Trial · NCT00981045
Evaluation of Efficacy and Safety of Ferric Carboxymaltose (FCM) in Patients With Iron Deficiency Anemia and Impaired Renal Function
NCT00981045, 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. Evaluation of Efficacy and Safety of Ferric Carboxymaltose (FCM) in Patients With Iron Deficiency Anemia and Impaired Renal Function. Trials, record NCT00981045. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00981045
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of Efficacy and Safety of Ferric Carboxymaltose (FCM) in Patients With Iron Deficiency Anemia and Impaired Renal Function
- NCT number
- NCT00981045
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,561 participants, actual
- Lead sponsor
- American Regent, Inc.
- Conditions
- Iron Deficiency Anemia, Impaired Renal Function
- Interventions
- Ferric Carboxymaltose (FCM), Iron Sucrose (Venofer)
- First posted
- 2009-09-22
- Last updated
- 2018-02-20
- Results first posted
- 2013-10-18
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From Baseline to the Highest Observed Hemoglobin Any Time From Baseline to End of Study. | Day 56 | |
| Primary | Proportion of Subjects Experiencing at Least One Event in the Primary Composite Safety Endpoint in the Randomized Population. | Day 120 | The primary composite safety endpoint was defined as death due to any cause, nonfatal myocardial infarction, nonfatal stroke, unstable angina requiring hospitalization or medical intervention, arrhythmias, protocol-defined hypersensitive events, and protocol-defined hyposensitive events. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change From Baseline to the Highest Observed Hemoglobin Any Time From Baseline to End of Study. | Day 56 | g/dL | MEAN | |
| PRIMARY | Proportion of Subjects Experiencing at Least One Event in the Primary Composite Safety Endpoint in the Randomized Population. | Day 120 | participants | NUMBER |
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 Change From Baseline to the Highest Observed Hemoglobin Any Time From Baseline to End of Study. | Ferric Carboxymaltose (FCM) | 1.13 | Standard Deviation 1.044 | g/dL | |
| Mean Change From Baseline to the Highest Observed Hemoglobin Any Time From Baseline to End of Study. | Iron Sucrose (Venofer) | 0.92 | Standard Deviation 0.917 | g/dL | |
| Proportion of Subjects Experiencing at Least One Event in the Primary Composite Safety Endpoint in the Randomized Population. | Ferric Carboxymaltose (FCM) | 175 | participants | ||
| Proportion of Subjects Experiencing at Least One Event in the Primary Composite Safety Endpoint in the Randomized Population. | Iron Sucrose (Venofer) | 156 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ferric Carboxymaltose (FCM) | 1,290 | |
| Overall Study | STARTED | Iron Sucrose (Venofer) | 1,294 | |
| Overall Study | COMPLETED | Ferric Carboxymaltose (FCM) | 1,276 | |
| Overall Study | COMPLETED | Iron Sucrose (Venofer) | 1,285 | |
| Overall Study | NOT COMPLETED | Ferric Carboxymaltose (FCM) | 14 | |
| Overall Study | NOT COMPLETED | Iron Sucrose (Venofer) | 9 |
Source ClinicalTrials.gov
Adverse events440
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 | Hypertension | Vascular disorders | Ferric Carboxymaltose (FCM) | 133 | 1,276 | |
| other | Hypertension | Vascular disorders | Iron Sucrose (Venofer) | 95 | 1,285 | |
| other | Nausea | Gastrointestinal disorders | Ferric Carboxymaltose (FCM) | 172 | 1,276 | |
| other | Nausea | Gastrointestinal disorders | Iron Sucrose (Venofer) | 56 | 1,285 | |
| serious | Anemia | Blood and lymphatic system disorders | Ferric Carboxymaltose (FCM) | 14 | 1,276 | |
| serious | Anemia | Blood and lymphatic system disorders | Iron Sucrose (Venofer) | 4 | 1,285 | |
| serious | Coagulopathy | Blood and lymphatic system disorders | Ferric Carboxymaltose (FCM) | 0 | 1,276 | |
| serious | Coagulopathy | Blood and lymphatic system disorders | Iron Sucrose (Venofer) | 1 | 1,285 | |
| serious | Normochromic normocytic anemia | Blood and lymphatic system disorders | Ferric Carboxymaltose (FCM) | 0 | 1,276 | |
| serious | Normochromic normocytic anemia | Blood and lymphatic system disorders | Iron Sucrose (Venofer) | 1 | 1,285 |
1 to 10 of 440Source ClinicalTrials.gov
See all 440 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ferric Carboxymaltose (FCM) | ||
| Total, all-cause mortality | Iron Sucrose (Venofer) | ||
| Total, other adverse events | Ferric Carboxymaltose (FCM) | 305 | 1,276 |
| Total, other adverse events | Iron Sucrose (Venofer) | 151 | 1,285 |
| Total, serious adverse events | Ferric Carboxymaltose (FCM) | 202 | 1,276 |
| Total, serious adverse events | Iron Sucrose (Venofer) | 197 | 1,285 |
Source ClinicalTrials.gov
Papers0
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Ferric Carboxymaltose (FCM) vs Iron Sucrose (Venofer): Proportion of Subjects Experiencing at Least One Event in the Primary Composite Safety Endpoint in the Randomized Population. | Trial comparisons |
| Ferric Carboxymaltose (FCM) vs Iron Sucrose (Venofer): serious adverse events | 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/NCT00981045
GET https://conductscience.org/api/trials/v1/NCT00981045/events?page=2