Trial · NCT02680756
Safety and Efficacy Study of Oral Ferric Maltol Compared to Intravenous Iron To Treat Iron Deficiency Anaemia in IBD
NCT02680756, Phase 3, Completed, Shield Therapeutics; results first posted 2020-02-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy Study of Oral Ferric Maltol Compared to Intravenous Iron To Treat Iron Deficiency Anaemia in IBD. Trials, record NCT02680756. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02680756
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy Study of Oral Ferric Maltol Compared to Intravenous Iron To Treat Iron Deficiency Anaemia in IBD
- NCT number
- NCT02680756
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 250 participants, actual
- Lead sponsor
- Shield Therapeutics
- Conditions
- Anemia, Iron-Deficiency, Inflammatory Bowel Disease, Crohn's Disease
- Interventions
- Ferric Maltol, Ferric Carboxy Maltose
- First posted
- 2016-02-11
- Last updated
- 2020-11-02
- Results first posted
- 2020-02-24
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects Achieving Either a 2g/dL Increase in Hb OR Normalization of Hb at Week 12 | Baseline to Week 12 | Number of subjects achieving either a 2g/dL increase in Hb OR normalization of Hb (\>=12g/dL women,\>=13g/dL men) at Week 12 |
| Primary | Number of Subjects Achieving Either a 2g/dL Increase in Hb OR Normalization of Hb at Week 12 | Baseline to Week 12 | Number of subjects achieving either a 2g/dL increase in Hb OR normalization of Hb (\>=12g/dL women, \>=13g/dL men) at Week 12 |
| Secondary | Change in Hb Concentration From Baseline to Week 12 | Baseline to Week 12 | Change in hemoglobin concentration from baseline to Week 12. |
| Secondary | Change in Hb Concentration From Baseline to Week 12 in Subjects With a Baseline Hb <9.5 g/dL | Baseline to Week 12 | Change in hemoglobin concentration from baseline to Week 12 in subjects with a baseline hemoglobin \<9.5 g/dL. |
| Secondary | Number of Subjects Who Experience a Change From Baseline in Hb Concentration ≥1.0 g/dL at Week 12 | Baseline to Week 12 | Number of subjects who experience a change from baseline in hemoglobin concentration ≥1.0 g/dL at Week 12. |
| Secondary | Number of Subjects With Baseline Hb <9.5g/dL That Achieve an Increase in Hb Concentration of ≥1 g/dL at Week 12 | Baseline to Week 12 | Number of subjects with baseline hemoglobin \<9.5g/dL that achieve an increase in hemoglobin concentration of ≥1 g/dL at Week 12. |
| Secondary | Number of Subjects With Hb Concentration Within Normal Limits at Week 12 | Baseline to Week 12 | Number of subjects with Hb concentration within normal limits at Week 12 (normal limit definition: \>=12g/dL women, \>=13g/dL men) |
| Secondary | Number of Subjects With Baseline Hb Concentration <9.5 g/dL That is Within Normal Limits at Week 12 | Baseline to Week 12 | Number of subjects with baseline Hb concentration \<9.5 g/dL that is within normal limits at Week 12 (normal limit definition: \>=12g/dL women, \>=13g/dL men) |
| Secondary | Proportion of Subjects Who Are Non-anaemic at 6 Months and 12 Months | Baseline to Month 6 | Long term efficacy endpoints i.e. proportion of subjects who are non-anaemic at 6 months and 12 months (normal limit definition: \>=12g/dL women, \>=13g/dL men) |
| Secondary | Change in Hb Concentration From Baseline to Week 4 | Baseline to Week 4 | Change in hemoglobin concentration from baseline to Week 4. |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects Achieving Either a 2g/dL Increase in Hb OR Normalization of Hb at Week 12 | Baseline to Week 12 | ITT (MI) | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Subjects Achieving Either a 2g/dL Increase in Hb OR Normalization of Hb at Week 12 | Baseline to Week 12 | re-evaluated PP | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in Hb Concentration From Baseline to Week 12 | Baseline to Week 12 | ITT (MI) | g/dL | MEAN |
| SECONDARY | Change in Hb Concentration From Baseline to Week 12 in Subjects With a Baseline Hb <9.5 g/dL | Baseline to Week 12 | ITT (MI) | g/dL | MEAN |
| SECONDARY | Number of Subjects Who Experience a Change From Baseline in Hb Concentration ≥1.0 g/dL at Week 12 | Baseline to Week 12 | ITT (MI) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Baseline Hb <9.5g/dL That Achieve an Increase in Hb Concentration of ≥1 g/dL at Week 12 | Baseline to Week 12 | ITT (MI) Not all subjects were tested. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Hb Concentration Within Normal Limits at Week 12 | Baseline to Week 12 | ITT (MI) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Baseline Hb Concentration <9.5 g/dL That is Within Normal Limits at Week 12 | Baseline to Week 12 | ITT (MI) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Subjects Who Are Non-anaemic at 6 Months and 12 Months | Baseline to Month 6 | ITT (OC) Not all subjects were tested. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in Hb Concentration From Baseline to Week 4 | Baseline to Week 4 | ITT (MI) | g/dL | MEAN |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group80
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects Achieving Either a 2g/dL Increase in Hb OR Normalization of Hb at Week 12 | Oral Ferric Iron Compound | Responder | 84 | Participants | |
| Number of Subjects Achieving Either a 2g/dL Increase in Hb OR Normalization of Hb at Week 12 | Intravenous Iron | Responder | 105 | Participants | |
| Number of Subjects Achieving Either a 2g/dL Increase in Hb OR Normalization of Hb at Week 12 | Oral Ferric Iron Compound | Non-responder | 41 | Participants | |
| Number of Subjects Achieving Either a 2g/dL Increase in Hb OR Normalization of Hb at Week 12 | Intravenous Iron | Non-responder | 20 | Participants | |
| Number of Subjects Achieving Either a 2g/dL Increase in Hb OR Normalization of Hb at Week 12 | Oral Ferric Iron Compound | Responder | 53 | Participants | |
| Number of Subjects Achieving Either a 2g/dL Increase in Hb OR Normalization of Hb at Week 12 | Intravenous Iron | Responder | 75 | Participants | |
| Number of Subjects Achieving Either a 2g/dL Increase in Hb OR Normalization of Hb at Week 12 | Oral Ferric Iron Compound | Non-responder | 25 | Participants | |
| Number of Subjects Achieving Either a 2g/dL Increase in Hb OR Normalization of Hb at Week 12 | Intravenous Iron | Non-responder | 13 | Participants | |
| Change in Hb Concentration From Baseline to Week 12 | Oral Ferric Iron Compound | 2.45 | Standard Deviation 1.449 | g/dL | |
| Change in Hb Concentration From Baseline to Week 12 | Intravenous Iron | 3.04 | Standard Deviation 1.576 | g/dL |
1 to 10 of 80Source ClinicalTrials.gov
See all 80 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Oral Ferric Iron Compound | 125 | |
| Overall Study | STARTED | Intravenous Iron | 125 | |
| Overall Study | Received Treatment | Oral Ferric Iron Compound | 127 | |
| Overall Study | Received Treatment | Intravenous Iron | 120 | |
| Overall Study | COMPLETED | Oral Ferric Iron Compound | 93 | |
| Overall Study | COMPLETED | Intravenous Iron | 106 | |
| Overall Study | NOT COMPLETED | Oral Ferric Iron Compound | 32 | |
| Overall Study | NOT COMPLETED | Intravenous Iron | 19 |
Source ClinicalTrials.gov
Adverse events74
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 | General disorders | Oral Ferric Iron Compound | 12 | 127 | 13 |
| other | Abdominal pain | General disorders | Intravenous Iron | 15 | 120 | 29 |
| other | Nausea | Gastrointestinal disorders | Oral Ferric Iron Compound | 6 | 127 | 8 |
| other | Nausea | Gastrointestinal disorders | Intravenous Iron | 2 | 120 | 5 |
| other | Abdominal pain upper | Gastrointestinal disorders | Oral Ferric Iron Compound | 7 | 127 | 7 |
| other | Abdominal pain upper | Gastrointestinal disorders | Intravenous Iron | 2 | 120 | 2 |
| other | Colitis ulcerative | Gastrointestinal disorders | Oral Ferric Iron Compound | 4 | 127 | 4 |
| other | Colitis ulcerative | Gastrointestinal disorders | Intravenous Iron | 4 | 120 | 4 |
| other | Crohns disease | Gastrointestinal disorders | Oral Ferric Iron Compound | 3 | 127 | 3 |
| other | Crohns disease | Gastrointestinal disorders | Intravenous Iron | 4 | 120 | 5 |
1 to 10 of 74Source ClinicalTrials.gov
See all 74 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Oral Ferric Iron Compound | 1 | 127 |
| Total, all-cause mortality | Intravenous Iron | 0 | 120 |
| Total, other adverse events | Oral Ferric Iron Compound | 75 | 127 |
| Total, other adverse events | Intravenous Iron | 43 | 120 |
| Total, serious adverse events | Oral Ferric Iron Compound | 12 | 127 |
| Total, serious adverse events | Intravenous Iron | 4 | 120 |
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Oral Ferric Iron Compound vs Intravenous Iron: Number of Patients With Treatment-emergent Adverse Events (AEs) | Trial comparisons |
| Oral Ferric Iron Compound vs Intravenous Iron: deaths from any cause | Trial comparisons |
| Oral Ferric Iron Compound vs Intravenous Iron: Number of Patients With Treatment-emergent Serious Adverse Events (SAEs) | Trial comparisons |
| Oral Ferric Iron Compound vs Intravenous Iron: 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/NCT02680756
GET https://conductscience.org/api/trials/v1/NCT02680756/registered?page=2