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Meta-Analysis
. 2017 Aug 7;8(8):CD009904.
doi: 10.1002/14651858.CD009904.pub2.

Continuous erythropoiesis receptor activator (CERA) for the anaemia of chronic kidney disease

Valeria M Saglimbene  1 , Suetonia C Palmer, Marinella Ruospo, Patrizia Natale, Jonathan C Craig, Giovanni Fm Strippoli
Affiliations
Meta-Analysis

Continuous erythropoiesis receptor activator (CERA) for the anaemia of chronic kidney disease

Valeria M Saglimbene et al. Cochrane Database Syst Rev. .

Abstract

Background: Continuous erythropoiesis receptor activator (CERA) is a newer, longer acting ESA which might be preferred to other ESAs (epoetin or darbepoetin) based on its lower frequency of administration. Different dosing requirements and molecular characteristics of CERA compared with other ESAs may lead to different health outcomes (mortality, cardiovascular events, quality of life) in people with anaemia and chronic kidney disease (CKD).

Objectives: To assess benefits and harms of CERA compared with other epoetins (darbepoetin alfa and epoetin alfa or beta) or placebo/no treatment or CERA with differing strategy of administration for anaemia in individuals with CKD.

Search methods: We searched the Cochrane Kidney and Transplant Specialised Register to 13 June 2017 through contact with the Information Specialist using search terms relevant to this review. Studies contained in the Specialised Register are identified through search strategies specifically designed for CENTRAL, MEDLINE, and EMBASE; handsearching conference proceedings; and searching the International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov.

Selection criteria: We included randomised controlled trials (RCTs) of at least three months' duration, comparing CERA with a different ESA (darbepoetin alfa or epoetin alfa or beta) or placebo or standard care or versus CERA with different strategies for administration in people with any stage of CKD.

Data collection and analysis: Data were extracted by two independent investigators. We summarised patient-centred outcomes (all-cause and cardiovascular mortality, major adverse cardiovascular events, red cell blood transfusion, iron therapy, cancer, hypertension, seizures, dialysis vascular access thrombosis, drug injection-related events, hyperkalaemia and health-related quality of life and haemoglobin levels) using random effects meta-analysis. Treatment estimates were expressed as risk ratios (RR) and their 95% confidence intervals (CI) for dichotomous outcomes and mean differences or standardized mean difference with 95% CI for continuous outcomes.

Main results: We included 27 studies involving 5410 adults with CKD. Seven studies (1273 participants) involved people not requiring dialysis, 19 studies (4209 participants) involved people treated with dialysis and one study (71 participants) evaluated treatment in recipients of a kidney transplant. Treatment was given for 24 weeks on average. No data were available for children with CKD. Studies were generally at high or unclear risk of bias from allocation concealment and blinding of outcomes. Only two studies masked participants and investigators to treatment allocation. One study compared CERA with placebo, nine studies CERA with epoetin alfa or beta, nine studies CERA with darbepoetin alfa, and two studies compared CERA with epoetin alfa or beta and darbepoetin alfa. Three studies assessed the effects of differing frequencies of CERA administration and five assessed differing CERA doses.There was low certainty evidence that CERA had little or no effects on mortality (RR 1.07, 95% CI 0.73 to 1.57; RR 1.11, 95% CI 0.75 to 1.65), major adverse cardiovascular events (RR 5.09, 95% CI 0.25 to 105.23; RR 5.56, 95% CI 0.99 to 31.30), hypertension (RR 1.01, 95% CI 0.75 to 1.37; RR 1.00, 95% CI 0.79 to 1.28), need for blood transfusion (RR 1.02, 95% CI 0.72 to 1.46; RR 0.94, 95% CI 0.55 to 1.61), or additional iron therapy (RR 1.03, 95% CI 0.91 to 1.15; RR 0.99, 95% CI 0.95 to 1.03) compared to epoetin alfa/beta or darbepoetin alfa respectively. There was insufficient evidence to compare the effect of CERA to placebo on clinical outcomes. Only one low quality study reported that CERA compared to placebo might lead to little or no difference in the risk of major cardiovascular events (RR 2.97, 95% CI 0.31 to 28.18) and hypertension ((RR 0.73, 95% CI 0.35 to 1.52). There was low certainty evidence that different doses (higher versus lower) or frequency (twice versus once monthly) of CERA administration had little or no different effect on all-cause mortality (RR 3.95, 95% CI 0.17 to 91.61; RR 0.97, 95% CI 0.56 to 1.66), hypertension (RR 0.45, 95% CI 0.08 to 2.52; RR 0.85, 95% CI 0.60 to 1.21), and blood cell transfusions (RR 4.16, 95% CI 0.89 to 19.53; RR 0.91, 95% CI 0.51 to 1.62). No studies reported comparative treatment effects of different ESAs on health-related quality of life.

Authors' conclusions: There is low certainty evidence that CERA has little or no effects on patient-centred outcomes compared with placebo, epoetin alfa or beta or darbepoetin alfa for adults with CKD. The effects of CERA among children who have CKD have not studied in RCTs.

