Trial · NCT01950247
Evaluate the Utility of Serum Hepcidin Levels to Predict Response to Oral or IV Iron
NCT01950247, Phase 4, Completed, American Regent, Inc.; results first posted 2025-05-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluate the Utility of Serum Hepcidin Levels to Predict Response to Oral or IV Iron. Trials, record NCT01950247. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01950247
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluate the Utility of Serum Hepcidin Levels to Predict Response to Oral or IV Iron
- NCT number
- NCT01950247
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 1,025 participants, actual
- Lead sponsor
- American Regent, Inc.
- Conditions
- Iron Deficiency Anemia (IDA)
- Interventions
- Injectafer, SOC
- First posted
- 2013-09-25
- Last updated
- 2025-05-22
- Results first posted
- 2025-05-22
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Multidimensional Assessment of Fatigue (MAF) Scores | Baseline to Day 30 | The MAF scale has 16 items that measure the Global Fatigue Index (GFI), a composite score of Items 1 through 15. Items 1 through 14 were measured on a scale of 1 to 10, with 1 = not at all and 10 = a great deal. Items 15 and 16 had categorical responses: degree of agreement from 0 to 4, with 0=no days and 4=every day. Then, a Global Fatigue Index (GFI) is calculated by summing specific items and averaging others. The final GFI score ranges from 1 (no fatigue) to 50 (severe fatigue). The resulting score is given as the mean value. |
| Primary | Work Productivity and Activity Impairment Questionnaire (WPAI) Scores | Baseline and Day 30 | The WPAI consisted of six questions: 1 = currently employed; 2 = hours missed due to health problems; 3 = hours missed other reasons; 4 = hours actually worked; 5 = degree health affected productivity while working using a scale of 0 to 10, with 0 = PROBLEM had no effect on my work and 10 = PROBLEM completely prevented me from working; 6 = degree health affected productivity in regular unpaid activities using a scale of 0 to 10, with 0 = PROBLEM had no effect on my daily activities and 10 = PROBLEM completely prevented me from doing my daily activities. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity. |
| Primary | Treatment Satisfaction Questionnaire for Medication Version 1.4 Scores | Baseline and Day 30 | Participants rated 14 items with 4 domains. Scores for item 1 to 3, 9 to 11 and 14 ranged from 1=extremely dissatisfied to 7=extremely satisfied. Items 5 to 8, 12, 13 ranged from 1=extremely dissatisfied to 5=not at all dissatisfied. Item 4 was scored as: 0=No, 1=Yes. Effectiveness measured as (\[{sum of item 1 to 3} - 3\]/18)\*100; if 1 question (Q) was missing: (\[{sum of item 1 to 3} -2\]/12)\*100. Side-effect measured as if item 4=No, score=100; if not then (\[{sum of item 5 to 8} -4\]/16)\*100; if 1 Q was missing: (\[{sum of item 5 to 8} -3\]/12)\*100. Convenience measured as (\[{sum of item 9 to 11} -3\]/18)\*100; if 1 Q was missing: (\[{sum of item 9 to 11} - 2\]/12)\*100. Global satisfaction as (\[{sum of item 12 to 14} -3\]/14)\*100; if item 12 or 13 was missing: (\[{sum of item 12 to 14} -2\]/10)\*100; if item 14 was missing: (\[{sum of item 12 and 13} -2\]/8)\*100. All domains had scale of 0 (no satisfaction) to 100 (best level of satisfaction), higher score equals greater satisfaction |
| Primary | Short Form Health Survey, 12-Item (SF-12) v2 Quality of Life Scores. | Baseline and Day 30 | The SF-12 is a multipurpose short form to measure health status. There are 10 domains: Physical Composite Index (score range from 0-100); Physical Functioning Index (score range from 0-100); Role Limitation Physical Index (score range 0-100); Pain Index Score (score range from 0-100); General Health Index (score range from 0-100); Mental Health Composite Index (score range from 1-100); Vitality Index (score range from 0-100); Social Functioning Index (score rang 0-100); Role Limitation Emotional Index (score range 0-100); and SF-12 Mental Health Index (score range from 0-100), the higher the score means a better outcome. The overall scale and sub-scales were calculated with the standard SF-12 formulas. |
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 | Multidimensional Assessment of Fatigue (MAF) Scores | Baseline to Day 30 | Change from baseline to Day 30 | units on a scale | MEAN |
| PRIMARY | Work Productivity and Activity Impairment Questionnaire (WPAI) Scores | Baseline and Day 30 | Change from baseline to Day 30 | units on a scale | MEAN |
| PRIMARY | Treatment Satisfaction Questionnaire for Medication Version 1.4 Scores | Baseline and Day 30 | Change from baseline to Day 30 | units on a scale | MEAN |
| PRIMARY | Short Form Health Survey, 12-Item (SF-12) v2 Quality of Life Scores. | Baseline and Day 30 | Change from Baseline to Day 30 | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group38
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Multidimensional Assessment of Fatigue (MAF) Scores | Injectafer | -8.8 | Standard Deviation 11.38 | units on a scale | |
| Multidimensional Assessment of Fatigue (MAF) Scores | IV Iron Standard of Care (SOC) | -8.1 | Standard Deviation 11.28 | units on a scale | |
| Work Productivity and Activity Impairment Questionnaire (WPAI) Scores | Injectafer | Percent activity impairment due to problem | -15.2 | Standard Deviation 29.85 | units on a scale |
| Work Productivity and Activity Impairment Questionnaire (WPAI) Scores | IV Iron Standard of Care (SOC) | Percent activity impairment due to problem | -11.5 | Standard Deviation 29.43 | units on a scale |
| Work Productivity and Activity Impairment Questionnaire (WPAI) Scores | Injectafer | Percent impairment while working due to problem | -13.2 | Standard Deviation 28.75 | units on a scale |
| Work Productivity and Activity Impairment Questionnaire (WPAI) Scores | IV Iron Standard of Care (SOC) | Percent impairment while working due to problem | -8.5 | Standard Deviation 24.44 | units on a scale |
| Work Productivity and Activity Impairment Questionnaire (WPAI) Scores | Injectafer | Percent overall work impairment due to problem | -13.4 | Standard Deviation 31.66 | units on a scale |
| Work Productivity and Activity Impairment Questionnaire (WPAI) Scores | IV Iron Standard of Care (SOC) | Percent overall work impairment due to problem | -8.5 | Standard Deviation 25.89 | units on a scale |
| Work Productivity and Activity Impairment Questionnaire (WPAI) Scores | Injectafer | Percent work time missed due to problem | -3.2 | Standard Deviation 23.76 | units on a scale |
| Work Productivity and Activity Impairment Questionnaire (WPAI) Scores | IV Iron Standard of Care (SOC) | Percent work time missed due to problem | -2.5 | Standard Deviation 17.23 | units on a scale |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | IV Iron Standard of Care (SOC) | 512 | |
| Overall Study | STARTED | Injectafer | 513 | |
| Overall Study | COMPLETED | IV Iron Standard of Care (SOC) | 455 | |
| Overall Study | COMPLETED | Injectafer | 467 | |
| Overall Study | NOT COMPLETED | IV Iron Standard of Care (SOC) | 57 | |
| Overall Study | NOT COMPLETED | Injectafer | 46 |
Source ClinicalTrials.gov
Adverse events4
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 | Injectafer | 28 | 513 | 506 |
| other | Nausea | Gastrointestinal disorders | IV Iron Standard of Care (SOC) | 21 | 512 | 486 |
| serious | Cardiac disorders | Cardiac disorders | Injectafer | 4 | 513 | 506 |
| serious | Cardiac disorders | Cardiac disorders | IV Iron Standard of Care (SOC) | 1 | 512 | 486 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Injectafer | 1 | 513 |
| Total, all-cause mortality | IV Iron Standard of Care (SOC) | 1 | 512 |
| Total, other adverse events | Injectafer | 28 | 513 |
| Total, other adverse events | IV Iron Standard of Care (SOC) | 21 | 512 |
| Total, serious adverse events | Injectafer | 4 | 513 |
| Total, serious adverse events | IV Iron Standard of Care (SOC) | 1 | 512 |
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 |
|---|---|
| Injectafer vs IV Iron Standard of Care (SOC): deaths from any cause | Trial comparisons |
| Injectafer vs IV Iron Standard of Care (SOC): 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/NCT01950247
GET https://conductscience.org/api/trials/v1/NCT01950247/results?page=2