Inflammatory Bowel DiseasesPhase 4PRImeNCT05456932

Predicting Response to Iron Supplementation in Patients With Active Inflammatory Bowel Disease

A Phase 4 study testing Intravenous iron, Ferric maltol and Ferrous fumarate in people with Inflammatory Bowel Diseases and Iron-deficiency, run by Leiden University Medical Center at 5 sites in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Inflammatory Bowel Diseases, Iron-deficiency, Iron Deficiency Anemia
What is being tested?: Intravenous iron, Ferric maltol and Ferrous fumarate
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 90 participants
Where: 5 sitesNetherlands
Study dates: 19 Aug 2022to 31 Aug 2023
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Established IBD diagnosis (Crohn's disease, ulcerative colitis, IBD-unclassified)
Adults (≥18 years of age)
Active IBD (defined as any endoscopic, radiologic or biochemical disease activity [fecal calprotectin >150 mg/kg or C-reactive protein >5 mg/l])
Iron deficiency anemia (defined as ferritin <100 ug/l and hemoglobin <7.5 mmol/l for females or <8.5 mmol/l for males) or iron deficiency (defined as ferritin <100 ug/l and transferrin saturation <20%)
Documented informed consent

Who cannot join

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 <6.2 mmol/l for females and males)
Documented history of liver cirrhosis, heart failure, hemoglobinopathies, autoimmune hemolytic anemia, myelodysplastic syndrome, or chronic obstructive pulmonary disease
Documented history of recent treatment for a malignancy (excluding dermatological malignancies such as basal cell carcinoma or squamous cell carcinoma). Patients can be included if the treatment for malignancy has been finalized ≥6 months before the inclusion date.
Documented history of bariatric surgery or gastric/duodenal resections due to benign or malignant pathologies

Show all 12Show fewer

End-stage renal disease (impaired renal function, defined as estimated Glomerular Filtration Rate (eGFR) <30 ml/min/1.73m2)
Folic acid deficiency
Vitamin B12 deficiency
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)

Trial locations and contacts

5 sites in 1 country.

R. Loveikyte, MD contact

00315297902

patientenibd@lumc.nl

City, postcode or hospital

Sites recruiting now only

5 sites in 1 country

Netherlands5 sites, 5 recruiting

Amsterdam University Medical Center
Amsterdam
R. Loveikyte, MD
R.L. Goetgebuer, MD, PhD
Recruiting
University Medical Center Groningen
Groningen
R. Loveikyte, MD
G. Dijkstra, MD, PhD
Recruiting
Leiden University Medical Center (LUMC)
Leiden
R. Loveikyte, MD
A.E. van der Meulen - de Jong, MD, PhD
Recruiting
Maastricht University Medical Center+
Maastricht
R. Loveikyte, MD
Z Mujagic, MD, PhD
Recruiting
Radboud University Medical Center
Nijmegen
R. Loveikyte, MD
M. Duijvestein, MD, PhD
Recruiting

Other trials in Netherlands

About this study

Iron deficiency anemia is the most common systemic manifestation of Inflammatory Bowel Diseases (IBD)-Crohn's disease and ulcerative colitis. Iron deficiency with or without anemia poses a diagnostic and therapeutic challenge due to chronic gastrointestinal blood loss and the inflammatory nature of IBD. Recent illumination of iron metabolism has brought attention to the systemic iron regulator-hepcidin, a peptide hormone that regulates intestinal iron absorption and systemic iron availability. Elevated hepcidin is associated with oral iron malabsorption in IBD. This study aims to evaluate whether hepcidin concentration at baseline can predict response to oral and intravenous iron therapy in patients with IBD and concomitant iron deficiency with or without anemia.

Read the detailed description

The PRIme is a multicenter and randomized study that aims to evaluate the capacity of hepcidin at baseline to predict response to oral or intravenous iron therapy in patients with active IBD. Study participants will be randomized and allocated (open-label) to one of the three study arms: intravenous iron therapy, therapy with oral ferrous fumarate, or therapy with oral ferric maltol.

During the study, biochemical indices such as hemoglobin, iron status, hepcidin and related cytokines will be measured at week 6, 14, and 24 after the start of the therapy. In addition, the study will evaluate changes in oxidative stress, quality of live, and productivity.

