Iron Deficiency AnaemiaPhase 3NCT07739368
Safety and Efficacy Study of Ferric Maltol To Treat Iron Deficiency Anaemia in Chinese Patients With Inflammatory Bowel Disease
A Phase 3 study testing Ferric Maltol in people with Iron Deficiency Anaemia, run by Jiangsu Aosaikang Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iron Deficiency Anaemia
- What is being tested?
- Ferric Maltol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2021to 20 Mar 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years at the time of signing the informed consent form, male or female;
- UC or CD, with a Simple Clinical Colitis Activity Index (SCCAI) score < 5 or a Crohn's Disease Activity Index (CDAI) score < 220 at the screening visit;
- Anaemia, with Hb levels tested at the screening visit as follows: Hb ≥ 85 g/L and < 110 g/L for females, Hb ≥ 85 g/L and < 120 g/L for males;
- SIron deficiency, defined as ferritin < 30 µg/L at the screening visit, or ferritin < 100 µg/L and transferrin sa
Who cannot join
- Anaemia due to any cause other than iron deficiency, including but not limited to: untreated or untreatable severe malabsorption syndrome;
- Subjects who have received the following treatments within 12 weeks prior to randomization
- Blood transfusion
- Erythropoietin
- Prolyl hydroxylase inhibitors
- Subjects who have received the following treatments within 4 weeks prior to screening
Show all 21Show fewer
- 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)
- Vitamin B12 or folic acid measured at the screening visit was below the lower limit of normal;
- Subjects with known hypersensitivity or allergy to ferric maltol or any component of the investigational medicinal product;
- Subjects with known contraindications to iron preparation therapy, such as hemochromatosis, chronic hemolytic disease, sideroblastic anaemia, thalassemia, or lead poisoning-induced anaemia;
- Subjects with creatinine > 1.5 times the upper limit of normal measured at the screening visit;
- Subjects with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels ≥ 5 times the upper limit of normal measured at the screening visit;
- Subjects with severe cardiovascular, hepatic, renal, hematological, gastrointestinal, immune, endocrine, metabolic, or central nervous system diseases, which in the investigator's opinion might adversely affect the subject's safety and/or the efficacy of the investigational drug;
- Subjects with a history of malignancy within the past 5 years, except for excised basal cell carcinoma in situ;
- Subjects with significant neurological or psychiatric disorders leading to disorientation, memory impairment, or inability to report accurately, which might interfere with treatment compliance, study conduct, or interpretation of results (e.g., Alzheimer's disease, depression, anxiety, schizophrenia or other psychiatric disorders, alcohol or drug abuse);
- Subjects who have participated in another interventional clinical study within 4 weeks prior to randomization or would participate during this study;
- Subjects who are inmates of psychiatric hospitals or prisons;
- Female subjects who are pregnant or breastfeeding;
- Other situations deemed by the investigator as unsuitable for the patient to participate in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial With Ferric Maltol Capsules for the Treatment of Iron Deficiency Anemia in Subjects With Inflammatory Bowel Disease and Refractory/Intolerant to Oral Ferrous Preparations
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).
- Conditions
- Iron Deficiency Anaemia
- Being tested
- Ferric Maltol, Placebo Oral Capsule
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferric MaltolDrug
30 mg capsules to be taken orally twice a day for 12 weeks
Placebo Oral CapsuleDrug
Matching placebo capsules for Ferric Maltol to be taken orally twice a day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Ferric Maltol | Active comparator | 30mg capsules, taken orally twice a day Receives: Drug: Ferric Maltol |
| Matching placebo capsules for Ferric Maltol | Placebo comparator | taken orally twice a day Receives: Drug: Placebo Oral Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 12
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to Week 4
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.