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Conflict of interest statement

  1. Valeria Saglimbene: none known

  2. Suetonia Palmer: none known

  3. Marinella Ruospo: none known

  4. Patrizia Natale: none known

  5. Jonathan Craig: none known

  6. Giovanni FM Strippoli: none known

Figures

1
1
Study flow diagram.
2
2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
1.1
1.1. Analysis
Comparison 1 CERA versus epoetin alfa or beta, Outcome 1 All‐cause mortality.
1.2
1.2. Analysis
Comparison 1 CERA versus epoetin alfa or beta, Outcome 2 Major adverse cardiovascular event.
1.3
1.3. Analysis
Comparison 1 CERA versus epoetin alfa or beta, Outcome 3 Vascular access thrombosis.
1.4
1.4. Analysis
Comparison 1 CERA versus epoetin alfa or beta, Outcome 4 Cancer.
1.5
1.5. Analysis
Comparison 1 CERA versus epoetin alfa or beta, Outcome 5 Hypertension.
1.6
1.6. Analysis
Comparison 1 CERA versus epoetin alfa or beta, Outcome 6 Hyperkalaemia.
1.7
1.7. Analysis
Comparison 1 CERA versus epoetin alfa or beta, Outcome 7 Blood transfusion.
1.8
1.8. Analysis
Comparison 1 CERA versus epoetin alfa or beta, Outcome 8 Iron supplementation.
1.9
1.9. Analysis
Comparison 1 CERA versus epoetin alfa or beta, Outcome 9 Haemoglobin (end of treatment).
1.10
1.10. Analysis
Comparison 1 CERA versus epoetin alfa or beta, Outcome 10 Haemoglobin (change during treatment).
1.11
1.11. Analysis
Comparison 1 CERA versus epoetin alfa or beta, Outcome 11 Achieved haemoglobin level target.
1.12
1.12. Analysis
Comparison 1 CERA versus epoetin alfa or beta, Outcome 12 Exceeding haemoglobin level target.
1.13
1.13. Analysis
Comparison 1 CERA versus epoetin alfa or beta, Outcome 13 Epoetin dose (end of treatment).
1.14
1.14. Analysis
Comparison 1 CERA versus epoetin alfa or beta, Outcome 14 One or more hospital admissions.
1.15
1.15. Analysis
Comparison 1 CERA versus epoetin alfa or beta, Outcome 15 Serum ferritin at end of follow‐up.
1.16
1.16. Analysis
Comparison 1 CERA versus epoetin alfa or beta, Outcome 16 Transferrin saturation at end of follow‐up.
2.1
2.1. Analysis
Comparison 2 CERA versus darbepoetin alfa, Outcome 1 All‐cause mortality.
2.2
2.2. Analysis
Comparison 2 CERA versus darbepoetin alfa, Outcome 2 Cardiovascular mortality.
2.3
2.3. Analysis
Comparison 2 CERA versus darbepoetin alfa, Outcome 3 Major adverse cardiovascular event.
2.4
2.4. Analysis
Comparison 2 CERA versus darbepoetin alfa, Outcome 4 Hypertension.
2.5
2.5. Analysis
Comparison 2 CERA versus darbepoetin alfa, Outcome 5 Hyperkalaemia.
2.6
2.6. Analysis
Comparison 2 CERA versus darbepoetin alfa, Outcome 6 Achieved haemoglobin level target.
2.7
2.7. Analysis
Comparison 2 CERA versus darbepoetin alfa, Outcome 7 Haemoglobin (end of treatment).
2.8
2.8. Analysis
Comparison 2 CERA versus darbepoetin alfa, Outcome 8 Haemoglobin (change during treatment).
2.9
2.9. Analysis
Comparison 2 CERA versus darbepoetin alfa, Outcome 9 Epoetin dose (end of treatment).
2.10
2.10. Analysis
Comparison 2 CERA versus darbepoetin alfa, Outcome 10 Exceeding haemoglobin level target.
2.11
2.11. Analysis
Comparison 2 CERA versus darbepoetin alfa, Outcome 11 Time within the target haemoglobin range.
2.12
2.12. Analysis
Comparison 2 CERA versus darbepoetin alfa, Outcome 12 Need for one or more dose increase.
2.13
2.13. Analysis
Comparison 2 CERA versus darbepoetin alfa, Outcome 13 Need for one or more dose decrease.
2.14
2.14. Analysis
Comparison 2 CERA versus darbepoetin alfa, Outcome 14 Blood transfusion.
2.15
2.15. Analysis
Comparison 2 CERA versus darbepoetin alfa, Outcome 15 Iron supplementation.
2.16
2.16. Analysis
Comparison 2 CERA versus darbepoetin alfa, Outcome 16 Serum ferritin at the end of follow‐up.
2.17
2.17. Analysis
Comparison 2 CERA versus darbepoetin alfa, Outcome 17 Transferrin saturation at end of follow‐up.
3.1
3.1. Analysis
Comparison 3 CERA: once every 2 weeks (Q2W) versus once every 4 weeks (Q4W), Outcome 1 All‐cause mortality.
3.2
3.2. Analysis
Comparison 3 CERA: once every 2 weeks (Q2W) versus once every 4 weeks (Q4W), Outcome 2 Vascular access thrombosis.
3.3
3.3. Analysis
Comparison 3 CERA: once every 2 weeks (Q2W) versus once every 4 weeks (Q4W), Outcome 3 Hypertension.
3.4
3.4. Analysis
Comparison 3 CERA: once every 2 weeks (Q2W) versus once every 4 weeks (Q4W), Outcome 4 Hyperkalaemia.
3.5
3.5. Analysis
Comparison 3 CERA: once every 2 weeks (Q2W) versus once every 4 weeks (Q4W), Outcome 5 Haemoglobin (end of treatment).
3.6
3.6. Analysis
Comparison 3 CERA: once every 2 weeks (Q2W) versus once every 4 weeks (Q4W), Outcome 6 Haemoglobin (change during treatment).
3.7
3.7. Analysis
Comparison 3 CERA: once every 2 weeks (Q2W) versus once every 4 weeks (Q4W), Outcome 7 Achieved haemoglobin level target.
3.8
3.8. Analysis
Comparison 3 CERA: once every 2 weeks (Q2W) versus once every 4 weeks (Q4W), Outcome 8 Cancer.
3.9
3.9. Analysis
Comparison 3 CERA: once every 2 weeks (Q2W) versus once every 4 weeks (Q4W), Outcome 9 Blood transfusion.
3.10
3.10. Analysis
Comparison 3 CERA: once every 2 weeks (Q2W) versus once every 4 weeks (Q4W), Outcome 10 Epoetin dose (end of treatment).
4.1
4.1. Analysis
Comparison 4 CERA lower versus higher doses, Outcome 1 All‐cause mortality.
4.2
4.2. Analysis
Comparison 4 CERA lower versus higher doses, Outcome 2 Hypertension.
4.3
4.3. Analysis
Comparison 4 CERA lower versus higher doses, Outcome 3 Blood transfusion.
4.4
4.4. Analysis
Comparison 4 CERA lower versus higher doses, Outcome 4 Haemoglobin (change during treatment).
4.5
4.5. Analysis
Comparison 4 CERA lower versus higher doses, Outcome 5 Need for one or more dose decrease.
4.6
4.6. Analysis
Comparison 4 CERA lower versus higher doses, Outcome 6 Need for one or more dose increase.
4.7
4.7. Analysis
Comparison 4 CERA lower versus higher doses, Outcome 7 Achieved haemoglobin level target.
5.1
5.1. Analysis
Comparison 5 CERA versus placebo, Outcome 1 Major adverse cardiovascular event.
5.2
5.2. Analysis
Comparison 5 CERA versus placebo, Outcome 2 Cancer.
5.3
5.3. Analysis
Comparison 5 CERA versus placebo, Outcome 3 Hypertension.
5.4
5.4. Analysis
Comparison 5 CERA versus placebo, Outcome 4 Hyperkalaemia.
5.5
5.5. Analysis
Comparison 5 CERA versus placebo, Outcome 5 End of treatment eGFR [mL/min/1.73 m²].
See this image and copyright information in PMC

