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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
122
30 mg capsules to be taken orally twice a day for 12 weeks
Matching placebo capsules for Ferric Maltol to be taken orally twice a day for 12 weeks
Jiangsu Aosaikang Pharm
Nanjing, China
Change in Haemoglobin (Hb) Concentration From 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.
Time frame: Baseline to Week 12
Proportion of Subjects That Achieved ≥10 g/L Change From Baseline in Hb Concentration at Week 12
Proportion of subjects with an increase in Hb concentration of ≥10 g/L at Week 12 compared to baseline.
Time frame: Baseline to Week 12
Proportion of Subjects That Achieved ≥20 g/L Change From Baseline in Hb Concentration at Week 12
Proportion of subjects with an increase in Hb concentration of ≥20 g/L at Week 12 compared to baseline.
Time frame: Baseline to Week 12
Proportion of subjects with Hb concentration within the normal range at Week 12
Proportion of subjects with Hb concentration within the normal range at Week 12 compared to baseline.
Time frame: Baseline to Week 12
Change in Hb concentration from 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.
Time frame: Baseline to Week 4
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Change in Hb concentration from 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.
Time frame: Baseline to Week 8
Change in Serum Iron Concentration From Baseline to Week 12
Time frame: Baseline to Week 12
Change in Serum Ferritin Concentration From Baseline to Week 12
Time frame: Baseline to Week 12
Changes in Transferrin From Baseline to Week 12
Time frame: Baseline to Week 12
Changes in Total Iron-binding Capacity From Baseline to Week 12
Time frame: Baseline to Week 12
Change in Transferrin Saturation From Baseline to Week 12
Time frame: Baseline to Week 12
Change in Soluble Transferrin Receptor from Baseline to Week 12
Time frame: Baseline to Week 12