Search

Continuous erythropoietin receptor activator (CERA) is a third-generation erythropoiesis-stimulating agent that was developed for the treatment of anemia. However, misuse of CERA for doping in endurance sports has been reported. Previous studies have shown blood as the matrix of choice for the detection of CERA, due to its high molecular weight. The use of dried blood spots (DBSs) for anti-doping purposes constitutes a complementary approach to the standard urine and venous blood matrices and could facilitate sample collection and increase the number of blood samples available for analysis due to reduced costs of sample collection and transport. Here, we investigated whether CERA could be indirectly detected in extracts of single DBSs using an erythropoietin-specific immunoassay that is capable of providing results within approximately two hours. Reconstituted DBS samples were prepared from mixtures of red blood cell pellets and serum samples. The samples were collected in a previous clinical study in which six healthy volunteers were injected with a single, 200 μg dose of CERA. Using a commercially available ELISA kit, CERA was detected in the DBSs with a detection window of up to 20 days post-injection. Furthermore, in order to demonstrate the fitness-for-purpose, three authentic doping control serum samples, which were identified as containing CERA were analyzed by the presented methodological approach on DBS. The testing procedure described here could be used as a fast and cost-effective method for the detection of CERA abuse in sport.

BACKGROUND Erythropoiesis-stimulating agents (ESAs) are the mainstay of anemia therapy. Continuous erythropoietin receptor activator (CERA) is a highly effective, long-acting ESA developed for once-monthly dosing. A multitude of clinical studies has evaluated the safety and efficiency of this treatment option for patients with renal anemia. In times of permanent financial pressure on health care systems, the cost-effectiveness of CERA should be of particular importance for payers and clinicians. OBJECTIVE To critically analyze, from the nephrologists' point of view, the published literature focusing on the cost-effectiveness of CERA for anemia treatment. METHODS The detailed literature search covered electronic databases including MEDLINE, PubMed, and Embase, as well as international conference abstract databases. RESULTS Peer-reviewed literature analyzing the definite cost-effectiveness of CERA is scarce, and most of the available data originate from conference abstracts. Identified data are restricted to the treatment of anemia due to chronic kidney disease. Although the majority of studies suggest a considerable cost advantage for CERA, the published literature cannot easily be compared. While time and motion studies clearly indicate that a switch to CERA could minimize health care staff time in dialysis units, the results of studies comparing direct costs are more ambivalent, potentially reflecting the differences between health care systems and variability between centers. CONCLUSION Analyzed data are predominantly insufficient; they miss clear evidence and have to thus be interpreted with great caution. In this day and age of financial restraints, results from well-designed, head-to-head studies with clearly defined endpoints have to prove whether CERA therapy can achieve cost savings without compromising anemia management.

Stimulation of erythropoiesis by the third-generation erythropoietin drug, continuous erythropoietin receptor activator (CERA), a pegylated derivative of epoetin-β, has provided valuable therapeutic benefits to patients suffering from renal anemia, but has also rapidly found application as an illicit performance-enhancing strategy in endurance sports. We present here a novel method for selective determination of CERA in serum, based on polyethylene glycol precipitation, followed by a commercial homogeneous immunoassay. The developed method was highly discriminating between serum samples from CERA-treated patients and control subjects, as the covalently linked polyethylene glycol chain in CERA strongly enhanced the solubility of the protein in a polyethylene glycol-containing medium. Intravenous administration of CERA could be detected for several weeks in the majority of subjects tested. This assay outperforms the currently available CERA detection methods in terms of simplicity, convenience, cost, and throughput, making it ideal as a screening tool for doping control.

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 mu g/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.