Conditions: Inflammatory Bowel Diseases, Iron-deficiency, Iron Deficiency Anemia
Being tested: Intravenous iron, Ferric maltol, Ferrous fumarate
Keywords: IBD, Crohn's disease, Ulcerative colitis, Inflammatory Bowel Disease, Iron deficiency, Iron deficiency anemia
Medical subject headings: Inflammatory Bowel Diseases, Anemia, Iron-Deficiency, Crohn Disease, Colitis, Ulcerative, Iron Deficiencies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Intravenous ironDrug
Also called i.v. iron
Included participants will receive intravenous iron therapy, the dosage will be based on national pharmaceutical formulary.
Ferric maltolDrug
Also called Feraccru
Included participants will receive oral iron therapy with ferric maltol (twice a day 30mg for 12 weeks)
Ferrous fumarateDrug
Also called ferrofumaraat
Included participants will receive oral iron therapy with ferrous fumarate (twice a day 100mg for 12 weeks)

Study groups in NCT05456932
Study group	Role	What they receive
Intravenous iron	Experimental	Intravenous iron therapy Receives: Drug: Intravenous iron
Ferric maltol	Experimental	Treatment with oral ferric maltol Receives: Drug: Ferric maltol
Ferrous fumarate	Experimental	Treatment with oral ferrous fumarate Receives: Drug: Ferrous fumarate

What is being measured

The primary outcome is the main question the study is designed to answer.

The discriminative capacity of hepcidin at baseline to differentiate between response and non-response to iron therapy with oral ferrous fumarate
Hepcidin concentration will be measured in blood at baseline. Receiver Operating Characteristic (ROC) curve with associated Area Under the Curve (AUC) will be used to evaluate the discriminative ability of hepcidin concentration at baseline to differentiate between response and non-response to iron therapy with ferrous fumarate. Response to iron therapy will be evaluated at week 14 and will be defined as hemoglobin normalization (or >1.2 mmol/L increase) for patients with iron-deficiency anemia; for patients with non-anemic iron deficiency the response will be defined as normalization of iron stores (i.e., ferritin >100 ug/L and transferrin saturation >20%).
Measured: Week 14
The discriminative capacity of hepcidin at baseline to differentiate between response and non-response to iron therapy with oral ferric maltol
Hepcidin concentration will be measured in blood at baseline. Receiver Operating Characteristic (ROC) curve with associated Area Under the Curve (AUC) will be used to evaluate the discriminative ability of hepcidin concentration at baseline to differentiate between response and non-response to iron therapy with ferric maltol. Response to iron therapy will be evaluated at week 14 and will be defined as hemoglobin normalization (or >1.2 mmol/L increase) for patients with iron-deficiency anemia; for patients with non-anemic iron deficiency the response will be defined as normalization of iron stores (i.e., ferritin >100 ug/L and transferrin saturation >20%).
Measured: Week 14
The discriminative capacity of hepcidin at baseline to differentiate between response and non-response to intravenous iron therapy
Hepcidin concentration will be measured in blood at baseline. Receiver Operating Characteristic (ROC) curve with associated Area Under the Curve (AUC) will be used to evaluate the discriminative ability of hepcidin concentration at baseline to differentiate between response and non-response to intravenous iron therapy. Response to iron therapy will be evaluated at week 14 and will be defined as hemoglobin normalization (or >1.2 mmol/L increase) for patients with iron-deficiency anemia; for patients with non-anemic iron deficiency the response will be defined as normalization of iron stores (i.e., ferritin >100 ug/L and transferrin saturation >20%).
Measured: Week 14

Secondary outcomes (12)

Change in hepcidin
Change in hepcidin levels from baseline to weeks 6, 14, and 24 in all of the three groups
Measured: weeks 6, 14, and 24
Change in soluble Transferrin Receptor (sTfR)
Change in soluble Transferrin Receptor (sTfR) levels from baseline to weeks 6, 14, and 24 in all of the three groups.
Measured: weeks 6, 14, and 24
Change in interleukin 6 (IL-6)
Change in interleukin 6 (IL-6) levels from baseline to weeks 6, 14, and 24 in all of the three groups.
Measured: weeks 6, 14, and 24
Normalization of iron stores
Percentage of patients who achieve normalization of iron stores (an increase in transferrin saturation (transferrin saturation >20%) and an increase in ferritin above 100 ug/l) at weeks 6, 14, and 24 in all of the three groups.
Measured: weeks 6, 14, and 24
Correlation between response to iron therapy and disease activity
The correlation of disease activity (evaluated by fecal calprotectin levels) and response to iron therapy in all of the three groups.
Measured: week 14
Incidence of hypophosphatemia during iron therapy
Percentage of patients who experienced hypophosphatemia throughout iron therapy in all of the three groups
Measured: weeks 6, 14, and 24
Adverse events during iron therapy
Number of (serious) adverse events in all of the three groups.
Measured: weeks 6, 14, and 24
Change in clinical disease activity
Change in clinical disease activity (measured by mobile Health Index (mHI) 0-24 for patients with Crohn's disease and 0-34 for patients with ulcerative colitis; higher scores indicate a more active disease) from baseline to week 14, and week 24 in all of the three groups.
Measured: weeks 14 and 24
Change in quality of life
Change in quality of life (measured by 36-item Short Form Survey (SF-36) expressed on a scale 0-100 where higher scores indicate less disability and better quality of life) from baseline to week 14, and week 24 in all of the three groups.
Measured: weeks 14 and 24
Change in activity and productivity
Change in activity and productivity (measured by Work Productivity and Activity Impairment: Inflammatory Bowel Disease (WPAI:IBD) expressed as 0-100% where higher percentages indicate greater impairment) from baseline to week 14, and week 24 in all of the three groups.
Measured: weeks 14 and 24
Hematologic response during iron therapy
Percentage of patients who achieved an adequate hematologic response (defined by hemoglobin increase >1.2 mmol/L or hemoglobin normalization) at weeks 14 and 24 in all of the three groups.
Measured: weeks 14 and 24
Hemoglobin increase (>0.6 mmol/L) during iron therapy
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.
Measured: weeks 6 and 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Aug 202231 Aug 2023

