NDT Advance Access first published online on June 27, 2008
This version published online on July 8, 2008
Nephrology Dialysis Transplantation, doi:10.1093/ndt/gfn320
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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
1 Service de Nephrologie, Hôpital Lapeyronie, Montpellier, France 2 Unita’ Operativa di Nefrologia e Dialisi, Ospedali Riuniti di Bergamo, Bergamo, Italy 3 KFH-Dialysezentrums, Nuernberg, Germany 4 Hospital Reina Sofia, Servicio de Nefrologia, Cordoba, Spain 5 Department of Nephrology, Monash Medical Centre, Clayton, Australia 6 Divisione di Nefrologia e Dialisi, Azienda Ospedale di Lecco, Lecco, Italy 7 Divisione di Nefrologia e Dialisi, Fondazione ‘S. Maugeri’ IRCCS, Pavia, Italy 8 Department of Nephrology, Dialysis and Hypertension, O.L. Vrouw Ziekenhuis, Aalst, Belgium 9 University of Alberta Hospital, Edmonton, Canada 10 F. Hoffmann-La Roche Ltd, Basel, Switzerland
Correspondence and offprint requests to: Bernard Canaud, Hôpital Lapeyronie, Service de Nephrologie, 317 av. Du Doyen Gaston Giraud, F-34295, Montpellier, France. Tel: +33-4-6733-8479; Fax: +33-4-6760-3783; E-mail: b-canaud{at}chu-montpellier.fr
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Abstract |
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Background. Extending the administration interval of erythropoiesis-stimulating agents (ESAs) represents an opportunity to improve the efficiency of anaemia management in patients with chronic kidney disease (CKD). However, effective haemoglobin (Hb) maintenance can be challenging with epoetin alfa and epoetin beta administered at extended intervals. C.E.R.A., a continuous erythropoietin receptor activator, has a unique pharmacologic profile and long half-life (
130 h), allowing administration at extended intervals. Phase III results have demonstrated that C.E.R.A. administered once every 4 weeks effectively maintains stable Hb levels in patients with CKD on dialysis.
Methods. STRIATA (Stabilizing haemoglobin TaRgets in dialysis following IV C.E.R.A. Treatment for Anaemia) was a multicentre, open-label randomized phase III study to evaluate the efficacy and safety of intravenous C.E.R.A. administered once every 2 weeks (Q2W) for Hb maintenance following direct conversion from darbepoetin alfa (DA). Adult patients on dialysis receiving stable intravenous DA once weekly (QW) or Q2W were randomized (1:1) to continue their current DA regimen (n = 156) or receive intravenous C.E.R.A. Q2W (n = 157) for 52 weeks. Doses were adjusted to maintain Hb levels within ± 1.0 g/dl of baseline and between 10.0 and 13.5 g/dl. The primary endpoint was the mean Hb change between baseline and the evaluation period (weeks 29–36).
Results. Most patients (>80%) received DA QW before randomization. The mean (95% CI) difference between C.E.R.A. and DA in the primary endpoint was 0.18 g/dl (–0.05, 0.41), within a pre-defined non-inferiority limit. C.E.R.A. was clinically non-inferior to DA (P < 0.0001) in maintaining Hb levels. Both treatments were well tolerated.
Conclusions. Stable Hb levels were successfully maintained in patients on haemodialysis directly converted to Q2W intravenous C.E.R.A. from DA.
Keywords: anaemia; C.E.R.A.; darbepoetin alfa; dialysis; haemoglobin
* STRIATA is registered at www.clinicaltrials.gov (reference NCT00077766 [ClinicalTrials.gov] ). The list of STRIATA Study Investigators is given in the Appendix.
The original version was incorrect. Some errors remained but are now corrected.
Received for publication: 19. 9.07
Accepted in revised form: 19. 5.08