A Trial of Ferumoxytol for the Episodic Treatment of Iron Deficiency Anemia
31 de marzo de 2022 actualizado por: AMAG Pharmaceuticals, Inc.
A Phase III, Open-Label Extension Trial of the Safety and Efficacy of Ferumoxytol for the Episodic Treatment of Iron Deficiency Anemia
To evaluate the safety and efficacy of ferumoxytol for the episodic treatment of iron deficiency anemia (IDA).
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
634
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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British Columbia
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Vancouver, British Columbia, Canadá
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New Brunswick
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Saint John, New Brunswick, Canadá
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Ontario
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London, Ontario, Canadá
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Thornhill, Ontario, Canadá
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Vaughan, Ontario, Canadá
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Quebec
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Pointe-Claire, Quebec, Canadá
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Alabama
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Birmingham, Alabama, Estados Unidos
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Mobile, Alabama, Estados Unidos
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Montgomery, Alabama, Estados Unidos, 36106
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Montgomery, Alabama, Estados Unidos, 36116
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Arizona
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Phoenix, Arizona, Estados Unidos, 85032
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Phoenix, Arizona, Estados Unidos, 85015
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Tucson, Arizona, Estados Unidos, 85710
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Tucson, Arizona, Estados Unidos, 85712
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California
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Anaheim, California, Estados Unidos
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Bakersfield, California, Estados Unidos
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Buena Park, California, Estados Unidos
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Colton, California, Estados Unidos
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Los Angeles, California, Estados Unidos, 90036
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Los Angeles, California, Estados Unidos, 90057
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Los Angeles, California, Estados Unidos
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Mission Hills, California, Estados Unidos
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Orange, California, Estados Unidos
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San Diego, California, Estados Unidos, 92103
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San Diego, California, Estados Unidos, 92123
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San Diego, California, Estados Unidos, 92121
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Colorado
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Pueblo, Colorado, Estados Unidos
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Connecticut
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Bristol, Connecticut, Estados Unidos
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Groton, Connecticut, Estados Unidos
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Florida
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Boynton Beach, Florida, Estados Unidos, 33426
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Boynton Beach, Florida, Estados Unidos, 33472
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Clearwater, Florida, Estados Unidos, 33759
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Clearwater, Florida, Estados Unidos, 33756
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Hialeah, Florida, Estados Unidos
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Holiday, Florida, Estados Unidos
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Inverness, Florida, Estados Unidos
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Margate, Florida, Estados Unidos
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Miami, Florida, Estados Unidos, 33126
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Miami, Florida, Estados Unidos, 33143
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Miami, Florida, Estados Unidos, 33144
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Miami, Florida, Estados Unidos, 33175
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Miami, Florida, Estados Unidos, 33135
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Miami Lakes, Florida, Estados Unidos
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Naples, Florida, Estados Unidos
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Vero Beach, Florida, Estados Unidos
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West Palm Beach, Florida, Estados Unidos
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Zephyrhills, Florida, Estados Unidos
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Georgia
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Atlanta, Georgia, Estados Unidos, 30308
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Atlanta, Georgia, Estados Unidos, 30342
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Atlanta, Georgia, Estados Unidos, 30312
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Decatur, Georgia, Estados Unidos
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Dublin, Georgia, Estados Unidos
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Sandy Springs, Georgia, Estados Unidos
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Stockbridge, Georgia, Estados Unidos
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Illinois
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Aurora, Illinois, Estados Unidos
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Chicago, Illinois, Estados Unidos, 60616
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Skokie, Illinois, Estados Unidos, 60076
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Skokie, Illinois, Estados Unidos
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Springfield, Illinois, Estados Unidos
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Kansas
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Wichita, Kansas, Estados Unidos
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Louisiana
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New Orleans, Louisiana, Estados Unidos
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Maryland
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Bethesda, Maryland, Estados Unidos
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Hollywood, Maryland, Estados Unidos
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Michigan
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Bay City, Michigan, Estados Unidos, 48706
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Bay City, Michigan, Estados Unidos
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Wyoming, Michigan, Estados Unidos
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Missouri
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Kansas City, Missouri, Estados Unidos
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Nevada
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Las Vegas, Nevada, Estados Unidos
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New Jersey
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Lawrenceville, New Jersey, Estados Unidos
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Neptune, New Jersey, Estados Unidos
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Plainsboro, New Jersey, Estados Unidos
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Voorhees, New Jersey, Estados Unidos
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New Mexico
