| HOME | HELP | FEEDBACK | SUBSCRIPTIONS | ARCHIVE | SEARCH |
|
|
|
|||||||
|
|||||||||
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Received October 31, 2006
Accepted on April 16, 2007
ORIGINAL ARTICLES |
,
,
,
*Clinic of Nephrology Collegium Medicum, Jagiellonian University, Cracow, Poland; Department of Nephrology and Dialysis, "A Manzoni" Hospital, Lecco, Italy; Service de Néphrologie, CHU Clemenceau Centre, Caen, France; Department of Nephrology, University of Debrecen, Debrecen, and ||Fresenius Dialysis Center, University of Pecs, Pecs, Hungary; ¶Renal Services and Urology, Leicester General Hospital, Leicester, United Kingdom; and **Pharma Development, F. Hoffmann-La Roche Ltd., Basel, Switzerland
1 To whom correspondence should be addressed. E-mail: wladsul{at}mp.pl.
 |
Abstract |
|---|
C.E.R.A., a continuous erythropoietin receptor activator, is in development to provide anemia correction and stable maintenance of hemoglobin (Hb) levels at extended administration intervals in patients with chronic kidney disease (CKD). This study examined its efficacy and safety when administered up to once monthly in patients who have CKD and are on dialysis and randomly convert directly from epoetin 
or 
one to three times weekly. In this three-arm, comparator-controlled, open-label, randomized, parallel-group, Phase III study, 572 dialysis patients (
18 yr) who were receiving stable subcutaneous epoetin one to three times weekly were randomly assigned (1:1:1) to continue epoetin or to receive subcutaneous C.E.R.A. once monthly or twice monthly for 52 wk. Dosage was adjusted to maintain Hb ±1.0 g/dl of baseline level. Primary end point was mean change in Hb level between baseline and the evaluation period (weeks 29 to 36). Mean Hb levels during the evaluation period were similar between groups (once-monthly C.E.R.A. 11.5 g/dl; twice-monthly C.E.R.A. 11.7 g/dl; epoetin 11.5 g/dl). The difference between C.E.R.A. and epoetin in mean change (97.5% confidence interval) in Hb concentration between baseline and evaluation was -0.022 g/dl (-0.262 to 0.217) for once monthly and 0.141 g/dl (-0.098 to 0.380) for twice monthly. Analysis demonstrated that C.E.R.A. was as effective as epoetin in maintaining Hb and was well tolerated. Subcutaneous C.E.R.A. once or twice monthly successfully maintained tight and stable Hb levels in patients who were on dialysis and randomly converted directly from epoetin one to three times weekly.
This article has been cited by other articles:
|
|
 |
|
  T. J. Arneson, D. Zaun, Y. Peng, C. A. Solid, S. Dunning, and D. T. Gilbertson Comparison of methodologies to characterize haemoglobin variability in the US Medicare haemodialysis population Nephrol. Dial. Transplant., May 1, 2009; 24(5): 1378 - 1383. [Full Text] [PDF]
|
|
|
|
|
|
F. Locatelli, A. Covic, K.-U. Eckardt, A. Wiecek, R. Vanholder, and 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., February 1, 2009; 24(2): 348 - 354. [Full Text] [PDF]
|
|
|
|
 |
|
 F. Carrera and M. Burnier Use of darbepoetin alfa in the treatment of anaemia of chronic kidney disease: clinical and pharmacoeconomic considerations NDT Plus, January 1, 2009; 2(suppl_1): i9 - i17. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
B. Canaud, G. Mingardi, J. Braun, P. Aljama, P. G. Kerr, F. Locatelli, G. Villa, B. Van Vlem, A. W. McMahon, C. Kerloeguen, et al. Intravenous C.E.R.A. maintains stable haemoglobin levels in patients on dialysis previously treated with darbepoetin alfa: results from STRIATA, a randomized phase III study Nephrol. Dial. Transplant., November 1, 2008; 23(11): 3654 - 3661. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 I. C. Macdougall, R. Walker, R. Provenzano, F. de Alvaro, H. R. Locay, P. C. Nader, F. Locatelli, F. C. Dougherty, U. Beyer, and 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., March 1, 2008; 3(2): 337 - 347. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 S. Fishbane, A. Pannier, X. Liogier, P. Jordan, F. C. Dougherty, and B. Reigner Pharmacokinetic and Pharmacodynamic Properties of Methoxy Polyethylene Glycol-Epoetin Beta Are Unaffected by the Site of Subcutaneous Administration J. Clin. Pharmacol., November 1, 2007; 47(11): 1390 - 1397. [Abstract] [Full Text] [PDF]
|
|
| HOME | HELP | FEEDBACK | SUBSCRIPTIONS | ARCHIVE | SEARCH |
