Initial use of once-monthly administration of C.E.R.A. is effective and safe in correcting renal anemia in non-dialysis patients: the MERCUR trial.

BACKGROUND: Continuous erythropoietin receptor activator (C.E.R.A.) is routinely given once every 2 weeks to correct hemoglobin (Hb) level, but monthly use is recommended in the maintenance phase. PATIENTS AND METHODS: In an open-label, single- arm, multicenter trial, 184 ESA-naïve non-dialysis patients with renal anemia (Hb ≤ 10.5 g/dl) received C.E.R.A. monthly from the start of therapy. The trial comprised a titration phase (Months 2 - 7) and an evaluation phase (Months 8 - 9). Mean Hb increased from 9.8 ± 0.7 g/dl at baseline to 11.5 ± 1.1 g/ dl during the evaluation phase (mean change 1.6 ± 1.1 g/dl; 95% CI 1.4 - 1.8 g/dl). Among patients with two Hb values available during the evaluation phase, 18.1% (19/105) were maintained at 11.0 - 12.0 g/dl and 49.5% (52/105) at 11.0 - 13.0 g/dl. 20 patients started dialysis and received C.E.R.A during the titration phase.
RESULTS: Their mean Hb increased from 10.6 ± 1.6 g/dl (last pre-dialysis value) to 11.3 ± 1.6 g/dl. Nine patients (4.9%) experienced one adverse event with a suspected relation to C.E.R.A.; 5 were graded serious. 54 patients (29.3%) discontinued the study (22 for adverse events).
CONCLUSION: Although no control arm was included, such that robust comparisons cannot be drawn, these results suggest that C.E.R.A. therapy can be initiated once a month in non-dialysis CKD patients with renal anemia without appearing to compromise the rate or degree of Hb correction.

RCT Entities:   Population Interventions Outcomes