Un ensayo que compara ferumoxitol con sacarosa de hierro para el tratamiento de la anemia por deficiencia de hierro
31 de marzo de 2022 actualizado por: AMAG Pharmaceuticals, Inc.
Un ensayo de fase III, aleatorizado, abierto, controlado con activo, que compara ferumoxitol con hierro sacarosa para el tratamiento de la anemia por deficiencia de hierro
El propósito del estudio es evaluar la eficacia y seguridad del ferumoxitol intravenoso (IV) en comparación con el hierro sacarosa IV para el tratamiento de la anemia por deficiencia de hierro (IDA).
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
605
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Berlin, Alemania
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Frankfurt, Alemania, 60322
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Frankfurt, Alemania, 60431
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Mainz, Alemania, 55131
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Mainz, Alemania, D-55116
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Siegen, Alemania
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Wilhelmshaven, Alemania
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Adelaide, Australia
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Ballarat, Australia
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Concord, Australia
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Five Dock, Australia
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Gosford, Australia
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Kingswood, Australia
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Parkville, Australia
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Cheonan, Corea, república de
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Daegu, Corea, república de
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Incheon, Corea, república de, 400-711
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Incheon, Corea, república de, 405-760
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Seoul, Corea, república de, 110-774
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Seoul, Corea, república de, 134-701
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Seoul, Corea, república de, 135-710
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Seoul, Corea, república de, 138-736
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Seoul, Corea, república de, 158-710
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Seoul, Corea, república de
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Suwon, Corea, república de, 442-723
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Suwon, Corea, república de, 443-721
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Barcelona, España
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Manresa, España
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Santa Cruz De Tenerife, España
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Sevilla, España
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La Tronche, Francia
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Békéscsaba, Hungría
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Gyula, Hungría
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Komárom, Hungría
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Miskolc, Hungría
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Szekszárd, Hungría
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Szolnok, Hungría
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Vác, Hungría
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Zalaegerszeg, Hungría
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Padova, Italia
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Rozzano, Italia
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Daugavpils, Letonia
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Riga, Letonia, LV-1002
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Riga, Letonia, LV-1005
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Riga, Letonia, LV-1006
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Riga, Letonia, LV-1010
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Riga, Letonia, LV-1013
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Ventspils, Letonia, LV-3601
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Ventspils, Letonia
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Kaunas, Lituania, LT-48259
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Kaunas, Lituania, LT-49449
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Kaunas, Lituania, LT-50009
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Kaunas, Lituania, LT-50185
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Klaipėda, Lituania
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Vilnius, Lituania, LT-03215
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Vilnius, Lituania, LT-08661
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Šiauliai, Lituania
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Białystok, Polonia
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Katowice, Polonia
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Kraków, Polonia
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Sopot, Polonia
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Warszawa, Polonia, 02-341
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Warszawa, Polonia, 03-580
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Wrocław, Polonia
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Zgierz, Polonia
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Łęczyca, Polonia
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Cambridge, Reino Unido
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London, Reino Unido
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Braşov, Rumania
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Bucharest, Rumania, 011422
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Bucharest, Rumania, 020125
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Iaşi, Rumania
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Suceava, Rumania
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Timişoara, Rumania, 300158
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Timişoara, Rumania, 300593
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Târgu-Mureş, Rumania, 540136
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Târgu-Mureş, Rumania, 540461
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Cape Town, Sudáfrica, 7500
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Cape Town, Sudáfrica, 7530
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Durban, Sudáfrica, 4001
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Durban, Sudáfrica, 4091
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Roodepoort, Sudáfrica
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Stellenbosch, Sudáfrica
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Cherkasy, Ucrania
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Chernivtsi, Ucrania
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Donetsk, Ucrania, 83045
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Donetsk, Ucrania, 83114
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Ivano-Frankivsk, Ucrania
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Kyiv, Ucrania, 01030
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Kyiv, Ucrania, 01034
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Kyiv, Ucrania, 04050
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Kyiv, Ucrania, 04112
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Odessa, Ucrania
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Simferopol, Ucrania
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Vinnytsya, Ucrania
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Zaporizhzhya, Ucrania
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Los criterios clave de inclusión incluyen:
- Hombres y mujeres ≥18 años de edad
Participantes con IDA definida por tener:
- Hemoglobina <10,0 g/decilitro (dL)
- Saturación de transferrina (TSAT) <20%
- Participantes que tienen antecedentes de terapia con hierro oral insatisfactoria o en quienes no se puede usar hierro oral
- Las participantes femeninas en edad fértil que son sexualmente activas deben tener un método anticonceptivo eficaz durante al menos 1 mes antes de la selección y aceptar permanecer en el control de la natalidad hasta completar la participación en el estudio.
