Please use this identifier to cite or link to this item: https://hdl.handle.net/1/246
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dc.contributor.authorRoger, Simon Den
dc.contributor.authorKolmakova, Elenaen
dc.contributor.authorFung, Mapleen
dc.contributor.authorMalecki, Roberten
dc.contributor.authorVinhas, Joseen
dc.contributor.authorDellanna, Franken
dc.contributor.authorThomas, Marken
dc.contributor.authorManamley, Nicken
dc.contributor.authorFerenczi, Sandoren
dc.date.accessioned2015-04-27T23:31:37Zen
dc.date.available2015-04-27T23:31:37Zen
dc.date.issued2014-05en
dc.identifier.citationVolume 19, Issue 5, pp. 266-274en
dc.identifier.issn1440-1797en
dc.identifier.urihttps://elibrary.cclhd.health.nsw.gov.au/cclhdjspui/handle/1/246en
dc.description.abstractAIM: While darbepoetin alfa (DA) can be administered once monthly (QM) to maintain haemoglobin (Hb) concentrations in anaemic patients with chronic kidney disease not on dialysis (CKD-ND), the QM use of DA for anaemia correction has not been previously investigated. METHODS: In this randomized, double-blind, non-inferiority, active-controlled study, adult subjects with CKD-ND, Hb levels <10 g/dL, and not treated with an erythropoiesis-stimulating agent were randomized 1:1 to receive DA every 2 weeks (Q2W) or QM for 33 weeks with initial doses of 0.75 mug/kg Q2W or 1.5 mug/kg QM. Subjects were treated to target Hb levels of 10-12 g/dL and >/=1 g/dL increase from baseline. The primary end-point was Hb change between baseline and the evaluation period (weeks 29-33), with a non-inferiority margin of -0.5 g/dL. RESULTS: Three hundred and fifty-five subjects received >/=1 dose of DA. Mean (95% confidence interval [CI]) change in Hb between baseline and the evaluation period was 2.16 (1.98-2.33) g/dL for the Q2W group and 1.97 (1.80-2.14) g/dL for the QM group, the mean (95% CI) difference in Hb change being -0.19 (-0.43 to 0.05) g/dL. Most subjects (97.9% Q2W; 98.1% QM) achieved a Hb level >/=10.0 g/dL and >/=1.0 g/dL increase in Hb from baseline. Mean DA (SD) weekly equivalent doses over the evaluation period were 0.20 (0.23) and 0.27 (0.31) mug/kg per week for the Q2W and QM groups, respectively. Safety profiles were similar between groups. CONCLUSION: In subjects with CKD-ND, QM dosing was non-inferior to Q2W dosing for anaemia correction and had a similar safety profile.en
dc.subjectKidney Diseaseen
dc.subjectAnaemiaen
dc.subjectAnemiaen
dc.subjectDrug Therapyen
dc.titleDarbepoetin Alfa once monthly corrects Anaemia in patients with chronic kidney disease not on dialysisen
dc.typeJournal Articleen
dc.identifier.doi10.1111/nep.12214en
dc.description.pubmedurihttp://www.ncbi.nlm.nih.gov/pubmed/24506498en
dc.identifier.journaltitleNephrologyen
dc.type.studyortrialRandomized Controlled Clinical Trial/Controlled Clinical Trialen
dc.originaltypeTexten
item.openairecristypehttp://purl.org/coar/resource_type/c_18cf-
item.fulltextNo Fulltext-
item.grantfulltextnone-
item.openairetypeJournal Article-
item.cerifentitytypePublications-
Appears in Collections:Renal Medicine
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