Anemia is a common complication of chronic kidney disease (CKD), with erythropoietin deficiency being the major contributing factor. The availability of erythropoiesis-stimulating agents (ESAs) has been a seminal advance in the treatment of anemia related to chronic kidney disease. Over the course of the last decade and a half, newer generations of ESAs have become available. The first-generation ESAs or epoetins have a relatively shorter half-life and have traditionally been administered up to 3 times per week intravenously or subcutaneously to maintain adequate hemoglobin (Hb) levels. At the turn of the century, darbepoetin alfa, a hyperglycosylated form, became available for clinical use. It conferred greater metabolic stability in vivo owing to two additional N-linked carbohydrate chains attached to the protein backbone and has a half-life 3 times longer than that of epoetin (Macdougall et al 1999). Recently developed and undergoing phase III clinical trials is the third-generation ESA, Continuous Erythropoiesis Receptor Activator (CERA), which has a methoxy-polyethylene glycol polymer chain integrated and has a longer elimination half-life than the first- and second-generation ESAs. Its receptor binding characteristics also differ from those of previous ESAs. Its major advantage is that extended dosing intervals are possible in the management of anemia related to erythropoietin deficiency.

La correction et la stabilité du taux d'hémoglobine est un objectif majeur du traitement de l'anémie chez les hémodialysés chroniques. Toutefois, la cible d'hémoglobine > 11g/dl fixée par les recommandations demeure difficile à atteindre dans notre contexte. Le but de cette étude est d’évaluer la réponse au traitement par CERA (continuous erythropoietin receptor activator) chez une population d'hémodialysés chroniques naïfs de tout traitement par agent stimulant de l’érythropoïèse et étudier les différents facteurs associés à une mauvaise réponse au traitement. Il s'agit une étude prospective mono centrique faite au sein d'une population d’ hémodialysés chroniques. Ont été inclus les patients en hémodialyse depuis plus de 12 mois, naïfs de tout traitement par agent stimulant de l’érythropoïèse (ASE) et ayant un taux d'hémoglobine(Hb) < 10g/dl. L'administration régulière de la CERA et l'ajustement des doses ont été faits selon les recommandations. L’évaluation de la réponse, en fin de traitement, a porté sur l'atteinte ou non d'un taux d'hémoglobine cible > 11g/dl. Sur 87 patients en hémodialyse périodique, 22 (25,3%) sont naïfs de tout traitement par ASE. Il s'agit de 13 hommes et 9 femmes avec un âge moyen de 46 ± 19 ans et une ancienneté en hémodialyse de 67 ± 59 mois. Le taux initial d'hémoglobine est de 7,8 ± 1,3 g/dl. Au bout de 4 mois de traitement régulier par la CERA, le taux final d'Hb est de 10,9 ± 2,1g/dl et 63,6% des patients ont atteint la cible d'Hb > 11g/dl. La dose moyenne de CERA à la fin de l’étude est de 0,89 ± 0,35 µg/kg/15j. L'analyse des facteurs prédictifs montre que la réponse finale dépend du taux d'Hb initial (p = 0,002). En effet, quand le taux d'Hb initial est > 8 g/dl, le taux de réponse est de 88% vs 46% lorsque le taux d'Hb < 8g/dl (p1-3]. Cette complication commune de la maladie rénale chronique est multifactorielle dont le déficit en érythropoïétine est le principal facteur causal [4]. Dès l'avènement des agents stimulants de l’érythropoïèse (ASE) en 1980 et le développement des recommandations de bonnes pratiques médicales, la gestion de l'anémie rénale est devenue meilleure avec une amélioration de la qualité de vie des patients [5–9]. Les recommandations de bonne pratique suggèrent actuellement le maintien de l'Hb à un taux > 11 g/dl sans dépasser 13 g/dl [9, 10]. Cependant, le maintien d'un taux d'hémoglobine stable nécessite du temps, des ressources humaines et financières et exige des adaptations thérapeutiques fréquentes [11]. Le méthoxy polyéthylène glycol-époétine bêta, activateur continu du récepteur de l’érythropoïétine (C.E.R.A), est un nouvel ASE qui permet la correction de l'anémie et la stabilité du taux d'hémoglobine au rythme d'une injection mensuelle [12]. Le but de cette étude est d’évaluer la réponse au traitement par CERA chez une population d'hémodialysés chroniques naïfs de tout traitement par ASE et d’étudier les différents facteurs associés à la mauvaise réponse au traitement

