A Phase III Safety Study of Ferumoxytol Compared to Ferric Carboxymaltose for the Treatment of Iron Deficiency Anemia (IDA)
Sponsor
AMAG Pharmaceuticals, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02694978
Collaborator
(none)
2,014
127
2
16.6
15.9
1
Study Details
Study Description
Brief Summary
To evaluate the safety of 1.020 grams (g) of intravenous (IV) ferumoxytol compared to 1.500 g of IV ferric carboxymaltose (FCM).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
2014 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase III, Randomized, Multicenter, Double-Blind, Safety Study of Ferumoxytol Compared to Ferric Carboxymaltose for the Treatment of Iron Deficiency Anemia (IDA)
Actual Study Start Date
:
Feb 29, 2016
Actual Primary Completion Date
:
Jan 16, 2017
Actual Study Completion Date
:
Jul 17, 2017
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Ferumoxytol Participants received an IV infusion of ferumoxytol 510 milligram (mg) diluted (17 milliliter [mL]) in 233 mL 0.9% sodium chloride injection, United States Pharmacopeia (USP) (normal saline) (final volume 250 mL) over at least 15 minutes with a second dose 7-8 days after the first dose, for a total cumulative dose of 1.020 g. |
Drug: Ferumoxytol
Other Names:
|
| Active Comparator: FCM Participants received an IV infusion of FCM 750 mg diluted (15 mL) in 235 mL 0.9% sodium chloride injection, USP (normal saline) (final volume 250 mL) over at least 15 minutes with a second dose 7-8 days after the first dose, for a total cumulative dose of 1.500 g. |
Drug: FCM
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Participants With Treatment-Emergent (TE) Moderate To Severe Hypersensitivity Reactions (Rxns), Including Anaphylaxis, Or Moderate To Severe Hypotension [Day 1 (after first dosing) through Week 5]
All IV iron formulations carry some risk of serious hypersensitivity reactions or anaphylaxis. Signs and symptoms potentially representing hypersensitivity were recorded and adjudicated by a blinded Clinical Events Committee (CEC). Hypotension is defined as a >30% drop in systolic blood pressure from baseline or decrease of >20 mmHg for systolic blood pressure. Statistical analysis was only performed on composite data. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Secondary Outcome Measures
- Participants With Moderate To Severe Hypersensitivity Reactions, Including Anaphylaxis, Serious Cardiovascular Events, And Death [Day 1 (after first dosing) through Week 5]
All IV iron formulations carry some risk of serious hypersensitivity reactions or anaphylaxis. Signs and symptoms potentially representing hypersensitivity were recorded and adjudicated by a blinded Clinical Events Committee (CEC). A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
- Mean Change In Hemoglobin From Baseline To Week 5 [Baseline (Day 1), Week 5]
Mean change in hemoglobin from Baseline to Week 5 was calculated for each participant as: Hemoglobin Change = Hemoglobin (Week 5) - Hemoglobin (Baseline). Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information.
