Fixed-dose darbepoetin use as good as titration based use to minimize transfusions in CKD

Strategies using Darbepoetin Alfa to Avoid Transfusion in Chronic Kidney Disease (START-CKD) study was a phase 3, multicenter, randomized, double-blind, parallel-group study of 756 adults with stage-3 to -5 CKD and anaemia. Among 756 patients, 379 patients were randomized to the fixed-dose group and 377 to the titration-dose group. Over 2 years, similar proportions of both groups were transfused: 24.1% fixed-dose group vs 24.4% titration-dose group, with no difference in time to the first transfusion. Participants received transfusions as deemed necessary by the treating physician.

Key findings of the study were:

• Upon analysis, the researchers found that the titration-dose group achieved significantly higher median haemoglobin (9.9 g/dl) compared with the fixed-dose group (9.4 g/dl).
• They also found that the fixed-dose group had a significantly lower median cumulative dose of darbepoetin (median monthly dose of 30.9 µg) compared with the titration-dose group (53.6 µg median monthly dose).
• This difference, however, was balanced by a significantly lower median cumulative exposure to the ESA in the fixed-dose rather than titrated-dose group: median monthly dose 30.9 vs 53.6 µg, respectively, with a between-group difference of -22.1 µg.

The authors concluded, "These findings indicate no evidence of difference in incidence of red blood cell transfusion for a titration-dose strategy versus a fixed-dose strategy for darbepoetin. This suggests that a low fixed dose of darbepoetin may be used as an alternative to a dose-titration approach to minimize transfusions, with less cumulative dosing."

For further information:

https://jasn.asnjournals.org/content/32/2/469