Darbepoetin Alfa Once Monthly Dosing Schedule Maintains Hemoglobin Concentration Comparable to Every 2 Weeks Dosing Schedule in Advanced Chronic Kidney Disease Patients Not on Dialysis: A Multicenter, Phase 4 Study

This open-label, multicenter, single-arm phase 4 trial evaluated the efficacy and safety of once-monthly subcutaneous administration of darbepoetin alfa (DARB) compared with biweekly dosing in Korean patients with non-dialysis chronic kidney disease (ND-CKD) and anemia. Anemia in CKD is a major contributor to cardiovascular morbidity and mortality. Although DARB every-2-week dosing has been established as effective, once-monthly dosing may maintain Hb levels while improving patient adherence and reducing healthcare burden. No clinical data were previously available for the Korean population, which is rapidly aging and has a high prevalence of CKD. Study Design: A total of 65 patients entered a 12-week screening period during which they received DARB every 2 weeks. Of these, 40 patients met eligibility criteria (stable Hb ≥9.5 g/dL, \11 g/dL Change in iron parameters (serum ferritin, transferrin saturation) Total DARB dose administered Requirement for oral iron supplementation Incidence of adverse events and blood pressure changes Eligibility Criteria: Inclusion: Age ≥19 years Diagnosis of CKD not requiring dialysis eGFR ≤45 mL/min/1.73m² (MDRD formula) Mean Hb ≤11.5 g/dL during screening, with Hb ≥9.5 g/dL Stable DARB dosing during screening (\20% Exclusion: Non-CKD causes of anemia Acute myocar