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Ferric Maltol for Iron-Deficiency Anemia

Miami Clinical Research, Miami, FL
Iron-Deficiency Anemia+1 More ConditionsFerric Maltol - Drug
Eligibility
1 - 17
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Iron-Deficiency Anemia
  • Anemia

Treatment Effectiveness

Phase-Based Effectiveness

2 of 3
Phase 3
This is further along than 85% of similar trials

Similar Trials

1
Healthy individuals - post-iron
1
Coaching
1
CLENPIQ

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: 12 weeks

12 weeks
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
Hemoglobin
Assess the effect, in children aged 1 month to less than 2 years of age
Assess the effect, in children aged 2 to 17
Suspending Agents
Suspending Agents

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
Healthy individuals - post-iron
1
Coaching
1
CLENPIQ

Side Effects for

Oral Ferric Iron Compound
31%Gastrointestinal disorders
23%Infections and infestations
9%Skin and subcutaneous tissue disorders
9%Abdominal pain
8%Nasopharyngitis
7%General disorders and administration site conditions
7%Nervous system disorders
7%Musculoskeletal and connective tissue disorders
6%Abdominal pain upper
6%Injury, poisoning and procedural complications
5%Nausea
5%Diarrhoea
4%Constipation
4%Investigations
3%Psychiatric disorders
3%Colitis ulcerative
3%Metabolism and nutrition disorders
3%Respiratory, thoracic and mediastinal disorders
3%Headache
3%Faeces discoloured
3%Flatulence
3%Arthralgia
2%Urinary tract infection
2%Cardiac disorders
2%Crohns disease
2%Eye disorders
2%Asthenia
1%Pyrexia
1%Blood and lymphatic system disorders
1%Upper respiratory tract infection
1%Vomiting
This histogram enumerates side effects from a completed 2019 Phase 3 trial (NCT02680756) in the Oral Ferric Iron Compound ARM group. Side effects include: Gastrointestinal disorders with 31%, Infections and infestations with 23%, Skin and subcutaneous tissue disorders with 9%, Abdominal pain with 9%, Nasopharyngitis with 8%.

Awards & Highlights

Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

3 Treatment Groups

2 to 17 year old subjects - Ferrous Sulfate
1 of 3
1 month to 2 year old subjects (infants)
1 of 3
2 to 17 year old subjects - Ferric Maltol
1 of 3

Active Control

Experimental Treatment

110 Total Participants · 3 Treatment Groups

Primary Treatment: Ferric Maltol · No Placebo Group · Phase 3

1 month to 2 year old subjects (infants)
Drug
Experimental Group · 1 Intervention: Ferric Maltol · Intervention Types: Drug
2 to 17 year old subjects - Ferric Maltol
Drug
Experimental Group · 1 Intervention: Ferric Maltol · Intervention Types: Drug
2 to 17 year old subjects - Ferrous Sulfate
Drug
ActiveComparator Group · 1 Intervention: Ferrous sulfate · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ferric maltol
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 weeks

Who is running the clinical trial?

Shield TherapeuticsLead Sponsor
8 Previous Clinical Trials
852 Total Patients Enrolled

Eligibility Criteria

Age 1 - 17 · All Participants · 0 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Who else is applying?

What state do they live in?
North Carolina100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
Why did patients apply to this trial?
  • "I attempted over three years to participate in multiple protein-related CKD studies, but after labs, I was considered too healthy to proceed."
How many prior treatments have patients received?
0100.0%
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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