Iron Deficiency Anemia Clinical Trial
Official title:
A Phase III, Open-Label Extension Trial of the Safety and Efficacy of Ferumoxytol for the Episodic Treatment of Iron Deficiency Anemia
| Verified date | March 2022 |
| Source | AMAG Pharmaceuticals, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
To evaluate the safety and efficacy of ferumoxytol for the episodic treatment of iron deficiency anemia (IDA).
| Status | Completed |
| Enrollment | 634 |
| Est. completion date | April 23, 2013 |
| Est. primary completion date | September 24, 2012 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Clinical Trial Site | London | Ontario |
| Canada | Clinical Trial Site | Pointe-Claire | Quebec |
| Canada | Clinical Trial Site | Saint John | New Brunswick |
| Canada | Clinical Trial Site | Thornhill | Ontario |
| Canada | Clinical Trial Site | Vancouver | British Columbia |
| Canada | Clinical Trial Site | Vaughan | Ontario |
| Hungary | Clinical Trial Site | Bekescsaba | |
| Hungary | Clinical Trial Site | Gyula | |
| Hungary | Clinical Trial Site | Komárom | |
| Hungary | Clinical Trial Site | Szekszárd | |
| Hungary | Clinical Trial Site | Vác | |
| India | Clinical Trial Site | Aurangabad | Maharashtra |
| India | Clinical Trial Site | Bangalore | Karnataka |
| India | Clinical Trial Site | Bangalore | Karnataka |
| India | Clinical Trial Site | Chennai | Tamil Nadu |
| India | Clinical Trial Site | Guwahati | Assam |
| India | Clinical Trial Site | Hyderabad | Andhra Pradesh |
| India | Clinical Trial Site | Jaipur | Rajasthan |
| India | Clinical Trial Site | Lucknow | Uttar Pradesh |
| India | Clinical Trial Site | Lucknow | Uttar Pradesh |
| India | Clinical Trial Site | Madurai | Tamil Nadu |
| India | Clinical Trial Site | Nagpur | Maharashtra |
| India | Clinical Trial Site | Nashik | Maharashtra |
| India | Clinical Trial Site | Pune | Maharashtra |
| India | Clinical Trial Site | Secunderabad | Andhra Pradesh |
| Latvia | Clinical Trial Site | Daugavpils | |
| Latvia | Clinical Trial Site | Riga | |
| Latvia | Clinical Trial Site | Riga | |
| Latvia | Clinical Trial Site | Riga | |
| Latvia | Clinical Trial Site | Riga | |
| Latvia | Clinical Trial Site | Valmiera | |
| Latvia | Clinical Trial Site | Ventspils | |
| Latvia | Clinical Trial Site | Ventspils | |
| Poland | Clinical Trial Site | Bialystok | |
| Poland | Clinical Trial Site | Sopot | |
| Poland | Clinical Trial Site | Warszawa | |
| Poland | Clinical Trial Site | Wroclaw | |
| United States | Clinical Trial Site | Albuquerque | New Mexico |
| United States | Clinical Trial Site | Anaheim | California |
| United States | Clinical Trial Site | Arlington | Texas |
| United States | Clinical Trial Site | Atlanta | Georgia |
| United States | Clinical Trial Site | Atlanta | Georgia |
| United States | Clinical Trial Site | Atlanta | Georgia |
| United States | Clinical Trial Site | Aurora | Illinois |
| United States | Clinical Trial Site | Bakersfield | California |
| United States | Clinical Trial Site | Bay City | Michigan |
| United States | Clinical Trial Site | Bay City | Michigan |
| United States | Clinical Trial Site | Bethesda | Maryland |
| United States | Clinical Trial Site | Birmingham | Alabama |
| United States | Clinical Trial Site | Boynton Beach | Florida |
| United States | Clinical Trial Site | Boynton Beach | Florida |
| United States | Clinical Trial Site | Bristol | Connecticut |
| United States | Clinical Trial Site | Brooklyn | New York |
| United States | Clinical Trial Site | Buena Park | California |
| United States | Clinical Trial Site | Canton | Ohio |
| United States | Clinical Trial Site | Carlisle | Ohio |
| United States | Clinical Trial Site | Chesapeake | Virginia |
| United States | Clinical Trial Site | Chicago | Illinois |
| United States | Clinical Trial Site | Cincinnati | Ohio |
| United States | Clinical Trial Site | Cincinnati | Ohio |
| United States | Clinical Trial Site | Clearwater | Florida |
| United States | Clinical Trial Site | Clearwater | Florida |
| United States | Clinical Trial Site | Colton | California |
| United States | Clinical Trial Site | Columbia | South Carolina |
| United States | Clinical Trial Site | Columbus | Ohio |
| United States | Clinical Trial Site | Dallas | Texas |
| United States | Clinical Trial Site | Decatur | Georgia |
| United States | Clinical Trial Site | Dublin | Georgia |
| United States | Clinical Trial Site | Greer | South Carolina |
| United States | Clinical Trial Site | Groton | Connecticut |
| United States | Clinical Trial Site | Hialeah | Florida |
| United States | Clinical Trial Site | Holiday | Florida |
| United States | Clinical Trial Site | Hollywood | Maryland |
| United States | Clinical Trial Site | Houston | Texas |
| United States | Clinical Trial Site | Houston | Texas |
| United States | Clinical Trial Site | Houston | Texas |
| United States | Clinical Trial Site | Inverness | Florida |
| United States | Clinical Trial Site | Jenkintown | Pennsylvania |
| United States | Clinical Trial Site | Kansas City | Missouri |
| United States | Clinical Trial Site | Laredo | Texas |
| United States | Clinical Trial Site | Las Vegas | Nevada |
| United States | Clinical Trial Site | Lawrenceville | New Jersey |