Anemija, posljedica kronične bubrežne bolesti, čija učestalost raste napredovanjem bubrežnog zatajenja, u završnom je stupnju kronične bubrežne bolesti zastupljena u čak do 95% bolesnika. Lijekovi izbora u liječenju bubrežne anemije su pripravci eritropoetina iz skupine lijekova za stimulaciju eritropoeze (LSE). Veliki napredak u liječenju je uporaba metoksipolietilenglikol-epoetina beta, kontinuiranog aktivatora receptora za eritropoetin (CERA). Cilj studije OPATIJA je usporediti postizanje ciljnih vrijednosti hemoglobina (Hb) kao i njegovu varijabilnost uz učinkovitost i sigurnost uporabe u dvije usporedne skupine bolesnika. U jednoj je skupini bolesnika učinjena konverzija s kratkodjelujućih stimulatora eritropoeze na doze CERA navedene na samom proizvodu, dok je druga skupina liječena alternativnim dozama prema individualnim potrebama bolesnika. U ispitivanju je sudjelovalo 79 bolesnika. Bolesnici su bili podijeljeni u dvije usporedne skupine ranije liječene kratkodjelujućim LSE, od kojih je 36 bolesnika bilo u skupini koja je izravno konvertirana na CERA prema preporučenom doziranju navedenom na samom proizvodu. Drugu su skupinu činila 43 bolesnika koji su konvertirani prema dozama prilagođenima prethodnom doziranju kratkodjelujućih LSE. Tijekom osamnaestomjesečnog razdoblja svakom bolesniku u razmacima od najdulje dva mjeseca evidentirani su laboratorijski parametri anemije – razine hemoglobina te parametara statusa željeza (serumsko željezo, TSAT, feritin). Prema navedenim vrijednostima, u slučaju potrebe, prilagođavana je doza CERA te primjenjivana supstitucijska terapija pripravcima željeza. Nakon završetka studije dvije je skupine činio ukupno 51 bolesnik, od kojih je 26 bilo u skupini koja je dobivala preporučenu dozu CERA-e, a 25 bolesnika u skupini koja je dobivala alternativnu dozu. U skupini bolesnika koji su primali preporučene doze CERA prosječna vrijednost hemoglobina tijekom studije iznosila je 104,41 g/L uz prosječne mjesečne doze CERA 104,33 mcg. U skupini bolesnika koji su primali alternativne doze CERA prosječna vrijednost hemoglobina iznosila je 105,33 g/L uz prosječne mjesečne doze CERA 113,08 mcg. U skupini bolesnika koja je dobivala alternativne doze CERA, u 33% slučajeva vrijednosti Hb bile su unutar uskog ciljnog raspona 110-120 g/L. U 30% slučajeva vrijednosti su bile 100-110 g/L, u 29% manje od 100 g/L, a u 8% slučajeva su prelazile 120 g/L. Prosječne vrijednosti Hb na početku i na kraju ispitivanja međusobno se nisu statistički razlikovale osim u skupini bolesnika s nepoželjnim vrijednostima Hb>120 g/L, gdje je 7% bolesnika u skupini s preporučenim doziranjem imalo takve vrijednosti, dok u skupini s alternativnim doziranjem nije bilo bolesnika sa Hb>120 g/L (P=0,017). Varijabilnost hemoglobina s odstupanjima ve im od 10 i 20 g/L zabilježena je u obje skupine uz trend manje pojavnosti u alternativnoj skupini doziranja CERA. U zaključku je preporučeno i alternativno doziranje ime se postižu i održavaju ciljne vrijednosti hemoglobina uz njegovu manju varijabilnost pri primjeni individualiziranog doziranja. Rezultati su potvrdili potrebu individualnog pristupa u liječenju anemije bolesnika koji boluju od završnog stupnja kroničnog bubrežnog zatajenja te se lije e postupcima hemodijalize sukladno najnovijim smjernicama nefrološke struke., Introduction: Anemia is a well-documented consequence of chronic kidney disease, its frequency increases with the progression of renal failure and occurs in up to 95% of patients with end stage renal disease (ESRD). Erythropoietin stimulating agents (ESAs) have become the standard of care in the treatment of renal anemia. The use of methoxy polyethylene glycol-epoetin beta, continuous erythropoietin receptor activator, represents an important beneit in clinical practice. Aim: The aim of the OPATIJA study was to compare the eficacy and safety of maintaining hemoglobin levels in dialysis patients and to assess its variability in a parallel-group design. Patients were randomly assigned to receive methoxy polyethylene glycolepoetin beta once monthly in “normal” dose conversion according to the label of record or “low” or “alternative” dose conversion widely