Disposition of Recombinant Human Interleukin-10 in Subjects with Various Degrees of Renal Function

The pharmacokinetics of intravenously administered recombinant human interleukin‐10 (rHuIL‐10) were evaluated in 18 subjects with creatinine clearances (Clcr) between 2.7 and 116.7 mL/min/1.73m2. Serum samples for rHuIL‐10 were obtained over a 48‐hour period after a single 25 μg/kg IV bolus infusion. AUC, total body clearance (Clp), and steady‐state volume of distribution (Vdss) were derived by compartmental methods. Analysis of serum concentrations showed statistically significant group differences for log‐transformed 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 declined. A linear relationship between AUC and Clcr as well as Clp and Clcr demonstrates that the disposition of rHuIL‐10 is altered in subjects with renal insufficiency. No serious adverse events were noted.