SWITCH TO LOW DOSE C.E.R.A. MAINTAINS HEMOGLOBIN (HB) LEVELS IN NON DIALYSIS CHRONIC KIDNEY DISEASE (CKD): A MULTICENTRIC PROSPECTIVE STUDY IN ITALY

Introduction and Aims: Recent trials have emphasized the need of finding the lowest effective dose of erythropoiesis stimulating agents (ESA). This holds particularly true in non-dialysis CKD where ESA are prescribed at doses remarkably lower than in dialysis patients and long-acting agents are preferred. This study was aimed at evaluating efficacy of switching either darbepoetin (DA) or a/b epoetin (EPO) to the long-acting ESA (C.E.R.A.) at doses lower than those recommended by manufacturer. Methods: We selected consecutive adult CKD stage III-IV patients receiving either DA =60 μg/wk or EPO =12,000 IU/wk unchanged in the previous 3 months. We excluded patients with kidney transplant, iron deficiency, recent blood transfusion, bleeding, neoplasia, myocardial infarction or stroke in the last 3 months. Patients treated with DA =20 μg/wk or EPO =4,000 IU/wk were switched to C.E.R.A. 75 μg/ month; those treated with DA 21-40 μg/wk or EPO 4,001-8,000 IU/wk were switched to C.E.R.A. 100 μg/month and those receiving DA 41-60 μg/wk or EPO 8,001-12,000 IU/wk were switched to C.E.R.A. 120 μg/month. Patients were evaluated monthly in the 24 wks after switch. Primary endpoint was maintenance of Hb in the range 11-13 g/dL. Results: We selected 162 patients (safety population); of these, 152 (efficacy population) completed the study (8 were lost to follow-up and 2 reached ESRD). Mean age was 73±12 yrs and body weight was 73±15 kg; prevalence of males, diabetes and prior CV disease was 49%, 34% and 18%, respectively. Doses of DA (n=120) and EPO (n=32) before switching were 25±16 μg/wk and 5,630±3,214 IU/ wk, respectively. FP193 Table 1 *P=0.004 for trend C.E.R.A. dose was unchanged in 779 out of 912 visits (85%), increased in 55 (6%) and decreased in 78 (9%) visits. The mean number of dose adjustment per patient was 0.9±1.0. In safety population, no patients required blood transfusions; eight patients were hospitalized for CV (n=4), metabolic (n=2) and surgical causes (n=2). Blood pressure did not change; four patients had systolic level >180 mmHg in a single occasion. Conclusions: This study suggests that in CKD stage III-IV patients, switching from other ESAs to C.E.R.A. at doses lower than the recommended threshold is associated with maintenance of adequate anemia control in absence of safety concerns and with small percentage of dose changes during the follow-up.