spread according to previous ESA doses. Subjects and Methods: A total of 79 patients were included in the study. The patients who had undergone continuous maintenance intravenous ESA therapy were divided into two parallel groups: group 1 including 36 patients directly switched to CERA according to the manufacturer recommended dosage; and group 2 including 43 patients that were switched by using “low” or “alternative” dose conversion widely spread according to previous ESA doses. During the18-month period, each patient’s anemia parameters, i.e. hemoglobin level, serum iron concentration, TSAT and ferritin, were monitored at intervals not longer than two months. According to hemoglobin levels, the dosage of CERA was adjusted if needed along with oirn supplementation. Results: At the end of the study, the two groups consisted of 51 patients: 26 of those treated with the recommended dose of CERA and 25 treated with the alternative dose. In the normal conversion group, the mean hemoglobin level during the course of the study was 104.41 g/L with the mean monthly dose of 104.33 mcg CERA. In the alternative conversion group, the mean hemoglobin level during the course of the study was 105.33 g/L with the mean monthly dose of 113.08 mcg CERA. In the alternative conversion group, 33% of patients had Hb levels in the tight recommended range of 110-120 g/L. In 30% of patients, Hb levels were 100-110 g/L, in 29% less than 100 g/L, and in 8% more than 120 g/L. The mean Hb levels at the beginning and the end of the study did not differ signiicantly, except for the patient group with Hb levels >120 g/L, where 7% of patients with recommended dosing and none of the patients from the alternative dosing group had such levels (P=0.017). Hemoglobin variability higher than 10 and 20 g/L was recorded in both groups, but less frequently in the alternative CERA dosing group. Conclusion: Both treatments with the recommended and alternative conversion dosing achieved and maintained target hemoglobin level. Study results conirmed the need of individualized approach in the treatment of anemia in ESRD patients receiving hemodialysis, resulting in less potentially harmful hemoglobin variability.

Anemija, posljedica kronične bubrežne bolesti, čija učestalost raste napredovanjem bubrežnog zatajenja, u završnom je stupnju kronične bubrežne bolesti zastupljena u čak do 95% bolesnika. Lijekovi izbora u liječenju bubrežne anemije su pripravci eritropoetina iz skupine lijekova za stimulaciju eritropoeze (LSE). Veliki napredak u liječenju je uporaba metoksipolietilenglikol-epoetina beta, kontinuiranog aktivatora receptora za eritropoetin (CERA). Cilj studije OPATIJA je usporediti postizanje ciljnih vrijednosti hemoglobina (Hb) kao i njegovu varijabilnost uz učinkovitost i sigurnost uporabe u dvije usporedne skupine bolesnika. U jednoj je skupini bolesnika učinjena konverzija s kratkodjelujućih stimulatora eritropoeze na doze CERA navedene na samom proizvodu, dok je druga skupina liječena alternativnim dozama prema individualnim potrebama bolesnika. U ispitivanju je sudjelovalo 79 bolesnika. Bolesnici su bili podijeljeni u dvije usporedne skupine ranije liječene kratkodjelujućim LSE, od kojih je 36 bolesnika bilo u skupini koja je izravno konvertirana na CERA prema preporučenom doziranju navedenom na samom proizvodu. Drugu su skupinu činila 43 bolesnika koji su konvertirani prema dozama prilagođenima prethodnom doziranju kratkodjelujućih LSE. Tijekom osamnaestomjesečnog razdoblja svakom bolesniku u razmacima od najdulje dva mjeseca evidentirani su laboratorijski parametri anemije – razine hemoglobina te parametara statusa željeza (serumsko željezo, TSAT, feritin). Prema navedenim vrijednostima, u slučaju potrebe, prilagođavana je doza CERA te primjenjivana supstitucijska terapija pripravcima željeza. Nakon završetka studije dvije je skupine činio ukupno 51 bolesnik, od kojih je 26 bilo u skupini koja je dobivala preporučenu dozu CERA-e, a 25 bolesnika u skupini koja je dobivala alternativnu dozu. U skupini bolesnika koji su primali preporučene doze CERA prosječna vrijednost hemoglobina tijekom studije iznosila je 104,41 g/L uz prosječne mjesečne doze CERA 104,33 mcg. U skupini bolesnika koji su primali alternativne doze CERA prosječna vrijednost hemoglobina