- Mean Change In Hemoglobin Per Gram Of Iron Administered From Baseline To Week 5 [Baseline (Day 1), Week 5]
Mean change in hemoglobin per g of iron administered from Baseline (Day 1) to Week 5 was calculated for each participant as: Hemoglobin Change = Hemoglobin (Week 5) - Hemoglobin (Baseline). Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Key Inclusion Criteria include:
-
Participants with IDA and in whom IV iron treatment is indicated and defined as:
-
Participants with documented hemoglobin <12.0 g per deciliter (dL) for females and <14.0 g/dL for males within 60 days of dosing And
-
Participants with documented transferrin saturation (TSAT) ≤20% or Ferritin ≤100 nanograms (ng) per mL within 60 days of dosing
-
Documented history of unsatisfactory oral iron therapy or in whom oral iron cannot be tolerated, or for whom oral iron is considered medically inappropriate (as per oral iron history questionnaire)
-
All participants (male and female) of childbearing potential who are sexually active who agree to routinely use adequate contraception from randomization throughout the duration of the study
Key Exclusion Criteria include:
-
Known hypersensitivity reaction to any component of ferumoxytol or FCM
-
History of allergy to an IV iron
-
History of multiple drug allergies
-
Participants with dialysis-dependent chronic kidney disease
-
Hemoglobin ≤7.0 g/dL
-
Female participants who are pregnant, intend to become pregnant, are breastfeeding, have a positive serum/urine pregnancy test or not willing to use effective contraceptive precautions during the study (including females of childbearing potential who are partners of male participants)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Huntsville | Alabama | United States | |
| 2 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Tucson | Arizona | United States | 85741 |
| 3 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Tucson | Arizona | United States | |
| 4 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Anaheim | California | United States | |
| 5 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Chula Vista | California | United States | |
| 6 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Corona | California | United States | |
| 7 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Encino | California | United States | |
| 8 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Fountain Valley | California | United States | |
| 9 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Granada Hills | California | United States | |
| 10 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | La Mesa | California | United States | |
| 11 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Orange | California | United States | |
| 12 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Oxnard | California | United States | |
| 13 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Riverside | California | United States | |
| 14 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | San Diego | California | United States | |
| 15 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | West Hollywood | California | United States | |
| 16 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Westminster | California | United States | |
| 17 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Bristol | Connecticut | United States | |
| 18 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Norwalk | Connecticut | United States | |
| 19 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Clearwater | Florida | United States | |
| 20 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Gainesville | Florida | United States | |
| 21 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Lauderdale Lakes | Florida | United States | 33313 |
| 22 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Lauderdale Lakes | Florida | United States | |
| 23 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Miami Lakes | Florida | United States | |
| 24 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Miami | Florida | United States | 33135 |
| 25 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Miami | Florida | United States | |
| 26 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | North Miami | Florida | United States | |
| 27 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | South Miami | Florida | United States | |
| 28 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | West Palm Beach | Florida | United States | |
| 29 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Winter Haven | Florida | United States | |
| 30 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Atlanta | Georgia | United States | |
| 31 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Augusta | Georgia | United States | |
| 32 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Savannah | Georgia | United States | |
| 33 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Thomasville | Georgia | United States | |
| 34 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Elk Grove Village | Illinois | United States | |
| 35 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Evergreen Park | Illinois | United States | |
| 36 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Hazel Crest | Illinois | United States | |
| 37 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Skokie | Illinois | United States | 60202 |
| 38 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Skokie | Illinois | United States | |
| 39 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Wichita | Kansas | United States | |
| 40 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Crestview Hills | Kentucky | United States | |
| 41 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Metairie | Louisiana | United States | |
| 42 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | New Orleans | Louisiana | United States | |
| 43 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Baltimore | Maryland | United States | |
| 44 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Bethesda | Maryland | United States | |
| 45 | AMAG Pharmaceuticals, Inc. | Waltham | Massachusetts | United States | 02451 |
| 46 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Bay City | Michigan | United States | |
| 47 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Flint | Michigan | United States | |
| 48 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Saginaw | Michigan | United States | 48706 |
| 49 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Saginaw | Michigan | United States | |
| 50 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Chesterfield | Missouri | United States | |
| 51 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kansas City | Missouri | United States | |
| 52 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kirksville | Missouri | United States | |
| 53 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Las Vegas | Nevada | United States | |
| 54 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | East Setauket | New York | United States | |
| 55 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Flushing | New York | United States | |
| 56 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | New York | New York | United States | |
| 57 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Rosedale | New York | United States | |
| 58 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Asheville | North Carolina | United States | 28801 |
