mL/min (<0.50 mL/sec) and not requiring dialysis. G adobutrol (1.0 mol/L) was injected intravenously at randomly assigned doses of either 0.1 or 0.3 mmol per kilogram of body weight. Changes in vital si gns, clinical chemistry, and urinalysis results, including creatinine clear ance, were monitored before, at 6 hours, and then every 24 hours until 72 h ours (group 1) or 120 hours (group 2) after intravenous injection of gadobu trol. Hematologic results were checked every other day. RESULTS: No serious adverse event occurred, and no clinically relevant chan ges in vital signs, hematologic results, clinical chemistry, or urinalysis results were detected in the observation period. Markers for glomerular fil tration (creatinine, cystatin C, <beta>2-microglobulin, creatinine clearanc e) and tubular function (N-acetyl-beta -D-glucosaminidase, alpha1-microglob ulin) were unaffected by gadobutrol in both groups. CONCLUSION: Gadobutrol did not affect renal function and, therefore, proved to be a safe MR contrast agent in patients with impaired renal function. E ven in patients with marginal excretory function (creatinine clearance, <30 mL/min [<0.50 mL/sec]), prehydration or treatment with diuretics or hemodi alysis are not required after the administration of gadobutrol.