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dc.contributor.authorRoger, Simon Den
dc.contributor.authorLocatelli, Francescoen
dc.contributor.authorWoitas, Raineren
dc.contributor.authorLaville, Mauriceen
dc.contributor.authorTobe, Sheldonen
dc.contributor.authorProvenzano, Roberten
dc.contributor.authorGolper, Thomasen
dc.contributor.authorRuangkanchanasetr, Prajejen
dc.contributor.authorLee, Ho Yungen
dc.contributor.authorWu, Kwan-Dunen
dc.contributor.authorLadanyi, Agnesen
dc.contributor.authorMartinez-Castelao, Albertoen
dc.contributor.authorUlrich, Beyeren
dc.contributor.authorDougherty, Franken
dc.identifier.citationVolume 26, Issue 12, pp. 3980-3986en
dc.description.abstractBACKGROUND: 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.en
dc.subjectKidney Diseaseen
dc.subjectDrug Therapyen
dc.titleC.E.R.A. once every 4 weeks corrects Anaemia and maintains haemoglobin in patients with chronic kidney disease not on dialysisen
dc.typeJournal Articleen
dc.identifier.journaltitleNephrology Dialysis Transplantationen
dc.type.studyortrialMulticentre Studiesen
item.fulltextNo Fulltext-
item.openairetypeJournal Article-
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