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      Treatment of Anemia with Darbepoetin Alfa Administered de novo Once Every Other Week in Chronic Kidney Disease

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          Abstract

          Background/Aims: Darbepoetin alfa is an erythropoiesis-stimulating protein that works via the same mechanism and has a threefold longer serum half-life than recombinant human erythropoietin (rHuEPO). The objective of this study was to evaluate extending the dosing interval of darbepoetin alfa to once every other week administration for the treatment of anemia in patients with chronic kidney disease (CKD) not requiring dialysis who were naive to rHuEPO therapy. Methods: This was a multi-center, open-label study. Seventy-six rHuEPO-naive patients were enrolled to receive darbepoetin alfa (0.75 µg/kg) once every other week for up to 24 weeks. Doses were titrated to achieve and maintain a hemoglobin target of 11.0 to 13.0 g/dl. Results: Ninety-seven percent (95% CI: 0.92, 1.00) of patients completing 24 weeks of treatment achieved a hemoglobin response. The median time to response was 5 weeks (range 1–25 weeks). The median darbepoetin alfa dose at the time of response was 60 µg (range 30–130 µg). Darbepoetin alfa was safe and well tolerated, and no antibodies to darbepoetin alfa were detected. Conclusion: These results demonstrate the utility of darbepoetin alfa administered once every other week in rHuEPO-naive CKD patients. This new treatment paradigm may allow for more widespread management of anemia in patients with CKD.

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          Author and article information

          Journal
          AJN
          Am J Nephrol
          10.1159/issn.0250-8095
          American Journal of Nephrology
          S. Karger AG
          0250-8095
          1421-9670
          2003
          April 2003
          17 January 2003
          : 23
          : 2
          : 106-111
          Affiliations
          aLiverpool Hospital, Sydney, Australia; bAlton Ochsner Medical Foundation, New Orleans, La., cGenesis Clinical Research Corporation, Tampa, Fla., and dAmgen Inc., Thousand Oaks, Calif., USA; eRoyal Melbourne Hospital, Melbourne, Australia
          Article
          68041 Am J Nephrol 2003;23:106–111
          10.1159/000068041
          12481149
          © 2003 S. Karger AG, Basel

          Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher. Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug. Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.

          Page count
          Figures: 1, Tables: 4, References: 17, Pages: 6
          Product
          Self URI (application/pdf): https://www.karger.com/Article/Pdf/68041
          Categories
          Original Article: Patient-Oriented, Translational Research

          Cardiovascular Medicine, Nephrology

          Chronic kidney disease, Darbepoetin alfa, Aranesp, Anemia

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