Los criterios clave de exclusión incluyen:
- Antecedentes de alergia al hierro intravenoso
- Alergia a dos o más clases de fármacos
- Participantes en diálisis o con una tasa de filtración glomerular estimada <30 ml/minuto(min)/1,73 metro cuadrado (m^2)
- Mujeres participantes que están embarazadas, tienen la intención de quedar embarazadas, están amamantando, dentro de las 2 semanas posteriores al parto o tienen una prueba de embarazo en suero/orina positiva
- Hemoglobina ≤7,0 g/dL
- Ferritina sérica >600 nanogramos/mL
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Ferumoxitol
Los participantes recibieron un total de 2 dosis de ferumoxitol IV de 510 miligramos (mg) (17 mililitros [mL]).
La primera dosis IV de 510 mg se administró el día 1 (línea de base) y la segunda dosis de 2 a 8 (5±3) días después de la primera dosis, para una dosis total acumulada de 1,02 gramos (g).
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Ferumoxitol IV
Otros nombres:
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Comparador activo: Sacarosa de hierro
Los participantes recibieron una inyección o infusión IV de 200 mg (10 ml) de sacarosa de hierro el día 1 (línea de base) y otros 4 días no consecutivos durante un período de 14 días, para una dosis total acumulada de 1,0 g.
Los participantes que recibieron su primera exposición a hierro sacarosa por vía intravenosa recibieron una dosis de prueba el día 1 antes de recibir el resto de la primera dosis, según lo prescrito en el prospecto para algunos países.
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IV hierro sacarosa
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Participantes que lograron un aumento de ≥2,0 g/dL en la hemoglobina en cualquier momento desde el inicio hasta la semana 5
Periodo de tiempo: Línea de base (día 1) hasta la semana 5
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Se presentan los participantes que lograron un aumento de hemoglobina de ≥2,0 g/dl en cualquier momento desde el inicio hasta la semana 5. Se calculó el aumento de hemoglobina en cualquier momento desde el inicio hasta la semana 5 para cada participante en función de: Cambio de hemoglobina = Hemoglobina (Semana X) - Hemoglobina (Línea base), donde la Semana X fue cualquier visita posterior a la Línea base hasta la Semana 5 inclusive. El valor inicial se definió como el valor del día 1 (antes de la inyección del fármaco del estudio). Se usó el cribado o el valor más reciente antes del Día 1 para cualquier participante al que le faltara información del Día 1. Los participantes sin valores de hemoglobina posteriores al inicio se clasificaron como que no lograron un aumento de ≥2,0 g/dl. El análisis estadístico se realizó solo para los datos hasta la Semana 5. |
Línea de base (día 1) hasta la semana 5
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Participantes que alcanzaron un nivel de hemoglobina ≥12,0 g/dl en cualquier momento desde el inicio hasta la semana 5
Periodo de tiempo: Línea de base (día 1) hasta la semana 5
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Se presentan los participantes que alcanzaron un nivel de hemoglobina ≥12,0 g/dl en cualquier momento desde el inicio hasta la semana 5. Se calculó el aumento de hemoglobina en cualquier momento desde el inicio hasta la semana 5 para cada participante en función de: Cambio de hemoglobina = Hemoglobina (Semana X) - Hemoglobina (Línea base), donde la Semana X fue cualquier visita posterior a la Línea base hasta la Semana 5 inclusive. La Línea base se definió como el valor del Día 1 (antes de la inyección del fármaco del estudio). Se usó el cribado o el valor más reciente antes del Día 1 para cualquier participante al que le faltara información del Día 1. Los participantes sin ningún valor de hemoglobina posterior al inicio fueron tratados como no respondedores. |
Línea de base (día 1) hasta la semana 5
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Cambio medio en la hemoglobina desde el inicio hasta la semana 5
Periodo de tiempo: Línea de base (día 1), semana 5
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El cambio medio en la hemoglobina desde el valor inicial hasta la semana 5 se calculó para cada participante como: Cambio de hemoglobina = hemoglobina (semana 5) - hemoglobina (valor inicial). El valor inicial se definió como el valor del día 1 (antes de la inyección del fármaco del estudio). Se usó el cribado o el valor más reciente antes del Día 1 para cualquier participante al que le faltara información del Día 1. Si faltaba el valor de hemoglobina de la semana 5, el cambio desde el valor inicial se imputaba a cero. |
Línea de base (día 1), semana 5
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Cambio medio en TSAT desde el inicio hasta la semana 5