Update of

References

References to studies included in this review

Al‐Ali 2015 {published data only}
    1. Al‐Ali FS, El‐Sayed AM, Fawzy AA, Hamdy AF, Abdulla AE. Erythropoietin‐stimulating agents in the management of anemia of end‐stage renal disease patients on regular hemodialysis: a prospective randomized comparative study from Qatar. Hemodialysis International 2015;19(1):33‐43. [MEDLINE: ] - PubMed
AMICUS Study 2007 {published data only}
    1. Chanu P, Gieschke R, Reigner B, Dougherty FC. Pharmacokinetic parameters of C.E.R.A. and are not affected by age in patients with chronic kidney disease on dialysis [abstract no: SaP351]. Nephrology Dialysis Transplantation 2007;22(Suppl 6):vi351. [CENTRAL: CN‐00757500]
    1. Chanu P, Gieschke R, Reigner B, Dougherty FC. Pharmacokinetics of C.E.R.A. and stable maintenance of haemoglobin (Hb) levels with once‐monthly dosing in patients with chronic kidney disease (CKD) [abstract no: SaP325]. Nephrology Dialysis Transplantation 2007;22(Suppl 6):vi342. [CENTRAL: CN‐00757502]
    1. Fishbane S, Dalton C, Beswick R, Dutka P, Schmidt R. Efficacy of C.E.R.A., a continuous erythropoietin receptor activator, in the treatment of renal anemia: overview of 6 global phase 3 trials [abstract no: 59]. American Journal of Kidney Diseases 2007;49(4):A39. [CENTRAL: CN‐00756571]
    1. Klinger M, Arias M, Vargemezis V, Besarab A, Sulowicz W, Gerntholtz T, et al. C.E.R.A. (Continuous Erythropoietin Receptor Activator) administered at extended intervals corrects Hb levels in patients with CKD on dialysis [abstract no: SA‐PO212]. Journal of the American Society of Nephrology 2006;17(Abstracts):620A. [CENTRAL: CN‐00644218]
    1. Klinger M, Arias M, Vargemezis V, Besarab A, Sulowicz W, Gerntholtz T, et al. Efficacy of intravenous methoxy polyethylene glycol‐epoetin beta administered every 2 weeks compared with epoetin administered 3 times weekly in patients treated by hemodialysis or peritoneal dialysis: a randomized trial. American Journal of Kidney Diseases 2007;50(6):989‐1000. [MEDLINE: ] - PubMed
ARCTOS Study 2008 {published data only}
    1. Fishbane S, Dalton C, Beswick R, Dutka P, Schmidt R. Efficacy of C.E.R.A., a continuous erythropoietin receptor activator, in the treatment of renal anemia: overview of 6 global phase 3 trials [abstract no: 59]. American Journal of Kidney Diseases 2007;49(4):A39. [CENTRAL: CN‐00756571]
    1. Kessler M, Martinez‐Castelao A, Siamopoulos KC, Villa G, Spinowitz B, Dougherty FC, et al. C.E.R.A. once every 4 weeks in patients with chronic kidney disease not on dialysis: The ARCTOS extension study. Hemodialysis International 2010;14(2):233‐9. [MEDLINE: ] - PubMed
    1. Macdougall IC, Walker R, Provenzano R, Alvaro F, Locay HR, Nader PC, et al. C.E.R.A. (Continuous Erythropoietin Receptor Activator) administered at extended intervals corrects anemia and maintains stable Hb levels in patients with CKD not on dialysis [abstract no: SA‐PO208]. Journal of the American Society of Nephrology 2006;17(Abstracts):619A.
    1. Macdougall IC, Walker R, Provenzano R, Alvaro F, Locay HR, Nader PC, et al. C.E.R.A. corrects anemia in patients with chronic kidney disease not on dialysis: results of a randomized clinical trial. Clinical Journal of the American Society of Nephrology: CJASN 2008;3(2):337‐47. [MEDLINE: ] - PMC - PubMed
    1. Provenzano R, Macdougall IC, Law A, Ouyang Y, Bexon M. Anemia correction with C.E.R.A. in patients (pts) with chronic kidney disease (CKD) is unaffected by baseline hemoglobin (Hb) level [abstract no: SU‐PO796]. Journal of the American Society of Nephrology 2007;18(Abstracts Issue):760A. [CENTRAL: CN‐00747311]
BA16260 Study 2006 {published data only}
    1. Dougherty FC, Reigner B, Beyer U. Dose‐dependent erythropoietic responses to subcutaneous CERA (continuous erythropoiesis receptor activator) in multiple‐dose study of dialysis patients with chronic renal anaemia [abstract no: MP280]. 41st Congress. European Renal Association. European Dialysis and Transplantation Association; 2004 May 15‐18; Lisbon, Portugal. 2004:325. [CENTRAL: CN‐00509162]
    1. Provenzano R, Dougherty FC. Subcutaneous (SC) CERA (Continuous Erythropoietin Receptor Activator) administered once every 2 weeks effectively corrects anemia in patients with chronic kidney disease (CKD) on dialysis and not on dialysis [abstract no: 126]. American Journal of Kidney Diseases 2006;47(4):A50. [CENTRAL: CN‐00747315]
    1. Francisco AL, Sulowicz W, Dougherty FC. Subcutaneous CERA (continuous erythropoiesis receptor activator) has potent erythropoietic activity in dialysis patients with chronic renal anemia: an exploratory multiple‐dose study [abstract no: SA‐FC124]. Journal of the American Society of Nephrology 2003;14(Nov):27A‐8A. [CENTRAL: CN‐00550366]
    1. Francisco AL, Sulowicz W, Klinger M, Niemczyk S, Vargemezis V, Metivier F, et al. Continuous Erythropoietin Receptor Activator (C.E.R.A.) administered at extended administration intervals corrects anaemia in patients with chronic kidney disease on dialysis: a randomised, multicentre, multiple‐dose, phase II study.[Erratum appears in Int J Clin Pract. 2007 Oct;61(10):1776‐7]. International Journal of Clinical Practice 2006;60(12):1687‐96. [MEDLINE: ] - PubMed
