A Trial of Ferumoxytol for the Episodic Treatment of Iron Deficiency Anemia
31 marzo 2022 aggiornato da: 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).
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
634
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
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
-
-
-
-
Andhra Pradesh
-
Hyderabad, Andhra Pradesh, India
- Clinical Trial Site
-
Secunderabad, Andhra Pradesh, India
- Clinical Trial Site
-
-
Assam
-
Guwahati, Assam, India
- Clinical Trial Site
-
-
Karnataka
-
Bangalore, Karnataka, India, 560002
- Clinical Trial Site
-
Bangalore, Karnataka, India, 560054
- Clinical Trial Site
-
-
Maharashtra
-
Aurangabad, Maharashtra, India
- Clinical Trial Site
-
Nagpur, Maharashtra, India
- Clinical Trial Site
-
Nashik, Maharashtra, India
- Clinical Trial Site
-
Pune, Maharashtra, India
- Clinical Trial Site
-
-
Rajasthan
-
Jaipur, Rajasthan, India
- Clinical Trial Site
-
-
Tamil Nadu
-
Chennai, Tamil Nadu, India
- Clinical Trial Site
-
Madurai, Tamil Nadu, India
- Clinical Trial Site
-
-
Uttar Pradesh
-
Lucknow, Uttar Pradesh, India, 226003
- Clinical Trial Site
-
Lucknow, Uttar Pradesh, India
- Clinical Trial Site
-
-
-
-
-
Daugavpils, Lettonia
- Clinical Trial Site
-
Riga, Lettonia, LV-1002
- Clinical Trial Site
-
Riga, Lettonia, LV-1005
- Clinical Trial Site
-
Riga, Lettonia, LV-1006
- Clinical Trial Site
-
Riga, Lettonia, LV-1010
- Clinical Trial Site
-
Valmiera, Lettonia
- Clinical Trial Site
-
Ventspils, Lettonia, LV-3601
- Clinical Trial Site
-
Ventspils, Lettonia
- Clinical Trial Site
-
-
-
-
-
Białystok, Polonia
- Clinical Trial Site
-
Sopot, Polonia
- Clinical Trial Site
-
Warszawa, Polonia
- Clinical Trial Site
-
Wrocław, Polonia
- Clinical Trial Site
-
-
-
-
Alabama
-
Birmingham, Alabama, Stati Uniti
- Clinical Trial Site
-
Mobile, Alabama, Stati Uniti
- Clinical Trial Site
-
Montgomery, Alabama, Stati Uniti, 36106
- Clinical Trial Site
-
Montgomery, Alabama, Stati Uniti, 36116
- Clinical Trial Site
-
-
Arizona
-
Phoenix, Arizona, Stati Uniti, 85032
- Clinical Trial Site
-
Phoenix, Arizona, Stati Uniti, 85015
- Clinical Trial Site
-
Tucson, Arizona, Stati Uniti, 85710
- Clinical Trial Site
-
Tucson, Arizona, Stati Uniti, 85712
- Clinical Trial Site
-
-
California
-
Anaheim, California, Stati Uniti
- Clinical Trial Site
-
Bakersfield, California, Stati Uniti
- Clinical Trial Site
-
Buena Park, California, Stati Uniti
- Clinical Trial Site
-
Colton, California, Stati Uniti
- Clinical Trial Site
-
Los Angeles, California, Stati Uniti, 90036
- Clinical Trial Site
-
Los Angeles, California, Stati Uniti, 90057
- Clinical Trial Site
-
Los Angeles, California, Stati Uniti
- Clinical Trial Site
-
Mission Hills, California, Stati Uniti
- Clinical Trial Site
-
Orange, California, Stati Uniti
- Clinical Trial Site
-
San Diego, California, Stati Uniti, 92103
- Clinical Trial Site
-
San Diego, California, Stati Uniti, 92123
- Clinical Trial Site
-
San Diego, California, Stati Uniti, 92121
- Clinical Trial Site
-
-
Colorado
-
Pueblo, Colorado, Stati Uniti
