జర్నల్ ఆఫ్ నెఫ్రాలజీ & థెరప్యూటిక్స్

Hemoglobin Outcomes during Administration of Continuous Erythropoietin Receptor Activator (C.E.R.A): A Prospective, Observational, Multicenter Study

Abstract

Dirk Henrich*,Michael Rambausek

Objective: To evaluate Hb outcomes in patients with dialysis-dependent or non-dialysis dependent chronic kidney disease (CKD) receiving continuous erythropoietin receptor activator (C.E.R.A.) therapy under routine conditions at specialist nephrology centers in Germany.

Methods: In a 12-month, prospective, observational, multicenter study, Hb outcomes were assessed in 1,580 patients with CKD (1,184 dialysis-dependent, 326 non-dialysis dependent) given once-monthly C.E.R.A. under routine conditions.

Results: Across the total study population, mean hemoglobin was in the range 11.4–11.6 g/dL at all post-baseline visits. In the 962 patients on hemodialysis who were pretreated with ESA including C.E.R.A., mean (SD) hemoglobin was 11.4 (1.2) g/dL at baseline and 11.5 (1.1) g/dL at month 12; the mean (SD) number of C.E.R.A. dose changes was 3.0 (2.4). For the 227 non-dialysis dependent patients without prior ESA therapy, mean hemoglobin values were 10.6 (1.1) g/dL at baseline and 11.6 (1.3) g/dL at month 12, with a mean of 1.0 (1.4) dose changes. Presence of diabetic nephropathy showed no clinically relevant effect on hemoglobin response in either group. Overall, the proportion of patients with every hemoglobin measurement within narrow (≤ 2 g/dL) pre-specified ranges was low (<10%), but higher for the range 10.0–13.0 g/dL (28.7%), reflecting the known fluctuation in hemoglobin values over time. Patients managed at large centers were more likely to have hemoglobin range in the range 10–13 g/dL throughout the 12-month study, suggesting closer anemia management. In total, five patients (0.3%) discontinued C.E.R.A. due to adverse events.

Conclusion: Switching dialysis-dependent patients from more frequent ESA regimens to once-monthly C.E.R.A. therapy or initiating once-monthly C.E.R.A. de novo in predialysis CKD patients appears to be an effective therapeutic strategy regardless of diabetic status.