A Dose Conversion Study of Epoetin Alfa in Subjects With the Anemia of Chronic Kidney Disease.
A Dose Conversion Study of Epoetin Alfa in Subjects With the Anemia of Chronic Kidney Disease.
The purpose of this study was to evaluate hemoglobin stability in subjects who had received
 darbepoetin alfa for a minimum of 3 months prior to study entry who were then converted to
 epoetin alfa at the same dosing frequency to maintain a hemoglobin level of 12 plus or minus
 1 g/dL (range 11-13- g/dL).
This was a prospective, multicenter study in subjects with chronic kidney disease. The study
 was designed to address hemoglobin stability after drug conversion to epoetin alfa in
 subjects previously receiving darbepoetin alfa therapy.

 The study was to enroll approximately 180 subjects with chronic kidney disease. Eligible
 subjects were those with chronic kidney disease who were receiving darbepoetin alfa every
 two, three, or four weeks for a period of 3 months or more and who had a stable hemoglobin
 (Hb) level at study entry of 12 g/dL (plus or minus 1 g/dL (11-13 g/dL). Subjects receiving
 darbepoetin alfa every 2, 3 or 4 weeks were switched over to epoetin alfa which they received
 at the same dosing frequency ( every 2, 3 or 4 weeks) upon study entry and throughout the 24
 week study period. Clinical safety was assessed for the occurrence and severity of adverse
 events. Blood tests (Complete Blood Count, platelets, reticulocyte count, iron, were assessed
 at pre-determined intervals throughout the study. Vital signs (e.g. Blood pressure) were
 checked at each visit. Subjects received epoetin alfa at the same dosing frequency that they
 had previously received darbepoetin alfa. Subjects received 20,000 Units (U) epoetin alfa
 subcutaneously (SC) every two weeks; 30,000 U epoetin alfa SC every 3 weeks; or 40,000 U
 epoetin alfa SC every 4 weeks.
Inclusion Criteria:

 -  Subjects with chronic kidney disease defined as serum creatinine of 1.5 to 6.0 mg/dL
 for women and 2.0 to 6.0 mg/dL for men

 -  glomerular filtration rate (GFR) within 15-60 mL/min

 -  Subjects on darbepoetin alfa for 3 months or more and with a stable entry hemoglobin
 level of 12 (plus or minus 1 g/dL

 -  range 11-13 g/dL)

 -  Subjects receiving darbepoetin alfa on an every two, three, or four week dosing
 schedule

 -  female subjects with a reproductive potential must have a negative ruine pregnancy
 test within 7days of the first dose of study drug.

 Exclusion Criteria:

 -  No uncontrolled high blood pressure as assessed by the primary physician

 -  No known hypersensitivity to mammalian cell-derived products

 -  No known hypersensitivity to human albumin

 -  Not receiving dialysis or scheduled to receive dialysis during the course of the study

 -  No severe congestive heart failure (New York Heart Association Class IV)

 -  No known severe stable or unstable coronary artery disease.