Trial · NCT00982007
Efficacy and Safety of Intravenous Ferric Carboxymaltose (FCM) in Patients With Iron Deficiency Anemia (IDA)
NCT00982007, Phase 3, Completed, American Regent, Inc.; results first posted 2013-10-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of Intravenous Ferric Carboxymaltose (FCM) in Patients With Iron Deficiency Anemia (IDA). Trials, record NCT00982007. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00982007
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Intravenous Ferric Carboxymaltose (FCM) in Patients With Iron Deficiency Anemia (IDA)
- NCT number
- NCT00982007
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 997 participants, actual
- Lead sponsor
- American Regent, Inc.
- Conditions
- Iron Deficiency Anemia
- Interventions
- Ferric Carboxymaltose (FCM), Ferrous Sulfate Tablets, IV Iron (standard of care), Ferric Carboxymaltose (FCM)
- First posted
- 2009-09-22
- Last updated
- 2018-02-20
- Results first posted
- 2013-10-18
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Increase From Baseline to the Highest Observed Hemoglobin Value Between Baseline and Day 35 or Time of Intervention for Patients Taking FCM as Compared to That for Patients Taking Ferrous Sulfate. | Day 35 |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Increase From Baseline to the Highest Observed Hemoglobin Value Between Baseline and Day 35 or Time of Intervention for Patients Taking FCM as Compared to That for Patients Taking Ferrous Sulfate. | Day 35 | Modified Intent-to-Treat Population: Subjects who have received at least 1 dose of randomized study medication and had at least 1 post-baseline hemoglobin assessment | g/dL | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Mean Increase From Baseline to the Highest Observed Hemoglobin Value Between Baseline and Day 35 or Time of Intervention for Patients Taking FCM as Compared to That for Patients Taking Ferrous Sulfate. | Cohort 1 (Group A) - Ferric Carboxymaltose (FCM) | 1.57 | Standard Deviation 1.194 | g/dL | |
Mean Increase From Baseline to the Highest Observed Hemoglobin Value Between Baseline and Day 35 or Time of Intervention for Patients Taking FCM as Compared to That for Patients Taking Ferrous Sulfate. | Cohort 1 (Group B) - Ferrous Sulfate | 0.80 | Standard Deviation 0.799 | g/dL | |
Mean Increase From Baseline to the Highest Observed Hemoglobin Value Between Baseline and Day 35 or Time of Intervention for Patients Taking FCM as Compared to That for Patients Taking Ferrous Sulfate. | Cohort 2 (Group C) - Ferric Carboxymaltose (FCM) | 2.90 | Standard Deviation 1.640 | g/dL | |
Mean Increase From Baseline to the Highest Observed Hemoglobin Value Between Baseline and Day 35 or Time of Intervention for Patients Taking FCM as Compared to That for Patients Taking Ferrous Sulfate. | Cohort 2 (Group D) - IV Iron (Standard of Care) | 2.16 | Standard Deviation 1.252 | g/dL |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1 (Group A) - Ferric Carboxymaltose (FCM) | 250 | |
| Overall Study | STARTED | Cohort 1 (Group B) - Ferrous Sulfate | 257 | |
| Overall Study | STARTED | Cohort 2 (Group C) - Ferric Carboxymaltose (FCM) | 253 | |
| Overall Study | STARTED | Cohort 2 (Group D) - IV Iron (Standard of Care) | 251 | |
| Overall Study | COMPLETED | Cohort 1 (Group A) - Ferric Carboxymaltose (FCM) | 246 | |
| Overall Study | COMPLETED | Cohort 1 (Group B) - Ferrous Sulfate | 253 | |
| Overall Study | COMPLETED | Cohort 2 (Group C) - Ferric Carboxymaltose (FCM) | 253 | |
| Overall Study | COMPLETED | Cohort 2 (Group D) - IV Iron (Standard of Care) | 245 | |
| Overall Study | NOT COMPLETED | Cohort 1 (Group A) - Ferric Carboxymaltose (FCM) | 4 | |
| Overall Study | NOT COMPLETED | Cohort 1 (Group B) - Ferrous Sulfate | 4 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events188
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 | Cohort 1 (Group A) - Ferric Carboxymaltose (FCM) | 20 | 246 | |
| other | Nausea | Gastrointestinal disorders | Cohort 1 (Group B) - Ferrous Sulfate | 5 | 253 | |
| other | Nausea | Gastrointestinal disorders | Cohort 2 (Group C) - Ferric Carboxymaltose (FCM) | 10 | 253 | |
| other | Nausea | Gastrointestinal disorders | Cohort 2 (Group D) - IV Iron (Standard of Care) | 10 | 245 | |
| other | Hypophosphatemia | Metabolism and nutrition disorders | Cohort 1 (Group A) - Ferric Carboxymaltose (FCM) | 11 | 246 | |
| other | Hypophosphatemia | Metabolism and nutrition disorders | Cohort 1 (Group B) - Ferrous Sulfate | 0 | 253 | |
| other | Hypophosphatemia | Metabolism and nutrition disorders | Cohort 2 (Group C) - Ferric Carboxymaltose (FCM) | 16 | 253 | |
| other | Hypophosphatemia | Metabolism and nutrition disorders | Cohort 2 (Group D) - IV Iron (Standard of Care) | 0 | 245 | |
| serious | Anemia | Blood and lymphatic system disorders | Cohort 1 (Group A) - Ferric Carboxymaltose (FCM) | 1 | 246 | |
| serious | Anemia | Blood and lymphatic system disorders | Cohort 1 (Group B) - Ferrous Sulfate | 0 | 253 |
1 to 10 of 188Source ClinicalTrials.gov
See all 188 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 (Group A) - Ferric Carboxymaltose (FCM) | ||
| Total, all-cause mortality | Cohort 1 (Group B) - Ferrous Sulfate | ||
| Total, all-cause mortality | Cohort 2 (Group C) - Ferric Carboxymaltose (FCM) | ||
| Total, all-cause mortality | Cohort 2 (Group D) - IV Iron (Standard of Care) | ||
| Total, other adverse events | Cohort 1 (Group A) - Ferric Carboxymaltose (FCM) | 31 | 246 |
| Total, other adverse events | Cohort 1 (Group B) - Ferrous Sulfate | 5 | 253 |
| Total, other adverse events | Cohort 2 (Group C) - Ferric Carboxymaltose (FCM) | 26 | 253 |
| Total, other adverse events | Cohort 2 (Group D) - IV Iron (Standard of Care) | 10 | 245 |
| Total, serious adverse events | Cohort 1 (Group A) - Ferric Carboxymaltose (FCM) | 8 | 246 |
| Total, serious adverse events | Cohort 1 (Group B) - Ferrous Sulfate | 10 | 253 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00982007
GET https://conductscience.org/api/trials/v1/NCT00982007/events?page=2