Safety and Efficacy Study of Oral Ferric Maltol Compared to Intravenous Iron To Treat Iron Deficiency Anaemia in IBD
Condition: Anemia, Iron-Deficiency; Inflammatory Bowel Disease; Crohn's Disease
MeSH terms: Crohn Disease; Intestinal Diseases; Inflammatory Bowel Diseases; Anemia; Anemia, Iron-Deficiency; Iron Deficiencies
Intervention: Ferric Maltol; Ferric Carboxy Maltose
Intervention MeSH terms: Ferric maltol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 250.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Iron Deficiency; Anaemia; Crohn's Disease; Deficiency Diseases; Inflammatory Bowel Diseases; Intestinal Diseases

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).
    

Eligibility 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)