iznosila je 105,33 g/L uz prosječne mjesečne doze CERA 113,08 mcg. U skupini bolesnika koja je dobivala alternativne doze CERA, u 33% slučajeva vrijednosti Hb bile su unutar uskog ciljnog raspona 110-120 g/L. U 30% slučajeva vrijednosti su bile 100-110 g/L, u 29% manje od 100 g/L, a u 8% slučajeva su prelazile 120 g/L. Prosječne vrijednosti Hb na početku i na kraju ispitivanja međusobno se nisu statistički razlikovale osim u skupini bolesnika s nepoželjnim vrijednostima Hb>120 g/L, gdje je 7% bolesnika u skupini s preporučenim doziranjem imalo takve vrijednosti, dok u skupini s alternativnim doziranjem nije bilo bolesnika sa Hb>120 g/L (P=0,017). Varijabilnost hemoglobina s odstupanjima ve im od 10 i 20 g/L zabilježena je u obje skupine uz trend manje pojavnosti u alternativnoj skupini doziranja CERA. U zaključku je preporučeno i alternativno doziranje ime se postižu i održavaju ciljne vrijednosti hemoglobina uz njegovu manju varijabilnost pri primjeni individualiziranog doziranja. Rezultati su potvrdili potrebu individualnog pristupa u liječenju anemije bolesnika koji boluju od završnog stupnja kroničnog bubrežnog zatajenja te se lije e postupcima hemodijalize sukladno najnovijim smjernicama nefrološke struke., Introduction: Anemia is a well-documented consequence of chronic kidney disease, its frequency increases with the progression of renal failure and occurs in up to 95% of patients with end stage renal disease (ESRD). Erythropoietin stimulating agents (ESAs) have become the standard of care in the treatment of renal anemia. The use of methoxy polyethylene glycol-epoetin beta, continuous erythropoietin receptor activator, represents an important beneit in clinical practice. Aim: The aim of the OPATIJA study was to compare the eficacy and safety of maintaining hemoglobin levels in dialysis patients and to assess its variability in a parallel-group design. Patients were randomly assigned to receive methoxy polyethylene glycolepoetin beta once monthly in “normal” dose conversion according to the label of record or “low” or “alternative” dose conversion widely spread according to previous ESA doses. Subjects and Methods: A total of 79 patients were included in the study. The patients who had undergone continuous maintenance intravenous ESA therapy were divided into two parallel groups: group 1 including 36 patients directly switched to CERA according to the manufacturer recommended dosage; and group 2 including 43 patients that were switched by using “low” or “alternative” dose conversion widely spread according to previous ESA doses. During the18-month period, each patient’s anemia parameters, i.e. hemoglobin level, serum iron concentration, TSAT and ferritin, were monitored at intervals not longer than two months. According to hemoglobin levels, the dosage of CERA was adjusted if needed along with oirn supplementation. Results: At the end of the study, the two groups consisted of 51 patients: 26 of those treated with the recommended dose of CERA and 25 treated with the alternative dose. In the normal conversion group, the mean hemoglobin level during the course of the study was 104.41 g/L with the mean monthly dose of 104.33 mcg CERA. In the alternative conversion group, the mean hemoglobin level during the course of the study was 105.33 g/L with the mean monthly dose of 113.08 mcg CERA. In the alternative conversion group, 33% of patients had Hb levels in the tight recommended range of 110-120 g/L. In 30% of patients, Hb levels were 100-110 g/L, in 29% less than 100 g/L, and in 8% more than 120 g/L. The mean Hb levels at the beginning and the end of the study did not differ signiicantly, except for the patient group with Hb levels >120 g/L, where 7% of patients with recommended dosing and none of the patients from the alternative dosing group had such levels (P=0.017). Hemoglobin variability higher than 10 and 20 g/L was recorded in both groups, but less frequently in the alternative CERA dosing group. Conclusion: Both treatments with the recommended and alternative conversion dosing achieved and maintained target hemoglobin level. Study results conirmed the need of individualized approach in the treatment of anemia in ESRD patients receiving hemodialysis, resulting in less potentially harmful hemoglobin variability.

