Study to Assess Darbepoetin Alfa Dosing for the Correction of Anemia in Pediatric Patients With Chronic Kidney Disease

Amgen

Status and phase: Terminated; Phase 3

Conditions: Chronic Kidney Disease; Anemia; Kidney Disease

Treatments: Drug: Placebo; Drug: Darbepoetin Alfa

Study type: Interventional

Funder types: Industry

Identifiers

NCT00436748

20050256

Details and patient eligibility

About

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.

Enrollment: 116 patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Current diagnosis of Chronic Kidney Disease, either receiving or not receiving dialysis
• Anemic, with two consecutive screening hemoglobin values drawn at least 7 days apart < 11.0 g/dL
• Transferrin saturation (Tsat) greater than or equal to 20%

Exclusion criteria

• Any erythropoiesis stimulating agent (ESA) use within 12 weeks prior to randomization
• other hematologic disorders
• upper or lower gastrointenstinal bleeding within 6 months prior to randomization
• uncontrolled hypertension
• prior history (within 12 weeks prior to randomization) of acute myocardial ischemia, hospitalization for congestive heart failure, myocardial infarction, stroke or transient ischemic attack
• prior history (within 6 months prior to randomization) of thromboembolism

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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116 participants in 2 patient groups

Darbepoetin Alfa QW

Experimental group

Description:

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.

Treatment:

Drug: Darbepoetin Alfa

Darbepoetin Alfa Q2W

Experimental group

Description:

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.

Treatment:

Drug: Darbepoetin Alfa

Drug: Placebo