BA16285 Study 2007 {published data only}
    1. Besarab A, Beyer U, Dougherty FC. Long‐term intravenous CERA (Continuous Erythropoietin Receptor Activator) maintains hemoglobin concentrations in hemodialysis patients [abstract no: W‐PO40127]. Nephrology 2005;10(Suppl 1):A312‐3. [CENTRAL: CN‐00747326]
    1. Besarab A, Salifu MO, Lunde NM, Bansal V, Fishbane S, Dougherty FC, et al. 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. Clinical Therapeutics 2007;29(4):626‐39. [MEDLINE: ] - PubMed
    1. Dougherty FC, Beyer U. No changes in blood pressure in dialysis patients after 12 months of treatment with IV/SC CERA (Continuous Erythropoietin Receptor Activator) [abstract no: W‐PO40131]. Nephrology 2005;10(Suppl 1):A313‐4. [CENTRAL: CN‐00602138]
    1. Dougherty FC, Beyer U. Safety and tolerability profile of continuous erythropoietin receptor activator (CERA) with extended dosing intervals in patients with chronic kidney disease on dialysis [abstract no: W‐PO40130]. Nephrology 2005;10(Suppl 1):A313. [CENTRAL: CN‐00602137]
    1. Dougherty FC, Loghman‐Adham M, Schultze N, Beyer U. Adequate hemoglobin levels are maintained with continuous erythropoietin receptor activator (CERA) in dialysis patients regardless of gender, age, race and diabetic status [abstract no: MP206]. Nephrology Dialysis Transplantation 2005;20(Suppl 5):v269. [CENTRAL: CN‐00602143]
BA16286 Study 2007 {published data only}
    1. Dougherty FC, Beyer U. No changes in blood pressure in dialysis patients after 12 months of treatment with IV/SC CERA (Continuous Erythropoietin Receptor Activator) [abstract no: W‐PO40131]. Nephrology 2005;10(Suppl 1):A313‐4. [CENTRAL: CN‐00602138]
    1. Dougherty FC, Beyer U. Safety and tolerability profile of continuous erythropoietin receptor activator (CERA) with extended dosing intervals in patients with chronic kidney disease on dialysis [abstract no: W‐PO40130]. Nephrology 2005;10(Suppl 1):A313. [CENTRAL: CN‐00602137]
    1. Dougherty FC, Loghman‐Adham M, Schultze N, Beyer U. Adequate hemoglobin levels are maintained with continuous erythropoietin receptor activator (CERA) in dialysis patients regardless of gender, age, race and diabetic status [abstract no: MP206]. Nephrology Dialysis Transplantation 2005;20(Suppl 5):v269. [CENTRAL: CN‐00602143]
    1. Dutka P, Tilocca P, BA16285 and BA16286 Study Groups. CERA (Continuous Erythropoietin Receptor Activator) maintains stable hemoglobin concentrations in dialysis patients irrespective of gender, age, race or diabetic status [abstract]. Nephrology Nursing Journal 2006;33(2):138. [CENTRAL: CN‐00602144]
    1. Locatelli F, Villa G, Arias M, Marchesi D, Dougherty FC, Beyer U, et al. CERA (Continuous Erythropoietin receptor activator) maintains hemoglobin levels in dialysis patients when administered subcutaneously up to once every 4 weeks [abstract no: SU‐PO051]. Journal of the American Society of Nephrology 2004;15(Oct):543A. [CENTRAL: CN‐00626008]
Chen 2012e {published data only}
    1. Chen N, Qian JQ, Mei CL, Zhang AH, Xing CY, Wang L, et al. The efficacy and safety of continuous erythropoietin receptor activator in dialytic patients with chronic renal anemia: an open, randomized, controlled, multi‐center trial. Chung‐Hua Nei Ko Tsa Chih [Chinese Journal of Internal Medicine] 2012;51(7):502‐7. [MEDLINE: ] - PubMed
CORDATUS Study 2011 {published data only}
    1. Martinez‐Castelao A. C.E.R.A. once every 4 weeks (Q4W) corrects anaemia in chronic kidney disease (CKD) patients with low incidence of HB values outside the target range [abstract no: OSu057]. NDT Plus 2010;3(Suppl 3):iii298. [EMBASE: 70484207]
    1. Roger S. C.E.R.A. once every 4 weeks (Q4W) corrects anaemia in patients with chronic kidney disease (CKD) not on dialysis and demonstrates comparable safety to darbepoetin alfa [abstract no: 202]. Nephrology 2010;15(Suppl 4):79. [EMBASE: 70467206]
    1. Roger SD. C.E.R.A. once every 4 weeks (Q4W) corrects anaemia in patients with chronic kidney disease (CKD) not on dialysis and demonstrates comparable safety to darbepoetin alfa weekly (QW) or once every 2 weeks (Q2W) [abstract no: Sa535]. NDT Plus 2010;3(Suppl 3):iii219‐iii220. [EMBASE: 70484001]
    1. Roger SD, Locatelli F, Woitas RP, Laville M, Tobe SW, Provenzano R, et al. C.E.R.A. once every 4 weeks corrects anaemia and maintains haemoglobin in patients with chronic kidney disease not on dialysis. Nephrology Dialysis Transplantation 2011;26(12):3980‐6. [MEDLINE: ] - PMC - PubMed
Forni 2013 {published data only}
    1. Forni V, Bianchi G, Ogna A, Salvade I, Vuistiner P, Burnier M, et al. Reticulocyte dynamic and hemoglobin variability in hemodialysis patients treated with darbepoetin alfa and C.E.R.A.: a randomized controlled trial. BMC Nephrology 2013;14(1):157. [MEDLINE: ] - PMC - PubMed
Furukawa 2015 {published data only}
    1. Furukawa T, Okada K, Abe M, Tei R, Oikawa O, Maruyama N, et al. Randomized controlled trial of darbepoetin alpha versus continuous erythropoietin receptor activator injected subcutaneously once every four weeks in patients with chronic kidney disease at the pre‐dialysis stage. International Journal of Molecular Sciences 2015;16(12):30181‐9. [MEDLINE: ] - PMC - PubMed
Kakimoto‐Shino 2014 {published data only}