| United States | Clinical Trial Site | Levittown | Pennsylvania |
| United States | Clinical Trial Site | Longview | Texas |
| United States | Clinical Trial Site | Los Angeles | California |
| United States | Clinical Trial Site | Los Angeles | California |
| United States | Clinical Trial Site | Los Angeles | California |
| United States | Clinical Trial Site | Margate | Florida |
| United States | Clinical Trial Site | Marion | Ohio |
| United States | Clinical Trial Site | Marion | Ohio |
| United States | Clinical Trial Site | Mentor | Ohio |
| United States | Clinical Trial Site | Miami | Florida |
| United States | Clinical Trial Site | Miami | Florida |
| United States | Clinical Trial Site | Miami | Florida |
| United States | Clinical Trial Site | Miami | Florida |
| United States | Clinical Trial Site | Miami | Florida |
| United States | Clinical Trial Site | Miami Lakes | Florida |
| United States | Clinical Trial Site | Middletown | Ohio |
| United States | Clinical Trial Site | Mission Hills | California |
| United States | Clinical Trial Site | Mobile | Alabama |
| United States | Clinical Trial Site | Montgomery | Alabama |
| United States | Clinical Trial Site | Montgomery | Alabama |
| United States | Clinical Trial Site | Myrtle Beach | South Carolina |
| United States | Clinical Trial Site | Naples | Florida |
| United States | Clinical Trial Site | Neptune | New Jersey |
| United States | Clinical Trial Site | New Orleans | Louisiana |
| United States | Clinical Trial Site | New York | New York |
| United States | Clinical Trial Site | Norfolk | Virginia |
| United States | Clinical Trial Site | Norman | Oklahoma |
| United States | Clinical Trial Site | North Charleston | South Carolina |
| United States | Clinical Trial Site | Orange | California |
| United States | Clinical Trial Site | Orem | Utah |
| United States | Clinical Trial Site | Phoenix | Arizona |
| United States | Clinical Trial Site | Phoenix | Arizona |
| United States | Clinical Trial Site | Plainsboro | New Jersey |
| United States | Clinical Trial Site | Pueblo | Colorado |
| United States | Clinical Trial Site | Raleigh | North Carolina |
| United States | Clinical Trial Site | Rapid City | South Dakota |
| United States | Clinical Trial Site | San Antonio | Texas |
| United States | Clinical Trial Site | San Antonio | Texas |
| United States | Clinical Trial Site | San Antonio | Texas |
| United States | Clinical Trial Site | San Antonio | Texas |
| United States | Clinical Trial Site | San Diego | California |
| United States | Clinical Trial Site | San Diego | California |
| United States | Clinical Trial Site | San Diego | California |
| United States | Clinical Trial Site | Sandy Springs | Georgia |
| United States | Clinical Trial Site | Skokie | Illinois |
| United States | Clinical Trial Site | Skokie | Illinois |
| United States | Clinical Trial Site | Springfield | Illinois |
| United States | Clinical Trial Site | Stockbridge | Georgia |
| United States | Clinical Trial Site | Tucson | Arizona |
| United States | Clinical Trial Site | Tucson | Arizona |
| United States | Clinical Trial Site | Vero Beach | Florida |
| United States | Clinical Trial Site | Voorhees | New Jersey |
| United States | Clinical Trial Site | West Palm Beach | Florida |
| United States | Clinical Trial Site | Wichita | Kansas |
| United States | Clinical Trial Site | Winston-Salem | North Carolina |
| United States | Clinical Trial Site | Wyoming | Michigan |
| United States | Clinical Trial Site | Zanesville | Ohio |
| United States | Clinical Trial Site | Zephyrhills | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| AMAG Pharmaceuticals, Inc. |
United States, Canada, Hungary, India, Latvia, Poland,
Vadhan-Raj S, Ford DC, Dahl NV, Bernard K, Li Z, Allen LF, Strauss WE. Safety and efficacy of ferumoxytol for the episodic treatment of iron deficiency anemia in patients with a history of unsatisfactory oral iron therapy: Results of a phase III, open-label, 6-month extension study. Am J Hematol. 2016 Feb;91(2):E3-5. doi: 10.1002/ajh.24240. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Mean Change In Hemoglobin From TP Baseline To TP Week 5 Following The First Course Of Ferumoxytol | 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 | |
| Secondary | 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 | 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 | |
| Secondary | Percentage Of Participants With An Increase In Hemoglobin =2.0 g/dL At Any Time From TP Baseline To TP Week 5 | 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 | |
| Secondary | 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 | 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 | |
| Secondary | Mean Change In TSAT Following Each Course Of Ferumoxytol From TP Baseline To TP Week 5 Following Each Course Of Ferumoxytol | 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 | |
| Secondary | 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 | 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 | |
| Secondary | Time To Hemoglobin Increase Of =2.0 g/dL Or To A Hemoglobin Level Of =12.0 g/dL From Baseline | 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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