[Efficacy and safety of CERA in anemia correction in predialysis patients--Croatian experience].
To evaluate efficacy and safety of CERA (continuous erythropoietin receptor activator) administration for correcting anemia in the patients with chronic kidney disease (CKD), not on dialysis. We performed observational study on 27 CKD patients in stage 4 or 5 with renal anemia requiring use of erythropoiesis-stimulating agents (ESA). All patients received CERA (Mircera; Roche, Basel, Switzerland) subcutaneously in dose of 0.6 microg per kg every two weeks during the correction phase of anemia treatment or once monthly during the maintenance treatment. Dose of CERA was modified according to manufacturer instructions. Iron supplementation was administrated orally or intravenously in order to achieve serum ferritin 200-500 microg/L. Patients were followed up to 1 year (from 3-12 months). Response criteria for CERA were Hb increase >10 g/L above baseline or Hb > or = 110 g/L. Hb statistically significant (p < 0.05), increased during the observation period. The median at baseline was 94 g/L and after 6 months and one year were 108 g/L and 114.5 g/L respectively. Furthermore, the range of the lowest and highest values of Hb gradually decreased indicating less Hb fluctuation. After one year, all patients had Hb range 100 g/L to 120 g/L. There were no statistically significant differences between Hb between groups of patients stratified according to the primary kidney disease and age. During the study period two patients died due to myocardial infarction, probably not associated with CERA administration according to observed Hb levels (103 and 110 g/L). Only registered side effect was slight increase in arterial pressure, controlled with antihypertensive drugs. The majority of patients had reported better exercise tolerance and sleep and less irritability. The results of this observational study suggest that the use of CERA is effective and safe and leads to a successful correction of anemia in CKD patients who have not yet started renal replacement therapy.