    1. Kakimoto‐Shino M, Toya Y, Kuji T, Fujikawa T, Umemura S. Changes in hepcidin and reticulocyte hemoglobin equivalent levels in response to continuous erythropoietin receptor activator administration in hemodialysis patients: a randomized study. Therapeutic Apheresis & Dialysis 2014;18(5):421‐6. [MEDLINE: ] - PubMed
    1. Kuji T, Fujikawa T, Kakimoto‐Shino M, Shibata K, Toya Y, Umemura S. Changes in hepcidin and reticulocyte hemoglobin equivalent levels in response to continuous erythropoietin activator administration in hemodialysis patients [abstract]. Nephrology Dialysis Transplantation 2013;28(Suppl 1):i244‐5. [EMBASE: 71075732] - PubMed
Kinugasa 2011 {published data only}
    1. Kinugasa E, Yumita S, Sato T, Kurosawa A, Kitaoka T, Sugimoto H, et al. A dose‐finding study of C. E. R. A. (Continuous Erythropoietin Receptor Activator) in renal anemia patients on hemodialysis ‐ A randomized double‐blind comparative study. Japanese Pharmacology & Therapeutics 2011;39(Suppl 1):S9‐S19. [EMBASE: 2011317486]
MAXIMA Study 2007 {published data only}
    1. Barany P, Besarab A, Macdougall IC, Law A, Ouyang Y, Heifets M. Median hemoglobin (Hb) decline following C.E.R.A. dose interruption is similar to that with other erythropoiesis stimulating agents (ESAs) [abstract no: SU‐PO795]. Journal of the American Society of Nephrology 2007;18(Abstracts Issue):760A. [CENTRAL: CN‐00794522]
    1. Chanu P, Gieschke R, Reigner B, Dougherty FC. Pharmacokinetic parameters of C.E.R.A. and are not affected by age in patients with chronic kidney disease on dialysis [abstract no: SaP351]. Nephrology Dialysis Transplantation 2007;22(Suppl 6):vi351. [CENTRAL: CN‐00757500]
    1. Chanu P, Gieschke R, Reigner B, Dougherty FC. Pharmacokinetics of C.E.R.A. and stable maintenance of haemoglobin (Hb) levels with once‐monthly dosing in patients with chronic kidney disease (CKD) [abstract no: SaP325]. Nephrology Dialysis Transplantation 2007;22(Suppl 6):vi342. [CENTRAL: CN‐00757502]
    1. Fishbane S, Bernardo M, Locatelli F, delAguila M, Edwardes M, Bexon M. Once‐monthly intravenous (IV) C.E.R.A. maintains stable hemoglobin (Hb) in dialysis patients (pts), irrespective of age or gender [abstract no: SU‐PO779]. Journal of the American Society of Nephrology 2007;18(Abstracts Issue):756A. [CENTRAL: CN‐00757405]
    1. Fishbane S, Dalton C, Beswick R, Dutka P, Schmidt R. Efficacy of C.E.R.A., a continuous erythropoietin receptor activator, in the treatment of renal anemia: overview of 6 global phase 3 trials [abstract no: 59]. American Journal of Kidney Diseases 2007;49(4):A39. [CENTRAL: CN‐00756571]
Meier 2008 {published data only}
    1. Meier P. Efficacy of intravenous CERA administered once monthly compared with epoetin beta administered once weekly in patients with end‐stage kidney disease on hemodialysis: a randomized trial [abstract no: 65]. Swiss Medical Weekly 2008;138(Suppl 167):22S.
    1. Meier P, Meier R. Efficacy of intravenous CERA administered once monthly on haemoglobin levels compared with epoetin beta administered once weekly in patients with end‐stage kidney disease on hemodialysis: a randomized trial [abstract no: M571]. World Congress of Nephrology; 2009 May 22‐26; Milan, Italy. 2009.
NCT00442702 {published data only}
    1. NCT00442702. A randomized, open label study to compare the effect of monthly subcutaneous mircera with that of darbepoetin alfa, given according to local label, on the management of anemia in patients with chronic kidney disease not on dialysis. www.clinicaltrials.gov/show/NCT00442702 (first received 1 March 2007).
NCT00717821 {published data only}
    1. Locatelli F, Choukroun G, Truman M, Wiggenhauser A, Fliser D. Once‐monthly continuous erythropoietin receptor activator (CERA) in patients with hemodialysis‐dependent chronic kidney disease: pooled data from phase III trials. Advances in Therapy 2016;33(4):610‐25. [MEDLINE: ] - PMC - PubMed
    1. NCT00717821. A randomized, controlled, open label, French multicenter parallel group study to compare the hemoglobin maintenance with once monthly administration of mircera versus epoetin beta or darbepoetin alfa in patients with chronic kidney disease on hemodialysis. www.clinicaltrials.gov/ct2/show/NCT00717821 (first received 16 July 2008).
Oh 2014 {published data only}
    1. Oh J, Joo K, Chin H, Chae DW, Kim SG, Chung WK, et al. Mircera corrects anemia in Korean patients with chronic kidney disease on dialysis: Results from a randomized controlled multicenter study [abstract no: Su573]. NDT Plus 2010;3(Suppl 3):iii502‐3. [EMBASE: 70484793]
    1. Oh J, Joo KW, Chin HJ, Chae DW, Kim SG, Kim SJ, et al. Correction of anemia with continuous erythropoietin receptor activator in Korean patients on long‐term hemodialysis. Journal of Korean Medical Science 2014;29(1):76‐83. [MEDLINE: ] - PMC - PubMed
Otsuka 2015 {published data only}
    1. Otsuka T, Sakai Y, Yui S, Sukegawa M, Suzuki A, Mugishima K, et al. Comparison of pain and efficacy of darbepoetin alfa and epoetin beta pegol treatment in patients receiving peritoneal dialysis. Nihon Ika Daigaku Zasshi [Journal of Nippon Medical School] 2015;82(1):21‐6. [MEDLINE: ] - PubMed
PATRONUS Study 2010 {published data only}
