C.E.R.A. Once Every 4 Weeks Corrects Anaemia and Maintains Haemoglobin in Patients with Chronic Kidney Disease Not on Dialysis
Resource
NEPHROLOGY DIALYSIS TRANSPLANTATION v.26 n.12 pp.3980-3986
Journal
Nephrology Dialysis Transplantation
Pages
3980-3986
Date Issued
2011
Date
2011
Author(s)
Roger, S. D.
Locatelli, F.
Woitas, R. P.
Laville, M.
Tobe, S. W.
Provenzano, R.
Golper, T. A.
Ruangkanchanasetr, P.
Lee, H. Y.
Nowicki, M.
Ladanyi, A.
Martinez-Castelao, A.
Beyer, U.
Dougherty, F. C.
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.) Q 4W 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 lg/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.
Subjects
anaemia
CERA
chronic kidney disease
darbepoetin alfa
haemoglobin
SDGs
Other Subjects
continuous erythropoiesis receptor activator; hemoglobin; novel erythropoiesis stimulating protein; aged; anemia; article; chronic kidney disease; clinical assessment; constipation; controlled study; diarrhea; drug efficacy; drug fatality; drug safety; drug tolerability; drug withdrawal; erythrocyte transfusion; female; hemoglobin blood level; human; hyperkalemia; hypertension; hypotension; kidney disease; major clinical study; male; pneumonia; priority journal; randomized controlled trial; rhinopharyngitis; treatment duration; treatment response; upper respiratory tract infection; urinary tract infection; Aged; Anemia; Erythropoietin; Female; Hemoglobins; Humans; Male; Polyethylene Glycols; Renal Dialysis; Renal Insufficiency, Chronic