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A Trial of Ferumoxytol for the Episodic Treatment of Iron Deficiency Anemia

31 mars 2022 mis à jour par: 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).

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

634

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Clinical Trial Site
    • New Brunswick
      • Saint John, New Brunswick, Canada
        • Clinical Trial Site
    • Ontario
      • London, Ontario, Canada
        • Clinical Trial Site
      • Thornhill, Ontario, Canada
        • Clinical Trial Site
      • Vaughan, Ontario, Canada
        • Clinical Trial Site
    • Quebec
      • Pointe-Claire, Quebec, Canada
        • Clinical Trial Site
  • Hongrie
      • Bekescsaba, Hongrie
        • Clinical Trial Site
      • Gyula, Hongrie
        • Clinical Trial Site
      • Komárom, Hongrie
        • Clinical Trial Site
      • Szekszárd, Hongrie
        • Clinical Trial Site
      • Vác, Hongrie
        • Clinical Trial Site
  • Inde
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, Inde
        • Clinical Trial Site
      • Secunderabad, Andhra Pradesh, Inde
        • Clinical Trial Site
    • Assam
      • Guwahati, Assam, Inde
        • Clinical Trial Site
    • Karnataka
      • Bangalore, Karnataka, Inde, 560002
        • Clinical Trial Site
      • Bangalore, Karnataka, Inde, 560054
        • Clinical Trial Site
    • Maharashtra
      • Aurangabad, Maharashtra, Inde
        • Clinical Trial Site
      • Nagpur, Maharashtra, Inde
        • Clinical Trial Site
      • Nashik, Maharashtra, Inde
        • Clinical Trial Site
      • Pune, Maharashtra, Inde
        • Clinical Trial Site
    • Rajasthan
      • Jaipur, Rajasthan, Inde
        • Clinical Trial Site
    • Tamil Nadu
      • Chennai, Tamil Nadu, Inde
        • Clinical Trial Site
      • Madurai, Tamil Nadu, Inde
        • Clinical Trial Site
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, Inde, 226003
        • Clinical Trial Site
      • Lucknow, Uttar Pradesh, Inde
        • Clinical Trial Site
  • Lettonie
      • Daugavpils, Lettonie
        • Clinical Trial Site
      • Riga, Lettonie, LV-1002
        • Clinical Trial Site
      • Riga, Lettonie, LV-1005
        • Clinical Trial Site
      • Riga, Lettonie, LV-1006
        • Clinical Trial Site
      • Riga, Lettonie, LV-1010
        • Clinical Trial Site
      • Valmiera, Lettonie
        • Clinical Trial Site
      • Ventspils, Lettonie, LV-3601
        • Clinical Trial Site
      • Ventspils, Lettonie
        • Clinical Trial Site
  • Pologne
      • Białystok, Pologne
        • Clinical Trial Site
      • Sopot, Pologne
        • Clinical Trial Site
      • Warszawa, Pologne
        • Clinical Trial Site
      • Wrocław, Pologne
        • Clinical Trial Site
  • États-Unis
    • Alabama
      • Birmingham, Alabama, États-Unis
        • Clinical Trial Site
      • Mobile, Alabama, États-Unis
        • Clinical Trial Site
      • Montgomery, Alabama, États-Unis, 36106
        • Clinical Trial Site
      • Montgomery, Alabama, États-Unis, 36116
        • Clinical Trial Site
    • Arizona
      • Phoenix, Arizona, États-Unis, 85032
        • Clinical Trial Site
      • Phoenix, Arizona, États-Unis, 85015
        • Clinical Trial Site
      • Tucson, Arizona, États-Unis, 85710
        • Clinical Trial Site
      • Tucson, Arizona, États-Unis, 85712
        • Clinical Trial Site
    • California
      • Anaheim, California, États-Unis
        • Clinical Trial Site
      • Bakersfield, California, États-Unis
        • Clinical Trial Site
      • Buena Park, California, États-Unis
        • Clinical Trial Site
      • Colton, California, États-Unis
        • Clinical Trial Site
      • Los Angeles, California, États-Unis, 90036
        • Clinical Trial Site
      • Los Angeles, California, États-Unis, 90057
        • Clinical Trial Site
      • Los Angeles, California, États-Unis
        • Clinical Trial Site
      • Mission Hills, California, États-Unis
        • Clinical Trial Site
      • Orange, California, États-Unis
        • Clinical Trial Site
      • San Diego, California, États-Unis, 92103
        • Clinical Trial Site
      • San Diego, California, États-Unis, 92123
        • Clinical Trial Site
      • San Diego, California, États-Unis, 92121
        • Clinical Trial Site
    • Colorado
      • Pueblo, Colorado, États-Unis
        • Clinical Trial Site
    • Connecticut
      • Bristol, Connecticut, États-Unis
        • Clinical Trial Site
      • Groton, Connecticut, États-Unis
        • Clinical Trial Site
    • Florida
      • Boynton Beach, Florida, États-Unis, 33426
        • Clinical Trial Site
      • Boynton Beach, Florida, États-Unis, 33472
        • Clinical Trial Site
      • Clearwater, Florida, États-Unis, 33759
        • Clinical Trial Site
      • Clearwater, Florida, États-Unis, 33756
        • Clinical Trial Site
      • Hialeah, Florida, États-Unis
        • Clinical Trial Site
      • Holiday, Florida, États-Unis
        • Clinical Trial Site
      • Inverness, Florida, États-Unis
        • Clinical Trial Site
      • Margate, Florida, États-Unis
        • Clinical Trial Site
      • Miami, Florida, États-Unis, 33126
        • Clinical Trial Site
      • Miami, Florida, États-Unis, 33143