    1. Besarab A, Canaud B, Francisco ALM, Kerr P, Locatelli F, Lok CE, et al. Randomized comparison of IV C.E.R.A. (Continuous Erythropoietin Receptor Activator) and Darbepoetin Alfa (DA) at extended administration intervals for the maintenance of Hb levels in patients with CKD on dialysis: rationale and design [abstract no: PUB377]. Journal of the American Society of Nephrology 2006;17(Abstracts):896A. [CENTRAL: CN‐00740564]
    1. Carrera F. C.E.R.A. vs darbepoetin alfa as maintenance therapy for anaemia in patients with chronic kidney disease (CKD): The PATRONUS Study [abstract no: M558]. World Congress of Nephrology; 2009 May 22‐26; Milan, Italy. 2009.
    1. Carrera F, Lok CE, Francisco A, Locatelli F, Mann JF, Canaud B, et al. Maintenance treatment of renal anaemia in haemodialysis patients with methoxy polyethylene glycol‐epoetin beta versus darbepoetin alfa administered monthly: a randomized comparative trial. Nephrology Dialysis Transplantation 2010;25(12):4009‐17. [MEDLINE: ] - PMC - PubMed
    1. Locatelli F, PATRONUS Study Group. Once‐monthly C.E.R.A. is superior to darbepoetin alfa for maintaining hemoglobin levels in hemodialysis patients regardless of age, gender, diabetic status or presence of hyperlipidemia [abstract no: SA‐PO2412]. Journal of the American Society of Nephrology 2009;20:663A. [CENTRAL: CN‐00747328]
    1. Mann JF, PATRONUS Study Group. Risk factors for vascular events in hemodialysis patients receiving once‐monthly C.E.R.A. or once‐monthly darbepoetin alfa: post hoc analysis of the PATRONUS Study [abstract no: PUB414]. Journal of the American Society of Nephrology 2009;20:921A. [CENTRAL: CN‐00747329]
PRIMAVERA Study 2011 {published data only}
    1. Fliser D, Dellanna F, Koch M, Seufert J, Witzke O, Hauser IA. The Primavera study protocol design: evaluating the effect of continuous erythropoiesis receptor activator (C.E.R.A.) on renal function in non‐anemic patients with chronic kidney disease. Contemporary Clinical Trials 2011;32(6):786‐92. [MEDLINE: ] - PubMed
    1. Fliser D, Dellanna F, Koch M, Wiggenhauser A, PRIMAVERA Study Group. Early low‐dose erythropoiesis‐stimulating agent therapy and progression of moderate chronic kidney disease: a randomized, placebo‐controlled trial. Nephrology Dialysis Transplantation 2017;32(2):279‐87. [MEDLINE: ] - PubMed
PROTOS Study 2007 {published data only}
    1. Barany P, Besarab A, Macdougall IC, Law A, Ouyang Y, Heifets M. Median hemoglobin (Hb) decline following C.E.R.A. dose interruption is similar to that with other erythropoiesis stimulating agents (ESAs) [abstract no: SU‐PO795]. Journal of the American Society of Nephrology 2007;18(Abstracts Issue):760A. [CENTRAL: CN‐00794522]
    1. Chanu P, Gieschke R, Reigner B, Dougherty FC. Pharmacokinetic parameters of C.E.R.A. and are not affected by age in patients with chronic kidney disease on dialysis [abstract no: SaP351]. Nephrology Dialysis Transplantation 2007;22(Suppl 6):vi351. [CENTRAL: CN‐00757500]
    1. Chanu P, Gieschke R, Reigner B, Dougherty FC. Pharmacokinetics of C.E.R.A. and stable maintenance of haemoglobin (Hb) levels with once‐monthly dosing in patients with chronic kidney disease (CKD) [abstract no: SaP325]. Nephrology Dialysis Transplantation 2007;22(Suppl 6):vi342. [CENTRAL: CN‐00757502]
    1. Fishbane S, Dalton C, Beswick R, Dutka P, Schmidt R. Efficacy of C.E.R.A., a continuous erythropoietin receptor activator, in the treatment of renal anemia: overview of 6 global phase 3 trials [abstract no: 59]. American Journal of Kidney Diseases 2007;49(4):A39. [CENTRAL: CN‐00756571]
    1. Fishbane S, Liu S, Beswick R, Nissenson A. C.E.R.A. every 2 or 4 weeks maintains hemoglobin control in CKD patients on dialysis with and without congestive heart failure: pooled phase III analysis [abstract no: F‐PO834]. Journal of the American Society of Nephrology 2007;18(Abstracts):285A.
Provenzano 2007 {published data only}
    1. Besarab A, Provenzano R, Macdougall IC, Ellison DH, Maxwell AP, Sulowicz W, et al. Dose‐dependent erythropoietic responses to subcutaneous (SC) CERA (Continuous Erythropoietin Receptor Activator) in a multi‐dose study of patients (pts) with chronic kidney disease (CKD) not on dialysis [abstract no: SA‐PO930]. Journal of the American Society of Nephrology 2005;16:760A. [CENTRAL: CN‐00747325]
    1. Provenzano R, Besarab A, Macdougall IC, Dougherty FC, Beyer U. CERA (Continuous Erythropoietin Receptor Activator) administered up to once every 3 weeks corrects anemia in patients with chronic kidney disease not on dialysis. [abstract no: SU‐PO056]. Journal of the American Society of Nephrology 2004;15(Oct):544A. [CENTRAL: CN‐00747313]
    1. Provenzano R, Besarab A, Macdougall IC, Ellison DH, Maxwell AP, Sulowicz W, et al. Subcutaneous CERA (continuous erythropoietin receptor activator) maintains hemoglobin levels with administration intervals up to 3 weeks in chronic kidney disease patients not on dialysis [abstract no: SA‐PO929]. Journal of the American Society of Nephrology 2005;16:760A. [CENTRAL: CN‐00747324]
    1. Provenzano R, Besarab A, Macdougall IC, Ellison DH, Maxwell AP, Sulowicz W, et al. The continuous erythropoietin receptor activator (C.E.R.A.) corrects anemia at extended administration intervals in patients with chronic kidney disease not on dialysis: results of a phase II study. Clinical Nephrology 2007;67(5):306‐17. [MEDLINE: ] - PubMed
