CompletedPhase 3

Safety and Efficacy Study of Ferric Maltol To Treat Iron Deficiency Anaemia in Chinese Patients With Inflammatory Bowel Disease

China122 participantsStarted 2021-09-01

Plain-language 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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. Blood transfusion
. Erythropoietin
. Prolyl hydroxylase inhibitors
. Oral/intramuscular/intravenous iron preparations (including sustained-release iron preparations)
. Immunosuppressants known to induce anaemia, including but not limited to methotrexate, cyclosporine A, or tacrolimus
. Traditional Chinese medicine prescriptions, herbs, or proprietary Chinese medicines with blood-tonifying effects (with anaemia as an indication in the package insert)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Haemoglobin (Hb) Concentration From Baseline to Week 12

Timeframe: Baseline to Week 12

Trial details

NCT IDNCT07739368

SponsorJiangsu Aosaikang Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-02-20

View on ClinicalTrials.gov More Iron Deficiency Anaemia trials