C.E.R.A. once every 4 weeks in patients with chronic kidney disease not on dialysis: The ARCTOS extension study

Hemodialysis International

Volumn 14, Issue 2, 2010, Pages 233-239

  Kessler, Michèle ^a   Martínez Castelao, Alberto ^b   Siamopoulos, Kostas C ^c   Villa, Giuseppe ^d   Spinowitz, Bruce ^e   Dougherty, Frank C ^f   Beyer, Ulrich ^f  

^a UNIVERSITY HOSPITAL OF NANCY   (France)

^b HOSPITAL UNIVERSITARI DE BELLVITGE   (Spain)

^c UNIVERSITY HOSPITAL OF IOANNINA   (Greece)

^d IRCCS   (Italy)

^e NEW YORK HOSPITAL QUEENS   (United States)

^f F HOFFMANN LA ROCHE LTD   (Switzerland)

Author keywords

Anemia; C.E.R.A.; Chronic kidney disease; Hemoglobin

Indexed keywords

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

ADULT; AGED; ANEMIA; ARTHRALGIA; ARTICLE; BACKACHE; CHILL; CHRONIC KIDNEY DISEASE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; COUGHING; DIALYSIS; DIARRHEA; DIZZINESS; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG FATALITY; DRUG SAFETY; DRUG TOLERABILITY; FEASIBILITY STUDY; FEMALE; HUMAN; HYPERKALEMIA; HYPERTENSION; KIDNEY DISEASE; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; PERIPHERAL EDEMA; PHASE 3 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; URINARY TRACT INFECTION; VOMITING; CHRONIC KIDNEY FAILURE; DRUG ADMINISTRATION; METABOLISM; MIDDLE AGED; RENAL REPLACEMENT THERAPY; SUBCUTANEOUS DRUG ADMINISTRATION;

AGED; AGED, 80 AND OVER; ANEMIA; DRUG ADMINISTRATION SCHEDULE; ERYTHROPOIETIN; ERYTHROPOIETIN, RECOMBINANT; FEMALE; HEMATINICS; HEMOGLOBINS; HUMANS; INJECTIONS, SUBCUTANEOUS; MALE; MIDDLE AGED; POLYETHYLENE GLYCOLS; RENAL DIALYSIS; RENAL INSUFFICIENCY, CHRONIC;

EID: 77956404447     PISSN: 14927535     EISSN: 15424758     Source Type: Journal    
DOI: 10.1111/j.1542-4758.2009.00421.x     Document Type: Article

References (24)