    1. Provenzano R, Dougherty FC. Subcutaneous (SC) CERA (Continuous Erythropoietin Receptor Activator) administered once every 2 weeks effectively corrects anemia in patients with chronic kidney disease (CKD) on dialysis and not on dialysis [abstract no: 126]. American Journal of Kidney Diseases 2006;47(4):A50. [CENTRAL: CN‐00747315]
RUBRA Study 2008 {published data only}
    1. Barany P, Besarab A, Macdougall IC, Law A, Ouyang Y, Heifets M. Median hemoglobin (Hb) decline following C.E.R.A. dose interruption is similar to that with other erythropoiesis stimulating agents (ESAs) [abstract no: SU‐PO795]. Journal of the American Society of Nephrology 2007;18(Abstracts Issue):760A. [CENTRAL: CN‐00794522]
    1. Fishbane S, Dalton C, Beswick R, Dutka P, Schmidt R. Efficacy of C.E.R.A., a continuous erythropoietin receptor activator, in the treatment of renal anemia: overview of 6 global phase 3 trials [abstract no: 59]. American Journal of Kidney Diseases 2007;49(4):A39. [CENTRAL: CN‐00756571]
    1. Spinowitz B, Coyne DW, Fraticelli M, Azer M, Dalal S, Villa G, et al. C.E.R.A. (continuous erythropoietin receptor activator) administered once every 2 weeks via pre‐filled syringe (PFS) maintains stable Hb levels in patients with CKD on dialysis [abstract no: PUB376]. Journal of the American Society of Nephrology 2006;17(Abstracts):895A. [CENTRAL: CN‐00653773]
    1. Spinowitz B, Coyne DW, Lok CE, Fraticelli M, Azer M, Dalal S, et al. C.E.R.A. maintains stable control of hemoglobin in patients with chronic kidney disease on dialysis when administered once every two weeks. American Journal of Nephrology 2008;28(2):280‐9. [MEDLINE: ] - PubMed
STRIATA Study 2008 {published data only}
    1. Barany P, Besarab A, Macdougall IC, Law A, Ouyang Y, Heifets M. Median hemoglobin (Hb) decline following C.E.R.A. dose interruption is similar to that with other erythropoiesis stimulating agents (ESAs) [abstract no: SU‐PO795]. Journal of the American Society of Nephrology 2007;18(Abstracts Issue):760A. [CENTRAL: CN‐00794522]
    1. Canaud B, Braun J, Locatelli F, Villa G, Vlem B, Sanz Guajardo D, et al. Intravenous (IV) C.E.R.A. (continuous erythropoietin receptor activator) administered once every 2 weeks maintains stable haemoglobin (Hb) levels in patients with chronic kidney disease (CKD) on dialysis [abstract no: SP425]. Nephrology Dialysis Transplantation 2006;21(Suppl 4):iv157. [CENTRAL: CN‐00690645]
    1. Canaud B, Mingardi G, Braun J, Aljama P, Kerr PG, Locatelli F, et al. Intravenous C.E.R.A. maintains stable haemoglobin levels in patients on dialysis previously treated with darbepoetin alfa: results from STRIATA, a randomized phase III study. Nephrology Dialysis Transplantation 2008;23(11):3654‐61. [MEDLINE: ] - PMC - PubMed
    1. Fishbane S, Dalton C, Beswick R, Dutka P, Schmidt R. Efficacy of C.E.R.A., a continuous erythropoietin receptor activator, in the treatment of renal anemia: overview of 6 global phase 3 trials [abstract no: 59]. American Journal of Kidney Diseases 2007;49(4):A39. [CENTRAL: CN‐00756571]
TIVOLI Study 2013 {published data only}
    1. Campistol JM, Carreno A, Morales JM, Pallardo L, Franco A, Navarro D, et al. Once‐monthly pegylated epoetin beta versus darbepoetin alfa every two weeks in renal transplant recipients: a randomized trial. Transplantation 2013;95(2):e6‐e10. [MEDLINE: ] - PubMed
    1. Carreno A, Campistol JM, Arias M, Morales JM, Pallardo L, Franco A. A randomised, multicenter, phase IIIb clinical trial to evaluate efficacy and safety of C.E.R.A. once a month versus darbepoetin alfa in renal transplant recipients with chronic renal anaemia (TIVOLI Study Group) [abstract no: F164]. NDT Plus 2011;4(Suppl 2):4.s2.32.
    1. Carreno A, Campistol JM, Arias M, Morales JM, Pallardo L, Franco A. A randomised, multicenter, phase IIIb clinical trial to evaluate efficacy and safety of C.E.R.A. once a month versus darbepoetin alfa in renal transplant recipients with chronic renal anaemia (TIVOLI study group) [abstract no: F164]. American Journal of Transplantation 2011;11:36. [EMBASE: 70405062]
Toida 2014 {published data only}
    1. Toida T, Sato Y, Fujimoto S. A randomized control study on the procedure for switching epoetin beta (EPO) to epoetin beta pegol (CERA) in the treatment of renal anemia in maintenance hemodialysis patients [abstract]. Nephrology Dialysis Transplantation 2014;29(Suppl 3):iii499‐iii500. [EMBASE: 71492907] - PubMed
    1. Toida T, Sato Y, Shibata N, Kitamura K, Fujimoto S. A randomized control study on the procedure for switching epoetin beta (EPO) to epoetin beta pegol (CERA) in the treatment of renal anemia in maintenance hemodialysis patients. Blood Purification 2014;38(3‐4):174‐9. [MEDLINE: ] - PubMed
Tsubakihara 2011 {published data only}
    1. Tsubakihara Y, Bessho M, Suzuki M, JH22757 Study Group. C.E.R.A. administrated subcutaneously (SC) once every four weeks (Q4W) is non‐inferior to epoetin (EPO) once every two weeks (Q2W) in Japanese patients (pts) with chronic kidney disease (CKD) not on dialysis [abstract no: F167]. NDT Plus 2011;4(Suppl 2):4.s2.32.

