Disposition of recombinant human interleukin-10 in subjects with various degrees of renal function

The pharmacokinetics of intravenously administered recombinant human interl eukin-10 (rHuIL-10) were evaluated in 18 subjects with creatinine clearance s (Clcr) between 2.7 and 116.7 mL/min/1.73m(2). Serum samples for rHuIL-10 were obtained over a 48-hour period after a single 25 mu g/kg IV bolus infu sion. AUC, total body clearance (Clp), and steady-state volume of distribut ion (Vdss) were derived by compartmental methods. Analysis of serum concent rations showed statistically significant group differences for log-transfor med AUC and original scale Clp (p < 0.01). The AUC and effective half-life increased, while the mean Clp of rHuIL-10 decreased as renal function decli ned. A linear relationship between AUC and Clcr as well as Clp and Clcr dem onstrates that the disposition of rHuIL-10 is altered in subjects with rena l insufficiency No serious adverse events were noted. Journal of Clinical P harmacology 1999;39:1015-1020 (C)1999 the American College of Clinical Phar macology.