- Clinical Trial Site
-
-
Connecticut
-
Bristol, Connecticut, Stati Uniti
- Clinical Trial Site
-
Groton, Connecticut, Stati Uniti
- Clinical Trial Site
-
-
Florida
-
Boynton Beach, Florida, Stati Uniti, 33426
- Clinical Trial Site
-
Boynton Beach, Florida, Stati Uniti, 33472
- Clinical Trial Site
-
Clearwater, Florida, Stati Uniti, 33759
- Clinical Trial Site
-
Clearwater, Florida, Stati Uniti, 33756
- Clinical Trial Site
-
Hialeah, Florida, Stati Uniti
- Clinical Trial Site
-
Holiday, Florida, Stati Uniti
- Clinical Trial Site
-
Inverness, Florida, Stati Uniti
- Clinical Trial Site
-
Margate, Florida, Stati Uniti
- Clinical Trial Site
-
Miami, Florida, Stati Uniti, 33126
- Clinical Trial Site
-
Miami, Florida, Stati Uniti, 33143
- Clinical Trial Site
-
Miami, Florida, Stati Uniti, 33144
- Clinical Trial Site
-
Miami, Florida, Stati Uniti, 33175
- Clinical Trial Site
-
Miami, Florida, Stati Uniti, 33135
- Clinical Trial Site
-
Miami Lakes, Florida, Stati Uniti
- Clinical Trial Site
-
Naples, Florida, Stati Uniti
- Clinical Trial Site
-
Vero Beach, Florida, Stati Uniti
- Clinical Trial Site
-
West Palm Beach, Florida, Stati Uniti
- Clinical Trial Site
-
Zephyrhills, Florida, Stati Uniti
- Clinical Trial Site
-
-
Georgia
-
Atlanta, Georgia, Stati Uniti, 30308
- Clinical Trial Site
-
Atlanta, Georgia, Stati Uniti, 30342
- Clinical Trial Site
-
Atlanta, Georgia, Stati Uniti, 30312
- Clinical Trial Site
-
Decatur, Georgia, Stati Uniti
- Clinical Trial Site
-
Dublin, Georgia, Stati Uniti
- Clinical Trial Site
-
Sandy Springs, Georgia, Stati Uniti
- Clinical Trial Site
-
Stockbridge, Georgia, Stati Uniti
- Clinical Trial Site
-
-
Illinois
-
Aurora, Illinois, Stati Uniti
- Clinical Trial Site
-
Chicago, Illinois, Stati Uniti, 60616
- Clinical Trial Site
-
Skokie, Illinois, Stati Uniti, 60076
- Clinical Trial Site
-
Skokie, Illinois, Stati Uniti
- Clinical Trial Site
-
Springfield, Illinois, Stati Uniti
- Clinical Trial Site
-
-
Kansas
-
Wichita, Kansas, Stati Uniti
- Clinical Trial Site
-
-
Louisiana
-
New Orleans, Louisiana, Stati Uniti
- Clinical Trial Site
-
-
Maryland
-
Bethesda, Maryland, Stati Uniti
- Clinical Trial Site
-
Hollywood, Maryland, Stati Uniti
- Clinical Trial Site
-
-
Michigan
-
Bay City, Michigan, Stati Uniti, 48706
- Clinical Trial Site
-
Bay City, Michigan, Stati Uniti
- Clinical Trial Site
-
Wyoming, Michigan, Stati Uniti
- Clinical Trial Site
-
-
Missouri
-
Kansas City, Missouri, Stati Uniti
- Clinical Trial Site
-
-
Nevada
-
Las Vegas, Nevada, Stati Uniti
- Clinical Trial Site
-
-
New Jersey
-
Lawrenceville, New Jersey, Stati Uniti
- Clinical Trial Site
-
Neptune, New Jersey, Stati Uniti
- Clinical Trial Site
-
Plainsboro, New Jersey, Stati Uniti
- Clinical Trial Site
-
Voorhees, New Jersey, Stati Uniti
- Clinical Trial Site
-
-
New Mexico
-
Albuquerque, New Mexico, Stati Uniti
- Clinical Trial Site
-
-
New York
-
Brooklyn, New York, Stati Uniti
- Clinical Trial Site
-
New York, New York, Stati Uniti, 10038
- Clinical Trial Site
-
-
North Carolina
-
Raleigh, North Carolina, Stati Uniti
- Clinical Trial Site
-
