NCT01428154

Study to Evaluate Darbepoetin Alfa in Pediatric Subjects With Anemia Due to Chronic Kidney Disease

An Open-label, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Darbepoetin Alfa in Paediatric Subjects From Birth to Less Than 1 Year of Age With Anemia Due to Chronic Kidney Disease

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 1 Year
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find out more about darbepoetin alfa in children less than 1 year of age with anemia (a decrease in red blood cells) due to kidney failure. This study will see if darbepoetin alfa is safe and well tolerated and whether it causes any side effects by taking blood samples and checking vital signs (heart rate, body temperature, and blood pressure tests) at specific times throughout the study. In addition, the study will evaluate the amount of darbepoetin alfa in the blood over time and look at special markers in the blood to evaluate how darbepoetin alfa works on anemia. Darbepoetin alfa is approved by the United States Food and Drug Administration (FDA) and European Medicines Agency (EMA) for use in adults, but not for all ages of pediatric subjects. Therefore, studies need to be conducted in pediatric subjects (children) to determine the appropriate dose to use in younger children.

Conditions

• Anemia
• Chronic Kidney Disease

Interventions

Type	Name	Description
DRUG	Darbepoetin alfa	A single 1.5 μg/kg subcutaneous (SC) dose administration on day 1

Timeline

• Start date: 2016-04-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2011-09-02
• Last updated: 2016-06-17