| 59 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Asheville | North Carolina | United States | |
| 60 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Charlotte | North Carolina | United States | |
| 61 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Greensboro | North Carolina | United States | |
| 62 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Hickory | North Carolina | United States | |
| 63 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Jacksonville | North Carolina | United States | |
| 64 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Morehead City | North Carolina | United States | |
| 65 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Raleigh | North Carolina | United States | |
| 66 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Wilmington | North Carolina | United States | |
| 67 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Winston-Salem | North Carolina | United States | |
| 68 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Cincinnati | Ohio | United States | 45224 |
| 69 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Cincinnati | Ohio | United States | |
| 70 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Marion | Ohio | United States | |
| 71 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Norman | Oklahoma | United States | |
| 72 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Tulsa | Oklahoma | United States | 74104 |
| 73 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Tulsa | Oklahoma | United States | |
| 74 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Jenkintown | Pennsylvania | United States | |
| 75 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Levittown | Pennsylvania | United States | |
| 76 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Scottdale | Pennsylvania | United States | |
| 77 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Smithfield | Pennsylvania | United States | |
| 78 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Upland | Pennsylvania | United States | |
| 79 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Greenville | South Carolina | United States | 29615 |
| 80 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Greenville | South Carolina | United States | |
| 81 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Greer | South Carolina | United States | |
| 82 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Rapid City | South Dakota | United States | |
| 83 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Germantown | Tennessee | United States | |
| 84 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kingsport | Tennessee | United States | |
| 85 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Memphis | Tennessee | United States | |
| 86 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Austin | Texas | United States | |
| 87 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Fort Sam Houston | Texas | United States | |
| 88 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Houston | Texas | United States | 77030 |
| 89 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Houston | Texas | United States | 77081 |
| 90 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Houston | Texas | United States | |
| 91 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Longview | Texas | United States | |
| 92 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | San Antonio | Texas | United States | 78215 |
| 93 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | San Antonio | Texas | United States | 78217 |
| 94 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | San Antonio | Texas | United States | 78229 |
| 95 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | San Antonio | Texas | United States | |
| 96 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Schertz | Texas | United States | |
| 97 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Orem | Utah | United States | |
| 98 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Fredericksburg | Virginia | United States | |
| 99 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Norfolk | Virginia | United States | |
| 100 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Seattle | Washington | United States | |
| 101 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Sault Ste. Marie | Ontario | Canada | |
| 102 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Vaughan | Ontario | Canada | |
| 103 | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Montréal | Quebec | Canada | |
| 104 | For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Budapest | Hungary | ||
| 105 | For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Debrecen | Hungary | ||
| 106 | For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Komárom | Hungary | ||
| 107 | For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Szekszárd | Hungary | ||
| 108 | For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Vác | Hungary | ||
| 109 | For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Jelgava | Latvia | ||
| 110 | For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kraslava | Latvia | ||
| 111 | For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Liepāja | Latvia | ||
| 112 | For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Riga | Latvia | LV-1002 | |
| 113 | For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Riga | Latvia | LV-1006 | |
| 114 | For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Riga | Latvia | LV-1010 | |
| 115 | For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Ventspils | Latvia | ||
| 116 | For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kaunas | Lithuania | LT-44320 | |
| 117 | For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kaunas | Lithuania | LT-48259 | |
| 118 | For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kaunas | Lithuania | LT-49449 | |
| 119 | For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Klaipėda | Lithuania | ||
| 120 | For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Utena | Lithuania | ||
| 121 | For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Vilnius | Lithuania | ||
| 122 | For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Šiauliai | Lithuania | ||
| 123 | For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Białystok | Poland | 15-224 | |
| 124 | For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Białystok | Poland | 15-732 | |
| 125 | For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Warszawa | Poland | ||
| 126 | For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Wrocław | Poland | ||
| 127 | For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Ponce | Puerto Rico |
Sponsors and Collaborators
- AMAG Pharmaceuticals, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Adkinson NF, Strauss WE, Bernard K, Kaper RF, Macdougall IC, Krop JS. Comparative safety of intravenous Ferumoxytol versus Ferric Carboxymaltose for the Treatment of Iron Deficiency Anemia: rationale and study design of a randomized double-blind study with a focus on acute hypersensitivity reactions. J Blood Med. 2017 Sep 26;8:155-163. doi: 10.2147/JBM.S142236. eCollection 2017.
- Adkinson NF, Strauss WE, Macdougall IC, Bernard KE, Auerbach M, Kaper RF, Chertow GM, Krop JS. Comparative safety of intravenous ferumoxytol versus ferric carboxymaltose in iron deficiency anemia: A randomized trial. Am J Hematol. 2018 May;93(5):683-690. doi: 10.1002/ajh.25060. Epub 2018 Feb 24.
Responsible Party:
AMAG Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT02694978
Other Study ID Numbers:
- AMAG-FER-IDA-304
First Posted:
Mar 1, 2016
Last Update Posted:
Jun 11, 2018
Last Verified:
May 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by AMAG Pharmaceuticals, Inc.
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Participants with iron deficiency anemia (IDA), <12.0 grams (g) per deciliter (dL) for females and <14.0 g/dL for males within 60 days of dosing and transferrin saturation (TSAT) <20% or Ferritin ≤100 nanograms (ng) per milliliter (mL) within 60 days of dosing and a history of unsatisfactory oral iron therapy or in whom oral iron could not be used. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Ferumoxytol | Ferric Carboxymaltose (FCM) |
|---|---|---|
| Arm/Group Description | Participants received an IV infusion of ferumoxytol 510 milligram (mg) diluted (17 milliliter [mL]) in 233 mL 0.9% sodium chloride injection, United States Pharmacopeia (USP) (normal saline) (final volume 250 mL) over at least 15 minutes with a second dose 7-8 days after the first dose, for a total cumulative dose of 1.020 g. | Participants received an IV infusion of FCM 750 mg diluted (15 mL) in 235 mL 0.9% sodium chloride injection, USP (normal saline) (final volume 250 mL) over at least 15 minutes with a second dose 7-8 days after the first dose, for a total cumulative dose of 1.500 g. |
| Period Title: Overall Study | ||
| STARTED | 1006 | 1008 |
| Received at Least 1 Dose of Study Drug | 997 | 1000 |
| COMPLETED | 935 | 948 |
| NOT COMPLETED | 71 | 60 |
Baseline Characteristics
| Arm/Group Title | Ferumoxytol | Ferric Carboxymaltose (FCM) | Total |
|---|---|---|---|
| Arm/Group Description | Participants received an IV infusion of ferumoxytol 510 mg diluted (17 mL) in 233 mL 0.9% sodium chloride injection, USP (normal saline) (final volume 250 mL) over at least 15 minutes with a second dose 7-8 days after the first dose, for a total cumulative dose of 1.020 g. | Participants received an IV infusion of FCM 750 mg diluted (15 mL) in 235 mL 0.9% sodium chloride injection, USP (normal saline) (final volume 250 mL) over at least 15 minutes with a second dose 7-8 days after the first dose, for a total cumulative dose of 1.500 g. | Total of all reporting groups |
| Overall Participants | 997 | 1000 | 1997 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
55.6
(17.30)
|
54.8
(17.02)
|
55.2
(17.16)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
743
74.5%
|
776
77.6%
|
1519
76.1%
|
| Male |
254
25.5%
|
224
22.4%
|
478
23.9%
|
Outcome Measures
| Title | Participants With Treatment-Emergent (TE) Moderate To Severe Hypersensitivity Reactions (Rxns), Including Anaphylaxis, Or Moderate To Severe Hypotension |
|---|---|
| Description | All IV iron formulations carry some risk of serious hypersensitivity reactions or anaphylaxis. Signs and symptoms potentially representing hypersensitivity were recorded and adjudicated by a blinded Clinical Events Committee (CEC). Hypotension is defined as a >30% drop in systolic blood pressure from baseline or decrease of >20 mmHg for systolic blood pressure. Statistical analysis was only performed on composite data. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. |
| Time Frame | Day 1 (after first dosing) through Week 5 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety population included any randomized participant who received any amount of study drug. Treatment group was based on actual treatment. |
| Arm/Group Title | Ferumoxytol | Ferric Carboxymaltose (FCM) |
|---|---|---|
| Arm/Group Description | Participants received an IV infusion of ferumoxytol 510 mg diluted (17 mL) in 233 mL 0.9% sodium chloride injection, USP (normal saline) (final volume 250 mL) over at least 15 minutes with a second dose 7-8 days after the first dose, for a total cumulative dose of 1.020 g. | Participants received an IV infusion of FCM 750 mg diluted (15 mL) in 235 mL 0.9% sodium chloride injection, USP (normal saline) (final volume 250 mL) over at least 15 minutes with a second dose 7-8 days after the first dose, for a total cumulative dose of 1.500 g. |
| Measure Participants | 997 | 1000 |
| Moderate hypersensitivity reaction |
3
0.3%
|
6
0.6%
|
| Severe hypersensitivity reaction |
1
0.1%
|
0
0%
|
| Anaphylaxis |
0
0%
|
0
0%
|
| Moderate hypotension |
2
0.2%
|
1
0.1%
|
| Severe hypotension |
0
0%
|
0
0%
|
| Any TE moderate to severe hypersensitivity rxn |
6
0.6%
|
7
0.7%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Ferumoxytol, Ferric Carboxymaltose (FCM) |
|---|---|---|
| Comments | Statistical analysis was only performed on composite reaction data (that is, the "Any TE moderate to severe hypersensitivity rxn" row in the data table). | |
| Type of Statistical Test | Non-Inferiority | |
| Comments | The non-inferiority margin of 2.64% was used for the primary endpoint statistical analysis. | |
| Statistical Test of Hypothesis | p-Value | 0.0001 |
| Comments | ||
| Method | Wald | |
| Comments | The p-value was calculated using the Wald large sample assumption. | |
| Method of Estimation | Estimation Parameter | Treatment difference |
| Estimated Value | -0.10 | |
| Confidence Interval |
(2-Sided) 95% -0.80 to 0.61 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Participants With Moderate To Severe Hypersensitivity Reactions, Including Anaphylaxis, Serious Cardiovascular Events, And Death |
|---|---|
| Description | All IV iron formulations carry some risk of serious hypersensitivity reactions or anaphylaxis. Signs and symptoms potentially representing hypersensitivity were recorded and adjudicated by a blinded Clinical Events Committee (CEC). A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. |
| Time Frame | Day 1 (after first dosing) through Week 5 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety population included any randomized participant who received any amount of study drug. Treatment group was based on actual treatment. |
| Arm/Group Title | Ferumoxytol | Ferric Carboxymaltose (FCM) |
|---|---|---|
| Arm/Group Description | Participants received an IV infusion of ferumoxytol 510 mg diluted (17 mL) in 233 mL 0.9% sodium chloride injection, USP (normal saline) (final volume 250 mL) over at least 15 minutes with a second dose 7-8 days after the first dose, for a total cumulative dose of 1.020 g. | Participants received an IV infusion of FCM 750 mg diluted (15 mL) in 235 mL 0.9% sodium chloride injection, USP (normal saline) (final volume 250 mL) over at least 15 minutes with a second dose 7-8 days after the first dose, for a total cumulative dose of 1.500 g. |
| Measure Participants | 997 | 1000 |
| Moderate hypersensitivity reaction |
3
0.3%
|
6
0.6%
|
| Severe hypersensitivity reaction |
1
0.1%
|
0
0%
|
| Anaphylaxis |
0
0%
|
0
0%
|
| Serious cardiovascular event |
6
0.6%
|
13
1.3%
|
| Death |
4
0.4%
|
2
0.2%
|
| Any moderate to severe hypersensitivity rxn |
13
1.3%
|
20
2%
|
| Title | Mean Change In Hemoglobin From Baseline To Week 5 |
|---|---|
| Description | Mean change in hemoglobin from Baseline to Week 5 was calculated for each participant as: Hemoglobin Change = Hemoglobin (Week 5) - Hemoglobin (Baseline). Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information. |
| Time Frame | Baseline (Day 1), Week 5 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat (ITT) population: any randomized participant who had any exposure to study drug, based on randomized treatment assignment. |
| Arm/Group Title | Ferumoxytol | Ferric Carboxymaltose (FCM) |
|---|---|---|
| Arm/Group Description | Participants received an IV infusion of ferumoxytol 510 mg diluted (17 mL) in 233 mL 0.9% sodium chloride injection, USP (normal saline) (final volume 250 mL) over at least 15 minutes with a second dose 7-8 days after the first dose, for a total cumulative dose of 1.020 g. | Participants received an IV infusion of FCM 750 mg diluted (15 mL) in 235 mL 0.9% sodium chloride injection, USP (normal saline) (final volume 250 mL) over at least 15 minutes with a second dose 7-8 days after the first dose, for a total cumulative dose of 1.500 g. |
| Measure Participants | 997 | 1000 |
| Mean (Standard Deviation) [g/dL] |
1.38
(1.351)
|
1.63
(1.535)
|
| Title | Mean Change In Hemoglobin Per Gram Of Iron Administered From Baseline To Week 5 |
|---|---|
| Description | Mean change in hemoglobin per g of iron administered from Baseline (Day 1) to Week 5 was calculated for each participant as: Hemoglobin Change = Hemoglobin (Week 5) - Hemoglobin (Baseline). Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information. |
| Time Frame | Baseline (Day 1), Week 5 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population: any randomized participant who had any exposure to study drug, based on randomized treatment assignment. |
| Arm/Group Title | Ferumoxytol | Ferric Carboxymaltose (FCM) |
|---|---|---|
| Arm/Group Description | Participants received an IV infusion of ferumoxytol 510 mg diluted (17 mL) in 233 mL 0.9% sodium chloride injection, USP (normal saline) (final volume 250 mL) over at least 15 minutes with a second dose 7-8 days after the first dose, for a total cumulative dose of 1.020 g. | Participants received an IV infusion of FCM 750 mg diluted (15 mL) in 235 mL 0.9% sodium chloride injection, USP (normal saline) (final volume 250 mL) over at least 15 minutes with a second dose 7-8 days after the first dose, for a total cumulative dose of 1.500 g. |
| Measure Participants | 997 | 1000 |
| Mean (Standard Deviation) [g/dL] |
1.35
(1.353)
|
1.10
(1.050)
|
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Ferumoxytol | Ferric Carboxymaltose (FCM) | ||
| Arm/Group Description | Participants received an IV infusion of ferumoxytol 510 mg diluted (17 mL) in 233 mL 0.9% sodium chloride injection, USP (normal saline) (final volume 250 mL) over at least 15 minutes with a second dose 7-8 days after the first dose, for a total cumulative dose of 1.020 g. | Participants received an IV infusion of FCM 750 mg diluted (15 mL) in 235 mL 0.9% sodium chloride injection, USP (normal saline) (final volume 250 mL) over at least 15 minutes with a second dose 7-8 days after the first dose, for a total cumulative dose of 1.500 g. | ||
All Cause Mortality |
||||
| Ferumoxytol | Ferric Carboxymaltose (FCM) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Ferumoxytol | Ferric Carboxymaltose (FCM) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 36/997 (3.6%) | 35/1000 (3.5%) | ||
| Blood and lymphatic system disorders | ||||
| Haemorrhagic anaemia | 2/997 (0.2%) | 0/1000 (0%) | ||
| Anaemia vitamin B12 deficiency | 1/997 (0.1%) | 0/1000 (0%) | ||
| Cardiac disorders | ||||
| Cardiac failure congestive | 1/997 (0.1%) | 3/1000 (0.3%) | ||
| Cardiorespiratory arrest | 1/997 (0.1%) | 0/1000 (0%) | ||
| Left ventricular failure | 1/997 (0.1%) | 0/1000 (0%) | ||
| Angina pectoris | 0/997 (0%) | 2/1000 (0.2%) | ||
| Atrial fibrillation | 0/997 (0%) | 2/1000 (0.2%) | ||
| Cardiac failure | 0/997 (0%) | 1/1000 (0.1%) | ||
| Cardiac failure chronic | 0/997 (0%) | 1/1000 (0.1%) | ||
| Acute myocardial infarction | 0/997 (0%) | 1/1000 (0.1%) | ||
| Gastrointestinal disorders | ||||
| Gastric ulcer haemorrhage | 1/997 (0.1%) | 1/1000 (0.1%) | ||
| Abdominal pain | 1/997 (0.1%) | 0/1000 (0%) | ||
| Ascites | 1/997 (0.1%) | 0/1000 (0%) | ||
| Pancreatitis acute | 1/997 (0.1%) | 0/1000 (0%) | ||
| Gastric haemorrhage | 0/997 (0%) | 1/1000 (0.1%) | ||
| Gastroduodenal ulcer | 0/997 (0%) | 1/1000 (0.1%) | ||
| Gastrointestinal haemorrhage | 0/997 (0%) | 1/1000 (0.1%) | ||
| Impaired gastric emptying | 0/997 (0%) | 1/1000 (0.1%) | ||
| Pancreatitis chronic | 0/997 (0%) | 1/1000 (0.1%) | ||
| General disorders | ||||
| Chest pain | 0/997 (0%) | 1/1000 (0.1%) | ||
| Hepatobiliary disorders | ||||
| Hepatitis acute | 0/997 (0%) | 1/1000 (0.1%) | ||
| Immune system disorders | ||||
| Anaphylactic reaction | 1/997 (0.1%) | 0/1000 (0%) | ||
| Infections and infestations | ||||
| Gastroenteritis | 3/997 (0.3%) | 1/1000 (0.1%) | ||
| Pneumonia | 2/997 (0.2%) | 0/1000 (0%) | ||
| Osteomyelitis chronic | 1/997 (0.1%) | 0/1000 (0%) | ||
| Joint abscess | 1/997 (0.1%) | 0/1000 (0%) | ||
| Anal abscess | 1/997 (0.1%) | 0/1000 (0%) | ||
| Cellulitis | 1/997 (0.1%) | 1/1000 (0.1%) | ||
| Sepsis | 1/997 (0.1%) | 0/1000 (0%) | ||
| Sepsis syndrome | 1/997 (0.1%) | 0/1000 (0%) | ||
| Osteomyelitis | 0/997 (0%) | 1/1000 (0.1%) | ||
| Injury, poisoning and procedural complications | ||||
| Anastomotic ulcer | 1/997 (0.1%) | 0/1000 (0%) | ||
| Intentional overdose | 1/997 (0.1%) | 0/1000 (0%) | ||
| Fall | 0/997 (0%) | 1/1000 (0.1%) | ||
| Post-procedural haemorrhage | 0/997 (0%) | 1/1000 (0.1%) | ||
| Wound dehiscence | 0/997 (0%) | 1/1000 (0.1%) | ||
| Metabolism and nutrition disorders | ||||
| Fluid overload | 1/997 (0.1%) | 1/1000 (0.1%) | ||
| Hyperkalaemia | 1/997 (0.1%) | 0/1000 (0%) | ||
| Hypokalaemia | 1/997 (0.1%) | 0/1000 (0%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Haemarthrosis | 1/997 (0.1%) | 0/1000 (0%) | ||
| Arthritis | 0/997 (0%) | 1/1000 (0.1%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Adenocarcinoma of colon | 1/997 (0.1%) | 1/1000 (0.1%) | ||
| Bladder cancer | 0/997 (0%) | 1/1000 (0.1%) | ||
| Breast cancer metastatic | 0/997 (0%) | 1/1000 (0.1%) | ||
| Metastatic uterine cancer | 0/743 (0%) | 1/776 (0.1%) | ||
| Mixed hepatocellular cholangiocarcinoma | 0/997 (0%) | 1/1000 (0.1%) | ||
| Nervous system disorders | ||||
| Seizure | 2/997 (0.2%) | 0/1000 (0%) | ||
| Syncope | 3/997 (0.3%) | 3/1000 (0.3%) | ||
| Cerebrovascular accident | 1/997 (0.1%) | 0/1000 (0%) | ||
| Restless legs syndrome | 0/997 (0%) | 1/1000 (0.1%) | ||
| Pregnancy, puerperium and perinatal conditions | ||||
| Abortion spontaneous | 1/743 (0.1%) | 0/776 (0%) | ||
| Ectopic pregnancy | 1/743 (0.1%) | 0/776 (0%) | ||
| Psychiatric disorders | ||||
| Completed suicide | 1/997 (0.1%) | 0/1000 (0%) | ||
| Bipolar disorder | 0/997 (0%) | 1/1000 (0.1%) | ||
| Renal and urinary disorders | ||||
| Acute kidney injury | 2/997 (0.2%) | 0/1000 (0%) | ||
| End stage renal disease | 0/997 (0%) | 1/1000 (0.1%) | ||
| Haematuria | 0/997 (0%) | 1/1000 (0.1%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Pleural effusion | 1/997 (0.1%) | 0/1000 (0%) | ||
| Respiratory distress | 1/997 (0.1%) | 0/1000 (0%) | ||
| Respiratory failure | 1/997 (0.1%) | 0/1000 (0%) | ||
| Asthma | 0/997 (0%) | 1/1000 (0.1%) | ||
| Pulmonary embolism | 0/997 (0%) | 1/1000 (0.1%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Rash maculopapular | 1/997 (0.1%) | 0/1000 (0%) | ||
| Vascular disorders | ||||
| Aortic stenosis | 1/997 (0.1%) | 0/1000 (0%) | ||
| Hypertensive crisis | 1/997 (0.1%) | 0/1000 (0%) | ||
| Aortic aneurysm | 0/997 (0%) | 1/1000 (0.1%) | ||
| Hypertensive emergency | 0/997 (0%) | 1/1000 (0.1%) | ||
| Hypotension | 0/997 (0%) | 1/1000 (0.1%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Ferumoxytol | Ferric Carboxymaltose (FCM) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 186/997 (18.7%) | 245/1000 (24.5%) | ||
| Gastrointestinal disorders | ||||
| Nausea | 35/997 (3.5%) | 60/1000 (6%) | ||
| Diarrhoea | 29/997 (2.9%) | 33/1000 (3.3%) | ||
| Abdominal pain | 17/997 (1.7%) | 21/1000 (2.1%) | ||
| Constipation | 14/997 (1.4%) | 13/1000 (1.3%) | ||
| Vomiting | 11/997 (1.1%) | 13/1000 (1.3%) | ||
| General disorders | ||||
| Fatigue | 30/997 (3%) | 36/1000 (3.6%) | ||
| Chest discomfort | 8/997 (0.8%) | 11/1000 (1.1%) | ||
| Pyrexia | 7/997 (0.7%) | 22/1000 (2.2%) | ||
| Chest pain | 10/997 (1%) | 4/1000 (0.4%) | ||
| Metabolism and nutrition disorders | ||||
| Hypophosphataemia | 0/997 (0%) | 18/1000 (1.8%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Back pain | 19/997 (1.9%) | 16/1000 (1.6%) | ||
| Arthralgia | 14/997 (1.4%) | 12/1000 (1.2%) | ||
| Nervous system disorders | ||||
| Headache | 60/997 (6%) | 82/1000 (8.2%) | ||
| Dizziness | 25/997 (2.5%) | 40/1000 (4%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Cough | 15/997 (1.5%) | 13/1000 (1.3%) | ||
| Dyspnoea | 11/997 (1.1%) | 18/1000 (1.8%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Pruritus | 12/997 (1.2%) | 11/1000 (1.1%) | ||
| Urticaria | 3/997 (0.3%) | 13/1000 (1.3%) | ||
| Vascular disorders | ||||
| Flushing | 11/997 (1.1%) | 16/1000 (1.6%) | ||
| Hypertension | 7/997 (0.7%) | 15/1000 (1.5%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
If there is no multi-site publication within 18 months after the Study has been completed or terminated at all Study sites, and all data have been received by Sponsor, the Site, and SMO shall have the right to publish its results from the Study for non-commercial purposes, if submitted to Sponsor for review 60 days prior to submission of publication. Publication must remove all confidential information and may be delayed by up to 180 days to allow Sponsor to protect its interests.
Results Point of Contact
| Name/Title | Medical Information |
|---|---|
| Organization | AMAG Pharmaceuticals, Inc. |
| Phone | 1-877-411-2510 |
| amag@druginfo.com |
Responsible Party:
AMAG Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT02694978
Other Study ID Numbers:
- AMAG-FER-IDA-304
First Posted:
Mar 1, 2016
Last Update Posted:
Jun 11, 2018
Last Verified:
May 1, 2018