Efficacy and tolerability of intravenous continuous erythropoietin receptor activator: A 19-week, phase ii, multicenter, randomized, open-label, dose-finding study with a 12-month extension phase in patients with chronic renal disease

Besarab, Anatole; Salifu, Moro O.; Lunde, Norman M.; Bansal, Vinod; Fishbane, Steven; Dougherty, Frank C.; Beyer, Ulrich

doi:10.1016/j.clinthera.2007.04.014

Cited by 36 publications

(24 citation statements)

References 28 publications

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“…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).…”

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confidence: 99%

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

2012

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♦ Background and Objectives: The extent to which hemo globin (Hb) cycling occurs in peritoneal dialysis (PD) patients is unclear. It is also uncertain whether different types of erythropoiesisstimulating agents (ESAs) affect such cycling. We performed a retrospective cohort study of our PD population before and after the entire program was switched from epoetin beta (NeoRecormon: HoffmanLaRoche, Basel, Switzerland) to continuous erythropoietin receptor activator [CERA (Mircera: Hoffman-LaRoche)]. ♦ Design, Setting, Participants, and Measurements: The study included 79 patients receiving PD for endstage renal failure and being treated with an ESA. Hemoglobin concentrations were measured monthly, and each study period ran for 12 months. Patient demographics and details of intercurrent illness and hospital admission were collected. ♦ Results: There was a trend to fewer patients on CERA (26 patients, 68.4%) than on epoetin beta (36 patients, 87.8%, p = 0.054) experiencing Hb excursions. The CERA group also required fewer dose changes. However, there was no differ ence in the proportion of patients experiencing complete Hb cycles. On logistic regression, the factors associated with Hb cycling were ESA dose increase or decrease and hospital admission. We also observed a positive correla tion between the delta ESA dose and the amplitude of Hb excursion, suggesting that the dose changes were causal, rather than reactive. ♦ Conclusions: Hemoglobin cycling occurs in PD patients and is largely a consequence of current practice in ESA dos ing, plus the effects of intercurrent illness. The longer half life of CERA may offer a small advantage in reducing the degree of Hb variability, possibly because of fewer dose changes per patient.

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confidence: 99%

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

2012

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“…was documented to be well tolerated, with no association of the pattern of AEs with the dosage or schedule of regimen (4). In a recent meta-analysis of phase II-III data on C.E.R.A treatment, C.E.R.A was determined to be associated with significantly lower rates of AEs and SAEs as compared with other ESAs (29).…”

Section: Discussionmentioning

confidence: 99%

“…Management of anemia has been considered challenging, involving the frequent administration of conventional ESAs along with the need for Hb monitoring and dose adjustments (4,26,27). Given the complexity of clinical management of dialysis patients, the introduction of extended administration intervals and less frequent dose changes has been considered to offer a simplified and less time-consuming care and thus to allow the fair distribution of healthcare resources along with a reduction in healthcare costs (4,30).…”

Section: Discussionmentioning

confidence: 99%

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Subcutaneous C.E.R.A. for the Treatment of Chronic Renal Anemia in Predialysis Patients

et al. 2016

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Background:We investigated the efficacy, safety and tolerability of once-monthly administration of C.E.R.A. in erythropoiesis stimulating agents (ESAs) naive predialysis patients with CKD for anemia treatment Study Design: Single arm, open label study. Methods: A total of 75 patients (mean (SD) age was 52.8 (16.4) years, 76.0% were female) were included in this study conducted between 12 August 2008 and 30 October 2009 in 9 centers across Turkey. The mean change in Hb concentration (g/dL) between baseline (week 0) and the efficacy evaluation period (EEP) was the primary efficacy parameter evaluated in three consecutive periods including a dose titration period (DTP; with initial 1.2 μg/kg dose of C.E.R.A., subcutaneously, 28 weeks), EEP (8 weeks) and a long-term safety period (16 weeks). Results: Our analysis revealed an improvement in Hb levels from baseline value of 9.4 (0.4) g/dL to time adjusted average level of 11.4 (0.7) g/dL in EEP in the per protocol (PP) population and from 9.3 (0.5) g/dL to 11.1 (1.0) g/dL in intent-to-treat (ITT) population. Mean (SD) change in Hb levels from baseline to EEP was 2.0 (0.7) g/dl in the PP population (primary endpoint) and 1.7 (1.1) g/dL in the ITT population. The percentage of patients whose Hb concentrations remained within the target range of 10.0-12.0 g/dL throughout the EEP was 43.9% (95% CI: 28.5-60.3%) in the PP population and 38.7% (95% CI: 27.6% to 50.6%) in the ITP population. A total of 206 adverse events (AE) were reported in 77.0% of patients with hypertension (20%) as the most frequent AE. Conclusion: Once-monthly subcutaneous C.E.R.A. administration is effective and safe in the treatment of anemia in pre-dialysis patients with CKD, who are not currently treated with ESAs.

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“…Methoxy-PEG-epoetin beta contains a single methoxy-PEG polymer of 30 kDa integrated via amide bonds between the amino groups of either the alanine in position 1 or one of the lysines in positions 45 or 52 of EPO [97]. Methoxy-PEG-epoetin beta has an extremely long half-life (130-140 hr), which allows for less frequent application [98][99][100][101]. Darbepoetin alfa and methoxy-PEG-epoetin beta doses are given in lg instead of in IU.…”

Section: Calibration Of Epoetinsmentioning

confidence: 99%

Biosimilar epoetins and other “follow‐on” biologics: Update on the European experiences

Jelkmann¹

2010

American J Hematol

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After the patents of biopharmaceuticals have expired, based on specific regulatory approval pathways copied products (“biosimilars” or “follow‐on biologics”) have been launched in the EU. This article summarizes experiences with hematopoietic medicines, namely the epoetins (two biosimilars traded under five different brand names) and the filgrastims (two biosimilars, six brand names). Physicians and pharmacists should be familiar with the legal and pharmacological specialities of biosimilars: The production process can differ from that of the original, clinical indications can be extrapolated, glycoproteins contain varying isoforms, the formulation may differ from the original, and biopharmaceuticals are potentially immunogenic. Only on proof of quality, efficacy and safety, biosimilars are a viable option because of their lower costs. Am. J. Hematol. 2010. © 2010 Wiley‐Liss, Inc.

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Efficacy and tolerability of intravenous continuous erythropoietin receptor activator: A 19-week, phase ii, multicenter, randomized, open-label, dose-finding study with a 12-month extension phase in patients with chronic renal disease

Cited by 36 publications

References 28 publications

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

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

Subcutaneous C.E.R.A. for the Treatment of Chronic Renal Anemia in Predialysis Patients

Biosimilar epoetins and other “follow‐on” biologics: Update on the European experiences

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