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

31 maart 2022 bijgewerkt door: 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).

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

634

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Geneesmiddel: Ferumoxytol
IV Ferumoxytol
Andere namen:
  • Feraheme

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Mean Change In Hemoglobin From TP Baseline To TP Week 5 Following The First Course Of Ferumoxytol
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

AMAG Pharmaceuticals, Inc.

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

27 juli 2010

Primaire voltooiing (Werkelijk)

24 september 2012

Studie voltooiing (Werkelijk)

23 april 2013

Studieregistratiedata

Eerst ingediend

29 april 2010

Eerst ingediend dat voldeed aan de QC-criteria

30 april 2010

Eerst geplaatst (Schatting)

3 mei 2010

Updates van studierecords

Laatste update geplaatst (Werkelijk)

21 april 2022

Laatste update ingediend die voldeed aan QC-criteria

31 maart 2022

Laatst geverifieerd

1 maart 2022

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • AMAG-FER-IDA-303

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