First posted13 Jul 2022
Study start19 Aug 2022
Primary completion31 Aug 2023 (estimated)
Study completion31 Aug 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 90 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05456932
Sponsor's protocol ID: NL79105.058.22
Other IDs: 2022-000894-16
Acronym: PRIme
Status last verified: Mar 2023
First submitted: 10 May 2022
Last updated: 31 Mar 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Koppelman LJM, Loveikyte R, Goetgebuer RL, van der Marel S, de Vries AC, Dijkstra G, van der Meulen-de Jong AE; Dutch Iron Study Group. Clinical Trial: Predicting Response to Iron Therapy in Patients With Active Inflammatory Bowel Disease Using Hepcidin and Functional Iron Indices: A Multicentre Randomised Trial. Aliment Pharmacol Ther. 2026 Jul;64(2):166-176. doi: 10.1111/apt.70775. Epub 2026 Jun 8.
PubMed 42261111
Loveikyte R, Duijvestein M, Mujagic Z, Goetgebuer RL, Dijkstra G, van der Meulen-de Jong AE. Predicting response to iron supplementation in patients with active inflammatory bowel disease (PRIme): a randomised trial protocol. BMJ Open. 2024 Jan 30;14(1):e077511. doi: 10.1136/bmjopen-2023-077511.
PubMed 38296290

Want to know more?

R. Loveikyte, MD

00315297902

patientenibd@lumc.nl

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Inflammatory Bowel Diseases trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Predicting Response to Iron Supplementation in Patients With Active Inflammatory Bowel Disease
ClinicalTrials.gov ID: NCT05456932
Acronym / sponsor ID: PRIme / NL79105.058.22
Conditions: Inflammatory Bowel Diseases, Iron-deficiency, Iron Deficiency Anemia
Keywords: IBD, Crohn's disease, Ulcerative colitis, Inflammatory Bowel Disease, Iron deficiency, Iron deficiency anemia
Phase: Phase 4
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 90 participants (estimated)
Lead sponsor: Leiden University Medical CenterUniversity, hospital or other
Collaborators: University Medical Center Groningen, Radboud University Medical Center, Maastricht University Medical Center, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study start: 19 Aug 2022 (actual)
Primary completion: 31 Aug 2023 (estimated)
Study completion: 31 Aug 2023 (estimated)
First posted: 13 Jul 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Intravenous iron	Experimental	Drug: Intravenous ironIntravenous iron therapy
Ferric maltol	Experimental	Drug: Ferric maltolTreatment with oral ferric maltol
Ferrous fumarate	Experimental	Drug: Ferrous fumarateTreatment with oral ferrous fumarate

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Established IBD diagnosis (Crohn's disease, ulcerative colitis, IBD-unclassified)
Adults (≥18 years of age)
Active IBD (defined as any endoscopic, radiologic or biochemical disease activity [fecal calprotectin >150 mg/kg or C-reactive protein >5 mg/l])
Iron deficiency anemia (defined as ferritin <100 ug/l and hemoglobin <7.5 mmol/l for females or <8.5 mmol/l for males) or iron deficiency (defined as ferritin <100 ug/l and transferrin saturation <20%)
Documented informed consent

Key exclusion criteria (12 listed)

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 <6.2 mmol/l for females and males)
Documented history of liver cirrhosis, heart failure, hemoglobinopathies, autoimmune hemolytic anemia, myelodysplastic syndrome, or chronic obstructive pulmonary disease
Documented history of recent treatment for a malignancy (excluding dermatological malignancies such as basal cell carcinoma or squamous cell carcinoma). Patients can be included if the treatment for malignancy has been finalized ≥6 months before the inclusion date.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Intravenous ironAlso: i.v. ironIncluded participants will receive intravenous iron therapy, the dosage will be based on national pharmaceutical formulary.	Drug	Intravenous iron
Ferric maltolAlso: FeraccruIncluded participants will receive oral iron therapy with ferric maltol (twice a day 30mg for 12 weeks)	Drug	Ferric maltol
Ferrous fumarateAlso: ferrofumaraatIncluded participants will receive oral iron therapy with ferrous fumarate (twice a day 100mg for 12 weeks)	Drug	Ferrous fumarate

