Continuous Erythropoietin Receptor Activator (C.E.R.A.) administered at extended administration intervals corrects anaemia in patients with chronic kidney disease on dialysis: a randomised, multicentre, multiple-dose, phase II study.

摘要: This dose-finding, open-label study examined the potential of subcutaneous Continuous Erythropoietin Receptor Activator (C.E.R.A.) to correct anaemia at extended administration intervals in 61 erythropoiesis-stimulating agent-naive patients with chronic kidney disease (CKD) on dialysis. After a 4-week run-in, were randomised C.E.R.A. 0.15, 0.30 and 0.45 microg/kg/week. Within these dose groups, further once weekly, every 2 weeks or 3 treatment. Mean changes haemoglobin (Hb) increased increasing during period 6 where no adjustments permitted. The effect was independent schedule. Erythropoietic responses sustained until end (12 weeks) all groups. In total, 90% microg/kg/week group 79% responded treatment (Hb increase > =1.0 g/dl), compared 72% 0.15 group. Faster median response time associated (51, 38 31 days, respectively) unrelated frequency. generally well tolerated. Our results suggest that 0.60 microg/kg twice monthly would be suitable starting for initiation correction CKD Phase III studies will confirm feasibility using anaemia.