Effect of a continuous erythropoietin receptor activator (C.E.R.A.) on stable haemoglobin in patients with CKD on dialysis: Once monthly administration

Current Medical Research and Opinion

Volumn 23, Issue 5, 2007, Pages 969-979

  Locatelli, Francesco ^a   Villa, Giuseppe ^b   De Francisco, Angel L M ^c   Albertazzi, Alberto ^d   Adrogue, Horacio J ^e   Dougherty, Frank C ^f   Beyer, Ulrich ^f  

^a A MANZONI HOSPITAL   (Italy)

^b IRCCS   (Italy)

^c HOSPITAL UNIVERSITARIO MARQUÉS DE VALDECILLA   (Spain)

^d UNIVERSITY OF MODENA AND REGGIO EMILIA   (Italy)

^e MICHAEL E DEBAKEY VETERANS AFFAIRS MEDICAL CENTER   (United States)

^f F HOFFMANN LA ROCHE LTD   (Switzerland)

Author keywords

Administration, once monthly; C.E.R.A; Continuous erythropoietin receptor activator; Dialysis; Haemoglobin

Indexed keywords

CONTINUOUS ERYTHROPOIESIS RECEPTOR ACTIVATOR; MIRCERA; RECOMBINANT ERYTHROPOIETIN; UNCLASSIFIED DRUG;

ADULT; AGED; ANEMIA; ARTERIOVENOUS FISTULA; ARTICLE; BLOOD SAMPLING; CHRONIC KIDNEY DISEASE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; COUGHING; DIALYSIS; DOSAGE SCHEDULE COMPARISON; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG DOSE INCREASE; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FEMALE; FEVER; HEADACHE; HUMAN; HYPERTENSION; HYPOTENSION; LABORATORY TEST; LOADING DRUG DOSE; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; MUSCLE CRAMP; MUSCLE SPASM; PHASE 2 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; UNSPECIFIED SIDE EFFECT;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; ALGORITHMS; ANEMIA; CHRONIC DISEASE; DRUG ADMINISTRATION SCHEDULE; ERYTHROPOIETIN; FEMALE; HEMOGLOBINS; HUMANS; KIDNEY DISEASES; MALE; MIDDLE AGED; POLYETHYLENE GLYCOLS; RENAL DIALYSIS; TREATMENT OUTCOME;

EID: 34249040576     PISSN: 03007995     EISSN: None     Source Type: Journal    
DOI: 10.1185/030079907X182103     Document Type: Article

References (29)