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Albuquerque, New Mexico, Estados Unidos
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New York
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Brooklyn, New York, Estados Unidos
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New York, New York, Estados Unidos, 10038
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North Carolina
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Raleigh, North Carolina, Estados Unidos
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Winston-Salem, North Carolina, Estados Unidos
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Ohio
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Canton, Ohio, Estados Unidos
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Carlisle, Ohio, Estados Unidos
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Cincinnati, Ohio, Estados Unidos, 45224
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Cincinnati, Ohio, Estados Unidos, 45242
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Columbus, Ohio, Estados Unidos, 43231
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Marion, Ohio, Estados Unidos, 43302
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Marion, Ohio, Estados Unidos
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Mentor, Ohio, Estados Unidos
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Middletown, Ohio, Estados Unidos
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Zanesville, Ohio, Estados Unidos
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Oklahoma
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Norman, Oklahoma, Estados Unidos
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Pennsylvania
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Jenkintown, Pennsylvania, Estados Unidos
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Levittown, Pennsylvania, Estados Unidos
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South Carolina
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Columbia, South Carolina, Estados Unidos
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Greer, South Carolina, Estados Unidos
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Myrtle Beach, South Carolina, Estados Unidos
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North Charleston, South Carolina, Estados Unidos
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South Dakota
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Rapid City, South Dakota, Estados Unidos
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Texas
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Arlington, Texas, Estados Unidos
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Dallas, Texas, Estados Unidos
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Houston, Texas, Estados Unidos, 77030
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Houston, Texas, Estados Unidos, 77074
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Houston, Texas, Estados Unidos
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Laredo, Texas, Estados Unidos
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Longview, Texas, Estados Unidos
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San Antonio, Texas, Estados Unidos, 78205
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San Antonio, Texas, Estados Unidos, 78229
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San Antonio, Texas, Estados Unidos
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San Antonio, Texas, Estados Unidos, 78215
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Utah
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Orem, Utah, Estados Unidos
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Virginia
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Chesapeake, Virginia, Estados Unidos
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Norfolk, Virginia, Estados Unidos
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Bekescsaba, Hungría
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Gyula, Hungría
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Komárom, Hungría
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Szekszárd, Hungría
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Vác, Hungría
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Andhra Pradesh
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Hyderabad, Andhra Pradesh, India
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Secunderabad, Andhra Pradesh, India
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Assam
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Guwahati, Assam, India
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Karnataka
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Bangalore, Karnataka, India, 560002
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Bangalore, Karnataka, India, 560054
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Maharashtra
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Aurangabad, Maharashtra, India
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Nagpur, Maharashtra, India
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Nashik, Maharashtra, India
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Pune, Maharashtra, India
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Rajasthan
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Jaipur, Rajasthan, India
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Tamil Nadu
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Chennai, Tamil Nadu, India
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Madurai, Tamil Nadu, India
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Uttar Pradesh
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Lucknow, Uttar Pradesh, India, 226003
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Lucknow, Uttar Pradesh, India
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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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Valmiera, Letonia
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Ventspils, Letonia, LV-3601
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Ventspils, Letonia
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Białystok, Polonia
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Sopot, Polonia
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Warszawa, Polonia
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Wrocław, Polonia
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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
Key Inclusion Criteria include:
- Participants who completed participation in study AMAG-FER-IDA-301 [NCT01114139]
- Female participants of childbearing potential who are sexually active must be on an effective method of birth control and agree to remain on birth control until completion of participation in the study
Key Exclusion Criteria include:
- Experienced a serious adverse event (SAE) related to ferumoxytol in study AMAG-FER-IDA-301
- Female participants who are pregnant, intend to become pregnant, are breastfeeding, or have a positive serum/urine pregnancy test
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: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Ferumoxytol
Participants received ferumoxytol or placebo during AMAG-FER-IDA-301 [NCT01114139].
Participants enrolled in AMAG-FER-IDA-303, a 6-month Extension Study, were evaluated monthly and could receive treatment with ferumoxytol only if they met criteria defined as persistent or recurrent IDA, hemoglobin <11.0 grams per deciliter (g/dL) and transferrin saturation (TSAT) <20% at any evaluation visit, (except study termination visit).
Participants who met criteria began a 5-week treatment period (TP) and received 2 doses of ferumoxytol 510 mg intravenously (IV).
The first IV 510-mg dose was administered on TP Day 1 (Baseline); the second 2-8 (5±3) days after Dose 1.
The first treatment course with ferumoxytol for participants who previously received placebo in AMAG-FER-IDA-301 was considered Course 1; Course 2 included participants who previously received ferumoxytol in AMAG-FER-IDA-301; subsequent treatment courses were serially numbered.
