The first human cell line-derived erythropoietin, epoetin-delta (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.