Anaemia management with C.E.R.A. in routine clinical practice: OCEANE (CohorteMircera patients non-dialysés), a national, multicenter, longitudinal, observational prospective study, in patients with chronic kidney disease not on dialysis

BMJ Open

Volumn 3, Issue 3, 2013, Pages

  Frimat, Luc ^a   Mariat, Christophe ^b   Landais, Paul ^c   Koné, Sébastien ^d   Commenges, Bénédicte ^d   Choukroun, Gabriel ^e  

^a CHU NANCY BRABOIS   (France)

^b HÔPITAL NORD   (France)

^c HÔPITAL NECKER ENFANTS MALADES   (France)

^d Roche   (France)

^e AMIENS UNIVERSITY HOSPITAL   (France)

Author keywords

[No Author keywords available]

Indexed keywords

CONTINUOUS ERYTHROPOIESIS RECEPTOR ACTIVATOR; HEMOGLOBIN;

ADULT; AGED; ANEMIA; ARTERY THROMBOSIS; ARTICLE; BRAIN INFARCTION; BRAIN ISCHEMIA; CEREBROVASCULAR ACCIDENT; CHRONIC KIDNEY DISEASE; CLINICAL PRACTICE; CONFUSION; DEEP VEIN THROMBOSIS; DIABETES MELLITUS; DRUG INDUCED HEADACHE; DRUG WITHDRAWAL; DRY SKIN; FEMALE; FOLLOW UP; GASTROINTESTINAL HEMORRHAGE; HUMAN; HYPERTENSION; HYPOTENSION; INFLUENZA; LONGITUDINAL STUDY; LUNG EMBOLISM; LYMPHOMA; MAJOR CLINICAL STUDY; MALE; MENTAL DISEASE; METABOLIC DISORDER; MULTICENTER STUDY; NEOPLASM; NEPHROLOGIST; NUTRITIONAL DISORDER; OBSERVATIONAL STUDY; OUTCOME ASSESSMENT; PROSPECTIVE STUDY; PRURITUS; PURE RED CELL ANEMIA; SIDE EFFECT; THROMBOCYTE COUNT; THROMBOCYTHEMIA; THROMBOCYTOPENIA; TONGUE EDEMA; URINARY TRACT INFECTION;

EID: 84877674595     PISSN: None     EISSN: 20446055     Source Type: Journal    
DOI: 10.1136/bmjopen-2012-001888     Document Type: Article

References (29)

1. European Medicines Agency (EMEA). Public Statement. Epoetins and the risk of tumour growth progression and thromboembolic events in cancer patients and cardiovascular risks in patients with chronic kidney disease. 23 October 2007. Doc ref: EMEA/496188/2007. http://www.emea.europa.eu/docs/en-GB/document- library/Public-statement/2009/11/WC500015604.pdf (accessed 12 Jun 2012).
2. Locatelli F, Aljama P, Canaud B, et al. on behalf of the Anaemia Working Group of European Renal Best Practice (ERBP). Target haemoglobin to aim for with erythropoiesis-stimulating agents: A position statement by ERBP following publication of the Trial to Reduce cardiovascular Events with Aranesp Therapy (TREAT) study. Nephrol Dial Transplant 2010;25:2846-50.
3. Locatelli F, Covic A, Eckardt KU, et al. on behalf of the ERA-EDTA ERBP Advisory Board. Anaemia management in patients with chronic kidney disease: A position statement by the Anaemia Working Group of European Renal Best Practice (ERBP). Nephrol Dial Transplant 2009;24:348-54.
4. Locatelli F, Aljama P, Barany P, et al. European Best Practice Guidelines Working Group. Revised European Best Practice Guidelines for the management of anaemia in patients with chronic renal failure. Nephrol Dial Transplant 2004;19:ii1-47.
5. Afssaps. Traitement de l'anémie au cours de l'insuffisance rénale chronique de l'adulte: Recommandations de l'Afssaps. Nephrol Ther 2005;1:S1-48.
6. Rossert J, Gassmann-Mayer C, Frei D, et al. Prevalence and predictors of epoetin hyporesponsiveness in chronic kidney disease patients. Nephrol Dial Transplant 2007;22:794-800. (Pubitemid 46351687)
7. Solomon S, Uno H, Lewis EF, et al. Erythropoietic response and outcomes in kidney disease and type 2 diabetes. N Engl J Med 2010;363:1146-55.
8. Szczech LA, Barnhart HX, Inrig JK, et al. Secondary analysis of the CHOIR trial epoetin-alpha dose and achieved hemoglobin outcomes. Kidney Int 2008;74:791-8.
9. Regidor D, McClellan WM, Kewalramani R, et al. Changes in erythropoiesis-stimulating agent (ESA) dosing and haemoglobin levels in US non-dialysis chronic kidney disease patients between 2005 and 2009. Nephrol Dial Transplant 2011;26:1583-91.
10. Topf JM. CERA: Third-generation erythropoiesis-stimulating agent. Expert Opin Pharmacother 2008;9:839-49. (Pubitemid 351566197)
11. Mircera®, Summary of Product Characteristics (SmPC) of 20 July 2007. http://www.ema.europa.eu/docs/fr-FR/document-library/EPAR-Summary-for-the- public/human/000739/WC500033667.pdf (accessed 12 Jun 2012).
12. Macdougall IC, Walker R, Provenzano R, et al. on behalf of the ARCTOS study investigators. C.E.R.A. corrects anemia in patients with chronic kidney disease not on dialysis: Results of a randomized clinical trial. Clin J Am Soc Nephrol 2008;3:337-47.
13. Kessler M, Martinez-Castelao A, Siamopoulos KC, et al. C.E.R.A. once every 4 weeks in patients with chronic kidney disease not on dialysis: The ARCTOS extension study. Hemodial Int 2010;14:233-9.
14. Provenzano R, Besarab A, Macdougall IC, 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. Clin Nephrol 2007;67:306-17. (Pubitemid 46739105)
15. Minutolo R, Zamboli P, Chiodini P, et al. Conversion of darbepoetin to low doses of CERA maintains hemoglobin levels in non-dialysis chronic kidney disease patients. Blood Purif 2010;30:186-94.
16. Besarab A, Salifu MO, Lunde NM, 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. Clin Ther 2007;29:626-39. (Pubitemid 47018271)
17. Roger SD, Locatelli F, Woitas RP, et al. C.E.R.A., once every 4 weeks corrects anaemia and maintains haemoglobin in patients with chronic kidney disease not on dialysis. Nephrol Dial Transplant 2011;26:3980-6.
18. Sanchez-Fructuoso A, Guirado L, Ruiz JC, et al. on behalf of the AnemiaTrans Study Group. Anemia control in kidney transplant patients treated with methoxy polyethylene glycol-epoetin beta (Mircera): The Anemiatrans Group. Transplant Proc 2010;42:2931-4.
19. Recommandations. Déontologie et bonnes pratiques en épidémiologie. Internet site. Révision des recommandations de 1998. Proposition du groupe de travail ad hoc de l'ADELF. December 2003. http://adelf.isped.u-bordeaux2.fr/(accessed 12 Jun 2012).
20. Claudot F, Alla F, Fresson J, et al. Ethics and observational studies in medical research: Various rules in a common framework. Int J Epidemiol 2009;38:1104-8.
21. HAS. Transparency Commission. Mircera©. Opinion of 19 December 2007. http//www.has-sante.fr/portail/upload/docs/application/pdf/ct-5111-mircera-.pdf (accessed 12 Jun 2012).
22. Valderrábano F, Hörl WH, Macdougall IC, et al. PRE-dialysis survey on anaemia management. Nephrol Dial Transplant 2003;18:89-100. (Pubitemid 36104483)
23. Lacson E, Ofsthun N, Lazarus JM. Effect of variability in anemia management on hemoglobin outcomes in ESRD. Am J Kidney Dis 2003;41:111-24. (Pubitemid 36043358)
24. Yilmaz MI, Solak Y, Covic A, et al. Renal anemia of inflammation: The name is self-explanatory. Blood Purif 2011;32:220-5.
25. Registre français des traitements de suppléance de l'insuffisance rénale chronique. Réseau Epidémiologie et Information en Néphrologie. Rapport annuel. 2009. http://www. agence-biomedecine.fr/uploads/document/Rapport-REIN-2009-Web %20sept2011.pdf (accessed 12 Jun 2012).
26. Pérez-Garcia R, Martin-Malo A, Fort J, et al. Baseline characteristics of an incident haemodialysis population in Spain: Results from ANSWER-a multicentre, prospective, observational cohort study. Nephrol Dial Transplant 2009;24:578-88.
27. Deray G. La variabilité de l'hémoglobine chez le patient dialysé. Nephrol Ther 2008;4:549-52.
28. Mann JFE, de Francisco A, Nassar G, et al. Fewer dose changes with once-monthly C.E.R.A. in patients with chronic kidney disease. Clin Nephrol 2011;1:9-15.
29. Locatelli F, Mann JF, Aldigier JC, et al. C.E.R.A. safety profile: A pooled analysis in patients with chronic kidney disease. Clin Nephrol 2010;73:94-103.