IBDPhase 4NCT03466983
A Trial Comparing the Incidence of Hypophosphatemia in Relation to Treatment With Iron Isomaltoside and Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia Due to Inflammatory Bowel Disease
A Phase 4 study testing Iron Isomaltoside and Ferric Carboxymaltose in people with IBD, run by Pharmacosmos A/S at 1 site in Denmark.
Trial summary
Treatment with iron isomaltoside and ferric carboxymaltose in subjects with iron deficiency anaemia due to inflammatory bowel disease and comparison of the incidence of hypophosphatemia Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IBD
- What is being tested?
- Iron Isomaltoside and Ferric Carboxymaltose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteDenmark
- Study dates
- 23 May 2018to 25 May 2020
- 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
- Men or women ≥ 18 years
- Subjects diagnosed with IBD
- Hb < 13 g/dL
- Body weight ≥ 50 kg
- S-ferritin <100 ng/mL
- eGFR ≥ 65 mL/min/1.73 m2
Show all 9Show fewer
- S-phosphate > 2.5 mg/dL
- Oral iron preparations are ineffective or cannot be used or where there is a clinical need to de-liver iron rapidly
- Willingness to participate and signing the Informed Consent Form (ICF)
Who cannot join
- Anaemia predominantly caused by factors other than IDA according to Investigator's judgment
- Hb ≥ 10 g/dL and body weight < 70 kg
- Hemochromatosis or other iron storage disorders
- Known hypersensitivity reaction to any component of iron isomaltoside or ferric carboxymaltose
- Previous serious hypersensitivity reactions to any IV iron compounds
- Treatment with IV iron within the last 30 days prior to screening
Show all 18Show fewer
- Treatment with erythropoietin or erythropoietin-stimulation agents, red blood cell transfusion, radiotherapy, and/or chemotherapy within the last 30 days prior to screening
- Received an investigational drug within the last 30 days prior to screening
- Planned surgical procedure within the trial period
- hepatic enzymes > 3 times upper limit of normal
- Surgery under general anaesthesia within the last 30 days prior to screening
- Any non-viral infection within the last 30 days prior to screening
- Alcohol or drug abuse within the past 6 months
- Untreated hyperparathyroidism
- Kidney transplantation
- Conditions that interfere with the subject's ability to understand the requirements of the trial and/or presumable non-compliance
- Any other laboratory abnormality, medical condition, or psychiatric disorders which, in the opinion of the Investigator, will put the subject's disease management at risk or may result in the subject being unable to comply with the trial requirements
- Pregnant or nursing women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blinded, Comparative Trial Comparing the Incidence of Hypophosphatemia in Relation to Repeated Treatment Courses of Iron Isomaltoside and Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia Due to Inflammatory Bowel Disease
Treatment with iron isomaltoside and ferric carboxymaltose in subjects with iron deficiency anaemia due to inflammatory bowel disease and comparison of the incidence of hypophosphatemia
Read the detailed description
Existing IV iron complexes differ in relation to the compounds capability to induce unintended hypophosphatemia to a degree defined as medical significant.
This trial is designed evaluate the effect of IV iron isomaltoside compared to IV ferric carboxymaltose on phosphate in subjects with IDA due to inflammatory bowel disease .
- Conditions
- IBD
- Being tested
- Iron Isomaltoside, Ferric Carboxymaltose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron IsomaltosideDrug
Also called Monofer
administered IV
Ferric CarboxymaltoseDrug
Also called Ferinject
administered IV
| Study group | Role | What they receive |
|---|---|---|
| Iron Isomaltoside | Experimental | Iron Isomaltoside (Monofer) administered IV Receives: Drug: Iron Isomaltoside |
| Ferric Carboxymaltose | Active comparator | Ferric Carboxymaltose (Injectafer) administered IV Receives: Drug: Ferric Carboxymaltose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hypophosphatemia
s-phosphate < 2 mg/dL
Measured: any time from baseline to day 35
Secondary outcomes (3)
Incidence of hypophosphatemia
s-phosphate < 2 mg/dL
Measured: any time from baseline to week 10
Incidence of s-phosphate < 1.0 mg/dL
s-phosphate < 1.0 mg/dL
Measured: any time from baseline to day 35
Time with hypophosphatemia
time with s-phosphate < 2.0 mg/dL
Measured: number of days any time from baseline to week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2018
- Study start23 May 2018
- Primary completion25 May 2020
- Study completion25 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IBDStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmacosmos A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03466983
- Sponsor's protocol ID
- P-Monofer-IBD-03
- Status last verified
- Feb 2021
- First submitted
- 6 Mar 2018
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bjorner JB, Kennedy N, Lindgren S, Pollock RF. Hypophosphatemia attenuates improvements in vitality after intravenous iron treatment in patients with inflammatory bowel disease. Qual Life Res. 2024 Aug;33(8):2285-2294. doi: 10.1007/s11136-024-03642-y. Epub 2024 Jun 14.
