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

Phase 3

Completed

• Conditions: Anemia, Iron-Deficiency; Crohn's Disease; Inflammatory Bowel Disease
• Interventions: Drug: Ferric Carboxy Maltose; Drug: Ferric Maltol

• Registration Number: NCT02680756
• Lead Sponsor: Shield Therapeutics

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).

Detailed Description

A phase 3b, randomized, controlled, multicentre study with oral ferric maltol or intravenous iron (FCM), for the treatment of iron deficiency anaemia in subjects with inflammatory bowel disease.

Approximately 242 eligible subjects will be randomised (1:1) to receive one of the following treatments for the duration of the study treatment period (52 weeks):

* Oral ferric maltol, 30 mg capsule bid.

* Intravenous iron (ferric carboxy maltose) as per SPC

In the FCM arm IV iron treatment will be repeated if the subject is iron deficient at any of the study visits.

Subject participation in the study will consist of 3 periods:

* Screening: Up to 14 days

* Randomised Treatment: 52 weeks

* Post-treatment safety follow-up: 14 days after study medication discontinuation

Primary efficacy and safety of ferric maltol and Intravenous iron (ferric carboxy maltose) will be evaluated after the first 12 weeks.

End of study evaluations will occur at Week 52 or premature discontinuation.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-02-09
• Study First Submitted QC: 2016-02-09
• Study First Posted: 2016-02-11
• Primary Completion: 2018-10
• Study Completion: 2019-01
• Results First Submitted: 2019-11-19
• Results First Submitted QC: 2020-02-11
• Results First Posted: 2020-02-24
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-28
• Last Update Posted: 2020-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intravenous iron	Ferric Carboxy Maltose	Administered as per the local summary of product characteristics (SPC)
Oral ferric iron compound	Ferric Maltol	30 mg capsules to be taken orally twice a day for 52 weeks

Primary Outcome Measures

Name	Time	Method
Number of Subjects Achieving Either a 2g/dL Increase in Hb OR Normalization of Hb at Week 12	Baseline to 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

Secondary Outcome Measures

Name	Time	Method
Change in Hb Concentration From Baseline to Week 12 in Subjects With a Baseline Hb <9.5 g/dL	Baseline to Week 12	Change in hemoglobin concentration from baseline to Week 12 in subjects with a baseline hemoglobin \<9.5 g/dL.
Proportion of Subjects Who Are Non-anaemic at 6 Months and 12 Months	Baseline to Month 6	Long term efficacy endpoints i.e. proportion of subjects who are non-anaemic at 6 months and 12 months (normal limit definition: \>=12g/dL women, \>=13g/dL men)
Change in Hb Concentration From Baseline to Week 12	Baseline to Week 12	Change in hemoglobin concentration from 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 who experience a change from baseline in hemoglobin concentration ≥1.0 g/dL at 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 baseline hemoglobin \<9.5g/dL that achieve an increase in hemoglobin concentration of ≥1 g/dL at Week 12.
Change in Hb Concentration From Baseline to Week 4	Baseline to Week 4	Change in hemoglobin concentration from baseline to Week 4.
Number of Subjects With Hb Concentration Within Normal Limits at Week 12	Baseline to Week 12	Number of subjects with Hb concentration within normal limits at Week 12 (normal limit definition: \>=12g/dL women, \>=13g/dL men)
Number of Subjects With Baseline Hb Concentration <9.5 g/dL That is Within Normal Limits at Week 12	Baseline to Week 12	Number of subjects with baseline Hb concentration \<9.5 g/dL that is within normal limits at Week 12 (normal limit definition: \>=12g/dL women, \>=13g/dL men)
Change in Hb Concentration From Baseline to Week 4 in Subjects With a Baseline Hb <9.5 g/dL	Baseline to Week 4	Change in hemoglobin concentration from baseline to Week 4 in subjects with a baseline hemoglobin \<9.5 g/dL.
Number of Subjects With Baseline Hb <9.5g/dL That Achieve an Increase in Hb Concentration of ≥2 g/dL at Week 12	Baseline to Week 12	Number of subjects with baseline hemoglobin \<9.5g/dL that achieve an increase in hemoglobin concentration of ≥2 g/dL at Week 12.
Number of Subjects With Baseline Hb <9.5g/dL That Achieve an Increase in Hb Concentration of ≥1 g/dL at Week 4	Baseline to Week 4	Number of subjects with baseline hemoglobin \<9.5g/dL that achieve an increase in hemoglobin concentration of ≥1 g/dL at Week 4.
Number of Subjects With Baseline Hb Concentration <9.5 g/dL That is Within Normal Limits at Week 4	Baseline to Week 4	Number of subjects with baseline Hb concentration \<9.5 g/dL that is within normal limits at Week 4 (normal limit definition: \>=12g/dL women, \>=13g/dL men)
Number of Subjects With Baseline Hb <9.5g/dL That Achieve an Increase in Hb Concentration of ≥2 g/dL at Week 4	Baseline to Week 4	Number of subjects with baseline hemoglobin \<9.5g/dL that achieve an increase in hemoglobin concentration of ≥2 g/dL at Week 4
Number of Subjects With Hb Concentration Within Normal Limits at Week 4	Baseline to Week 4	Number of subjects with Hb concentration within normal limits at Week 4 (normal limit definition: \>=12g/dL women, \>=13g/dL men)
Number of Subjects Who Experience a Change From Baseline in Hb Concentration ≥2.0 g/dL at Week 12	Baseline to Week 12	Number of subjects who experience a change from baseline in hemoglobin concentration ≥2.0 g/dL at Week 12.
Number of Subjects Who Experience a Change From Baseline in Hb Concentration ≥1.0 g/dL at Week 4	Baseline to Week 4	Number of subjects who experience a change from baseline in hemoglobin concentration ≥1.0 g/dL at Week 4.
Number of Subjects Who Experience a Change From Baseline in Hb Concentration ≥2.0 g/dL at Week 4	Baseline to Week 4	Number of subjects who experience a change from baseline in hemoglobin concentration ≥2.0 g/dL at Week 4.