Safety and Efficacy Study of Oral Ferric Maltol Compared to Intravenous Iron To Treat Iron Deficiency Anaemia in IBD

NCT02680756 | Completed Phase 3 Results

• 1 other identifier: ST10-01-304
• Study Type: interventional
• Target: 250
• Locations: 6 countries
• Sites: 44

Brief Summary

The purpose of this study is to compare the efficacy of ferric maltol and intravenous iron (IVI) Ferric Carboxy Maltose in the treatment of iron deficiency anaemia (IDA) and subsequent maintenance of haemoglobin in subjects with Inflammatory Bowel Disease (IBD).

Conditions

Anemia, Iron-Deficiency; Inflammatory Bowel Disease; Crohn's Disease

Keywords

Iron Deficiency; Anaemia; Crohn's Disease; Deficiency Diseases; Inflammatory Bowel Diseases; Intestinal Diseases

Outcome Measures

Primary Outcomes (2)

• Number of Subjects Achieving Either a 2g/dL Increase in Hb OR Normalization of Hb at Week 12

  Number of subjects achieving either a 2g/dL increase in Hb OR normalization of Hb (\>=12g/dL women,\>=13g/dL men) at Week 12

  Baseline to Week 12

• Number of Subjects Achieving Either a 2g/dL Increase in Hb OR Normalization of Hb at Week 12

  Number of subjects achieving either a 2g/dL increase in Hb OR normalization of Hb (\>=12g/dL women, \>=13g/dL men) at Week 12

  Baseline to Week 12

Secondary Outcomes (17)

• Change in Hb Concentration From Baseline to Week 12

  Baseline to Week 12

• Change in Hb Concentration From Baseline to Week 12 in Subjects With a Baseline Hb <9.5 g/dL

  Baseline to Week 12

• Number of Subjects Who Experience a Change From Baseline in Hb Concentration ≥1.0 g/dL at Week 12

  Baseline to Week 12

• Number of Subjects With Baseline Hb <9.5g/dL That Achieve an Increase in Hb Concentration of ≥1 g/dL at Week 12

  Baseline to Week 12

• Number of Subjects With Hb Concentration Within Normal Limits at Week 12

  Baseline to Week 12

Other Outcomes (3)

• Change From Baseline Physical Component and Mental Component Score

  Baseline to Week 52 (LOCF)

• Number of Patients With Treatment-emergent Adverse Events (AEs)

  Baseline to Week 52

• Number of Patients With Treatment-emergent Serious Adverse Events (SAEs)

  Baseline to Week 52

Study Arms (2)

Oral ferric iron compound

EXPERIMENTAL

30 mg capsules to be taken orally twice a day for 52 weeks

Drug: Ferric Maltol

Intravenous iron

ACTIVE COMPARATOR

Administered as per the local summary of product characteristics (SPC)