        • Clinical Trial Site
      • Miami, Florida, États-Unis, 33144
        • Clinical Trial Site
      • Miami, Florida, États-Unis, 33175
        • Clinical Trial Site
      • Miami, Florida, États-Unis, 33135
        • Clinical Trial Site
      • Miami Lakes, Florida, États-Unis
        • Clinical Trial Site
      • Naples, Florida, États-Unis
        • Clinical Trial Site
      • Vero Beach, Florida, États-Unis
        • Clinical Trial Site
      • West Palm Beach, Florida, États-Unis
        • Clinical Trial Site
      • Zephyrhills, Florida, États-Unis
        • Clinical Trial Site
    • Georgia
      • Atlanta, Georgia, États-Unis, 30308
        • Clinical Trial Site
      • Atlanta, Georgia, États-Unis, 30342
        • Clinical Trial Site
      • Atlanta, Georgia, États-Unis, 30312
        • Clinical Trial Site
      • Decatur, Georgia, États-Unis
        • Clinical Trial Site
      • Dublin, Georgia, États-Unis
        • Clinical Trial Site
      • Sandy Springs, Georgia, États-Unis
        • Clinical Trial Site
      • Stockbridge, Georgia, États-Unis
        • Clinical Trial Site
    • Illinois
      • Aurora, Illinois, États-Unis
        • Clinical Trial Site
      • Chicago, Illinois, États-Unis, 60616
        • Clinical Trial Site
      • Skokie, Illinois, États-Unis, 60076
        • Clinical Trial Site
      • Skokie, Illinois, États-Unis
        • Clinical Trial Site
      • Springfield, Illinois, États-Unis
        • Clinical Trial Site
    • Kansas
      • Wichita, Kansas, États-Unis
        • Clinical Trial Site
    • Louisiana
      • New Orleans, Louisiana, États-Unis
        • Clinical Trial Site
    • Maryland
      • Bethesda, Maryland, États-Unis
        • Clinical Trial Site
      • Hollywood, Maryland, États-Unis
        • Clinical Trial Site
    • Michigan
      • Bay City, Michigan, États-Unis, 48706
        • Clinical Trial Site
      • Bay City, Michigan, États-Unis
        • Clinical Trial Site
      • Wyoming, Michigan, États-Unis
        • Clinical Trial Site
    • Missouri
      • Kansas City, Missouri, États-Unis
        • Clinical Trial Site
    • Nevada
      • Las Vegas, Nevada, États-Unis
        • Clinical Trial Site
    • New Jersey
      • Lawrenceville, New Jersey, États-Unis
        • Clinical Trial Site
      • Neptune, New Jersey, États-Unis
        • Clinical Trial Site
      • Plainsboro, New Jersey, États-Unis
        • Clinical Trial Site
      • Voorhees, New Jersey, États-Unis
        • Clinical Trial Site
    • New Mexico
      • Albuquerque, New Mexico, États-Unis
        • Clinical Trial Site
    • New York
      • Brooklyn, New York, États-Unis
        • Clinical Trial Site
      • New York, New York, États-Unis, 10038
        • Clinical Trial Site
    • North Carolina
      • Raleigh, North Carolina, États-Unis
        • Clinical Trial Site
      • Winston-Salem, North Carolina, États-Unis
        • Clinical Trial Site
    • Ohio
      • Canton, Ohio, États-Unis
        • Clinical Trial Site
      • Carlisle, Ohio, États-Unis
        • Clinical Trial Site
      • Cincinnati, Ohio, États-Unis, 45224
        • Clinical Trial Site
      • Cincinnati, Ohio, États-Unis, 45242
        • Clinical Trial Site
      • Columbus, Ohio, États-Unis, 43231
        • Clinical Trial Site
      • Marion, Ohio, États-Unis, 43302
        • Clinical Trial Site
      • Marion, Ohio, États-Unis
        • Clinical Trial Site
      • Mentor, Ohio, États-Unis
        • Clinical Trial Site
      • Middletown, Ohio, États-Unis
        • Clinical Trial Site
      • Zanesville, Ohio, États-Unis
        • Clinical Trial Site
    • Oklahoma
      • Norman, Oklahoma, États-Unis
        • Clinical Trial Site
    • Pennsylvania
      • Jenkintown, Pennsylvania, États-Unis
        • Clinical Trial Site
      • Levittown, Pennsylvania, États-Unis
        • Clinical Trial Site
    • South Carolina
      • Columbia, South Carolina, États-Unis
        • Clinical Trial Site
      • Greer, South Carolina, États-Unis
        • Clinical Trial Site
      • Myrtle Beach, South Carolina, États-Unis
        • Clinical Trial Site
      • North Charleston, South Carolina, États-Unis
        • Clinical Trial Site
    • South Dakota
      • Rapid City, South Dakota, États-Unis
        • Clinical Trial Site
    • Texas
      • Arlington, Texas, États-Unis
        • Clinical Trial Site
      • Dallas, Texas, États-Unis
        • Clinical Trial Site
      • Houston, Texas, États-Unis, 77030
        • Clinical Trial Site
      • Houston, Texas, États-Unis, 77074
        • Clinical Trial Site
      • Houston, Texas, États-Unis
        • Clinical Trial Site
      • Laredo, Texas, États-Unis
        • Clinical Trial Site
      • Longview, Texas, États-Unis
        • Clinical Trial Site
      • San Antonio, Texas, États-Unis, 78205
        • Clinical Trial Site
      • San Antonio, Texas, États-Unis, 78229
        • Clinical Trial Site
      • San Antonio, Texas, États-Unis
        • Clinical Trial Site
      • San Antonio, Texas, États-Unis, 78215
        • Clinical Trial Site
    • Utah
      • Orem, Utah, États-Unis
        • Clinical Trial Site
    • Virginia
      • Chesapeake, Virginia, États-Unis
        • Clinical Trial Site
      • Norfolk, Virginia, États-Unis
        • Clinical Trial Site

