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Darbepoetin Alfa

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

Ensayo de AMGEN INC en Anemia · Chronic Kidney Disease · Kidney Disease (del registro, en inglés).

Más ensayos de: Anemia · Enfermedad renal crónica.

Fase

Fase 3

Estado

Interrumpido

Participantes

116

previstos

Centros

67

Fin del objetivo primario

mar 2014

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, triple ciego. Comenzó en sep 2008.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «FDA and EMA agreed that the information that had been submitted to date was acceptable to meet the requirements of the post-marketing commitment.».

Qué mide

Proportion of Participants Achieving Hemoglobin ≥ 10.0 g/dL (del registro, en inglés) (24 semanas)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe 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.

Más ensayos de AMGN

Todos los de AMGN, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT00436748), actualizada en nov 2022.