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

• Status: Terminated
• Trial end date: 2014-03-03
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Darbepoetin alfa

Criteria

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