title: Effect of renal function on the pharmacokinetics of palifermin.
abstract: Palifermin (deltaN23KGF) 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 palifermin 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.
authors.affiliation: Amgen Inc, One Amgen Center Drive, MS 38-3-A, Thousand Oaks, CA 91320-1799, USA. bgillesp@amgen.com
authors.forename: B
authors.initials: B
authors.lastname: Gillespie
authors.forename: P
authors.initials: P
authors.lastname: Zia-Amirhosseini
authors.forename: M
authors.initials: M
authors.lastname: Salfi
authors.forename: T
authors.initials: T
authors.lastname: Kakkar
authors.forename: J
authors.initials: J
authors.lastname: Wang
authors.forename: S
authors.initials: S
authors.lastname: Gupta
authors.forename: B
authors.initials: B
authors.lastname: Smith
authors.forename: R
authors.initials: R
authors.lastname: Robson
authors.forename: J T
authors.initials: JT
authors.lastname: Sullivan
mesh_terms: D000328:Adult; D000368:Aged; D019540:Area Under Curve; D005221:Fatigue / Q000139:chemically induced; D005260:Female; D051523:Fibroblast Growth Factor 7 / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics*; D006207:Half-Life; D006261:Headache / Q000139:chemically induced; D006801:Humans; D007275:Injections, Intravenous; D007668:Kidney / Q000502:physiology* / Q000503:physiopathology; D007676:Kidney Failure, Chronic / Q000378:metabolism / Q000473:pathology / Q000503:physiopathology; D007677:Kidney Function Tests; D008297:Male; D008657:Metabolic Clearance Rate; D008875:Middle Aged; D009055:Mouth / Q000187:drug effects / Q000473:pathology; D051437:Renal Insufficiency / Q000378:metabolism / Q000473:pathology / Q000503:physiopathology; D012720:Severity of Illness Index; D017695:Soft Tissue Injuries / Q000139:chemically induced; D013280:Stomatitis / Q000139:chemically induced
chemical_list: D051523:Fibroblast Growth Factor 7