Primary outcome

The discriminative capacity of hepcidin at baseline to differentiate between response and non-response to iron therapy with oral ferrous fumarate
Time frame: Week 14
Hepcidin concentration will be measured in blood at baseline. Receiver Operating Characteristic (ROC) curve with associated Area Under the Curve (AUC) will be used to evaluate the discriminative ability of hepcidin concentration at baseline to differentiate between response and non-response to iron therapy with ferrous fumarate. Response to iron therapy will be evaluated at week 14 and will be defined as hemoglobin normalization (or >1.2 mmol/L increase) for patients with iron-deficiency anemia; for patients with non-anemic iron deficiency the response will be defined as normalization of iron stores (i.e., ferritin >100 ug/L and transferrin saturation >20%).
The discriminative capacity of hepcidin at baseline to differentiate between response and non-response to iron therapy with oral ferric maltol
Time frame: Week 14
Hepcidin concentration will be measured in blood at baseline. Receiver Operating Characteristic (ROC) curve with associated Area Under the Curve (AUC) will be used to evaluate the discriminative ability of hepcidin concentration at baseline to differentiate between response and non-response to iron therapy with ferric maltol. Response to iron therapy will be evaluated at week 14 and will be defined as hemoglobin normalization (or >1.2 mmol/L increase) for patients with iron-deficiency anemia; for patients with non-anemic iron deficiency the response will be defined as normalization of iron stores (i.e., ferritin >100 ug/L and transferrin saturation >20%).
The discriminative capacity of hepcidin at baseline to differentiate between response and non-response to intravenous iron therapy
Time frame: Week 14
Hepcidin concentration will be measured in blood at baseline. Receiver Operating Characteristic (ROC) curve with associated Area Under the Curve (AUC) will be used to evaluate the discriminative ability of hepcidin concentration at baseline to differentiate between response and non-response to intravenous iron therapy. Response to iron therapy will be evaluated at week 14 and will be defined as hemoglobin normalization (or >1.2 mmol/L increase) for patients with iron-deficiency anemia; for patients with non-anemic iron deficiency the response will be defined as normalization of iron stores (i.e., ferritin >100 ug/L and transferrin saturation >20%).

12 secondary outcomes

Change in hepcidin
Time frame: weeks 6, 14, and 24
Change in soluble Transferrin Receptor (sTfR)
Time frame: weeks 6, 14, and 24
Change in interleukin 6 (IL-6)
Time frame: weeks 6, 14, and 24
Normalization of iron stores
Time frame: weeks 6, 14, and 24
Correlation between response to iron therapy and disease activity
Time frame: week 14
Incidence of hypophosphatemia during iron therapy
Time frame: weeks 6, 14, and 24
Adverse events during iron therapy
Time frame: weeks 6, 14, and 24
Change in clinical disease activity
Time frame: weeks 14 and 24
Change in quality of life
Time frame: weeks 14 and 24
Change in activity and productivity
Time frame: weeks 14 and 24
Hematologic response during iron therapy
Time frame: weeks 14 and 24
Hemoglobin increase (>0.6 mmol/L) during iron therapy
Time frame: weeks 6 and 14

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
Derived from this study: PubMed 42261111Koppelman LJM, Loveikyte R, Goetgebuer RL, van der Marel S, de Vries AC, Dijkstra G, van der Meulen-de Jong AE; Dutch Iron Study Group. Clinical Trial: Predicting Response to Iron Therapy in Patients With Active Inflammatory Bowel Disease Using Hepcidin and Functional Iron Indices: A Multicentre Randomised Trial. Aliment Pharmacol Ther. 2026 Jul;64(2):166-176. doi: 10.1111/apt.70775. Epub 2026 Jun 8.
Derived from this study: PubMed 38296290Loveikyte R, Duijvestein M, Mujagic Z, Goetgebuer RL, Dijkstra G, van der Meulen-de Jong AE. Predicting response to iron supplementation in patients with active inflammatory bowel disease (PRIme): a randomised trial protocol. BMJ Open. 2024 Jan 30;14(1):e077511. doi: 10.1136/bmjopen-2023-077511.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

R. Loveikyte, MD contact

00315297902

patientenibd@lumc.nl

A.E. van der Meulen - de Jong, MD, PhD principal investigator

LUMC

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact R. Loveikyte, MD (00315297902, patientenibd@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The discriminative capacity of hepcidin at baseline to differentiate between response and non-response to iron therapy with oral ferrous fumarate (time frame: Week 14). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05456932, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2023; AzTrials last refreshed its copy on 1 Nov 2026.