1. Hsu CY, McCulloch CE, Curhan GC. Epidemiology of anemia associated with chronic renal insufficiency among adults in the United States: Results from the Third National Health and Nutrition Examination Survey. J Am Soc Nephrol 2002, 13:504-510.
2. McClellan W, Aronoff SL, Bolton WK. The prevalence of anemia in patients with chronic kidney disease. Curr Med Res Opin 2004, 20:1501-1510.
3. Foley RN, Parfrey PS, Harnett JD, Kent GM, Murray DC, Barre PE. The impact of anemia on cardiomyopathy, morbidity, and mortality in end-stage renal disease. Am J Kidney Dis 1996, 28:53-61.
4. Levin A. Prevalence of cardiovascular damage in early renal disease. Nephrol Dial Transplant 2001, 16((Suppl 2)):7-11.
5. Locatelli F, Aljama P, Bárány P. European Best Practice Guidelines Working Group. Revised European best practice guidelines for the management of anemia in patients with chronic renal failure. Nephrol Dial Transplant 2004, 19((Suppl 2)):ii1-ii47.
6. Gouva C, Nikolopoulos P, Ioannidis JPA, Siamopoulos KC. Treating anemia early in renal failure patients slows the decline of renal function: A randomized controlled trial. Kidney Int 2004, 66:753-760.
7. Obrador GT, Roberts T, St Peter WL, Frazier E, Pereira BJ, Collins AJ. Trends in anemia at initiation of dialysis in the United States. Kidney Int 2001, 60:1875-1884.
8. Valderrábano F, Hörl WH, Macdougall IC, Rossert J, Rutkowski B, Wauters JP. Pre-dialysis survey on anemia management. Nephrol Dial Transplant 2003, 18:89-100.
9. McClellan WM, Jurkovitz C, Abramson J. The epidemiology and control of anemia among pre-ESRD patients with chronic kidney disease. Eur J Clin Invest 2005, 35((Suppl 3)):58-65.
10. Annual Data Report: Atlas of chronic kidney disease and end-stage renal disease in the United States 2007, US Renal Data System., Bethesda, MD, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, p. 76
11. Pereira BJ. Overcoming barriers to the early detection and treatment of chronic kidney disease and improving outcomes for end-stage renal disease. Am J Manag Care 2002, 8((Suppl)):S122-S135.
12. Halstenson CE, Macres M, Katz SA. Comparative pharmacokinetics and pharmacodynamics of epoetin alfa and epoetin beta. Clin Pharmacol Ther 1991, 50:702-712.
13. Macdougall IC, Gray SJ, Elston O. Pharmacokinetics of novel erythropoiesis stimulating protein compared with epoetin alfa in dialysis patients. J Am Soc Nephrol 1999, 10:2392-2395.
14. Macdougall IC, Robson R, Opatrna S. 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, 1:1211-1215.
15. Padhi D, Ni L, Cooke B, Marino R, Jang G. An extended terminal half-life for darbepoetin alfa: Results from a single-dose pharmacokinetic study in patients with chronic kidney disease not receiving dialysis. Clin Pharmacokinet 2006, 45:503-510.
16. http://emc.medicines.org.uk/emc/assets/c/html/DisplayDoc.asp?DocumentID=19960, MIRCERA® SPC (Summary of Product Characteristics). Section 4.2. Posology and Method of Administration, Available from, (accessed date: June 16, 2008)
17. Macdougall IC, Walker R, Provenzano R. 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, 3:337-347. on behalf of the ARCTOS Study Investigators.
18. Levin NW, Fishbane S, Valdés Cañedo F. 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, 370:1415-1421. on behalf of the MAXIMA Study Investigators.
19. Sulowicz W, Locatelli F, Ryckelynck J-P. Once-monthly subcutaneous C.E.R.A. maintains stable hemoglobin control in patients with chronic kidney disease on dialysis converted directly from epoetin one to three times weekly. Clin J Am Soc Nephrol 2007, 2:637-646. on behalf of the PROTOS Study Investigators.
20. Provenzano R, Bhaduri S, Singh AK. PROMPT Study Group. Extended epoetin alfa dosing as maintenance treatment for the anemia of chronic kidney disease: The PROMPT study. Clin Nephrol 2005, 64:113-123.
21. Ling B, Walczyk M, Agarwal A, Carroll W, Liu W, Brenner R. Darbepoetin alfa administered once monthly maintains hemoglobin concentrations in patients with chronic kidney disease. Clin Nephrol 2005, 63:327-334.
22. Agarwal AK, Silver MR, Reed JE. An open-label study of darbepoetin alfa administered once monthly for the maintenance of haemoglobin concentrations in patients with chronic kidney disease not receiving dialysis. J Intern Med 2006, 260:577-585.
23. Disney A, Jersey PD, Kirkland G. Darbepoetin alfa administered monthly maintains haemoglobin concentrations in patients with chronic kidney disease not receiving dialysis: A multicentre, open-label, Australian study. Nephrology (Carlton) 2007, 12:95-101.
24. Hoggard J, Crouch T, McMurray S. Preference for monthly darbepoetin alfa dosing in patients with chronic kidney disease not receiving dialysis. Curr Med Res Opin 2006, 22:2023-2030.