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Key Inclusion Criteria include:

  1. Participants who completed participation in study AMAG-FER-IDA-301 [NCT01114139]
  2. 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:

  1. Experienced a serious adverse event (SAE) related to ferumoxytol in study AMAG-FER-IDA-301
  2. Female participants who are pregnant, intend to become pregnant, are breastfeeding, or have a positive serum/urine pregnancy test

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Médicament: Ferumoxytol
Ferumoxytol IV
Autres noms:
  • Feraheme

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Mean Change In Hemoglobin From TP Baseline To TP Week 5 Following The First Course Of Ferumoxytol
Délai: TP Baseline (Day 1), TP Week 5

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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
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
Délai: TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3

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
Percentage Of Participants With An Increase In Hemoglobin ≥2.0 g/dL At Any Time From TP Baseline To TP Week 5
Délai: TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3
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.
TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3
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
Délai: TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3
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.
TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3
Mean Change In TSAT Following Each Course Of Ferumoxytol From TP Baseline To TP Week 5 Following Each Course Of Ferumoxytol
Délai: TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3
Mean change in TSAT from TP Baseline to TP Week 5 following each course of ferumoxytol.
TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3
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
Délai: TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3

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
Time To Hemoglobin Increase Of ≥2.0 g/dL Or To A Hemoglobin Level Of ≥12.0 g/dL From Baseline
Délai: TP Baseline (Day 1) up to TP Week 5 for Courses 1, 2, and 3

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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

AMAG Pharmaceuticals, Inc.

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

27 juillet 2010

Achèvement primaire (Réel)

24 septembre 2012

Achèvement de l'étude (Réel)

23 avril 2013

Dates d'inscription aux études

Première soumission

29 avril 2010

Première soumission répondant aux critères de contrôle qualité

30 avril 2010

Première publication (Estimation)

3 mai 2010

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

21 avril 2022

Dernière mise à jour soumise répondant aux critères de contrôle qualité

31 mars 2022

Dernière vérification

1 mars 2022

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • AMAG-FER-IDA-303

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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