Measured: Baseline to Week 8
Change in Serum Iron Concentration From Baseline to Week 12
Measured: Baseline to Week 12
Change in Serum Ferritin Concentration From Baseline to Week 12
Measured: Baseline to Week 12
Changes in Transferrin From Baseline to Week 12
Measured: Baseline to Week 12
Changes in Total Iron-binding Capacity From Baseline to Week 12
Measured: Baseline to Week 12
Change in Transferrin Saturation From Baseline to Week 12
Measured: Baseline to Week 12
Change in Soluble Transferrin Receptor from Baseline to Week 12
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start1 Sep 2021
- Primary completion20 Feb 2025
- Study completion20 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency AnaemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Aosaikang Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07739368
- Sponsor's protocol ID
- ASK109-LC-1
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial With Ferric Maltol Capsules for the Treatment of Iron Deficiency Anemia in Subjects With Inflammatory Bowel Disease and Refractory/Intolerant to Oral Ferrous Preparations
- ClinicalTrials.gov ID
- NCT07739368
- Acronym / sponsor ID
- ASK109-LC-1
- Conditions
- Iron Deficiency Anaemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Jiangsu Aosaikang Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 20 Feb 2025 (actual)
- Study completion
- 20 Mar 2025 (actual)
- First posted
- 31 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ferric Maltol | Active comparator | Drug: Ferric Maltol30mg capsules, taken orally twice a day |
| Matching placebo capsules for Ferric Maltol | Placebo comparator | Drug: Placebo Oral Capsuletaken orally twice a day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years at the time of signing the informed consent form, male or female;
- UC or CD, with a Simple Clinical Colitis Activity Index (SCCAI) score < 5 or a Crohn's Disease Activity Index (CDAI) score < 220 at the screening visit;
- Anaemia, with Hb levels tested at the screening visit as follows: Hb ≥ 85 g/L and < 110 g/L for females, Hb ≥ 85 g/L and < 120 g/L for males;
- SIron deficiency, defined as ferritin < 30 µg/L at the screening visit, or ferritin < 100 µg/L and transferrin sa
Key exclusion criteria (21 listed)
- Anaemia due to any cause other than iron deficiency, including but not limited to: untreated or untreatable severe malabsorption syndrome;
- Subjects who have received the following treatments within 12 weeks prior to randomization
- Subjects who have received the following treatments within 4 weeks prior to screening
- Vitamin B12 or folic acid measured at the screening visit was below the lower limit of normal;
- Subjects with known hypersensitivity or allergy to ferric maltol or any component of the investigational medicinal product;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferric Maltol30 mg capsules to be taken orally twice a day for 12 weeks | Drug | Ferric Maltol |
| Placebo Oral CapsuleMatching placebo capsules for Ferric Maltol to be taken orally twice a day for 12 weeks | Drug | Matching placebo capsules for Ferric Maltol |
Primary outcome
Change in Haemoglobin (Hb) Concentration From Baseline to Week 12
Time frame: 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.
11 secondary outcomes
Proportion of Subjects That Achieved ≥10 g/L Change From Baseline in Hb Concentration at Week 12
Time frame: Baseline to Week 12
Proportion of Subjects That Achieved ≥20 g/L Change From Baseline in Hb Concentration at Week 12
Time frame: Baseline to Week 12
Proportion of subjects with Hb concentration within the normal range at Week 12
Time frame: Baseline to Week 12
Change in Hb concentration from baseline to Week 4
Time frame: Baseline to Week 4
Change in Hb concentration from baseline to Week 8
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Iron Deficiency Anaemia
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life
Heart Failure With Preserved Ejection Fraction, Iron Deficiencies
Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
RecruitingPhase 4
The Effects of Low-Dose Versus High-Dose Intravenous IRON Therapy With Ferric DerisomaltOSE in Patients With Chronic Heart Failure and Iron Deficiency
Heart Failure, Iron Deficiency
Enrolling by invitationObservational study
Long-term Impacts of Psychosocial Stimulation and Iron Supplementation
Iron Deficiency Anemia, Parenting Intervention
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ferric Maltol in people with Iron Deficiency Anaemia, run by Jiangsu Aosaikang Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Haemoglobin (Hb) Concentration From Baseline to Week 12 (time frame: Baseline to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.