References to studies excluded from this review

Macdougall 2006 {published data only}
    1. Macdougall IC, Reigner B, Dougherty FC. Consistent pharmacokinetic properties of CERA (Continuous Erythropoietin Receptor Activator) in healthy volunteers and in patients with CKD) [abstract no: 89]. American Journal of Kidney Diseases 2006;47(4):A41. [CENTRAL: CN‐00583919]
    1. Macdougall IC, Robson R, Opatrna S, Liogier X, Pannier A, Jordan P, et al. Pharmacokinetics and pharmacodynamics of intravenous and subcutaneous continuous erythropoietin receptor activator (C.E.R.A.) in patients with chronic kidney disease. Clinical Journal of the American Society of Nephrology: CJASN 2006;1(6):1211‐5. [MEDLINE: ] - PubMed
    1. Macdougall IC, Robson R, Opatrna S, Liogier X, Pannier A, Reigner B, et al. Pharmacologic profile of CERA (continuous erythropoietin receptor activator) in chronic kidney disease (CKD) patients (pts) following intravenous (IV) and subcutaneous (SC) administration [abstract no: SA‐PO926]. Journal of the American Society of Nephrology 2005;16:759A. [CENTRAL: CN‐00795029] - PubMed

References to studies awaiting assessment

N0107151969 {published data only}
    1. Warwicker P. A randomised, controlled, open‐label, multi‐center, parallel‐group study to demonstrate the efficacy and safety of RO0503821 when administered with pre‐filled syringes for the maintenance treatment of anaemia in patients with chronic kidney disease. National Research Register, UK [www.nrr.nhs.uk/] 2004. [CENTRAL: CN‐00487652]

References to ongoing studies

NCT00773513 {published data only}
    1. NCT00773513. A randomized, open label study to assess all‐cause mortality and cardiovascular morbidity in patients with chronic kidney disease on dialysis and those not on renal replacement therapy under treatment with MIRCERA® or reference ESAs. www.clinicaltrials.gov/ct2/show/NCT00773513 (first received 15 October 2008).
UMIN000008073 {published data only}
    1. Ishikawa E. Methoxy polyethylene glycol‐epoetin beta once a month versus darbepoetin alfa once a week for treatment of anemia in hemodialysis patients: a randomized, multicenter, open‐label trial. upload.umin.ac.jp/cgi‐open‐bin/ctr_e/ctr_view cgi?recptno=R000009496 (first received 6 January 2012).
UMIN000009472 {published data only}
    1. Mitsuiki K. Investigation of responses to erythropoiesis stimulating agents (ESA) for the initial treatment of renal anemia in patients with chronic kidney disease. upload.umin.ac.jp/cgi‐open‐bin/ctr_e/ctr_view cgi?recptno=R000011078 (first received 4 December 2012).

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References to other published versions of this review

Palmer 2012
    1. Palmer SC, Nand K, Dwi Nur Hidayati L, Munasinghe A, Nelson C, Khafaji MM, et al. Continuous erythropoiesis receptor activator (CERA) for the anaemia of chronic kidney disease. Cochrane Database of Systematic Reviews 2012, Issue 6. [DOI: 10.1002/14651858.CD009904] - DOI - PMC - PubMed

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