Journal
JOURNAL OF CLINICAL PHARMACOLOGY
Volume 46, Issue 12, Pages 1460-1468Publisher
WILEY
DOI: 10.1177/0091270006292705
Keywords
polifermin; renal clearance; keratinocyte growth factor; chronic kidney disease; mucositis
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Polifermin (Delta N23KGF) decreases the incidence, severity, and duration of oral mucositis. The objectives of this open-label study were to evaluate the pharmacokinetics of single-dose palifermin in subjects with varying degrees of renal function. A single 90-mcg/kg, intravenous dose of polifermin was administered to 31 subjects with varying levels of renal function (normal to requiring hemodialysis). Pharmacokinetic analyses were conducted using serum palifermin concentrations. There was considerable overlap in mean palifermin serum clearance among the groups, ranging from 318 to 495 mL/h/kg, indicating that the level of renal function did not affect clearance in humans; thus, no dose adjustment of palifermin is indicated for patients with renal dysfunction.
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