Anemia, Iron-Deficiency, Inflammatory Bowel Disease, Crohn's Disease
Conditions
Keywords
Iron Deficiency, Anaemia, Crohn's Disease, Deficiency Diseases, Inflammatory Bowel Diseases, Intestinal Diseases
Brief summary
The purpose of this study is to compare the efficacy of ferric maltol and intravenous iron (IVI) Ferric Carboxy Maltose in the treatment of iron deficiency anaemia (IDA) and subsequent maintenance of haemoglobin in subjects with Inflammatory Bowel Disease (IBD).
Detailed description
A phase 3b, randomized, controlled, multicentre study with oral ferric maltol or intravenous iron (FCM), for the treatment of iron deficiency anaemia in subjects with inflammatory bowel disease. Approximately 242 eligible subjects will be randomised (1:1) to receive one of the following treatments for the duration of the study treatment period (52 weeks): * Oral ferric maltol, 30 mg capsule bid. * Intravenous iron (ferric carboxy maltose) as per SPC In the FCM arm IV iron treatment will be repeated if the subject is iron deficient at any of the study visits. Subject participation in the study will consist of 3 periods: * Screening: Up to 14 days * Randomised Treatment: 52 weeks * Post-treatment safety follow-up: 14 days after study medication discontinuation Primary efficacy and safety of ferric maltol and Intravenous iron (ferric carboxy maltose) will be evaluated after the first 12 weeks. End of study evaluations will occur at Week 52 or premature discontinuation.
Interventions
Sponsors
Shield Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All of the following criteria must be met to randomize a subject in the study: 1. Subjects must be competent to understand the information given in the Independent Ethics Committee (IEC) or Institutional Review Board (IRB) approved informed consent form and must sign and date the informed consent prior to any study mandated procedure 2. Subjects must be willing and able to comply with study requirements 3. Age ≥ 18 years 4. Subjects must have a confirmed diagnosis of IBD (endoscopic and/or biopsy) 5. Subjects must be considered suitable for intravenous iron treatment by the Investigator 6. Subjects must have iron deficiency anaemia defined by the following criteria: 1. Hb 8.0 g/dL and ≤11.0 g/dL for women OR a Hb 8.0 g/dL and ≤12.0 g/dL for men 2. AND Ferritin \<30ng/ml OR Ferritin \<100 ng/ml WITH Transferrin saturation (TSAT) \<20% 7. Female subjects of childbearing potential (including perimenopausal females who have had a menstrual period within 1 year prior to screening) must agree to use a reliable method of contraception until they have completed the study and for at least 4 weeks following their final study visit. Reliable contraception is defined as a method which results in a low failure rate, i.e., less than 1% per year when used consistently and correctly, such as implants, injectables, some intrauterine contraceptive devices (IUDs), complete sexual abstinence, or a vasectomized partner. Oral contraceptive medications are allowed in this study. Female subjects who are surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) or postmenopausal (defined as no menstrual period within 1 year of screening) are also allowed to participate. A subject who meets any of the following criteria is not eligible for participation in the study. 1. Subject with anaemia due to any cause other than iron deficiency, including, but not limited to: 1. Untreated or untreatable severe malabsorption syndrome 2. Immunosuppressant use. Immunosuppressants are permitted so long as there is no clinical evidence or suspicion of the immunosuppressant contributing to the subject's anaemia or affecting erythropoiesis. Variations to dosing are permitted at the discretion of the investigator so long as there is no clinical evidence or suspicion of the immunosuppressant contributing to the subject's anaemia or affecting erythropoiesis 2. Subject who has received prior to screening: 1. Within 8 weeks intramuscular or intravenous (IV) iron or administration of depot iron preparation 2. Within 2 weeks a blood transfusion 3. Oral iron supplementation, taken specifically to treat anaemia, within the previous 4 weeks (Over the Counter (OTC) multivitamins containing iron are permitted) 3. Subjects with active inflammatory bowel disease as defined by a SCCAI score greater than 5 at Screening or a CDAI score greater than 300 in the Screening period (as assessed using the Screening haematocrit (HCT) and CDAI diary card completed by the subject for 7 days prior to planned randomization). 4. Subjects with known hypersensitivity or allergy to either the active substance or excipients of ferric maltol capsules or ferric carboxymaltose solution for IV administration 5. Subjects who have had serious adverse reactions to previous doses of ferric carboxymaltose or any other intravenous iron. 6. Subjects with contraindication for treatment with iron preparations, e.g. hemochromatosis, chronic hemolytic disease, sideroblastic anaemia, thalassemia, or lead intoxication induced anaemia. 7. Subjects with vitamin B12 or folic acid deficiency as determined by the central laboratory screening results. Subjects may start vitamin B12 or folate replacement and rescreen after at least 2 weeks. 8. Subjects who are pregnant or breast feeding. 9. Concomitant medical conditions with significant active bleeding likely to initiate or prolong anaemia. 10. Participation in any other interventional clinical study within 30 days prior to screening. 11. Subject with cardiovascular, liver, renal, haematologic, gastrointestinal, immunologic, endocrine, metabolic, or central nervous system disease that, in the opinion of the Investigator, may adversely affect the safety of the subject or severely limit the lifespan of the subject (i.e. unlikely to complete the full duration of the study). 12. Subject with significant neurologic or psychiatric symptoms resulting in disorientation, memory impairment, or inability to report accurately that might interfere with treatment compliance, study conduct or interpretation of the results (e.g., Alzheimer's disease, schizophrenia or other psychosis, active or current alcohol or drug abuse) 13. Subject who is an inmate of a psychiatric ward, prison, or other state institution. 14. Subject who is an Investigator or any other team member involved directly or indirectly in the conduct of the clinical study. 15. Subjects with severe renal impairment: creatinine clearance \<30 mL/min. (Applicable to US sites Only)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Hb Concentration From Baseline to Week 4 | Baseline to Week 4 | Change in hemoglobin concentration from baseline to Week 4. |
| Number of Subjects With Baseline Hb Concentration <9.5 g/dL That is Within Normal Limits at Week 4 | Baseline to Week 4 | Number of subjects with baseline Hb concentration \<9.5 g/dL that is within normal limits at Week 4 (normal limit definition: \>=12g/dL women, \>=13g/dL men) |
| Number of Subjects Who Experience a Change From Baseline in Hb Concentration ≥2.0 g/dL at Week 4 | Baseline to Week 4 | Number of subjects who experience a change from baseline in hemoglobin concentration ≥2.0 g/dL at Week 4. |
| Number of Subjects With Baseline Hb <9.5g/dL That Achieve an Increase in Hb Concentration of ≥2 g/dL at Week 4 | Baseline to Week 4 | Number of subjects with baseline hemoglobin \<9.5g/dL that achieve an increase in hemoglobin concentration of ≥2 g/dL at Week 4 |
| Change in Hb Concentration From Baseline to Week 12 | Baseline to Week 12 | Change in hemoglobin concentration from baseline to Week 12. |
| 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. |
| 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. |
| 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. |
| 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) |
| 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) |
| 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) |
| Change in Hb Concentration From Baseline to Week 4 in Subjects With a Baseline Hb <9.5 g/dL | Baseline to Week 4 | Change in hemoglobin concentration from baseline to Week 4 in subjects with a baseline hemoglobin \<9.5 g/dL. |
| Number of Subjects Who Experience a Change From Baseline in Hb Concentration ≥2.0 g/dL at Week 12 | Baseline to Week 12 | Number of subjects who experience a change from baseline in hemoglobin concentration ≥2.0 g/dL at Week 12. |
| Number of Subjects With Baseline Hb <9.5g/dL That Achieve an Increase in Hb Concentration of ≥2 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 ≥2 g/dL at Week 12. |
| Number of Subjects Who Experience a Change From Baseline in Hb Concentration ≥1.0 g/dL at Week 4 | Baseline to Week 4 | Number of subjects who experience a change from baseline in hemoglobin concentration ≥1.0 g/dL at Week 4. |
| Number of Subjects With Baseline Hb <9.5g/dL That Achieve an Increase in Hb Concentration of ≥1 g/dL at Week 4 | Baseline to Week 4 | Number of subjects with baseline hemoglobin \<9.5g/dL that achieve an increase in hemoglobin concentration of ≥1 g/dL at Week 4. |
| Number of Subjects With Hb Concentration Within Normal Limits at Week 4 | Baseline to Week 4 | Number of subjects with Hb concentration within normal limits at Week 4 (normal limit definition: \>=12g/dL women, \>=13g/dL men) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Treatment-emergent Serious Adverse Events (SAEs) | Baseline to Week 52 | Number of Patients with Treatment-emergent Serious Adverse Events (SAEs). |
| Number of Patients With Treatment-emergent Adverse Events (AEs) | Baseline to Week 52 | Number of Patients with Treatment-emergent Adverse Events (AEs). |
| Change From Baseline Physical Component and Mental Component Score | Baseline to Week 52 (LOCF) | A multipurpose, proprietary health survey with 36 questions. It was constructed to survey health status in the Medical Outcomes Study and designed for use in clinical practice and research & general population surveys. The SF-36 includes one multi-item scale that assesses 8 health components: Physical Functioning Component; Social Functioning Component; Role-Physical Component; Bodily Pain Component; Mental Health Component; Role-Emotional Component; Vitality Component; & General Health Component. These 8 health component scales can be further summarised into 2 summary scores, the Mental Component Score & the Physical Component Score where higher values mean a better outcome. Both scales range from 0 to 100, where higher scores indicate better health status. The survey will be administered at study visits as indicated in the schedule of assessments, commencing pre-randomization at Visit 2. The survey will be completed by the subjects in their native language. |
Countries
Belgium, France, Germany, Hungary, Spain, United States
Participant flow
Pre-assignment details
A total of 462 subjects were screened; of these, 212 subjects were not randomised (202 screening failures and 10 not assigned). 250 subjects (54% of the screened population) were randomised: 125 subjects to the ferric maltol group and 125 subjects to the IV iron group.
Participants by arm
| Arm | Count |
|---|---|
| Oral Ferric Iron Compound 30 mg capsules to be taken orally twice a day
Ferric Maltol | 125 |
| Intravenous Iron Administered as per the local SmPC/PI
Ferric Carboxymaltose | 125 |
| Total | 250 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 10 | 2 |
| Overall Study | Blood transfusion for any reason | 0 | 1 |
| Overall Study | Death | 1 | 0 |
| Overall Study | Hb ≤7.5 g/dL | 0 | 2 |
| Overall Study | Lost to Follow-up | 7 | 6 |
| Overall Study | None of above or not recorded | 3 | 2 |
| Overall Study | Physician Decision | 4 | 1 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | TSAT above 60% or a ferritin above 800 m | 1 | 0 |
| Overall Study | Withdrawal by Subject | 5 | 5 |
Baseline characteristics
| Characteristic | Oral Ferric Iron Compound | Intravenous Iron | Total |
|---|---|---|---|
| Age, Continuous | 40.0 years STANDARD_DEVIATION 14.58 | 40.4 years STANDARD_DEVIATION 15.54 | 40.2 years STANDARD_DEVIATION 15.04 |
| Age, Customized Age range | 40.0 years | 40.4 years | 40.2 years |
| Baseline Hb <9.5 g/dL | 38 Participants | 35 Participants | 73 Participants |
| Baseline Hb ≥9.5 g/dL | 87 Participants | 90 Participants | 177 Participants |
| Fertility status (females) Not available | 1 Participants | 1 Participants | 2 Participants |
| Fertility status (females) Post-menopausal | 13 Participants | 16 Participants | 29 Participants |
| Fertility status (females) Potentially fertile | 46 Participants | 54 Participants | 100 Participants |
| Fertility status (females) Sterile | 8 Participants | 6 Participants | 14 Participants |
| IBD subgroup Crohn's disease | 79 Participants | 79 Participants | 158 Participants |
| IBD subgroup Ulcerative colitis | 46 Participants | 46 Participants | 92 Participants |
| Race/Ethnicity, Customized Ethnicity Hispanic or Latino | 15 Participants | 20 Participants | 35 Participants |
| Race/Ethnicity, Customized Ethnicity Not Hispanic or Latino | 99 Participants | 94 Participants | 193 Participants |
| Race/Ethnicity, Customized Ethnicity Not Reported | 8 Participants | 8 Participants | 16 Participants |
| Race/Ethnicity, Customized Ethnicity Unknown | 3 Participants | 3 Participants | 6 Participants |
| Race/Ethnicity, Customized Race American Indian/Alaskan Native | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Asian | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Race Black/African American | 6 Participants | 3 Participants | 9 Participants |
| Race/Ethnicity, Customized Race Native American/Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Other | 8 Participants | 8 Participants | 16 Participants |
| Race/Ethnicity, Customized Race White | 110 Participants | 111 Participants | 221 Participants |
| Screening Hb for randomisation <10 g/dL Female or <11 g/dL Male | 67 Participants | 67 Participants | 134 Participants |
| Screening Hb for randomisation ≥10 g/dL Female or ≥11 g/dL Male | 58 Participants | 58 Participants | 116 Participants |
| Sex: Female, Male Female | 68 Participants | 77 Participants | 145 Participants |
| Sex: Female, Male Male | 57 Participants | 48 Participants | 105 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 127 | 0 / 120 |
| other Total, other adverse events | 75 / 127 | 43 / 120 |
| serious Total, serious adverse events | 12 / 127 | 4 / 120 |
Outcome results
Primary
Number of Subjects Achieving Either a 2g/dL Increase in Hb OR Normalization of Hb at 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
Time frame: Baseline to Week 12
Population: ITT (MI)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Ferric Iron Compound | Number of Subjects Achieving Either a 2g/dL Increase in Hb OR Normalization of Hb at Week 12 | Responder | 84 Participants |
| Oral Ferric Iron Compound | Number of Subjects Achieving Either a 2g/dL Increase in Hb OR Normalization of Hb at Week 12 | Non-responder | 41 Participants |
| Intravenous Iron | Number of Subjects Achieving Either a 2g/dL Increase in Hb OR Normalization of Hb at Week 12 | Responder | 105 Participants |
| Intravenous Iron | Number of Subjects Achieving Either a 2g/dL Increase in Hb OR Normalization of Hb at Week 12 | Non-responder | 20 Participants |
p-value: 0.29895% CI: [-0.28, -0.06]t-test, 2 sided
Primary
Number of Subjects Achieving Either a 2g/dL Increase in Hb OR Normalization of Hb at 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
Time frame: Baseline to Week 12
Population: re-evaluated PP
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Ferric Iron Compound | Number of Subjects Achieving Either a 2g/dL Increase in Hb OR Normalization of Hb at Week 12 | Responder | 53 Participants |
| Oral Ferric Iron Compound | Number of Subjects Achieving Either a 2g/dL Increase in Hb OR Normalization of Hb at Week 12 | Non-responder | 25 Participants |
| Intravenous Iron | Number of Subjects Achieving Either a 2g/dL Increase in Hb OR Normalization of Hb at Week 12 | Responder | 75 Participants |
| Intravenous Iron | Number of Subjects Achieving Either a 2g/dL Increase in Hb OR Normalization of Hb at Week 12 | Non-responder | 13 Participants |
p-value: 0.34195% CI: [-0.3, -0.05]t-test, 2 sided
Secondary
Change in Hb Concentration From Baseline to Week 12
Change in hemoglobin concentration from baseline to Week 12.
Time frame: Baseline to Week 12
Population: ITT (MI)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Ferric Iron Compound | Change in Hb Concentration From Baseline to Week 12 | 2.45 g/dL | Standard Deviation 1.449 |
| Intravenous Iron | Change in Hb Concentration From Baseline to Week 12 | 3.04 g/dL | Standard Deviation 1.576 |
Secondary
Change in Hb Concentration From Baseline to Week 12 in Subjects With a Baseline Hb <9.5 g/dL
Change in hemoglobin concentration from baseline to Week 12 in subjects with a baseline hemoglobin \<9.5 g/dL.
Time frame: Baseline to Week 12
Population: ITT (MI)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Ferric Iron Compound | Change in Hb Concentration From Baseline to Week 12 in Subjects With a Baseline Hb <9.5 g/dL | 2.83 g/dL | Standard Deviation 1.493 |
| Intravenous Iron | Change in Hb Concentration From Baseline to Week 12 in Subjects With a Baseline Hb <9.5 g/dL | 4.18 g/dL | Standard Deviation 1.686 |
Secondary
Change in Hb Concentration From Baseline to Week 4
Change in hemoglobin concentration from baseline to Week 4.
Time frame: Baseline to Week 4
Population: ITT (MI)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Ferric Iron Compound | Change in Hb Concentration From Baseline to Week 4 | 1.27 g/dL | Standard Deviation 0.974 |
| Intravenous Iron | Change in Hb Concentration From Baseline to Week 4 | 2.19 g/dL | Standard Deviation 1.133 |
Secondary
Change in Hb Concentration From Baseline to Week 4 in Subjects With a Baseline Hb <9.5 g/dL
Change in hemoglobin concentration from baseline to Week 4 in subjects with a baseline hemoglobin \<9.5 g/dL.
Time frame: Baseline to Week 4
Population: ITT (MI)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Ferric Iron Compound | Change in Hb Concentration From Baseline to Week 4 in Subjects With a Baseline Hb <9.5 g/dL | 1.35 g/dl | Standard Deviation 0.993 |
| Intravenous Iron | Change in Hb Concentration From Baseline to Week 4 in Subjects With a Baseline Hb <9.5 g/dL | 2.99 g/dl | Standard Deviation 1.092 |
Secondary
Number of Subjects Who Experience a Change From Baseline in Hb Concentration ≥1.0 g/dL at Week 12
Number of subjects who experience a change from baseline in hemoglobin concentration ≥1.0 g/dL at Week 12.
Time frame: Baseline to Week 12
Population: ITT (MI)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Ferric Iron Compound | Number of Subjects Who Experience a Change From Baseline in Hb Concentration ≥1.0 g/dL at Week 12 | Responder | 107 Participants |
| Oral Ferric Iron Compound | Number of Subjects Who Experience a Change From Baseline in Hb Concentration ≥1.0 g/dL at Week 12 | Non-responder | 18 Participants |
| Intravenous Iron | Number of Subjects Who Experience a Change From Baseline in Hb Concentration ≥1.0 g/dL at Week 12 | Responder | 111 Participants |
| Intravenous Iron | Number of Subjects Who Experience a Change From Baseline in Hb Concentration ≥1.0 g/dL at Week 12 | Non-responder | 14 Participants |
Secondary
Number of Subjects Who Experience a Change From Baseline in Hb Concentration ≥1.0 g/dL at Week 4
Number of subjects who experience a change from baseline in hemoglobin concentration ≥1.0 g/dL at Week 4.
Time frame: Baseline to Week 4
Population: ITT (MI)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Ferric Iron Compound | Number of Subjects Who Experience a Change From Baseline in Hb Concentration ≥1.0 g/dL at Week 4 | Non-responder | 50 Participants |
| Oral Ferric Iron Compound | Number of Subjects Who Experience a Change From Baseline in Hb Concentration ≥1.0 g/dL at Week 4 | Responder | 75 Participants |
| Intravenous Iron | Number of Subjects Who Experience a Change From Baseline in Hb Concentration ≥1.0 g/dL at Week 4 | Responder | 105 Participants |
| Intravenous Iron | Number of Subjects Who Experience a Change From Baseline in Hb Concentration ≥1.0 g/dL at Week 4 | Non-responder | 20 Participants |
Secondary
Number of Subjects Who Experience a Change From Baseline in Hb Concentration ≥2.0 g/dL at Week 12
Number of subjects who experience a change from baseline in hemoglobin concentration ≥2.0 g/dL at Week 12.
Time frame: Baseline to Week 12
Population: ITT (MI)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Ferric Iron Compound | Number of Subjects Who Experience a Change From Baseline in Hb Concentration ≥2.0 g/dL at Week 12 | Responder | 76 Participants |
| Oral Ferric Iron Compound | Number of Subjects Who Experience a Change From Baseline in Hb Concentration ≥2.0 g/dL at Week 12 | Non-responder | 49 Participants |
| Intravenous Iron | Number of Subjects Who Experience a Change From Baseline in Hb Concentration ≥2.0 g/dL at Week 12 | Responder | 96 Participants |
| Intravenous Iron | Number of Subjects Who Experience a Change From Baseline in Hb Concentration ≥2.0 g/dL at Week 12 | Non-responder | 29 Participants |
Secondary
Number of Subjects Who Experience a Change From Baseline in Hb Concentration ≥2.0 g/dL at Week 4
Number of subjects who experience a change from baseline in hemoglobin concentration ≥2.0 g/dL at Week 4.
Time frame: Baseline to Week 4
Population: ITT (MI)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Ferric Iron Compound | Number of Subjects Who Experience a Change From Baseline in Hb Concentration ≥2.0 g/dL at Week 4 | Responder | 26 Participants |
| Oral Ferric Iron Compound | Number of Subjects Who Experience a Change From Baseline in Hb Concentration ≥2.0 g/dL at Week 4 | Non-responder | 99 Participants |
| Intravenous Iron | Number of Subjects Who Experience a Change From Baseline in Hb Concentration ≥2.0 g/dL at Week 4 | Responder | 75 Participants |
| Intravenous Iron | Number of Subjects Who Experience a Change From Baseline in Hb Concentration ≥2.0 g/dL at Week 4 | Non-responder | 50 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
Number of subjects with baseline hemoglobin \<9.5g/dL that achieve an increase in hemoglobin concentration of ≥1 g/dL at Week 12.
Time frame: Baseline to Week 12
Population: ITT (MI) Not all subjects were tested.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Ferric Iron Compound | Number of Subjects With Baseline Hb <9.5g/dL That Achieve an Increase in Hb Concentration of ≥1 g/dL at Week 12 | Responder | 35 Participants |
| Oral Ferric Iron Compound | Number of Subjects With Baseline Hb <9.5g/dL That Achieve an Increase in Hb Concentration of ≥1 g/dL at Week 12 | Non-responder | 3 Participants |
| Intravenous Iron | Number of Subjects With Baseline Hb <9.5g/dL That Achieve an Increase in Hb Concentration of ≥1 g/dL at Week 12 | Responder | 32 Participants |
| Intravenous Iron | Number of Subjects With Baseline Hb <9.5g/dL That Achieve an Increase in Hb Concentration of ≥1 g/dL at Week 12 | Non-responder | 3 Participants |
Secondary
Number of Subjects With Baseline Hb <9.5g/dL That Achieve an Increase in Hb Concentration of ≥1 g/dL at Week 4
Number of subjects with baseline hemoglobin \<9.5g/dL that achieve an increase in hemoglobin concentration of ≥1 g/dL at Week 4.
Time frame: Baseline to Week 4
Population: ITT (MI)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Ferric Iron Compound | Number of Subjects With Baseline Hb <9.5g/dL That Achieve an Increase in Hb Concentration of ≥1 g/dL at Week 4 | Responder | 22 Participants |
| Oral Ferric Iron Compound | Number of Subjects With Baseline Hb <9.5g/dL That Achieve an Increase in Hb Concentration of ≥1 g/dL at Week 4 | Non-responder | 14 Participants |
| Intravenous Iron | Number of Subjects With Baseline Hb <9.5g/dL That Achieve an Increase in Hb Concentration of ≥1 g/dL at Week 4 | Responder | 31 Participants |
| Intravenous Iron | Number of Subjects With Baseline Hb <9.5g/dL That Achieve an Increase in Hb Concentration of ≥1 g/dL at Week 4 | Non-responder | 2 Participants |
Secondary
Number of Subjects With Baseline Hb <9.5g/dL That Achieve an Increase in Hb Concentration of ≥2 g/dL at Week 12
Number of subjects with baseline hemoglobin \<9.5g/dL that achieve an increase in hemoglobin concentration of ≥2 g/dL at Week 12.
Time frame: Baseline to Week 12
Population: ITT (MI)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Ferric Iron Compound | Number of Subjects With Baseline Hb <9.5g/dL That Achieve an Increase in Hb Concentration of ≥2 g/dL at Week 12 | Responder | 26 Participants |
| Oral Ferric Iron Compound | Number of Subjects With Baseline Hb <9.5g/dL That Achieve an Increase in Hb Concentration of ≥2 g/dL at Week 12 | Non-responder | 12 Participants |
| Intravenous Iron | Number of Subjects With Baseline Hb <9.5g/dL That Achieve an Increase in Hb Concentration of ≥2 g/dL at Week 12 | Responder | 30 Participants |
| Intravenous Iron | Number of Subjects With Baseline Hb <9.5g/dL That Achieve an Increase in Hb Concentration of ≥2 g/dL at Week 12 | Non-responder | 5 Participants |
Secondary
Number of Subjects With Baseline Hb <9.5g/dL That Achieve an Increase in Hb Concentration of ≥2 g/dL at Week 4
Number of subjects with baseline hemoglobin \<9.5g/dL that achieve an increase in hemoglobin concentration of ≥2 g/dL at Week 4
Time frame: Baseline to Week 4
Population: ITT (MI)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Ferric Iron Compound | Number of Subjects With Baseline Hb <9.5g/dL That Achieve an Increase in Hb Concentration of ≥2 g/dL at Week 4 | Responder | 5 Participants |
| Oral Ferric Iron Compound | Number of Subjects With Baseline Hb <9.5g/dL That Achieve an Increase in Hb Concentration of ≥2 g/dL at Week 4 | Non-responder | 33 Participants |
| Intravenous Iron | Number of Subjects With Baseline Hb <9.5g/dL That Achieve an Increase in Hb Concentration of ≥2 g/dL at Week 4 | Non-responder | 7 Participants |
| Intravenous Iron | Number of Subjects With Baseline Hb <9.5g/dL That Achieve an Increase in Hb Concentration of ≥2 g/dL at Week 4 | Responder | 28 Participants |
Secondary
Number of Subjects With Baseline Hb Concentration <9.5 g/dL That is Within Normal Limits at 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)
Time frame: Baseline to Week 12
Population: ITT (MI)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Ferric Iron Compound | Number of Subjects With Baseline Hb Concentration <9.5 g/dL That is Within Normal Limits at Week 12 | Responder | 12 Participants |
| Oral Ferric Iron Compound | Number of Subjects With Baseline Hb Concentration <9.5 g/dL That is Within Normal Limits at Week 12 | Non-responder | 26 Participants |
| Intravenous Iron | Number of Subjects With Baseline Hb Concentration <9.5 g/dL That is Within Normal Limits at Week 12 | Responder | 28 Participants |
| Intravenous Iron | Number of Subjects With Baseline Hb Concentration <9.5 g/dL That is Within Normal Limits at Week 12 | Non-responder | 7 Participants |
Secondary
Number of Subjects With Baseline Hb Concentration <9.5 g/dL That is Within Normal Limits at Week 4
Number of subjects with baseline Hb concentration \<9.5 g/dL that is within normal limits at Week 4 (normal limit definition: \>=12g/dL women, \>=13g/dL men)
Time frame: Baseline to Week 4
Population: ITT (MI)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Ferric Iron Compound | Number of Subjects With Baseline Hb Concentration <9.5 g/dL That is Within Normal Limits at Week 4 | Responder | 2 Participants |
| Oral Ferric Iron Compound | Number of Subjects With Baseline Hb Concentration <9.5 g/dL That is Within Normal Limits at Week 4 | Non-responder | 36 Participants |
| Intravenous Iron | Number of Subjects With Baseline Hb Concentration <9.5 g/dL That is Within Normal Limits at Week 4 | Responder | 15 Participants |
| Intravenous Iron | Number of Subjects With Baseline Hb Concentration <9.5 g/dL That is Within Normal Limits at Week 4 | Non-responder | 20 Participants |
Secondary
Number of Subjects With Hb Concentration Within Normal Limits at Week 12
Number of subjects with Hb concentration within normal limits at Week 12 (normal limit definition: \>=12g/dL women, \>=13g/dL men)
Time frame: Baseline to Week 12
Population: ITT (MI)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Ferric Iron Compound | Number of Subjects With Hb Concentration Within Normal Limits at Week 12 | Responder | 69 Participants |
| Oral Ferric Iron Compound | Number of Subjects With Hb Concentration Within Normal Limits at Week 12 | Non-responder | 56 Participants |
| Intravenous Iron | Number of Subjects With Hb Concentration Within Normal Limits at Week 12 | Responder | 101 Participants |
| Intravenous Iron | Number of Subjects With Hb Concentration Within Normal Limits at Week 12 | Non-responder | 24 Participants |
Secondary
Number of Subjects With Hb Concentration Within Normal Limits at Week 4
Number of subjects with Hb concentration within normal limits at Week 4 (normal limit definition: \>=12g/dL women, \>=13g/dL men)
Time frame: Baseline to Week 4
Population: ITT (MI)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Ferric Iron Compound | Number of Subjects With Hb Concentration Within Normal Limits at Week 4 | Responder | 31 Participants |
| Oral Ferric Iron Compound | Number of Subjects With Hb Concentration Within Normal Limits at Week 4 | Non-responder | 94 Participants |
| Intravenous Iron | Number of Subjects With Hb Concentration Within Normal Limits at Week 4 | Responder | 60 Participants |
| Intravenous Iron | Number of Subjects With Hb Concentration Within Normal Limits at Week 4 | Non-responder | 65 Participants |
Secondary
Proportion of Subjects Who Are Non-anaemic at 6 Months and 12 Months
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)
Time frame: Baseline to Month 6
Population: ITT (OC) Not all subjects were tested.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Oral Ferric Iron Compound | Proportion of Subjects Who Are Non-anaemic at 6 Months and 12 Months | week 24 | Non-anaemic | 52 Participants |
| Oral Ferric Iron Compound | Proportion of Subjects Who Are Non-anaemic at 6 Months and 12 Months | week 24 | Anaemic | 28 Participants |
| Oral Ferric Iron Compound | Proportion of Subjects Who Are Non-anaemic at 6 Months and 12 Months | week 52 | Non-anaemic | 37 Participants |
| Oral Ferric Iron Compound | Proportion of Subjects Who Are Non-anaemic at 6 Months and 12 Months | week 52 | Anaemic | 24 Participants |
| Intravenous Iron | Proportion of Subjects Who Are Non-anaemic at 6 Months and 12 Months | week 52 | Anaemic | 20 Participants |
| Intravenous Iron | Proportion of Subjects Who Are Non-anaemic at 6 Months and 12 Months | week 24 | Non-anaemic | 58 Participants |
| Intravenous Iron | Proportion of Subjects Who Are Non-anaemic at 6 Months and 12 Months | week 52 | Non-anaemic | 36 Participants |
| Intravenous Iron | Proportion of Subjects Who Are Non-anaemic at 6 Months and 12 Months | week 24 | Anaemic | 27 Participants |
Other Pre-specified
Change From Baseline Physical Component and Mental Component Score
A multipurpose, proprietary health survey with 36 questions. It was constructed to survey health status in the Medical Outcomes Study and designed for use in clinical practice and research & general population surveys. The SF-36 includes one multi-item scale that assesses 8 health components: Physical Functioning Component; Social Functioning Component; Role-Physical Component; Bodily Pain Component; Mental Health Component; Role-Emotional Component; Vitality Component; & General Health Component. These 8 health component scales can be further summarised into 2 summary scores, the Mental Component Score & the Physical Component Score where higher values mean a better outcome. Both scales range from 0 to 100, where higher scores indicate better health status. The survey will be administered at study visits as indicated in the schedule of assessments, commencing pre-randomization at Visit 2. The survey will be completed by the subjects in their native language.
Time frame: Baseline to Week 52 (LOCF)
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Ferric Iron Compound | Change From Baseline Physical Component and Mental Component Score | Physical component score | 3.0 score on a scale | Standard Deviation 7.62 |
| Oral Ferric Iron Compound | Change From Baseline Physical Component and Mental Component Score | Mental component score | 3.3 score on a scale | Standard Deviation 8.32 |
| Intravenous Iron | Change From Baseline Physical Component and Mental Component Score | Physical component score | 2.5 score on a scale | Standard Deviation 7.52 |
| Intravenous Iron | Change From Baseline Physical Component and Mental Component Score | Mental component score | 2.6 score on a scale | Standard Deviation 7.6 |
Other Pre-specified
Number of Patients With Treatment-emergent Adverse Events (AEs)
Number of Patients with Treatment-emergent Adverse Events (AEs).
Time frame: Baseline to Week 52
Population: 3 subjects were randomised to IV iron but were given ferric maltol in error.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oral Ferric Iron Compound | Number of Patients With Treatment-emergent Adverse Events (AEs) | 75 Participants |
| Intravenous Iron | Number of Patients With Treatment-emergent Adverse Events (AEs) | 43 Participants |
Other Pre-specified
Number of Patients With Treatment-emergent Serious Adverse Events (SAEs)
Number of Patients with Treatment-emergent Serious Adverse Events (SAEs).
Time frame: Baseline to Week 52
Population: 3 subjects were randomised to IV iron but were given ferric maltol in error.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oral Ferric Iron Compound | Number of Patients With Treatment-emergent Serious Adverse Events (SAEs) | 9 Participants |
| Intravenous Iron | Number of Patients With Treatment-emergent Serious Adverse Events (SAEs) | 3 Participants |