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QUANTITATIVE CLINICAL PHARMACOLOGY

Population Pharmacokinetic Modeling of Epoetin Delta in Pediatric Patients With Chronic Kidney Disease

William Knebel, PharmD, PhD, Mary Palmen, PhD, James A. Dowell, PhD and Marc Gastonguay, PhD

From Metrum Research Group LLC, Tariffville, Connecticut (Dr Knebel, Dr Gastonguay), and Shire Pharmaceuticals, Basingstoke, Hampshire, UK (Dr Palmen, Dr Dowell).

This analysis quantifies the population pharmacokinetics of subcutaneous and intravenous epoetin delta, an epoetin produced in a human cell line, in pediatric patients with chronic kidney disease and estimates the effects of covariate factors on epoetin delta and epoetin alfa pharmacokinetic parameters. Erythropoietin serum concentration data, taken from a phase III study conducted in 60 patients aged 1 to 17 years, were best described by a 1-compartment model with first-order absorption and elimination. The typical point estimates were clearance (0.268 L/h), central volume of distribution (1.03 L), absorption rate constant (0.0554 h–1), and bioavailability (0.708) for a 35-kg male ≤10 years who was predialysis and on subcutaneous epoetin delta treatment. Erythropoietin pharmacokinetic parameters were similar in pediatric patients as compared with adults when scaled by weight. The subcutaneous administration of epoetin alfa exhibited lower systemic bioavailability than subcutaneous administration of epoetin delta.

Key Words: Epoetin delta • erythropoietin • pediatrics • chronic kidney disease • population pharmacokinetic modeling

Address for reprints: William Knebel, PharmD, PhD, 2 Tunxis Road, Suite 112, Tariffville, CT 06081; e-mail: billk{at}metrumrg.com.


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