The first human cell line-derived erythropoietin, epoetin-? (Dynepo®), in the management of anemia in patients with chronic kidney disease

AIMS: To evaluate the efficacy and safety of the first human cell line-derived erythropoietin, epoetin-delta, in the management of anemia in patients with chronic kidney disease. METHODS: This was a multicenter, randomized, double-blind, parallel-group, active-control, Phase III study. Patients aged > or = 18 years with chronic renal disease requiring hemodialysis, with hemoglobin (Hb) levels in the range 9.6-12.4 g/dl, and who had been treated with recombinant erythropoietin for > or = 90 days before study entry were eligible. In the initial double-blind comparative study phase, patients were randomized in a 3:1 ratio to 24-week treatment with either intravenous (i.v.) epoetin-delta (ED) or epoetin-alpha (EA). Patients then entered a 28-week open-label phase, receiving i.v. ED at a dose equal to that of i.v. ED or EA which they received at the end of the blinded phase. RESULTS: In total, 752 patients were randomized, of whom 555 patients subsequently received ED and 191 patients EA, with 583 patients (77.5%) completing the double-blind phase and entering the open-label phase. There was no significant difference between groups for the primary endpoint: the average Hb level from Weeks 12-24 of the study. The adjusted mean average Hb level for the modified intent-to-treat (mITT) population was 11.57 g/dl in the ED group (n = 491, mean dose 63.5 IU/kg) and 11.56 g/dl in the EA group (n = 175, mean dose 62.8 IU/kg). Efficacy was maintained on long-term use. Data for Weeks 12-52 show that ED maintained patients' Hb levels in the target range (10-12 g/dl) with a mean Hb level of 11.31 g/dl at a mean ED dose of 63.7 IU/kg. ED therapy was well tolerated, with a similar overall incidence of adverse events (AEs) (94.4%) to the EA group (92.1%) in the double-blind phase (most common events: hypotension, upper respiratory tract infection, muscle cramps, headache). AEs occurring during the open-label phase were generally similar in type and frequency to those reported during the double-blind phase. CONCLUSIONS: The human cell line-derived erythropoietin, epoetin-delta, provides an effective, well tolerated new option for the management of anemia in patients with chronic kidney disease.