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Ferric Maltol

DRUG5 trials

Sponsors

Shield Therapeutics, Leiden University Medical Center

Conditions

AnemiaAnemia, Iron-DeficiencyCrohn's DiseaseInflammatory Bowel DiseaseInflammatory Bowel DiseasesIron Deficiency AnemiaIron Deficiency, Anaemia in ChildrenIron-Deficiency

Phase 1

Evaluate the PK, Safety, Tolerability of Ferric Maltol at 3 Dosage Levels in Paediatric Subjects With Iron Deficiency
CompletedNCT03181451
Shield TherapeuticsIron-Deficiency, Iron Deficiency, Anaemia in Children
Start: 2017-03-14End: 2018-03-28Updated: 2021-10-06

Phase 3

Safety and Efficacy Study of Oral Ferric Maltol Compared to Intravenous Iron To Treat Iron Deficiency Anaemia in IBD
CompletedNCT02680756
Shield TherapeuticsAnemia, Iron-Deficiency, Crohn's Disease, Inflammatory Bowel Disease
Start: 2016-01-31End: 2019-01-31Updated: 2020-11-02
Study With Oral Ferric Maltol for the Treatment of Iron Deficiency Anemia in Subjects With Chronic Kidney Disease
CompletedNCT02968368
Shield TherapeuticsIron-Deficiency Anemia, Renal Insufficiency, Chronic
Start: 2016-12-01End: 2018-10-10Updated: 2020-11-02
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
CompletedNCT05126901
Shield TherapeuticsAnemia, Iron-deficiency
Start: 2021-11-03End: 2024-06-09Updated: 2025-11-10

Phase 4

Predicting Response to Iron Supplementation in Patients With Active Inflammatory Bowel Disease
NCT05456932
Leiden University Medical CenterInflammatory Bowel Diseases, Iron-deficiency, Iron Deficiency Anemia
Start: 2022-08-19End: 2023-08-31Target: 90Updated: 2023-03-31

Related Papers

Pharmacokinetics of ferric maltol oral suspension in children and adolescents (1 month to 17 years); A study of iron and maltol metabolism following single and multiple dosing
Blood2025-11-03
Predicting response to iron supplementation in patients with active inflammatory bowel disease (PRIme): a randomised trial protocol
BMJ Open2024-01-017 citations
Oral Ferric Maltol for the Treatment of Iron-Deficiency Anemia in Patients With CKD: A Randomized Trial and Open-Label Extension.
2021-05-2326 citations
Long-Term Effectiveness of Oral Ferric Maltol vs Intravenous Ferric Carboxymaltose for the Treatment of Iron-Deficiency Anemia in Patients With Inflammatory Bowel Disease: A Randomized Controlled Noninferiority Trial
Inflammatory Bowel Diseases2021-05-1430 citations
P420 Comparative efficacy and safety of oral ferric maltol in Inflammatory Bowel Disease patients with mild-to-moderate vs. more severe iron deficiency anaemia
Journal of Crohn s and Colitis2021-05-011 citations