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

Volumn 50, Issue 6, 2007, Pages 989-1000

  Klinger, Marian ^a   Arias, Manual ^b   Vargemezis, Vassilis ^c   Besarab, Anatole ^d   Sulowicz, Wladyslaw ^e   Gerntholtz, Trevor ^f   Ciechanowski, Kazimierz ^g   Dougherty, Frank C ^h   Beyer, Ulrich ^h  

^a WROCLAW MEDICAL UNIVERSITY   (Poland)

^b HOSPITAL UNIVERSITARIO MARQUÉS DE VALDECILLA   (Spain)

^c University General Hospital   (Greece)

^d HENRY FORD HOSPITAL   (United States)

^e JAGIELLONIAN UNIVERSITY MEDICAL COLLEGE   (Poland)

^f UNIVERSITY OF THE WITWATERSRAND   (South Africa)

^g POMERANIAN MEDICAL UNIVERSITY   (Poland)

^h F HOFFMANN LA ROCHE LTD   (Switzerland)

Author keywords

anemia correction; C.E.R.A.; Chronic kidney disease; continuous erythropoietin receptor activator; epoetin; hemoglobin; methoxy polyethylene glycol epoetin beta; renal anemia

Indexed keywords

FERRIC HYDROXIDE SUCROSE; FERROUS GLUCONATE; FERROUS SULFATE; HEMOGLOBIN; IRON DEXTRAN; METHOXY POLYETHYLENE GLYCOL EPOIETIN BETA; RECOMBINANT ERYTHROPOIETIN; UNCLASSIFIED DRUG;

ADULT; AGED; ANEMIA; ARTERIOVENOUS FISTULA; ARTICLE; BLEEDING; BLOOD VESSEL GRAFT; CARDIOVASCULAR DISEASE; CHRONIC KIDNEY DISEASE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEATH; DIABETES MELLITUS; DIABETIC NEPHROPATHY; DIALYSIS; DRUG EFFICACY; DRUG WITHDRAWAL; ERYTHROCYTE TRANSFUSION; FEMALE; GLOMERULONEPHRITIS; GRAFT OCCLUSION; HEMODIALYSIS; HEMODIALYSIS PATIENT; HEMOGLOBIN BLOOD LEVEL; HUMAN; HYPERLIPIDEMIA; HYPERTENSION; INTERSTITIAL NEPHRITIS; ISCHEMIC HEART DISEASE; KIDNEY FAILURE; KIDNEY POLYCYSTIC DISEASE; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; OPEN STUDY; PERITONEAL DIALYSIS; PHASE 3 CLINICAL TRIAL; PYELONEPHRITIS; RANDOMIZED CONTROLLED TRIAL; RISK FACTOR; THROMBOSIS; TREATMENT OUTCOME;

ANEMIA; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG CARRIERS; ERYTHROPOIETIN, RECOMBINANT; FEMALE; HEMOGLOBINS; HUMANS; HYPERTENSION; MALE; MIDDLE AGED; PERITONEAL DIALYSIS; POLYETHYLENE GLYCOLS; RENAL DIALYSIS; THROMBOSIS; TREATMENT OUTCOME;

EID: 36249017329     PISSN: 02726386     EISSN: None     Source Type: Journal    
DOI: 10.1053/j.ajkd.2007.08.013     Document Type: Article

References (38)