PubMed 38874697
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blinded, Comparative Trial Comparing the Incidence of Hypophosphatemia in Relation to Repeated Treatment Courses of Iron Isomaltoside and Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia Due to Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT03466983
- Acronym / sponsor ID
- P-Monofer-IBD-03
- Conditions
- IBD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Pharmacosmos A/SIndustry (pharma, biotech, devices)
- Study start
- 23 May 2018 (actual)
- Primary completion
- 25 May 2020 (actual)
- Study completion
- 25 May 2020 (actual)
- First posted
- 15 Mar 2018 (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.
Treatment with iron isomaltoside and ferric carboxymaltose in subjects with iron deficiency anaemia due to inflammatory bowel disease and comparison of the incidence of hypophosphatemia
Detailed description
Existing IV iron complexes differ in relation to the compounds capability to induce unintended hypophosphatemia to a degree defined as medical significant.
This trial is designed evaluate the effect of IV iron isomaltoside compared to IV ferric carboxymaltose on phosphate in subjects with IDA due to inflammatory bowel disease .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iron Isomaltoside | Experimental | Drug: Iron IsomaltosideIron Isomaltoside (Monofer) administered IV |
| Ferric Carboxymaltose | Active comparator | Drug: Ferric CarboxymaltoseFerric Carboxymaltose (Injectafer) administered IV |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Men or women ≥ 18 years
- Subjects diagnosed with IBD
- Hb < 13 g/dL
- Body weight ≥ 50 kg
- S-ferritin <100 ng/mL
Key exclusion criteria (18 listed)
- Anaemia predominantly caused by factors other than IDA according to Investigator's judgment
- Hb ≥ 10 g/dL and body weight < 70 kg
- Hemochromatosis or other iron storage disorders
- Known hypersensitivity reaction to any component of iron isomaltoside or ferric carboxymaltose
- Previous serious hypersensitivity reactions to any IV iron compounds
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 |
|---|---|---|
| Iron IsomaltosideAlso: Monoferadministered IV | Drug | Iron Isomaltoside |
| Ferric CarboxymaltoseAlso: Ferinjectadministered IV | Drug | Ferric Carboxymaltose |
Primary outcome
Incidence of hypophosphatemia
Time frame: any time from baseline to day 35
s-phosphate < 2 mg/dL
3 secondary outcomes
Incidence of hypophosphatemia
Time frame: any time from baseline to week 10
Incidence of s-phosphate < 1.0 mg/dL
Time frame: any time from baseline to day 35
Time with hypophosphatemia
Time frame: number of days any time from baseline to week 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Derived from this study: PubMed 38874697Bjorner JB, Kennedy N, Lindgren S, Pollock RF. Hypophosphatemia attenuates improvements in vitality after intravenous iron treatment in patients with inflammatory bowel disease. Qual Life Res. 2024 Aug;33(8):2285-2294. doi: 10.1007/s11136-024-03642-y. Epub 2024 Jun 14.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Iron Isomaltoside and Ferric Carboxymaltose in people with IBD, run by Pharmacosmos A/S at 1 site in Denmark.
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 9 inclusion and 18 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: finished, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of hypophosphatemia (time frame: any time from baseline to day 35). 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 NCT03466983, which also lists 1 linked publication.
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 21 Feb 2021.