Trial · NCT01114139
A Trial Comparing Ferumoxytol With Placebo for the Treatment of Iron Deficiency Anemia
NCT01114139, Phase 3, Completed, AMAG Pharmaceuticals, Inc.; results first posted 2018-06-11
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Trial Comparing Ferumoxytol With Placebo for the Treatment of Iron Deficiency Anemia. Trials, record NCT01114139. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01114139
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Trial Comparing Ferumoxytol With Placebo for the Treatment of Iron Deficiency Anemia
- NCT number
- NCT01114139
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 812 participants, actual
- Lead sponsor
- AMAG Pharmaceuticals, Inc.
- Conditions
- Iron Deficiency Anemia
- Interventions
- Ferumoxytol, Placebo
- First posted
- 2010-04-30
- Last updated
- 2022-04-21
- Results first posted
- 2018-06-11
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Participants Who Achieved A ≥2.0 g/dL Increase In Hemoglobin At Any Time From Baseline To Week 5 | Baseline (Day 1) through Week 5 | Participants who achieved a ≥2.0 g/dL increase in hemoglobin at any time from Baseline up to Week 5 are presented. Increase in hemoglobin at any time from Baseline up to Week 5 was calculated for each participant based on: Hemoglobin Change = Hemoglobin (Week X) - Hemoglobin (Baseline), where Week X was any post-Baseline visit up to and including Week 5. 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. Participants with no post-Baseline hemoglobin values were classified as not achieving a ≥2.0 g/dL increase. Statistical analysis was performed for data up to Week 5 only. |
| 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 X) - Hemoglobin (Baseline), where Week X was any post-Baseline visit up to and including Week 5. 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. If the Week 5 hemoglobin value was missing, the change from Baseline was imputed to be zero. Participants without any post-Baseline hemoglobin values were treated as non-responders. |
| Secondary | Participants Achieving A Hemoglobin Level ≥12.0 g/dL At Any Time From Baseline To Week 5 | Baseline (Day 1) through Week 5 | Participants who achieved a ≥12.0 g/dL hemoglobin level at any time from Baseline up to Week 5 are presented. Increase in hemoglobin at any time from Baseline up to Week 5 was calculated for each participant based on: Hemoglobin Change = Hemoglobin (Week X) - Hemoglobin (Baseline), where Week X was any post-Baseline visit up to and including Week 5. 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. Participants without any post-Baseline hemoglobin values were treated as non-responders. |
| Secondary | Mean Change In TSAT From Baseline To Week 5 | Baseline (Day 1), Week 5 | Mean change in TSAT from Baseline to Week 5 was calculated for each participant as: TSAT Change = TSAT (Week 5) - TSAT (Baseline). TSAT, measured as a percentage, was part of the iron panel laboratory evaluations. Of the transferrin available to bind iron, this value indicates how much serum iron is bound. For example, a value of 20% means that 20% of iron-binding sites of transferrin are being occupied by iron. 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. If the Week 5 TSAT value was missing, the change from Baseline was imputed to be zero. |
| Secondary | Mean Change In Functional Assessment Of Chronic Illness Therapy (FACIT)-Fatigue Score From Baseline To Week 5 | Baseline (Day 1), Week 5 | 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 Score from Baseline to Week 5 was calculated for each participant as: FACIT-Fatigue Score Change = FACIT-Fatigue Score (Week 5) - FACIT-Fatigue Score (Baseline). Baseline was defined as the Day 1 value (prior to first dose of study drug).The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information. If the Week 5 FACIT-Fatigue Score value was missing, the change from Baseline was imputed to be zero. |
| Secondary | Time To Hemoglobin Increase Of ≥2.0 g/dL Or A Hemoglobin Value Of ≥12.0 g/dL From Baseline | From Baseline (Day 1) up to Week 5 | The time to hemoglobin increase of ≥2.0 g/dL or hemoglobin value of ≥12.0 g/dL was defined as the days from Baseline (Day 1) to the first time the participant had an increase in hemoglobin of ≥2.0 g/dL or hemoglobin value of ≥12.0 g/dL, and was calculated using a Kaplan-Meier curve. Participants who did not have a hemoglobin increase of ≥2.0 g/dL or to a hemoglobin level ≥12.0 g/dL were censored at their last visit day. Participants without any post-Baseline study visits were not included. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Participants Who Achieved A ≥2.0 g/dL Increase In Hemoglobin At Any Time From Baseline To Week 5 | Baseline (Day 1) through Week 5 | Intent-To-Treat (ITT) Population: Any randomized participant who had any exposure to study drug (ferumoxytol or placebo) and was based upon randomized treatment assignment. | 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 (ferumoxytol or placebo) and was based upon randomized treatment assignment. | g/dL | MEAN |
| SECONDARY | Participants Achieving A Hemoglobin Level ≥12.0 g/dL At Any Time From Baseline To Week 5 | Baseline (Day 1) through Week 5 | ITT Population: Any randomized participant who had any exposure to study drug (ferumoxytol or placebo) and was based upon randomized treatment assignment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Change In TSAT 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 (ferumoxytol or placebo) and was based upon randomized treatment assignment. | percentage of saturation | MEAN |
| SECONDARY | Mean Change In Functional Assessment Of Chronic Illness Therapy (FACIT)-Fatigue Score 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 (ferumoxytol or placebo) and was based upon randomized treatment assignment. | units on a scale | MEAN |
| SECONDARY | Time To Hemoglobin Increase Of ≥2.0 g/dL Or A Hemoglobin Value Of ≥12.0 g/dL From Baseline | From Baseline (Day 1) up to Week 5 | Intent-To-Treat (ITT) Population: Any randomized participant who had any exposure to study drug (ferumoxytol or placebo) and was based upon randomized treatment assignment. | Days | MEAN |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Participants Who Achieved A ≥2.0 g/dL Increase In Hemoglobin At Any Time From Baseline To Week 5 | Ferumoxytol | Up to Week 2 | 252 | Participants | |
| Participants Who Achieved A ≥2.0 g/dL Increase In Hemoglobin At Any Time From Baseline To Week 5 | Placebo | Up to Week 2 | 5 | Participants | |
| Participants Who Achieved A ≥2.0 g/dL Increase In Hemoglobin At Any Time From Baseline To Week 5 | Ferumoxytol | Up to Week 3 | 386 | Participants | |
| Participants Who Achieved A ≥2.0 g/dL Increase In Hemoglobin At Any Time From Baseline To Week 5 | Placebo | Up to Week 3 | 7 | Participants | |
| Participants Who Achieved A ≥2.0 g/dL Increase In Hemoglobin At Any Time From Baseline To Week 5 | Ferumoxytol | Up to Week 4 | 460 | Participants | |
| Participants Who Achieved A ≥2.0 g/dL Increase In Hemoglobin At Any Time From Baseline To Week 5 | Placebo | Up to Week 4 | 8 | Participants | |
| Participants Who Achieved A ≥2.0 g/dL Increase In Hemoglobin At Any Time From Baseline To Week 5 | Ferumoxytol | Up to Week 5 | 493 | Participants | |
| Participants Who Achieved A ≥2.0 g/dL Increase In Hemoglobin At Any Time From Baseline To Week 5 | Placebo | Up to Week 5 | 11 | Participants | |
| Mean Change In Hemoglobin From Baseline To Week 5 | Ferumoxytol | 2.6 | Standard Deviation 1.52 | g/dL | |
| Mean Change In Hemoglobin From Baseline To Week 5 | Placebo | 0.1 | Standard Deviation 0.89 | g/dL |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 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 | 609 | |
| Overall Study | STARTED | Placebo | 203 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Ferumoxytol | 608 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Placebo | 200 | |
| Overall Study | COMPLETED | Ferumoxytol | 569 | |
| Overall Study | COMPLETED | Placebo | 187 | |
| Overall Study | NOT COMPLETED | Ferumoxytol | 40 | |
| Overall Study | NOT COMPLETED | Placebo | 16 |
Source ClinicalTrials.gov
Adverse events102
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 | Abdominal Pain | Gastrointestinal disorders | Ferumoxytol | 11 | 608 | |
| other | Abdominal Pain | Gastrointestinal disorders | Placebo | 5 | 200 | |
| other | Abdominal Pain Upper | Gastrointestinal disorders | Ferumoxytol | 7 | 608 | |
| other | Abdominal Pain Upper | Gastrointestinal disorders | Placebo | 1 | 200 | |
| other | Constipation | Gastrointestinal disorders | Ferumoxytol | 10 | 608 | |
| other | Constipation | Gastrointestinal disorders | Placebo | 3 | 200 | |
| other | Diarrhoea | Gastrointestinal disorders | Ferumoxytol | 17 | 608 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 6 | 200 | |
| other | Nausea | Gastrointestinal disorders | Ferumoxytol | 28 | 608 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 5 | 200 |
1 to 10 of 102Source ClinicalTrials.gov
See all 102 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 | Placebo | ||
| Total, other adverse events | Ferumoxytol | 198 | 608 |
| Total, other adverse events | Placebo | 56 | 200 |
| Total, serious adverse events | Ferumoxytol | 16 | 608 |
| Total, serious adverse events | Placebo | 6 | 200 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23983177 | BACKGROUND |
Source PubMed
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 Placebo: 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/NCT01114139
GET https://conductscience.org/api/trials/v1/NCT01114139/results?page=2