A randomized study of extended dosing regimens for initiation of epoetin alfa treatment for anemia of chronic kidney disease.
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.
Spinowitz
Bruce
B
New York Hospital Queens, 56-45 Main Street, Flushing, NY 11355, USA. bss9001@nyp.org
Germain
Michael
M
Benz
Robert
R
Wolfson
Marsha
M
McGowan
Tracy
T
Tang
K Linda
KL
Kamin
Marc
M
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
D006397:Hematinics; D006454:Hemoglobins; D058085:Iron Compounds; D011994:Recombinant Proteins; D014168:Transferrin; D004921:Erythropoietin; D000068817:Epoetin Alfa; D005293:Ferritins