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Ferumoxitol IV
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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Mean Change In Hemoglobin From TP Baseline To TP Week 5 Following The First Course Of Ferumoxytol
Periodo de tiempo: TP Baseline (Day 1), TP Week 5
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Mean change in hemoglobin from TP Baseline (Day 1) to TP Week 5 following the first dose of ferumoxytol was calculated as: Hemoglobin Change = Hemoglobin (TP Week 5) - Hemoglobin (TP Baseline) TP Baseline was the most recent value measured on/after the screening or the closest monthly evaluation visit prior to Day 1 dosing of Course 1. Change from Baseline used an imputed value of 0 for missing values at the post-baseline visit. |
TP Baseline (Day 1), TP Week 5
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Mean Change In Hemoglobin Following Each Course Of Ferumoxytol From TP Baseline To TP Week 5 Following Each Course Of Ferumoxytol After The First Course
Periodo de tiempo: TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3
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Mean change in hemoglobin from TP Baseline to TP Week 5 following each course of ferumoxytol after the first course was calculated for each participant as: Hemoglobin Change = Hemoglobin (TP Week 5) - Hemoglobin (TP Baseline) The first course of treatment with ferumoxytol for participants who had previously received placebo in AMAG-FER-IDA-301 was considered Course 1. The first course of treatment with ferumoxytol for participants who had previously received ferumoxytol in AMAG-FER-IDA-301 was considered Course 2; subsequent treatment courses were serially numbered. |
TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3
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Percentage Of Participants With An Increase In Hemoglobin ≥2.0 g/dL At Any Time From TP Baseline To TP Week 5
Periodo de tiempo: TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3
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Proportion of participants with an increase in hemoglobin ≥2.0 g/dL at any time from TP Baseline to TP Week 5 following each course of ferumoxytol.
The first course of treatment with ferumoxytol for participants who had previously received placebo in AMAG-FER-IDA-301 was considered Course 1.
The first course of treatment with ferumoxytol for participants who had previously received ferumoxytol in AMAG-FER-IDA-301 was considered Course 2; subsequent treatment courses were serially numbered.
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TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3
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Percentage Of Participants Who Achieved A Hemoglobin Level ≥12.0 g/dL At Any Time From TP Baseline To TP Week 5 Following Each Course Of Ferumoxytol
Periodo de tiempo: TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3
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Proportion of participants who achieved a hemoglobin level ≥12.0 g/dL at any time from TP Baseline to TP Week 5 following each course of ferumoxytol.
The first course of treatment with ferumoxytol for participants who had previously received placebo in AMAG-FER-IDA-301 was considered Course 1.
The first course of treatment with ferumoxytol for participants who had previously received ferumoxytol in AMAG-FER-IDA-301 was considered Course 2; subsequent treatment courses were serially numbered.
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TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3
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Mean Change In TSAT Following Each Course Of Ferumoxytol From TP Baseline To TP Week 5 Following Each Course Of Ferumoxytol
Periodo de tiempo: TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3
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Mean change in TSAT from TP Baseline to TP Week 5 following each course of ferumoxytol.
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TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3
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Patient-reported Outcome Measure: Mean Change In Functional Assessment Of Chronic Illness Therapy (FACIT)-Fatigue Questionnaire From TP Baseline To TP Week 5 Following Each Course Of Ferumoxytol
Periodo de tiempo: TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3
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The FACIT-Fatigue questionnaire is a 13-item questionnaire designed and validated to specifically assess the presence and impact of treatment on fatigue and related symptoms, such as tiredness, on health-related quality of life in anemic participants with cancer. The questionnaire has 13 items, each measured on a 4-point Likert scale. Scoring ranges from 0 (the most fatigued) to 52 (the least fatigued) points, with higher scores representing better functioning or less fatigue. Mean change in FACIT-Fatigue questionnaire from TP Baseline to TP Week 5 following each course of ferumoxytol was calculated as: FACIT-Fatigue Score Change = FACIT-Fatigue Score (Week 5) - FACIT-Fatigue Score (Baseline). TP Baseline was the most recent value measured on/after the screening or the closest monthly evaluation visit prior to Day 1 dosing in each course. If the TP Week 5 FACIT-Fatigue Score value was missing, the change from TP Baseline was conservatively imputed as zero. |
TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3
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Time To Hemoglobin Increase Of ≥2.0 g/dL Or To A Hemoglobin Level Of ≥12.0 g/dL From Baseline
Periodo de tiempo: TP Baseline (Day 1) up to TP Week 5 for Courses 1, 2, and 3
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Days to event was defined as the days from Baseline to the first time the participant met the criteria. Participants without any post-Baseline study visits were not included in this analysis. The first course of treatment with ferumoxytol for participants who had previously received placebo in AMAG-FER-IDA-301 was considered Course 1. The first course of treatment with ferumoxytol for participants who had previously received ferumoxytol in AMAG-FER-IDA-301 was considered Course 2; subsequent treatment courses were serially numbered. |
TP Baseline (Day 1) up to TP Week 5 for Courses 1, 2, and 3
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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.
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)
27 de julio de 2010
Finalización primaria (Actual)
24 de septiembre de 2012
Finalización del estudio (Actual)
23 de abril de 2013
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
Otros números de identificación del estudio
- AMAG-FER-IDA-303
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. .