Conditions: Anemia Chronic Kidney Disease Kidney Disease
Keywords: Chronic Kidney Disease Dialysis Anemia Nephrology Pediatric Hemodialysis Peritoneal Dialysis Chronic Renal Insufficiency
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 116
Healthy volunteers: no

Brief summary:
The primary objectives of this study are the following:

1. To test if the proportion of participants achieving a hemoglobin value greater than or equal to 10.0 g/dL at any time point after the first dose during the study is greater than 0.8 when administered de novo darbepoetin alfa once a week (QW) for treatment of anemia in pediatric patients with chronic kidney disease receiving and not receiving dialysis, and
2. To test if the proportion of participants achieving a hemoglobin value greater than or equal to 10.0 g/dL at any time point after the first dose during the study is greater than 0.8 when administered de novo darbepoetin alfa every 2 weeks (Q2W) for treatment of anemia in pediatric patients with chronic kidney disease receiving and not receiving dialysis.

Detailed description:

Arms:
arm 1: Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously. arm 2: Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.

Interventions: intervention 1: Darbepoetin Alfa intervention 2: Placebo
Intervention descriptions: intervention 1: Administered by subcutaneous or intravenous injection intervention 2: Matching placebo solution for subcutaneous or intravenous injection to maintain the blind in the Q2W arm.

Protocol document: