Trial · NCT02694978
A Phase III Safety Study of Ferumoxytol Compared to Ferric Carboxymaltose for the Treatment of Iron Deficiency Anemia (IDA)
NCT02694978, Phase 3, Completed, AMAG Pharmaceuticals, Inc.; results first posted 2018-06-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase III Safety Study of Ferumoxytol Compared to Ferric Carboxymaltose for the Treatment of Iron Deficiency Anemia (IDA). Trials, record NCT02694978. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02694978
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase III Safety Study of Ferumoxytol Compared to Ferric Carboxymaltose for the Treatment of Iron Deficiency Anemia (IDA)
- NCT number
- NCT02694978
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,014 participants, actual
- Lead sponsor
- AMAG Pharmaceuticals, Inc.
- Conditions
- Iron Deficiency Anemia
- Interventions
- Ferumoxytol, FCM
- First posted
- 2016-03-01
- Last updated
- 2023-07-25
- Results first posted
- 2018-06-11
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | The safety population included any randomized participant who received any amount of study drug. Treatment group was based on actual treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants With Moderate To Severe Hypersensitivity Reactions, Including Anaphylaxis, Serious Cardiovascular Events, And Death | Day 1 (after first dosing) through Week 5 | The safety population included any randomized participant who received any amount of study drug. Treatment group was based on actual treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Change In Hemoglobin From Baseline To Week 5 | Baseline (Day 1), Week 5 | Intent-to-treat (ITT) population: any randomized participant who had any exposure to study drug, based on randomized treatment assignment. | g/dL | MEAN |
| SECONDARY | Mean Change In Hemoglobin Per Gram Of Iron Administered From Baseline To Week 5 | Baseline (Day 1), Week 5 | ITT population: any randomized participant who had any exposure to study drug, based on randomized treatment assignment. | g/dL | MEAN |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Participants With Treatment-Emergent (TE) Moderate To Severe Hypersensitivity Reactions (Rxns), Including Anaphylaxis, Or Moderate To Severe Hypotension | Ferumoxytol | Moderate hypersensitivity reaction | 3 | Participants | |
| Participants With Treatment-Emergent (TE) Moderate To Severe Hypersensitivity Reactions (Rxns), Including Anaphylaxis, Or Moderate To Severe Hypotension | Ferric Carboxymaltose (FCM) | Moderate hypersensitivity reaction | 6 | Participants | |
| Participants With Treatment-Emergent (TE) Moderate To Severe Hypersensitivity Reactions (Rxns), Including Anaphylaxis, Or Moderate To Severe Hypotension | Ferumoxytol | Severe hypersensitivity reaction | 1 | Participants | |
| Participants With Treatment-Emergent (TE) Moderate To Severe Hypersensitivity Reactions (Rxns), Including Anaphylaxis, Or Moderate To Severe Hypotension | Ferric Carboxymaltose (FCM) | Severe hypersensitivity reaction | 0 | Participants | |
| Participants With Treatment-Emergent (TE) Moderate To Severe Hypersensitivity Reactions (Rxns), Including Anaphylaxis, Or Moderate To Severe Hypotension | Ferumoxytol | Anaphylaxis | 0 | Participants | |
| Participants With Treatment-Emergent (TE) Moderate To Severe Hypersensitivity Reactions (Rxns), Including Anaphylaxis, Or Moderate To Severe Hypotension | Ferric Carboxymaltose (FCM) | Anaphylaxis | 0 | Participants | |
| Participants With Treatment-Emergent (TE) Moderate To Severe Hypersensitivity Reactions (Rxns), Including Anaphylaxis, Or Moderate To Severe Hypotension | Ferumoxytol | Moderate hypotension | 2 | Participants | |
| Participants With Treatment-Emergent (TE) Moderate To Severe Hypersensitivity Reactions (Rxns), Including Anaphylaxis, Or Moderate To Severe Hypotension | Ferric Carboxymaltose (FCM) | Moderate hypotension | 1 | Participants | |
| Participants With Treatment-Emergent (TE) Moderate To Severe Hypersensitivity Reactions (Rxns), Including Anaphylaxis, Or Moderate To Severe Hypotension | Ferumoxytol | Severe hypotension | 0 | Participants | |
| Participants With Treatment-Emergent (TE) Moderate To Severe Hypersensitivity Reactions (Rxns), Including Anaphylaxis, Or Moderate To Severe Hypotension | Ferric Carboxymaltose (FCM) | Severe hypotension | 0 | Participants |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ferumoxytol | 1,006 | |
| Overall Study | STARTED | Ferric Carboxymaltose (FCM) | 1,008 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Ferumoxytol | 997 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Ferric Carboxymaltose (FCM) | 1,000 | |
| Overall Study | COMPLETED | Ferumoxytol | 935 | |
| Overall Study | COMPLETED | Ferric Carboxymaltose (FCM) | 948 | |
| Overall Study | NOT COMPLETED | Ferumoxytol | 71 | |
| Overall Study | NOT COMPLETED | Ferric Carboxymaltose (FCM) | 60 |
Source ClinicalTrials.gov
Adverse events176
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Ferumoxytol | 35 | 997 | |
| other | Nausea | Gastrointestinal disorders | Ferric Carboxymaltose (FCM) | 60 | 1,000 | |
| other | Diarrhoea | Gastrointestinal disorders | Ferumoxytol | 29 | 997 | |
| other | Diarrhoea | Gastrointestinal disorders | Ferric Carboxymaltose (FCM) | 33 | 1,000 | |
| other | Abdominal pain | Gastrointestinal disorders | Ferumoxytol | 17 | 997 | |
| other | Abdominal pain | Gastrointestinal disorders | Ferric Carboxymaltose (FCM) | 21 | 1,000 | |
| other | Constipation | Gastrointestinal disorders | Ferumoxytol | 14 | 997 | |
| other | Constipation | Gastrointestinal disorders | Ferric Carboxymaltose (FCM) | 13 | 1,000 | |
| other | Vomiting | Gastrointestinal disorders | Ferumoxytol | 11 | 997 | |
| other | Vomiting | Gastrointestinal disorders | Ferric Carboxymaltose (FCM) | 13 | 1,000 |
1 to 10 of 176Source ClinicalTrials.gov
See all 176 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ferumoxytol | ||
| Total, all-cause mortality | Ferric Carboxymaltose (FCM) | ||
| Total, other adverse events | Ferumoxytol | 186 | 997 |
| Total, other adverse events | Ferric Carboxymaltose (FCM) | 245 | 1,000 |
| Total, serious adverse events | Ferumoxytol | 36 | 997 |
| Total, serious adverse events | Ferric Carboxymaltose (FCM) | 35 | 1,000 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Ferumoxytol vs Ferric Carboxymaltose (FCM): serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02694978
GET https://conductscience.org/api/trials/v1/NCT02694978/results?page=2