1. Regidor D.L., Kopple J.D., Kovesdy C.P., et al. Associations between changes in hemoglobin and administered erythropoiesis-stimulating agent and survival in hemodialysis patients. J Am Soc Nephrol 17 (2006) 1181-1191
2. Halstenson C.E., Macres M., Katz S.A., et al. Comparative pharmacokinetics and pharmacodynamics of epoetin alfa and epoetin beta. Clin Pharmacol Ther 50 (1991) 702-712
3. Macdougall I.C., Gray S.J., Elston O., et al. Pharmacokinetics of novel erythropoiesis stimulating protein compared with epoetin alfa in dialysis patients. J Am Soc Nephrol 10 (1999) 2392-2395
4. Locatelli F., Aljama P., Bárány 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 19 suppl 2 (2004) ii1-ii47
5. National Kidney Foundation. KDOQI Clinical Practice Guidelines and Clinical Practice Recommendations for Anemia in Chronic Kidney Disease. Am J Kidney Dis 47 suppl 3 (2006) S11-S145
6. Jadoul M., Vanrenterghem Y., Foret M., Walker R., and Gray S.J. Darbepoetin alfa administered once monthly maintains haemoglobin levels in stable dialysis patients. Nephrol Dial Transplant 19 (2004) 898-903
7. Disney A., De Jersey P., Kirkland G., et al. Darbepoetin alfa administered monthly maintains haemoglobin concentrations in patients with chronic kidney disease not receiving dialysis: a multicentre, open-label, Australian study. Nephrology 12 (2007) 95-101
8. Grzeszczak W., Sulowicz W., Rutkowski B., et al., European Collaborative Group. The efficacy and safety of once-weekly and once-fortnightly subcutaneous epoetin β in peritoneal dialysis patients with chronic renal anaemia. Nephrol Dial Transplant 20 (2005) 936-944
9. Ling B., Walczyk M., Agarwal A., Carrol W., Lui W., and Brenner R. Darbepoetin alfa administered once monthly maintains hemoglobin concentrations in patients with chronic kidney disease. Clin Nephrol 63 (2005) 327-334
10. Provenzano R., Bhaduri S., Singh A.K., and PROMPT Study Group. Extended epoetin alfa dosing as maintenance treatment for the anemia of chronic kidney disease: The PROMPT study. Clin Nephrol 2 (2005) 113-123
11. Agarwal A.K., Silver M.R., Reed J.E., et al. 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 260 (2006) 577-585
12. Berns J.S., Elzein H., Lynn R.I., Fishbane S., Meisels I.S., and Deoreo P.B. Hemoglobin variability in epoetin-treated hemodialysis patients. Kidney Int 64 (2003) 1514-1521
13. Lacson Jr. E., Ofsthun N., and Lazarus J.M. Effect of variability in anemia management on hemoglobin outcomes in ESRD. Am J Kidney Dis 41 (2003) 111-124
14. Collins A.J., Brenner R.M., Ofman J.J., et al. Epoetin alfa use in patients with ESRD: an analysis of recent US prescribing patterns and hemoglobin outcomes. Am J Kidney Dis 46 (2005) 481-488
15. Fishbane S., and Berns J.S. Hemoglobin cycling in hemodialysis patients treated with recombinant human erythropoietin. Kidney Int 68 (2005) 1337-1343
16. Macdougall I.C., Wilson P., and Roche A. Impact of haemoglobin variability in haemodialysis patients receiving erythropoiesis-stimulating agents for the management of renal anaemia. J Am Soc Nephrol 16 (2005) 899A (abstr PUB541)
17. Xue J.L., Ma J.Z., Louis T.A., and Collins A.J. Forecast of the number of patients with end-stage renal disease in the United States to the year 2010. J Am Soc Nephrol 12 (2001) 2753-2758
18. Roderick P., Davies R., Jones C., Feest T., Smith S., and Farrington K. Simulation model of renal replacement therapy: predicting future demand in England. Nephrol Dial Transplant 19 (2004) 692-701
19. US Renal Data System. USRDS 2005 Annual Data Report (2005), The National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD
20. Macdougall I.C. CERA (continuous erythropoietin receptor activator): a new erythropoiesis-stimulating agent for the treatment of anemia. Curr Hematol Rep 4 (2005) 436-440
21. Dougherty F.C., Reigner B., Jordan P., and Pannier A. Continuous erythropoiesis receptor activator (CERA) provides dose-dependent erythropoietic activity with a prolonged half-life in healthy volunteers. Ann Oncol 15 suppl 3 (2004) iii157A (abstr 592P)
22. Macdougall I.C., Robson R., Opatrna S., 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 1 (2006) 1211-1215
23. Besarab A., Salifu M.O., Lunde N.M., et al., BA16285 Study Group. 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 29 (2007) 626-639
24. Locatelli F., Villa G., de Francisco A.L.M., et al., BA16286 Study Group. 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 23 (2007) 969-979
25. Provenzano R., Besarab A., Macdougall I.C., et al., BA16528 Study Group. 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 67 (2007) 306-317
26. de Francisco A.L., Sulowicz W., Klinger M., et al., BA16260 Study Investigators. 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. Int J Clin Pract 60 (2006) 1687-1696
27. Levin N.W., Fishbane S., Valdés Cañeno F., et al., MAXIMA study investigators. 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 370 (2007) 1415-1421
28. Sulowicz W., Locatelli F., Ryckelynck J.-P., et al. Once-monthly subcutaneous C.E.R.A. maintains stable Hb control in patients with chronic kidney disease on dialysis directly converted from epoetin one to three times weekly. Clin J Am Soc Nephrol 2 (2007) 637-646
29. Canaud B., Braun J., Locatelli F., 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. Nephrol Dial Transplant 21 suppl 4 (2006) iv157A (abstr SP425)
30. Coyne D.W., Ling B.N., Toto R., McDermott-Vitak A.D., Trotman M.L., and Jackson L. Novel erythropoiesis stimulating protein (NESP) corrects anemia in dialysis patients when administered at reduced dose frequency compared with recombinant-human erythropoietin (r-HuEPO). J Am Soc Nephrol 11 (2000) 263A (abstr A1380)
31. Suranyi M.G., Lindberg J.S., Navarro J., Elias C., Brenner R.M., and Walker R. Treatment of anaemia with darbepoetin alfa administered de novo once every other week in chronic kidney disease. Am J Nephrol 23 (2003) 106-111
32. Toto R.D., Pichette V., Navarro J., et al. Darbepoetin alfa effectively treats anemia in patients with chronic kidney disease with de novo every-other-week administration. Am J Nephrol 24 (2004) 453-460
33. Amico P., Dickenmann M., Steiger J., and Saldutto B. Extended dosing with darbepoetin alfa in patients with chronic kidney disease on hemodialysis. Nephrol Dial Transplant 21 suppl 4 (2006) iv154A (abstr SP417)
34. ® (darbepoetin alfa) administered once every 2 weeks (Q2W) maintains recommended haemoglobin (Hb) in chronic kidney disease (CKD) patients on haemodialysis switched from weekly (QW) dosing. Nephrol Dial Transplant 21 suppl 4 (2006) iv148-iv149 (abstr SP401)
35. Beusterien K.M., Nissenson A.R., Port F.K., Kelly M., Steinwald B., and Ware Jr. J.E. The effects of recombinant human erythropoietin on functional health and well-being in chronic dialysis patients. J Am Soc Nephrol 7 (1996) 763-773
36. Evans R.W., Rader B., and Manninen D.L. The quality of life of hemodialysis recipients treated with recombinant human erythropoietin. JAMA 263 (1990) 825-830
37. El Nahas A.M., and Bello A.K. Chronic kidney disease: the global challenge. Lancet 365 (2005) 331-340
38. Macdougall I.C., Walker R., Provenzano R., 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. J Am Soc Nephrol 17 (2006) 619A (abstr SA-PO208)