Periodo de tiempo: Línea de base (día 1), semana 5
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El cambio medio en TSAT desde el valor inicial hasta la semana 5 se calculó para cada participante como: Cambio de TSAT = TSAT (semana 5) - TSAT (valor inicial). El valor inicial se definió como el valor del día 1 (antes de la inyección del fármaco del estudio). Se usó el cribado o el valor más reciente antes del Día 1 para cualquier participante al que le faltara información del Día 1. Si faltaba el valor TSAT de la semana 5, el cambio desde la línea de base se imputaba a cero. |
Línea de base (día 1), semana 5
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Cambio medio en la puntuación de fatiga de la evaluación funcional de la terapia de enfermedades crónicas (FACIT) desde el inicio hasta la semana 5
Periodo de tiempo: Línea de base (día 1), semana 5
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El cuestionario FACIT-Fatigue es un cuestionario de 13 ítems diseñado y validado para evaluar específicamente la presencia y el impacto del tratamiento de la fatiga y los síntomas relacionados, como el cansancio, en la calidad de vida relacionada con la salud en participantes anémicos con cáncer. El cuestionario consta de 13 ítems, cada uno medido en una escala Likert de 4 puntos. La puntuación varía de 0 (el más fatigado) a 52 (el menos fatigado) puntos, y las puntuaciones más altas representan un mejor funcionamiento o menos fatiga. El cambio medio en la puntuación de fatiga FACIT desde el inicio hasta la semana 5 se calculó para cada participante como: FACIT-Fatigue Score Change = FACIT-Fatigue Score (Semana 5) - FACIT-Fatigue Score (Baseline). El valor inicial se definió como el valor del Día 1 (antes de la primera dosis del fármaco del estudio). El valor de detección o más reciente antes del Día 1 se utilizó para cualquier participante al que le faltaba información del Día 1. Si faltaba el valor FACIT-Fatigue Score de la semana 5, el cambio desde el valor inicial se imputaba a cero. |
Línea de base (día 1), semana 5
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Tiempo hasta el aumento de hemoglobina de ≥2,0 g/dl o valor de hemoglobina de ≥12,0 g/dl desde el inicio
Periodo de tiempo: Desde el inicio (día 1) hasta la semana 5
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El tiempo hasta el aumento de hemoglobina de ≥2,0 g/dl o el valor de hemoglobina de ≥12,0 g/dl se definió como los días desde el inicio (día 1) hasta la primera vez que el participante tuvo un aumento de hemoglobina de ≥2,0 g/dl o de hemoglobina valor de ≥12,0 g/dL, y se calculó mediante una curva de Kaplan-Meier.
Los participantes que no tuvieron un aumento de hemoglobina de ≥2,0 g/dL o un nivel de hemoglobina de ≥12,0 g/dL fueron censurados en su último día de visita.
No se incluyeron los participantes sin visitas de estudio posteriores al inicio.
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Desde el inicio (día 1) hasta la semana 5
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Hetzel D, Strauss W, Bernard K, Li Z, Urboniene A, Allen LF. A Phase III, randomized, open-label trial of ferumoxytol compared with iron sucrose for the treatment of iron deficiency anemia in patients with a history of unsatisfactory oral iron therapy. Am J Hematol. 2014 Jun;89(6):646-50. doi: 10.1002/ajh.23712.
- Strauss WE, Dahl NV, Li Z, Lau G, Allen LF. Ferumoxytol versus iron sucrose treatment: a post-hoc analysis of randomized controlled trials in patients with varying renal function and iron deficiency anemia. BMC Hematol. 2016 Jul 26;16:20. doi: 10.1186/s12878-016-0060-x. eCollection 2016.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
10 de agosto de 2010
Finalización primaria (Actual)
9 de noviembre de 2011
Finalización del estudio (Actual)
25 de junio de 2012
Fechas de registro del estudio
Enviado por primera vez
29 de abril de 2010
Primero enviado que cumplió con los criterios de control de calidad
30 de abril de 2010
Publicado por primera vez (Estimar)
3 de mayo de 2010
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
21 de abril de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
31 de marzo de 2022
Última verificación
1 de marzo de 2022
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades metabólicas
- Enfermedades hematológicas
- Trastornos Nutricionales
- Anemia Hipocrómica
- Trastornos del metabolismo del hierro
- Desnutrición
- Anemia, deficiencia de hierro
- Anemia
- Enfermedades por deficiencia
- Hematínicos
- Soluciones farmacéuticas
- Soluciones de nutrición parenteral
- Óxido ferrosoférrico
- Óxido férrico sacarificado
Otros números de identificación del estudio
- AMAG-FER-IDA-302
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .