Iron Deficiency Anaemia
Conditions
Brief summary
The purpose of this study is to determine whether Ferric Maltol, an oral ferric iron preparation, is safe and effective in the treatment of iron deficiency anaemia (IDA) in subjects with inflammatory bowel disease (IBD).
Interventions
DRUGFerric Maltol
30 mg capsules to be taken orally twice a day for 12 weeks
DRUGPlacebo Oral Capsule
Matching placebo capsules for Ferric Maltol to be taken orally twice a day for 12 weeks
Sponsors
Jiangsu Aosaikang Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years at the time of signing the informed consent form, male or female; * UC or CD, with a Simple Clinical Colitis Activity Index (SCCAI) score \< 5 or a Crohn's Disease Activity Index (CDAI) score \< 220 at the screening visit; * Anaemia, with Hb levels tested at the screening visit as follows: Hb ≥ 85 g/L and \< 110 g/L for females, Hb ≥ 85 g/L and \< 120 g/L for males; * SIron deficiency, defined as ferritin \< 30 µg/L at the screening visit, or ferritin \< 100 µg/L and transferrin sa
Exclusion criteria
* Anaemia due to any cause other than iron deficiency, including but not limited to: untreated or untreatable severe malabsorption syndrome; * Subjects who have received the following treatments within 12 weeks prior to randomization 1. Blood transfusion 2. Erythropoietin 3. Prolyl hydroxylase inhibitors * Subjects who have received the following treatments within 4 weeks prior to screening 1. Oral/intramuscular/intravenous iron preparations (including sustained-release iron preparations) 2. Immunosuppressants known to induce anaemia, including but not limited to methotrexate, cyclosporine A, or tacrolimus 3. Traditional Chinese medicine prescriptions, herbs, or proprietary Chinese medicines with blood-tonifying effects (with anaemia as an indication in the package insert) * Vitamin B12 or folic acid measured at the screening visit was below the lower limit of normal; * Subjects with known hypersensitivity or allergy to ferric maltol or any component of the investigational medicinal product; * Subjects with known contraindications to iron preparation therapy, such as hemochromatosis, chronic hemolytic disease, sideroblastic anaemia, thalassemia, or lead poisoning-induced anaemia; * Subjects with creatinine \> 1.5 times the upper limit of normal measured at the screening visit; * Subjects with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels ≥ 5 times the upper limit of normal measured at the screening visit; * Subjects with severe cardiovascular, hepatic, renal, hematological, gastrointestinal, immune, endocrine, metabolic, or central nervous system diseases, which in the investigator's opinion might adversely affect the subject's safety and/or the efficacy of the investigational drug; * Subjects with a history of malignancy within the past 5 years, except for excised basal cell carcinoma in situ; * Subjects with significant neurological or psychiatric disorders leading to disorientation, memory impairment, or inability to report accurately, which might interfere with treatment compliance, study conduct, or interpretation of results (e.g., Alzheimer's disease, depression, anxiety, schizophrenia or other psychiatric disorders, alcohol or drug abuse); * Subjects who have participated in another interventional clinical study within 4 weeks prior to randomization or would participate during this study; * Subjects who are inmates of psychiatric hospitals or prisons; * Female subjects who are pregnant or breastfeeding; * Other situations deemed by the investigator as unsuitable for the patient to participate in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Haemoglobin (Hb) Concentration From Baseline to Week 12 | Baseline to Week 12 | Primary efficacy endpoint, defined as the change in Hb concentration from Baseline to Week 12. Baseline was defined as the pre-dose Hb concentration measured at the Randomisation Visit. A mixed-effects model for repeated measures (MMRM) was used for the statistical analysis of the change in Hb from baseline after treatment. The model used the change in Hb from baseline at each post-treatment time point as the dependent variable, baseline Hb as a covariate, treatment group, visit, disease at screening (UC or CD), treatment group × visit interaction, and baseline Hb × visit interaction as fixed effects, and subject as a random effect. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects That Achieved ≥10 g/L Change From Baseline in Hb Concentration at Week 12 | Baseline to Week 12 | Proportion of subjects with an increase in Hb concentration of ≥10 g/L at Week 12 compared to baseline. |
| Proportion of Subjects That Achieved ≥20 g/L Change From Baseline in Hb Concentration at Week 12 | Baseline to Week 12 | Proportion of subjects with an increase in Hb concentration of ≥20 g/L at Week 12 compared to baseline. |
| Proportion of subjects with Hb concentration within the normal range at Week 12 | Baseline to Week 12 | Proportion of subjects with Hb concentration within the normal range at Week 12 compared to baseline. |
| Change in Hb concentration from baseline to Week 4 | Baseline to Week 4 | Defined as the change in Hb concentration from Baseline to Week 4. A mixed-effects model for repeated measures, as used for the primary efficacy endpoint, was employed. |
| Change in Hb concentration from baseline to Week 8 | Baseline to Week 8 | Defined as the change in Hb concentration from Baseline to Week 8. A mixed-effects model for repeated measures, as used for the primary efficacy endpoint, was employed. |
| Change in Serum Iron Concentration From Baseline to Week 12 | Baseline to Week 12 | — |
| Change in Serum Ferritin Concentration From Baseline to Week 12 | Baseline to Week 12 | — |
| Changes in Transferrin From Baseline to Week 12 | Baseline to Week 12 | — |
| Changes in Total Iron-binding Capacity From Baseline to Week 12 | Baseline to Week 12 | — |
| Change in Transferrin Saturation From Baseline to Week 12 | Baseline to Week 12 | — |
| Change in Soluble Transferrin Receptor from Baseline to Week 12 | Baseline to Week 12 | — |
Countries
China
Outcome results
None listed