Jan Galle *
Objective: To evaluate once-monthly continuous erythropoiesis receptor activator (C.E.R.A.) in patients with chronic kidney disease (CKD) for two years under standard conditions.
Methods: In a non-interventional study, C.E.R.A. was administered according to local practice in patients with dialysis dependent or non-dialysis dependent CKD.
Results: 206 patients were evaluable to month 24. In the dialysis dependent and non-dialysis dependent patients who had received ESA therapy prior to study entry, Hb remained stable from baseline to the end of the study: mean (SD) change was -0.3 (1.5) g/dL (n=148) and 0.3 (1.6) g/dL (n=33), respectively. The mean (SD) dose of C.E.R.A. was 114 (78) μg in dialysis dependent patients and 97 (71) μg in non-dialysis dependent patients at baseline, remaining virtually unchanged during the study (109 (76) μg and 99 (68) μg). During the two-year study, dialysis dependent and non-dialysis dependent patients received a mean of 6.1 and 4.3 dose changes, respectively. Discontinuation due to adverse events was rare (2.9%).
Conclusions: Once-monthly C.E.R.A. is effective and convenient in dialysis dependent and non-dialysis dependent patients with renal anemia under routine conditions for at least two years, and requires few dose changes. C.E.R.A. was well-tolerated with a good safety profile over the two-year study period.
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