Drug: Ferric Carboxy Maltose

Interventions

Ferric Maltol DRUG

Also known as: Feraccru, Ferric Trimaltol, ST10, ST10-01

Oral ferric iron compound

Ferric Carboxy Maltose DRUG

Intravenous iron

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

All of the following criteria must be met to randomize a subject in the study: 1. Subjects must be competent to understand the information given in the Independent Ethics Committee (IEC) or Institutional Review Board (IRB) approved informed consent form and must sign and date the informed consent prior to any study mandated procedure 2. Subjects must be willing and able to comply with study requirements 3. Age ≥ 18 years 4. Subjects must have a confirmed diagnosis of IBD (endoscopic and/or biopsy) 5. Subjects must be considered suitable for intravenous iron treatment by the Investigator 6. Subjects must have iron deficiency anaemia defined by the following criteria: 1. Hb 8.0 g/dL and ≤11.0 g/dL for women OR a Hb 8.0 g/dL and ≤12.0 g/dL for men 2. AND Ferritin \<30ng/ml OR Ferritin \<100 ng/ml WITH Transferrin saturation (TSAT) \<20% 7. Female subjects of childbearing potential (including perimenopausal females who have had a menstrual period within 1 year prior to screening) must agree to use a reliable method of contraception until they have completed the study and for at least 4 weeks following their final study visit. Reliable contraception is defined as a method which results in a low failure rate, i.e., less than 1% per year when used consistently and correctly, such as implants, injectables, some intrauterine contraceptive devices (IUDs), complete sexual abstinence, or a vasectomized partner. Oral contraceptive medications are allowed in this study. Female subjects who are surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) or postmenopausal (defined as no menstrual period within 1 year of screening) are also allowed to participate. A subject who meets any of the following criteria is not eligible for participation in the study. 1. Subject with anaemia due to any cause other than iron deficiency, including, but not limited to: 1. Untreated or untreatable severe malabsorption syndrome 2. Immunosuppressant use. Immunosuppressants are permitted so long as there is no clinical evidence or suspicion of the immunosuppressant contributing to the subject's anaemia or affecting erythropoiesis. Variations to dosing are permitted at the discretion of the investigator so long as there is no clinical evidence or suspicion of the immunosuppressant contributing to the subject's anaemia or affecting erythropoiesis 2. Subject who has received prior to screening: 1. Within 8 weeks intramuscular or intravenous (IV) iron or administration of depot iron preparation 2. Within 2 weeks a blood transfusion 3. Oral iron supplementation, taken specifically to treat anaemia, within the previous 4 weeks (Over the Counter (OTC) multivitamins containing iron are permitted) 3. Subjects with active inflammatory bowel disease as defined by a SCCAI score greater than 5 at Screening or a CDAI score greater than 300 in the Screening period (as assessed using the Screening haematocrit (HCT) and CDAI diary card completed by the subject for 7 days prior to planned randomization). 4. Subjects with known hypersensitivity or allergy to either the active substance or excipients of ferric maltol capsules or ferric carboxymaltose solution for IV administration 5. Subjects who have had serious adverse reactions to previous doses of ferric carboxymaltose or any other intravenous iron. 6. Subjects with contraindication for treatment with iron preparations, e.g. hemochromatosis, chronic hemolytic disease, sideroblastic anaemia, thalassemia, or lead intoxication induced anaemia. 7. Subjects with vitamin B12 or folic acid deficiency as determined by the central laboratory screening results. Subjects may start vitamin B12 or folate replacement and rescreen after at least 2 weeks. 8. Subjects who are pregnant or breast feeding. 9. Concomitant medical conditions with significant active bleeding likely to initiate or prolong anaemia. 10. Participation in any other interventional clinical study within 30 days prior to screening. 11. Subject with cardiovascular, liver, renal, haematologic, gastrointestinal, immunologic, endocrine, metabolic, or central nervous system disease that, in the opinion of the Investigator, may adversely affect the safety of the subject or severely limit the lifespan of the subject (i.e. unlikely to complete the full duration of the study). 12. Subject with significant neurologic or psychiatric symptoms resulting in disorientation, memory impairment, or inability to report accurately that might interfere with treatment compliance, study conduct or interpretation of the results (e.g., Alzheimer's disease, schizophrenia or other psychosis, active or current alcohol or drug abuse) 13. Subject who is an inmate of a psychiatric ward, prison, or other state institution. 14. Subject who is an Investigator or any other team member involved directly or indirectly in the conduct of the clinical study. 15. Subjects with severe renal impairment: creatinine clearance \<30 mL/min. (Applicable to US sites Only)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Shield Therapeutics: lead

Study Sites (44)

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Dothan, Alabama, United States

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Tucson, Arizona, United States

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Gainesville, Florida, United States

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Hollywood, Florida, United States

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Chevy Chase, Maryland, United States

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Saint Paul, Minnesota, United States

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St Louis, Missouri, United States

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Great Neck, New York, United States

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Lima, Ohio, United States

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Germantown, Tennessee, United States

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Nashville, Tennessee, United States

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Beaumont, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Bountiful, Utah, United States

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Bellevue, Washington, United States

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Seattle, Washington, United States

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Ghent, Belgium

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Clichy, France

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Lille, France

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Lyon, France

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Saint-Etienne, France

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Salouël, France

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Vandœuvre-lès-Nancy, France

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Berlin, Germany

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Dresden, Germany

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Hamburg, Germany

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Herne, Germany

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Jena, Germany

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Leipzig, Germany

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Lübeck, Germany

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Lüneburg, Germany

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Minden, Germany

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Oldenburg, Germany

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Schweinfurt, Germany

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Budapest, Hungary

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Miskolc, Hungary

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Szeged, Hungary

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Barcelona, Spain

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Córdoba, Spain

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Girona, Spain

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Madrid, Spain

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Santiago de Compostela, Spain

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Valencia, Spain

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MeSH Terms

Conditions

Anemia, Iron-Deficiency; Inflammatory Bowel Diseases; Crohn Disease; Iron Deficiencies; Anemia; Deficiency Diseases; Intestinal Diseases

Interventions

ferric maltol; ferric trimaltol

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Malnutrition; Nutrition Disorders

Results Point of Contact

• Title: Jackie Mitchell MA DPhil
• Organization: Shield Therapeutics

jmitchell@shieldtx.com

0044 752 565 6885

Study Officials

• Jackie Mitchell, PhD

  Shield Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2016
• First Posted: February 11, 2016
• Study Start: January 1, 2016
• Primary Completion: October 1, 2018
• Study Completion: January 1, 2019
• Last Updated: November 2, 2020
• Results First Posted: February 24, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); ES (6); FR (6); DE (11); US (17); HU (3)