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Received March 1, 2006
Accepted on July 24, 2006

ORIGINAL ARTICLES

Pharmacokinetics and Pharmacodynamics of Intravenous and Subcutaneous Continuous Erythropoietin Receptor Activator (C.E.R.A.) in Patients with Chronic Kidney Disease

Iain C. Macdougall ^*1, Richard Robson , Sylvie Opatrna , Xavier Liogier , Anne Pannier , Paul Jordan , Frank C. Dougherty , and Bruno Reigner

*Department of Renal Medicine, King’s College Hospital, London, United Kingdom; Christchurch Clinical Studies Trust, Christchurch, New Zealand; Charles University Medical School, Pilsen, Czech Republic; and F. Hoffmann-La Roche Ltd., Basel, Switzerland

¹ To whom correspondence should be addressed. E-mail: iain.macdougall{at}kingsch.nhs.uk.

	Abstract

Continuous Erythropoietin Receptor Activator (C.E.R.A.) is a new agent that is in development for the treatment of anemia with extended administration intervals in patients who have chronic kidney disease (CKD), both those on and those not on dialysis. This was an open-label, randomized, multicenter, two-period, crossover study in erythropoiesis-stimulating agent-naïve patients who had CKD and anemia and were receiving peritoneal dialysis. After a 1-wk run-in period, 16 patients were randomly assigned to receive a single administration of intravenous C.E.R.A. 0.4 µg/kg (n = 8) or subcutaneous C.E.R.A. 0.8 µg/kg (n = 8). Six weeks after the first administration of C.E.R.A. (4-wk assessment, 2-wk washout), the route of administration was switched so that all patients received single administrations of both intravenous C.E.R.A. 0.4 µg/kg and subcutaneous C.E.R.A. 0.8 µg/kg. C.E.R.A. had a prolonged and comparable half-life after intravenous (mean 134 h) and subcutaneous (mean 139 h) administration. Reticulocyte counts peaked at a median of 8 d after intravenous and subcutaneous administration with no difference in the time course between administration routes. This resulted in similar mean values for the area under the reticulocyte count-time curve (1191 x 10⁹ and 1193 x 10⁹·d per L, respectively) and the maximum absolute increase in reticulocyte counts (36 x 10⁹ and 41 x 10⁹/L, respectively). C.E.R.A. has a prolonged and comparable half-life after intravenous or subcutaneous injection, suggesting that extended administration intervals may be feasible in patients with CKD.

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