A randomized, double-blind, three-arm, placebo/active-controlled, multicenter clinical trial to evaluate the efficacy and safety of Ferrous Maltol Capsules in patients with inflammatory bowel disease complicated by iron deficiency anemia

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2026
INTERVENTION: Placebo Group:Placebo;Positive Control Group:Ferric maltol capsules (brand name: Feraccru);Trial Group:Ferric maltol capsules; CONDITION: Inflammatory bowel disease, IBD PRIMARY OUTCOME: Change from baseline in hemoglobin at 12 weeks; SECONDARY OUTCOME: Change from baseline in hemoglobin at 4 and 8 weeks;Proportion of subjects with hemoglobin increase >=10 g/L at week 12;Proportion of subjects with hemoglobin increase >=20 g/L at week 12;Proportion of subjects with hemoglobin within normal range at week 12;Change from baseline in iron metabolism parameters (serum iron, serum ferritin, transferrin saturation) at weeks 4, 8, and 12; INCLUSION CRITERIA: 1. Age 18 years or older (including 18 years), gender not restricted; 2. Current diagnosis of quiescent inflammatory bowel disease (including ulcerative colitis or Crohn's disease) accompanied by iron deficiency anemia, and meeting the following diagnostic criteria: (1) Quiescent ulcerative colitis is defined as a Simple Clinical Colitis Activity Inde X(SCCAI) score <4 points measured at screening. Quiescent Crohn's disease is defined as a Crohn's Disease Activity Inde X(CDAI) score <220 points measured at screening; (2) Anemia is defined as hemoglobin measured at screening: 90 g/L <= females <110 g/L, 90 g/L <= males <120 g/L; (3) Presence of iron deficiency, defined as serum ferritin <30 µg/L measured at screening, or serum ferritin <100 µg/L and transferrin saturation <20%; 3. Patients receiving protocol‐allowed immunosuppressant therapy at screening must have been on a stable dose for at least 4 weeks prior to randomization: (1) Allowed immunos
Epistemonikos ID: a473c0151ba4f7944dff796a078fdc780ef592b8
First added on: Oct 08, 2026