C.E.R.A. Maintains Stable Control of Hemoglobin in Patients with Chronic Kidney Disease on Dialysis when Administered Once Every Two Weeks

Abstract

Background/Aims: This Phase III study examined the efficacy and safety of C.E.R.A., a continuous erythropoietin receptor activator, given once every 2 weeks (Q2W) via subcutaneous or intravenous injection using pre-filled syringes, for maintaining hemoglobin (Hb) levels in patients with chronic kidney disease (CKD) on dialysis who converted directly from epoetin therapy. Methods: Patients (n = 336) were randomized 1:1 to continue epoetin at their current dose, route and administration interval (once to three times weekly (QW–TIW)), or receive C.E.R.A. Q2W by the same route as previous epoetin treatment for 36 weeks. Dosage was adjusted to maintain patients’ Hb within ±1.0 g/dl of baseline value and within 10.0–13.5 g/dl. Primary endpoint was mean change in Hb between baseline and the evaluation period (weeks 29–36). Results: Mean change in Hb for C.E.R.A. and epoetin was 0.088 and –0.030 g/dl, respectively (endpoint Hb 11.93 and 11.86 g/dl, respectively). Analysis showed that C.E.R.A. was as effective as epoetin in maintaining Hb (p < 0.0001), and was well tolerated. The administration route had no impact on primary endpoint. Conclusion: Q2W C.E.R.A. administered using pre-filled syringes effectively maintains stable control of Hb in patients on dialysis who convert directly from epoetin QW–TIW.

Dose-finding Study of Peginesatide for Anemia Correction in Chronic Kidney Disease Patients

“…The results from this study suggest that Hb responses to comparable doses of IV and SC peginesatide may be similar, which has also been shown with the long-acting ESAs, darbepoetin alfa (14 -17) and methoxy polyethylene glycol-epoetin beta (18,19). Future studies are needed to evaluate the similarity of IV and SC dose requirements for peginesatide.…”

2015 Japanese Society for Dialysis Therapy: Guidelines for Renal Anemia in Chronic Kidney Disease

“…It has also been reported that after anemia improves, CERA should be administered once every 4 weeks in the dose range of 25-250 μg to maintain the target Hb level. Reports show that the Hb level is maintained by administering CERA once every 2-4 weeks because of its long serum half-life [89][90][91][92][93][94]. However, the Maintenance of Haemoglobin Excels with IV Administration of CERA (MAXIMA) [90] and Patients Receiving CERA Once a Month for the Maintenance of Stable Hemoglobin (PROTOS) [91] studies, in which switching from rHuEPO to CERA in HD patients was examined in the form of RCTs, showed that an optimal Hb level, which is similar to the previous treatment with rHuEPO, was maintained by administering CERA once every 2 or 4 weeks but that the dose of CERA required to maintain an optimal Hb level once every 4 weeks was higher than that required once every 2 weeks.…”

Hemoglobin Variability with Epoetin Beta and Continuous Erythropoietin Receptor Activator in Patients on Peritoneal Dialysis

“…Furthermore, there has been very little study on whether different ESA types affect Hb stability. Continuous erythropoietin receptor activator [CERA (Mircera: Hoffman-LaRoche, Basel, Switzerland)] has a much longer mode of action than the first-generation recombinant epoetins and allows for successful anemia treatment with prolonged dosing intervals (10)(11)(12). Because ESA dose changes have been related to fluctuations in Hb, the lower number of dose changes with CERA may be beneficial (10).…”