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Title: C.E.R.A. once every 4 weeks corrects Anaemia and maintains haemoglobin in patients with chronic kidney disease not on dialysis
Authors: Roger, Simon D ;Locatelli, Francesco ;Woitas, Rainer ;Laville, Maurice ;Tobe, Sheldon ;Provenzano, Robert ;Golper, Thomas ;Ruangkanchanasetr, Prajej ;Lee, Ho Yung ;Wu, Kwan-Dun ;Ladanyi, Agnes ;Martinez-Castelao, Alberto ;Ulrich, Beyer ;Dougherty, Frank 
Issue Date: Apr-2011
Source: Volume 26, Issue 12, pp. 3980-3986
Journal title: Nephrology Dialysis Transplantation
Abstract: BACKGROUND: No previous randomized controlled studies have been reported examining de novo, once every 4 weeks (Q4W) administration of erythropoiesis-stimulating agents in chronic kidney disease (CKD) patients. We report results from a randomized multinational study that compared continuous erythropoietin receptor activator (C.E.R.A.) Q4W with darbepoetin alfa once weekly (QW) or every 2 weeks (Q2W) for the correction of anaemia in non-dialysis CKD patients. METHODS: Patients were randomized (1:1) to receive either 1.2 ug/kg C.E.R.A. Q4W or darbepoetin alfa QW/Q2W during a 20-week correction period and an 8-week evaluation period. Two primary end points were assessed: the haemoglobin (Hb) response rate and the change in average Hb concentration between baseline and evaluation. RESULTS: The Hb response rate for C.E.R.A. was 94.1%, significantly higher than the protocol-specified 60% response rate [95% confidence interval (CI): 89.1, 97.3; P < 0.0001] and comparable with darbepoetin alfa (93.5%; 95% CI: 88.4, 96.8; P < 0.0001). C.E.R.A. Q4W was non-inferior to darbepoetin alfa QW/Q2W, with similar mean Hb changes from baseline of 1.62 g/dL and 1.66 g/dL, respectively. Patients receiving C.E.R.A. showed a steady rise in Hb, with fewer patients above the target range during the first 8 weeks compared with darbepoetin alfa [39 patients (25.8%) versus 72 patients (47.7%); P < 0.0001]. Adverse event rates were comparable between the treatment groups. CONCLUSION: C.E.R.A. Q4W successfully corrects anaemia and maintains stable Hb levels within the recommended target range in non-dialysis CKD patients.
DOI: 10.1093/ndt/gfr160
ISSN: 0931-0509
Publicaton type: Journal Article
Keywords: Kidney Disease
Drug Therapy
Study or Trial: Multicentre Studies
Appears in Collections:Renal Medicine

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