Anemia Clinical Trial
Official title:
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
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.
n/a
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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