Predicting the effect of iron therapy in Inflammatory Bowel Disease

Predicting Response to Iron Supplementation in Patients with active Inflammatory Bowel Disease - PRIme

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-000894-16-NL

Enrollment

Registered

2022-03-21

Start date

2022-05-04

Completion date

Unknown

Last updated

2025-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Bowel Disease MedDRA version: 20.0 Level: PT Classification code 10022972 Term: Iron deficiency anaemia System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 20.0 Level: PT Classification code 10022970 Term: Iron deficiency System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 20.1 Level: PT Classification code 10021972 Term: Inflammatory bowel disease System Organ Class: 10017947 - Gastrointestinal disorders

Interventions

Trade Name: Feraccru Pharmaceutical Form: Capsule, hard INN or Proposed INN: FERRIC MALTOL CAS Number: 33725-54-1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 30

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Established IBD diagnosis (Crohn's disease, ulcerative colitis, IBD-unclassified) - Adults (=18 years of age) - Active IBD (defined as biochemical activity C-reactive protein >5 mg/L and/or fecal calprotectin >150 mg/kg or as any endoscopic or radiologic disease activity) - Iron deficiency anemia (defined as ferritin =65 years) no F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: - Blood transfusion or therapy with oral and/or intravenous iron in the past eight weeks - Documented intolerance to oral or intravenous iron - Severe anemia (defined as hemoglobin 100 fL + Hb <7.5 mmol/L for females or Hb <8.5 mmol/L for males). - Documented pregnancy or breastfeeding at the time of inclusion - Documented major operation (e.g., laparotomy) less than six weeks before inclusion - Unable to give informed consent due to inability to understand Dutch language or incapacitation (e.g., due to cognitive/psychological conditions or hospitalization in Intensive Care)

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate whether hepcidin levels at baseline can predict response to iron therapy: a. ferrous fumarate, b. ferric maltol, c. intravenous iron ;Secondary Objective: - Change in hepcidin, inflammation- and hypoxia-associated cytokines from baseline to weeks 6, 14, and 24 in all of the three groups. - Percentage of patients who achieved normalization of iron stores at weeks 6, 14, and 24 in all of the three groups. - The correlation of disease activity and response to iron therapy in all of the three groups. - Percentage of patients who experienced hypophosphatemia throughout iron therapy in all of the three groups. - (S)AEs and adverse reactions in all of the three groups. - Change in mHI, SF-36, WPAI from baseline to weeks 14 and 24 in all of the three groups. - Percentage of patients who achieved an adequate hematologic response or hemoglobin normalization at weeks 14 and 24 in all of the three groups. - Percentage of patients who experienced a =0.6 mmol/l change in hemoglobin from baseline to weeks 6 and 14 in all of the three groups. ;Primary end point(s): The discriminative capacity of hepcidin level at baseline to differentiate between response and non-reponse to iron therapy at week 14.;Timepoint(s) of evaluation of this end point: Week 14 of the study	—

Measure

Time frame

Main Objective: To evaluate whether hepcidin levels at baseline can predict response to iron therapy: a. ferrous fumarate, b. ferric maltol, c. intravenous iron ;Secondary Objective: - Change in hepcidin, inflammation- and hypoxia-associated cytokines from baseline to weeks 6, 14, and 24 in all of the three groups. - Percentage of patients who achieved normalization of iron stores at weeks 6, 14, and 24 in all of the three groups. - The correlation of disease activity and response to iron therapy in all of the three groups. - Percentage of patients who experienced hypophosphatemia throughout iron therapy in all of the three groups. - (S)AEs and adverse reactions in all of the three groups. - Change in mHI, SF-36, WPAI from baseline to weeks 14 and 24 in all of the three groups. - Percentage of patients who achieved an adequate hematologic response or hemoglobin normalization at weeks 14 and 24 in all of the three groups. - Percentage of patients who experienced a =0.6 mmol/l change in hemoglobin from baseline to weeks 6 and 14 in all of the three groups. ;Primary end point(s): The discriminative capacity of hepcidin level at baseline to differentiate between response and non-reponse to iron therapy at week 14.;Timepoint(s) of evaluation of this end point: Week 14 of the study

—

Secondary

Measure	Time frame
Secondary end point(s): - Change in hepcidin and inflammation- or hypoxia-associated cytokines from baseline to T6w, T14w, T24w - Number of patients (ferritin >100 mcg/L)at T6w, T14w, and T24w - Association between disease acitivty and response to iron therapy - Incidence of hypophosphatemia at any time post-baseline to T24w - Change in quality of life (SF-36), work productivity (WPAI) and IBD-clinical activity (mHI) from baseline to T14w, T24w - Number and type of (serious) adverse events - Number of patients with 0.6 mmol/L increase in HB from baseline to T6w, T14w - Number of patients who experienced =1.2 mmol/L increase or normalization of hemoglobin from baseline to T14w, T24w;Timepoint(s) of evaluation of this end point: Refer to section E.5.2.	—

Measure

Time frame

Secondary end point(s): - Change in hepcidin and inflammation- or hypoxia-associated cytokines from baseline to T6w, T14w, T24w - Number of patients (ferritin >100 mcg/L)at T6w, T14w, and T24w - Association between disease acitivty and response to iron therapy - Incidence of hypophosphatemia at any time post-baseline to T24w - Change in quality of life (SF-36), work productivity (WPAI) and IBD-clinical activity (mHI) from baseline to T14w, T24w - Number and type of (serious) adverse events - Number of patients with 0.6 mmol/L increase in HB from baseline to T6w, T14w - Number of patients who experienced =1.2 mmol/L increase or normalization of hemoglobin from baseline to T14w, T24w;Timepoint(s) of evaluation of this end point: Refer to section E.5.2.

—

Countries

Netherlands

Contacts

Public ContactA.E. van der Meulen - de Jong

Leiden University Medical Center

ae.meulen@lumc.nl0031715263507

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026