Conditions: Renal Insufficiency, Chronic Anemia Renal Dialysis Erythrocyte Transfusion
Keywords: Chronic Kidney Disease Anemia Hemodialysis Red Blood Cell Transfusion
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 216
Healthy volunteers: no

Brief summary:
The purpose of this study is to compare two different dosing methods of epoetin alfa and their effectiveness in maintaining hemoglobin levels between 10.0 to 11.0 g/dL in in patients with chronic kidney disease (CKD) receiving hemodialysis.

Detailed description:

Arms:
arm 1: Participants received epoetin alfa administered intravenously three times a week during hemodialysis for up to 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose changes may have occurred every 2 weeks according to the alternative dosing algorithm, where smaller, frequent dose adjustments were permitted based on six hemoglobin categories. arm 2: Participants received epoetin alfa administered intravenously three times a week during hemodialysis for 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose decreases were permitted every 2 weeks and beginning at week 5 dose increases could only occur ≥ 4 weeks from the last dose increase, according to the United States package insert (USPI) dosing algorithm which includes four categories of hemoglobin levels.

Interventions: intervention 1: Epoetin alfa
Intervention descriptions: intervention 1: Administered intravenously (IV) three times a week (TIW) by appropriately trained healthcare professionals during hemodialysis.

Protocol document: