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Darbepoetin alfa

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

Ensayo de AMGEN INC en Anemia · Enfermedad renal cronica.

Más ensayos de: Anemia · Enfermedad renal crónica.

Fase

Fase 1

Estado

Retirado antes de empezar

Fin del objetivo primario

nov 2016

estimado por el promotor

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en abr 2016.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Difficulty in recruitment. PDCO in the Day 30 summary report agrred to remove the PK study in children \<1 year of age.».

Qué mide

Number of subjects with clinically significant changes in physical examinations, laboratory safety tests, and vital signs (Assessed over 29 days) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe 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.

Más ensayos de AMGN

Todos los de AMGN, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT01428154), actualizada en jun 2016.