title: A randomized study of extended dosing regimens for initiation of epoetin alfa treatment for anemia of chronic kidney disease.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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 hemoglobin increase > or =1 g/dl. Serious adverse events were similar across all groups.
  
  
  CONCLUSIONS
  Epoetin alfa can be initiated Q4W in anemic CKD subjects.
authors.affiliation: New York Hospital Queens, 56-45 Main Street, Flushing, NY 11355, USA. bss9001@nyp.org
authors.forename: Bruce
authors.initials: B
authors.lastname: Spinowitz
authors.forename: Michael
authors.initials: M
authors.lastname: Germain
authors.forename: Robert
authors.initials: R
authors.lastname: Benz
authors.forename: Marsha
authors.initials: M
authors.lastname: Wolfson
authors.forename: Tracy
authors.initials: T
authors.lastname: McGowan
authors.forename: K Linda
authors.initials: KL
authors.lastname: Tang
authors.forename: Marc
authors.initials: M
authors.lastname: Kamin
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000740:Anemia / Q000097:blood / Q000188:drug therapy* / Q000209:etiology; D002908:Chronic Disease; D004334:Drug Administration Schedule; D000068817:Epoetin Alfa; D017707:Erythrocyte Transfusion; D004921:Erythropoietin / Q000008:administration & dosage* / Q000009:adverse effects; D005240:Feasibility Studies; D005260:Female; D005293:Ferritins / Q000097:blood; D006397:Hematinics / Q000008:administration & dosage* / Q000009:adverse effects; D006454:Hemoglobins / Q000378:metabolism; D006801:Humans; D007279:Injections, Subcutaneous; D058085:Iron Compounds / Q000008:administration & dosage; D007674:Kidney Diseases / Q000097:blood / Q000150:complications* / Q000188:drug therapy; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins; D014168:Transferrin / Q000378:metabolism; D016896:Treatment Outcome; D014481:United States
chemical_list: D006397:Hematinics; D006454:Hemoglobins; D058085:Iron Compounds; D011994:Recombinant Proteins; D014168:Transferrin; D004921:Erythropoietin; D000068817:Epoetin Alfa; D005293:Ferritins