1. Collins AJ, Li S, Gilbertson DT, Liu J, et al. Chronic kidney disease and cardiovascular disease in the Medicare population. Kidney Int 2003;64(Suppl):S24-S31
2. Alebiosu CO, Ayodele OE. The global burden of chronic kidney disease and the way forward. Ethn Dis 2005;15:418-23
3. US Renal Data System, USRDS 2005 Annual data report: atlas of end-stage renal disease in the United States. Bethesda (MD): National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases; 2005
4. Thorp ML, Eastman L, Smith DH, Johnson ES. Managing the burden of chronic kidney disease. Dis Manag 2006;9:115-21
5. Perlman RL, Finkelstein FO, Liu L, et al. Quality of life in chronic kidney disease (CKD): a cross-sectional analysis in the renal research institute-CKD study. Am J Kidney Dis 2005;45:658-66
6. Foley RN, Parfrey PS, Kent GM, et al. Serial change in echocardiographic parameters and cardiac failure in end-stage renal disease. J Am Soc Nephrol 2000;11:912-6
7. Silverberg D. Outcomes of anaemia management in renal insufficiency and cardiac disease. Nephrol Dial Transplant 2003;18(Suppl 2):ii7-ii12
8. Macdougall IC. Present and future strategies in the treatment of renal anaemia. Nephrol Dial Transplant 2001;16(Suppl 5):50-5
9. Collins AJ. Anaemia management prior to dialysis: cardiovascular and benefit observations. Nephrol Dial Transplant 2003;18 (Suppl 2):ii2-ii6
10. Ross SD, Fahrbach K, Frame D, et al. The effect of anemia treatment on selected health-related quality-of-life domains: a systematic review. Clin Ther 2003;25:1786-805
11. Locatelli F, Pisoni RL, Combe C, et al. Anaemia in haemodialysis patients of five European countries: association with morbidity and mortality in the Dialysis Outcomes and Practice Patterns Study (DOPPS). Nephrol Dial Transplant 2004:19:121-32
12. Regidor DL, Kopple JD, Kovesdy CP, et al. Associations between changes in hemoglobin and administered erythropoiesis-stimulating agent and survival in hemodialysis patients. J Am Soc Nephrol 2006;17:1181-91
13. 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 2004;19 (Suppl 2):ii1-ii47
14. Anon. KDOQI clinical practice guidelines and clinical practice recommendations for anemia in chronic kidney disease. Am J Kidney Dis 2006;47(Suppl 3):S11-S145
15. Valderrábano F, Hörl WH, Macdougall IC, et al. PRE-dialysis survey on anemia management. Nephrol Dial Transplant 2003;18:89-100
16. Jadoul M, Vanrenterghem Y, Foret M, et al.; on behalf of the Darbepoetin Alfa 20000144 Study Group. Darbepoetin alfa administered once monthly maintains haemoglobin levels in stable dialysis patients. Nephrol Dial Transplant 2004;19: 898-903
17. Macdougall IC. CERA (Continuous Erythropoietin Receptor Activator): a new erythropoiesis-stimulating agent for the treatment of anemia. Curr Hematol Rep 2005;4:436-40
18. Brandt M, Lanzendörfer M, Frische J, et al. Different receptor binding activity of C.E.R.A. (Continuous Erythropoietin Receptor Activator) compared with epoetin beta determined by surface plasmon resonance and competition assay on UT-7 cells. Nephrol Dial Transplant 2006;21(Suppl 4):iv9 [abstract SO018]
19. Dougherty FC, Reigner B, Jordan P, Pannier A. Continuous Erythropoiesis Receptor Activator (CERA) provides dose-dependent erythropoietic activity with a prolonged half-life in healthy volunteers. Ann Oncol 2004;15(Suppl 3):iii157 [abstract 592P]
20. Macdougall IC, Reigner B, Dougherty FC. Consistent pharmaco-kinetic properties of C.E.R.A. (Continuous Erythropoietin Receptor Activator) in healthy volunteers and in patients with CKD. Am J Kidney Dis 2006;47:A41 [abstract 89]
21. Macdougall IC, 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 2006;1:1211-5
22. de Francisco ALM, Sulowicz W, Klinger M, et al.; on behalf of the 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 2006;60:1687-96
23. Macdougall IC, Gray SJ, Elston O, et al. Pharmacokinetics of novel erythropoiesis stimulating protein compared with epoetin alfa in dialysis patients. J Am Soc Nephrol 1999;10: 2392-5
24. Padhi D, Ni L, Cooke B, et al. 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;45:503-10
25. Fishbane S, Berns JS. Hemoglobin cycling in hemodialysis patients treated with recombinant human erythropoietin. Kidney Int 2005;68:1337-43
26. Fishbane S. Recombinant human erythropoietin: has treatment reached its full potential? Semin Dial 2006;19:1-4
27. Strippoli GFM, Tognoni G, Navaneethan SD, et al. Haemoglobin targets: we were wrong, time to move on. Lancet 2007;369: 346-50
28. Lacson E Jr, Ofsthun N, Lazarus JM. Effect of variability in anemia management on hemoglobin outcomes in ESRD. Am J Kidney Dis 2003;41:111-24
29. Collins AJ, Brenner RM, Ofman JJ, et al. Epoetin alfa use in patients with ESRD: an analysis of recent US prescribing patterns and hemoglobin outcomes. Am J Kidney Dis 2005;46:481-8