A study of an iron medication for treatment of anaemia (low number of healthy blood cells) in people with inflammatory bowel disease (inflammation of all or part of digestive tract)

Phase 1

• Conditions: Iron deficiency anaemia with inflammatory bowel disease; MedDRA version: 18.1Level: PTClassification code 10022972Term: Iron deficiency anaemiaSystem Organ Class: 10005329 - Blood and lymphatic system disorders; MedDRA version: 18.1Level: LLTClassification code 10002062Term: Anaemia iron deficiencySystem Organ Class: 10005329 - Blood and lymphatic system disorders; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2015-002496-26-BE
• Lead Sponsor: Iron Therapeutics (UK) Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-10-07
• Study Completion: 2019-01-02
• Last Update Posted: 4 January 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

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 intolerant of oral ferrous products, or considered not suitable for oral ferrous products, and would be considered by the Investigator suitable for intravenous iron treatment
6. Subjects must have iron deficiency anaemia defined by the following
criteria:
a. 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
b. AND Ferritin <30 ng/ml or Ferritin <100 ng/ml WITH Transferrin saturation (TSAT) <20%.
7. Female subject 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 study completion 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 210
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

1. Subject with anaemia due to any cause other than iron deficiency, including, but not limited to,
a. Untreated or untreatable severe malabsorption syndrome
b. Immunosuppressant use. Immunosuppressants taken at a stable dose for 3 months prior to
randomisation and expected to stay stable throughout the study treatment period are permitted so
long as there is no clinical evidence or suspicion of the immunosuppressant contributing to the
subject’s anaemia.
2. Subject who has received prior to screening
a. Within 8 weeks intramuscular or intravenous (IV) injection or
administration of depot iron preparation
b. Within 2 weeks a blood transfusion
c. 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. Subject 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 FCM.
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 results and the clinical opinion of the investigator. Subjects may start vitamin B12 or folate replacement and rescreen after 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, hematologic, 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the efficacy of ferric maltol and intravenous iron (FCM) in the treatment and maintenance of iron deficiency anaemia in subjects with IBD in whom other oral iron therapies have failed.;Secondary Objective: To evaluate the safety and tolerability of ferric maltol and IVI in subjects over a treatment duration of 52 weeks.<br>To evaluate long-term healthcare resources utilized in the management of IDA in IBD.;Primary end point(s): Number of subjects achieving either a 2g/dL increase in<br>Hb OR normalization of Hb (>12g/dL women, >13g/dL men) at week 12;Timepoint(s) of evaluation of this end point: Baseline, week 12