Winston-Salem, North Carolina, Stati Uniti
- Clinical Trial Site
-
-
Ohio
-
Canton, Ohio, Stati Uniti
- Clinical Trial Site
-
Carlisle, Ohio, Stati Uniti
- Clinical Trial Site
-
Cincinnati, Ohio, Stati Uniti, 45224
- Clinical Trial Site
-
Cincinnati, Ohio, Stati Uniti, 45242
- Clinical Trial Site
-
Columbus, Ohio, Stati Uniti, 43231
- Clinical Trial Site
-
Marion, Ohio, Stati Uniti, 43302
- Clinical Trial Site
-
Marion, Ohio, Stati Uniti
- Clinical Trial Site
-
Mentor, Ohio, Stati Uniti
- Clinical Trial Site
-
Middletown, Ohio, Stati Uniti
- Clinical Trial Site
-
Zanesville, Ohio, Stati Uniti
- Clinical Trial Site
-
-
Oklahoma
-
Norman, Oklahoma, Stati Uniti
- Clinical Trial Site
-
-
Pennsylvania
-
Jenkintown, Pennsylvania, Stati Uniti
- Clinical Trial Site
-
Levittown, Pennsylvania, Stati Uniti
- Clinical Trial Site
-
-
South Carolina
-
Columbia, South Carolina, Stati Uniti
- Clinical Trial Site
-
Greer, South Carolina, Stati Uniti
- Clinical Trial Site
-
Myrtle Beach, South Carolina, Stati Uniti
- Clinical Trial Site
-
North Charleston, South Carolina, Stati Uniti
- Clinical Trial Site
-
-
South Dakota
-
Rapid City, South Dakota, Stati Uniti
- Clinical Trial Site
-
-
Texas
-
Arlington, Texas, Stati Uniti
- Clinical Trial Site
-
Dallas, Texas, Stati Uniti
- Clinical Trial Site
-
Houston, Texas, Stati Uniti, 77030
- Clinical Trial Site
-
Houston, Texas, Stati Uniti, 77074
- Clinical Trial Site
-
Houston, Texas, Stati Uniti
- Clinical Trial Site
-
Laredo, Texas, Stati Uniti
- Clinical Trial Site
-
Longview, Texas, Stati Uniti
- Clinical Trial Site
-
San Antonio, Texas, Stati Uniti, 78205
- Clinical Trial Site
-
San Antonio, Texas, Stati Uniti, 78229
- Clinical Trial Site
-
San Antonio, Texas, Stati Uniti
- Clinical Trial Site
-
San Antonio, Texas, Stati Uniti, 78215
- Clinical Trial Site
-
-
Utah
-
Orem, Utah, Stati Uniti
- Clinical Trial Site
-
-
Virginia
-
Chesapeake, Virginia, Stati Uniti
- Clinical Trial Site
-
Norfolk, Virginia, Stati Uniti
- Clinical Trial Site
-
-
-
-
-
Bekescsaba, Ungheria
- Clinical Trial Site
-
Gyula, Ungheria
- Clinical Trial Site
-
Komárom, Ungheria
- Clinical Trial Site
-
Szekszárd, Ungheria
- Clinical Trial Site
-
Vác, Ungheria
- Clinical Trial Site
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
Ferumossitolo IV
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Mean Change In Hemoglobin From TP Baseline To TP Week 5 Following The First Course Of Ferumoxytol
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
27 luglio 2010
Completamento primario (Effettivo)
24 settembre 2012
Completamento dello studio (Effettivo)
23 aprile 2013
Date di iscrizione allo studio
Primo inviato
29 aprile 2010
Primo inviato che soddisfa i criteri di controllo qualità
30 aprile 2010
Primo Inserito (Stima)
3 maggio 2010
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
21 aprile 2022
Ultimo aggiornamento inviato che soddisfa i criteri QC
31 marzo 2022
Ultimo verificato
1 marzo 2022
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- AMAG-FER-IDA-303
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .