Once-Monthly Continuous Erythropoietin Receptor Activator (C.E.R.A.) in Patients with Hemodialysis-Dependent Chronic Kidney Disease: Pooled Data from Phase III Trials

Advances in Therapy

Volumn 33, Issue 4, 2016, Pages 610-625

  Locatelli, Francesco ^a   Choukroun, Gabriel ^b   Truman, Matt ^c   Wiggenhauser, Alfons ^d   Fliser, Danilo ^e  

^a A MANZONI HOSPITAL   (Italy)

^b UNIVERSITÉ DE PICARDIE JULES VERNE   (France)

^c Roche Products Australia   (Australia)

^d ROCHE INNOVATION CENTER MUNICH   (Germany)

^e SAARLAND UNIVERSITY   (Germany)

Author keywords

Anemia, chronic kidney disease; Continuous erythropoiesis; Efficacy; Hemodialysis; Patient subgroups; Pooled analysis; Receptor activator

Indexed keywords

CONTINUOUS ERYTHROPOIESIS RECEPTOR ACTIVATOR; HEMOGLOBIN; NOVEL ERYTHROPOIESIS STIMULATING PROTEIN; RECOMBINANT ERYTHROPOIETIN; ANTIANEMIC AGENT; ERYTHROPOIETIN; MACROGOL DERIVATIVE;

ADULT; ANEMIA; ARTERIOSCLEROSIS; ARTICLE; CARDIOVASCULAR RISK; CHRONIC KIDNEY DISEASE; CONTROLLED STUDY; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG SAFETY; FEMALE; HEMODIALYSIS; HEMOGLOBIN BLOOD LEVEL; HUMAN; HYPERTENSION; HYPERTENSIVE CRISIS; INTERVENTION STUDY; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; OPEN STUDY; OUTCOME ASSESSMENT; PHLEBITIS; RANDOMIZED CONTROLLED TRIAL; RETROSPECTIVE STUDY; RISK ASSESSMENT; STENOSIS; THROMBOEMBOLISM; TREATMENT RESPONSE; ADVERSE EFFECTS; AGED; COMPLICATION; DOSE RESPONSE; MIDDLE AGED; PHASE 3 CLINICAL TRIAL (TOPIC); PROCEDURES; RANDOMIZED CONTROLLED TRIAL (TOPIC); RENAL INSUFFICIENCY, CHRONIC; STATISTICS; TREATMENT OUTCOME;

AGED; ANEMIA; CLINICAL TRIALS, PHASE III AS TOPIC; DOSE-RESPONSE RELATIONSHIP, DRUG; ERYTHROPOIETIN; FEMALE; HEMATINICS; HEMOGLOBINS; HUMANS; MALE; MIDDLE AGED; OUTCOME AND PROCESS ASSESSMENT (HEALTH CARE); POLYETHYLENE GLYCOLS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RENAL DIALYSIS; RENAL INSUFFICIENCY, CHRONIC; STATISTICS AS TOPIC;

EID: 84960363688     PISSN: 0741238X     EISSN: 18658652     Source Type: Journal    
DOI: 10.1007/s12325-016-0309-6     Document Type: Article

References (27)

1. Portoles J, Gorriz JL, Rubio E, de Alvaro F, Garcia F, Alvarez-Chivas V, et al. The development of anemia is associated to poor prognosis in NKF/KDOQI stage 3 chronic kidney disease. BMC Nephrol. 2013;14:2.
2. Kovesdy CP, Trivedi BK, Kalantar-Zadeh K, Anderson JE. Association of anemia with outcomes in men with moderate and severe chronic kidney disease. Kidney Int. 2006;69:560–4.
3. Locatelli F, Covic A, Eckardt KU, Wiecek A, Vanholder R. Anaemia management in patients with chronic kidney disease: a position statement by the Anaemia Working Group of European Renal Best Practice (ERBP). Nephrol Dial Transpl. 2009;24:348–54.
4. Locatelli F, Del Vecchio L. An expert opinion on the current treatment of anemia in patients with kidney disease. Expert Opin Pharmacother. 2012;13:495–503.
5. Palmer SC, Saglimbene V, Mavridis D, Salanti G, Craig JC, Tonelli M, et al. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2014;12:CD010590.
6. 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. Clin J Am Soc Nephrol. 2006;1:1211–5.
7. Locatelli F, Villa G, de Francisco AL, Albertazzi A, Adrogue HJ, Dougherty FC, et al. Effect of a continuous erythropoietin receptor activator (C.E.R.A.) on stable haemoglobin in patients with CKD on dialysis: once monthly administration. Curr Med Res Opin. 2007;23:969–79.
8. Levin NW, Fishbane S, Canedo FV, Zeig S, Nassar GM, Moran JE, et al. Intravenous methoxy polyethylene glycol-epoetin beta for haemoglobin control in patients with chronic kidney disease who are on dialysis: a randomised non-inferiority trial (MAXIMA). Lancet. 2007;370:1415–21.
9. Sulowicz W, Locatelli F, Ryckelynck JP, Balla J, Csiky B, Harris K, et al. Once-monthly subcutaneous C.E.R.A. maintains stable hemoglobin control in patients with chronic kidney disease on dialysis and converted directly from epoetin one to three times weekly. Clin J Am Soc Nephrol. 2007;2:637–46.
10. Dellanna F, Winkler RE, Bozkurt F, Schettler V, Graf S, Bockreiss N, et al. Dosing strategies for conversion of haemodialysis patients from short-acting erythropoiesis stimulating agents to once-monthly C.E.R.A.: experience from the MIRACEL study. Int J Clin Pract. 2011;65:64–72.
11. Weinreich T, Leistikow F, Hartmann HG, Vollgraf G, Dellanna F. Monthly continuous erythropoietin receptor activator treatment maintains stable hemoglobin levels in routine clinical management of hemodialysis patients. Hemodial Int. 2012;16:11–9.
12. Fliser D, Kleophas W, Dellanna F, Winkler RE, Backs W, Kraatz U, et al. Evaluation of maintenance of stable haemoglobin levels in haemodialysis patients converting from epoetin or darbepoetin to monthly intravenous C.E.R.A.: the MIRACEL study. Curr Med Res Opin. 2010;26:1083–9.
13. Mann JF, de Francisco A, Nassar G, Canaud B. Fewer dose changes with once-monthly C.E.R.A. in patients with chronic kidney disease. Clin Nephrol. 2011;76:9–15.
14. Carrera F, Lok CE, de 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. Nephrol Dial Transpl. 2010;25:4009–17.
15. Bastos K, Lucarelli LA, De Francesco-Daher E, Filho RP, Henriquez C, Espinoza B, et al. C.E.R.A. maintains stable hemoglobin in Latin American patients on dialysis. Int Urol Nephrol. 2012;45:1355–64.
16. 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. Zhonghua Nei Ke Za Zhi. 2012;51:502–7.
17. Dellanna F, Dickenmann M, Shilo V, Kleophas W. Prognostic value of N-terminal Pro-B-type natriuretic peptide (NT-proBNP) concentrations in patients with end stage renal disease. Proceedings of Kidney Week; 2012 Oct 30–Nov 4; San Diego, CA, USA. American Society of Nephrology; 2012.
18. European Medicines Agency: Mircera Summary of Product Characteristics. 2009 [updated 07/10/2014; cited 04/03/15]. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000739/WC500033672.pdf. Accessed 4 Mar 2015.
19. Locatelli F, Dusilova-Sulkova S. Characteristics of patients with chronic kidney disease on dialysis with a poor response to continuous erythropoietin receptor activator (C.E.R.A.) once monthly: an analysis of 10 international trials. Nephrol Dial Transpl. 2012;27(suppl 2):ii133–ii145.
20. Fliser D, Shilo V. Continuous erythropoietin receptor activator (C.E.R.A.) once monthly maintains stable hemoglobin values in high-risk patients with chronic kidney disease on dialysis: an analysis of 10 international trials. Nephrol Dial Transpl. 2012;27(suppl 2):ii133–ii145.
21. Locatelli F, Mann JF, Aldigier JC, Sanz Guajardo D, Schmidt R, Van Vlem B, et al. C.E.R.A. safety profile: a pooled analysis in patients with chronic kidney disease. Clin Nephrol. 2010;73:94–103.
22. Locatelli F, Choukroun G, Fliser D, Moecks J, Wiggenhauser A. Dosing of continuous erythropoietin receptor activator (C.E.R.A.) once monthly vs darbepoetin, epoetin alfa or epoetin beta in high-risk patients with chronic kidney disease on dialysis: an analysis of 13 international trials Nephrol Dial Transpl. 2014:29(Suppl 3):iii491–iii500.
23. Locatelli F, de Francisco A, Deray G, Fliser D, Armstrong G, Dougherty FC, et al. Mortality and cardiovascular morbidity associated with haemoglobin levels: a pooled analysis of randomised controlled trials. Nephron Clin Pract. 2014;128:323–32.
24. Locatelli F, Altieri P, Andrulli S, Sau G, Bolasco P, Pedrini LA, et al. Predictors of haemoglobin levels and resistance to erythropoiesis-stimulating agents in patients treated with low-flux haemodialysis, haemofiltration and haemodiafiltration: results of a multicentre randomized and controlled trial. Nephrol Dial Transpl. 2012;27:3594–600.
25. Locatelli F, Hannedouche T, Martin-Malo A, Jacobson SH, Vanholder R, Ronco C, et al. The relationship of NT-proBNP and dialysis parameters with outcome of incident haemodialysis patients: results from the membrane permeability outcome study. Blood Purif. 2013;35:216–23.
26. Locatelli F, Barany P, Covic A, De Francisco A, Del Vecchio L, Goldsmith D, et al. Kidney disease: improving global outcomes guidelines on anaemia management in chronic kidney disease: a european renal best practice position statement. Nephrol Dial Transpl. 2013;28:1346–59.
27. Lagrand WK, Visser CA, Hermens WT, Niessen HW, Verheugt FW, Wolbink GJ, et al. C-reactive protein as a cardiovascular risk factor: more than an epiphenomenon? Circulation. 1999;100:96–102.