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Iron Supplement

Ferric Maltol for Anemia (FORTIS Trial)

Phase 3
Recruiting
Research Sponsored by Shield Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥1 month and ≤17 years at the time of informed consent
Female subjects of childbearing potential must agree to use a highly effective method of contraception until study completion and for at least 4 weeks following their final study visit. Highly effective contraception is defined as a method with a low failure rate, such as implants, injectables, some intrauterine contraceptive devices (IUDs), a vasectomised partner, and oral contraceptive medications.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

FORTIS Trial Summary

This trial is testing if a new form of iron supplement is safe and tolerated by children aged 1 month to 17 years old with iron deficiency anaemia.

Who is the study for?
This trial is for children and adolescents aged 1 month to 17 years with iron deficiency anemia, as confirmed by specific blood tests. Adolescents must agree to use effective contraception if applicable. Exclusions include other causes of anemia, certain medical treatments or conditions that affect iron absorption or utilization, active infections requiring antibiotics, and known allergies to the study drugs.Check my eligibility
What is being tested?
The trial aims to compare the safety and gastrointestinal effects of two oral iron supplements: ferric maltol suspension versus ferrous sulfate liquid in treating iron deficiency anemia over a period of 12 weeks. It includes a single-arm study focusing on infants aged between 1 month and less than 2 years.See study design
What are the potential side effects?
Potential side effects may include gastrointestinal discomfort such as stomach pain, constipation or diarrhea, nausea, vomiting; allergic reactions; changes in stool color; teeth staining (in liquid forms); headache; dizziness; or skin rash.

FORTIS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 1 month and 17 years old.
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I will use effective birth control during and 4 weeks after the study.
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I have low iron and hemoglobin levels according to recent tests.

FORTIS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Hemoglobin
Suspending Agents
Secondary outcome measures
Assess the PK in children and adolescents aged 2 to 17 years
Assess the PK, in children aged 1 month to less than 2 years of age
Assess the effect, in children aged 1 month to less than 2 years of age
+2 more

Side effects data

From 2019 Phase 3 trial • 250 Patients • NCT02680756
31%
Gastrointestinal disorders
23%
Infections and infestations
9%
Abdominal pain
9%
Skin and subcutaneous tissue disorders
8%
Nasopharyngitis
7%
Nervous system disorders
7%
Musculoskeletal and connective tissue disorders
7%
General disorders and administration site conditions
6%
Injury, poisoning and procedural complications
6%
Abdominal pain upper
5%
Nausea
5%
Diarrhoea
4%
Constipation
4%
Investigations
3%
Faeces discoloured
3%
Flatulence
3%
Colitis ulcerative
3%
Respiratory, thoracic and mediastinal disorders
3%
Psychiatric disorders
3%
Metabolism and nutrition disorders
3%
Arthralgia
3%
Headache
2%
Cardiac disorders
2%
Crohns disease
2%
Urinary tract infection
2%
Eye disorders
2%
Asthenia
1%
Blood and lymphatic system disorders
1%
Vomiting
1%
Upper respiratory tract infection
1%
Pyrexia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Oral Ferric Iron Compound
Intravenous Iron

FORTIS Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: 2 to 17 year old subjects - Ferric MaltolExperimental Treatment1 Intervention
Subjects aged 2-17 will be randomised 1:1 to receive ferric maltol oral suspension or ferrous sulfate oral liquid. The first 12 subjects randomised to ferric maltol in each age sub-group (2 - 9 yrs, 10 - 17 yrs respectively) will enter a PK phase with 2 PK days. Following PK Day 2 subjects will continue until Week 12. Once the 18 subjects in each age subgroup have finished their PK visits, they will continue until week 12. Ferrous sulfate 125 mg/ml (25 mg elemental iron) or equivalent dose will be used for all children/adolescents. To maximise the iron replenishment for subjects within this group as well; aged 2 - 17 yrs will be dosed 6 mg/kg to the maximum of 4 ml BID. Subjects randomised to ferrous sulfate oral liquid will not need to complete the PK period.
Group II: 1 month to 2 year old subjects (infants)Experimental Treatment1 Intervention
Subjects aged 1 month to less than 2 years will enter a Pre-assignment phase: baseline urine samples are collected and subjects will take a single dose of 0.1 ml/kg ferric maltol suspension. Further 3 samples up to 12h will be taken. Subjects showing evidence of absorption, metabolism and elimination of maltol will enter the treatment phase and be assigned to the ferric maltol arm. The first 6 subjects screened will perform the pre-assignment PK phase. After review by the investigator, and medical monitors , if Maltol Glucuronide is shown to be adequately eliminated, timepoint 20-24 hrs (+ 4hrs) will not be performed on subsequent subjects. Subjects will be assigned to receive ferric maltol oral suspension and start the 0.1 ml/kg BID dose on V2 and continue for 7-10 days. On V3 they will perform the same PK assessments as on Pre-assignment PK visit.
Group III: 2 to 17 year old subjects - Ferrous SulfateActive Control1 Intervention
Subjects aged 2-17 will be randomised 1:1 to receive ferric maltol oral suspension or ferrous sulfate oral liquid. Ferrous sulfate 125 mg/ml (25 mg elemental iron) or equivalent dose will be used for all children/adolescents. To maximise the iron replenishment for subjects within this group as well; aged 2 - 17 yrs will be dosed 6 mg/kg to the maximum of 4 ml BID. Subjects randomised to ferrous sulfate oral liquid will not need to complete the PK period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ferric maltol
FDA approved

Find a Location

Who is running the clinical trial?

Shield TherapeuticsLead Sponsor
8 Previous Clinical Trials
852 Total Patients Enrolled
5 Trials studying Anemia
732 Patients Enrolled for Anemia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What conditions does Ferric Maltol commonly help with?

"Ferric Maltol can improve folic acid levels in patients and also treat hypochromic anemia, iron deficiency anemia, and help breastfeeding women."

Answered by AI

Does this research project seek out participants who are 50 years or older?

"This trial is seeking young patients that are between 1 month and 17 years old."

Answered by AI

Are medical professionals still needed for this research project?

"That is correct, the study is still looking for volunteers. According to the clinicaltrials.gov website, the clinical trial was posted on October 4th, 2021 and was last edited on November 8th, 2021. The trial is looking for a total of 110 participants from 10 different locations."

Answered by AI

Has Ferric Maltol completed the FDA's approval process?

"Ferric Maltol's safety is supported by some efficacy data and multiple rounds of safety testing, so it was given a 3."

Answered by AI

Are there any previous examples of Ferric Maltol being used in a clinical setting?

"As of right now, there are a total of 14 ongoing clinical trials investigating the efficacy of Ferric Maltol. 6 of those trials are in their final stage, Phase 3. The majority of the trials are taking place in Galveston, Texas; however, there are 42 locations across the United States running these studies."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Recent research and studies
clinicaltrials.govStudy
Evaluate the Safety and Efficacy of Ferric Maltol Oral Suspension vs. Ferrous Sulfate Oral Liquid in Children and Adolescents Aged 2 to 17 Years With Iron-deficiency Anaemia, With a Single Arm Study in Infants Aged 1 Month to Less Than 2 Years
2021. "Evaluate the Safety and Efficacy of Ferric Maltol Oral Suspension vs. Ferrous Sulfate Oral Liquid in Children and Adolescents Aged 2 to 17 Years With Iron-deficiency Anaemia, With a Single Arm Study in Infants Aged 1 Month to Less Than 2 Years". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05126901.
All > Anemia
~28 spots leftby Apr 2025
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