U ovoj opservacijskoj studiji prikazali smo sigurnost i učinkovitost primjene CERA u liječenju anemije kronične bubrežne bolesti (KBB) u predijaliznih bolesnika. U praćenje je bilo uključeno ukupno 27 bolesnika u 4. i 5. stadiju KBB s anemijom u kojih je bilo indicirana primjena lijekova koji stimuliraju eritropoezu (LSE). Svi su bolesnici primili ERA upkutano u dozi od 0,6 μg/kg svaka dva tjedna u razdoblju od korekcije anemije ili jednom mjesečno nakon toga. Bolesnici su praćeni u razdoblju od 3-12 mjeseci. Pod odgovorom na terapiju s CERA podrazumijevalo se ili porast vrijednosti Hb za barem 10 g/L unutra perioda od mjesec dana ili postizanje ciljnih vrijednosti Hb. Godinu dana nakon početka primjene CERA svi su bolesnici imali Hb u rasponu 100-120 g/L, a smanjila se i fluktuacija Hb. Nije bilo statistički značajne razlike u razini Hb ovisno o uzroku osnovne bubrežne bolesti i dobi bolesnika. Na kraju praćenja većina je bolesnika navela bolje podnošenje napora, te bolje spavanje i manju razdražljivost. Osim povišenja arterijskog tlaka koji je uspješno kontroliran primjenom antihipetenzivne terapije, nismo uočili druge nuspojave primjene CERA Rezultati pokazuju da je primjena CERA učinkovita i sigurna u liječenju anemije u bolesnika s KBB koji nisu započeli liječenje nadomještanjem bubrežne funkcije., Aim: to evaluate efficacy and safety of cera (continuous erythropoietin receptor activator) administration for correcting anemia in the patients with chronic kidney disease (ckd), not on dialysis. methods: We performed observational study on 27 ckd patients in stage 4 or 5 with renal anemia requiring use of erythropoiesis-stimulating agents (esa). all patients received cera (mircera®; roche, basel, switzerland) subcutaneously in dose of 0.6 μg per kg very two weeks during the correction phase of anemia treatment or once monthly during the maintenance treatment. dose of cera was modified according to manufacturer instructions. iron supplementation was administrated orally or intravenously in order to achieve serum ferritin 200-500 μg/L. Patients were followed up to 1 year (from 3-12 months). response riteria for cera were Hb increase

Background/Aims: Finding the lowest effective dose of erythropoietin-stimulating agents is critical in the management of renal anemia. We evaluated the efficacy of converting darbepoetin to CERA at doses lower than those usually recommended. Methods: We selected consecutive non-dialysis chronic kidney disease patients treated with darbepoetin doses ≤40 µg/week in absence of iron deficiency, recent blood transfusion, bleeding, neoplasia, myocardial infarction/stroke in the last 3 months. Darbepoetin ≤20 µg/week was shifted to CERA 75 µg/month, while darbepoetin 21–40 µg/week to CERA 100 µg/month. Primary endpoint was the change in hemoglobin (Hb goal, 11–13 g/dl) at month 3, 6, 9 and 12. Results: Studied patients (n = 37) were aged 70 ± 13 years and GFR was 30 ± 12 ml/min/1.73 m2; prevalence of males, diabetes and prior cardiovascular disease was 43, 45 and 40%, respectively. Before switching, efficacy population received darbepoetin 18 ± 10 µg/week with 28 patients receiving ≤20 µg/week. Prevalence of Hb goal at baseline was 75.7% and did not change at months 3 (70.3%), 6 (70.3%), 9 (72.2%), and 12 (80.0%). CERA dose remained unchanged during the study (81 ± 11, 82 ± 16, 91 ± 30, 90 ± 54 and 88 ± 61 µg/month). Out of the 438 visits performed, CERA dose was increased in 52 (11.9%) and reduced in 36 (8.2%) visits. Blood pressure, Hb, GFR, transferrin saturation and ferritin did not change. Conclusions: In chronic kidney disease patients treated with darbepoetin doses ≤40 µg/week, CERA can be efficaciously used at doses lower than those recommended.