Comparison of the effects of weekly and biweekly intravenous CERA administration on erythropoiesis: A randomized controlled trial

Abstract

Although continuous erythropoietin receptor activators (CERAs) are widely used erythropoiesis‐stimulating agents for correcting renal anemia in patients undergoing hemodialysis (HD), few reports have examined weekly CERA administration. In this randomized controlled trial, we compared the efficacy and changes in the parameters of iron metabolism and erythropoiesis between weekly and biweekly CERA administration. In total, 120 patients undergoing maintenance HD were randomized to the weekly or biweekly group. The primary end point was the total CERA dose needed to maintain the target hemoglobin (Hb) levels during a 12‐week evaluation period. There was no significant difference in the total dose between the weekly and biweekly groups (median 175.0 [interquartile range (IQR) 93.8–337.5] µg/12 weeks vs. 300.0 [IQR 125.0–375.0] µg/12 weeks, P = .18). The mean Hb levels during the evaluation period were 10.9 ± 0.8 g/dL in the weekly group and 10.7 ± 0.8 g/dL in the biweekly group (P = .25). Weekly CERA administration was well tolerated. Weekly CERA administration similarly managed anemia as biweekly administration in patients undergoing HD.

Effectiveness of pegylated erythropoietin in renal anaemia patients on dialysis-a multicentre, cross-sectional, observational outcome study

“…These results are in line with the previously published studies, which have suggested a target Hb level of >10 g/dl in this patient population. 16,17,22 In this study, approximately half (51.46%) of the patients achieved Hb levels >10 g/dl at 3 months in both weekly and 10-day dose groups.…”

“…27 Recently, Kawai of anaemia was similar in weekly or biweekly CERA administration groups. 17 In line with these reports, the dosing used in our patients included a weekly dose or once every 10 days.…”

“…15 Several reports have established the efficacy of a biweekly dosing schedule in maintaining Hb levels with a low average dose. 16,17,22,25,26 In a randomized trial, Kakimoto-Shino et al indicated that weekly CERA administration can also improve iron utilization for erythropoiesis and subsequently increase Hb levels. 27 Recently, Kawai of anaemia was similar in weekly or biweekly CERA administration groups.…”

“…In the study by Kawai et al a weekly CERA administration showed mean Hb levels of 10.9 g/dl at the 3-month evaluation period in patients undergoing hemodialysis. 17 The target Hb levels of 10-11. 28 PegEPO in our study also showed an improvement in Hb in patients who had previously received treatment with other ESAs.…”

“…16 In addition, few reports has been indicated that the weekly CERA administration is effective in the renal anaemia patients undergoing the hemodialysis. 17 Pegylated erythropoietin (methoxy polyethylene glycolepoetin β) under the CERA category has been approved for the treatment of anaemia in CKD by the US food and drug administration. 15 Intas Pharmaceuticals Ltd. has developed a biosimilar pegylated recombinant human erythropoietin (PegEPO) formulation.…”