A randomized study of extended dosing regimens for initiation of epoetin alfa treatment for anemia of chronic kidney disease.

Clinical Journal of the American Society of Nephrology : CJASN
Bruce SpinowitzEpoetin Alfa Extended Dosing Study Group

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

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 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

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Citations

Sep 16, 2011·World Journal of Urology·Ephrem O OlwenyJeffrey A Cadeddu
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
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
Aug 28, 2012·American Journal of Kidney Diseases : the Official Journal of the National Kidney Foundation·Ioannis KoulouridisBertrand L Jaber
Mar 4, 2017·Journal of Veterinary Internal Medicine·E H FiocchiM B Callan
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

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