Abstract
Although epoetin alfa is commonly initiated weekly (QW) in anemic chronic kidney disease (CKD) patients, recent evidence indicates that it can be initiated every 2 wk (Q2W) and used in maintenance therapy every 4 wk (Q4W). This study examined the feasibility of initiating epoetin alfa Q4W in anemic CKD patients not receiving dialysis. This open-label study randomized subjects (1:2:2:2) to treatment with epoetin alfa 10,000 IU QW, 20,000 IU Q2W, 20,000 IU Q4W, or 40,000 IU Q4W for 16 wk. Subjects were > or =18 yr, had hemoglobin <11 g/dl, a glomerular filtration rate of 15 to 90 ml/min per 1.73 m(2), and had not received erythropoietic therapy within 8 wk. The primary analysis was a noninferiority comparison of the 40,000 IU Q4W to the 20,000 IU Q2W group in the per-protocol population with respect to hemoglobin change from baseline to the end of study. Of 262 subjects randomized, 229 comprised the per-protocol population. Mean hemoglobin change from baseline for the 40,000 IU Q4W group (1.24 g/dl) was not inferior to the 20,000 IU Q2W group (1.11 g/dl) with the lower limit of 95% CI, -0.21 g/dl. In the QW, 20,000 IU Q2W, 20,000 IU Q4W, and 40,000 IU Q4W groups, 90%, 87%, 75%, and 86% of subjects, respectively, achieved a hemogl...Continue Reading
References
Mar 13, 1999·Annals of Internal Medicine·A S LeveyD Roth
Sep 27, 2003·Clinical Therapeutics·Anke RichterSusan L Dennett
Jul 1, 2004·Clinical Nephrology·R ProvenzanoUNKNOWN POWER Study Group
Jun 30, 2005·Nephrology, Dialysis, Transplantation : Official Publication of the European Dialysis and Transplant Association - European Renal Association·Michael GermainMario Curzi
Aug 24, 2005·Clinical Nephrology·R ProvenzanoUNKNOWN PROMPT Study Group
Aug 21, 2007·Clinical Journal of the American Society of Nephrology : CJASN·Robert BenzMarsha Wolfson
Apr 11, 2008·Clinical Journal of the American Society of Nephrology : CJASN·Bruce SpinowitzUNKNOWN Epoetin Alfa Extended Dosing Study Group
Citations
Sep 16, 2011·World Journal of Urology·Ephrem O OlwenyJeffrey A Cadeddu
Jan 23, 2013·Drugs·Walter H Hörl
Jun 5, 2010·Nephrology, Dialysis, Transplantation : Official Publication of the European Dialysis and Transplant Association - European Renal Association·Fernando CarreraUNKNOWN PATRONUS Investigators
May 13, 2009·Current Opinion in Nephrology and Hypertension·Steven Fishbane
Nov 12, 2010·Clinical Drug Investigation·Jaya GobinDavid B Simon
Oct 8, 2009·Clinical Journal of the American Society of Nephrology : CJASN·Pablo E PergolaPeter Bowers
Apr 18, 2008·Clinical Journal of the American Society of Nephrology : CJASN·Tracy McGowanMarsha Wolfson
Feb 27, 2010·Clinical Journal of the American Society of Nephrology : CJASN·Pablo E PergolaPeter Bowers
Sep 30, 2009·World Journal of Gastroenterology : WJG·Rosario Moreno LópezFernando Gomollón García
Apr 11, 2008·Clinical Journal of the American Society of Nephrology : CJASN·Bruce SpinowitzUNKNOWN Epoetin Alfa Extended Dosing Study Group
Jun 21, 2011·Current Medical Research and Opinion·Brigitte Schiller, Anatole Besarab
Aug 28, 2012·American Journal of Kidney Diseases : the Official Journal of the National Kidney Foundation·Ioannis KoulouridisBertrand L Jaber
Apr 1, 2011·Journal of the American Medical Directors Association·Meenakshi PatelTracy McGowan
Feb 11, 2014·Nephrology·Simon D RogerSándor Ferenczi
Nov 15, 2011·Medical Hypotheses·Vladimir Trkulja
Mar 4, 2017·Journal of Veterinary Internal Medicine·E H FiocchiM B Callan
Apr 17, 2018·PLoS Computational Biology·Joydeep SarkarGerald M Saidel
Jan 10, 2017·The Cochrane Database of Systematic Reviews·Deirdre HahnElisabeth M Hodson
Jun 27, 2008·Clinical Journal of the American Society of Nephrology : CJASN·Rowan G Walker
Jun 10, 2009·Expert Opinion on Pharmacotherapy·Rebecca J Schmidt
Jul 7, 2019·Pharmacy : Journal of Pharmacy, Education and Practice·Linda AwdishuDanuta Trzebinska