Inflammatory Bowel DiseasePhase 3IBD-02NCT01599702
Iron Isomaltoside 1000 (Monofer®) Administered by a High Dosing Regimen in Subjects With Inflammatory Bowel Disease
A Phase 3 study testing Iron Isomaltoside 1000 in people with Inflammatory Bowel Disease, run by Pharmacosmos A/S at 1 site in Denmark.
Trial summary
The study is a prospective, non-controlled, open-label multi-centre pilot safety study of iron isomaltoside 1000 (Monofer®) administered to subjects with anaemia and Inflammatory Bowel Disease (IBD). Based upon haemoglobin (Hb) level, the subjects are divided into two treatment groups, A and B. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Disease
- What is being tested?
- Iron Isomaltoside 1000
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteDenmark
- Study dates
- May 2012to Dec 2014
- Phase
- Phase 3
- 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
- Subjects with age ≥ 18 years
- Subjects diagnosed with IBD either in remission or active
- Hb < 12 g/dL for women and Hb < 13 g/dL for men
- Subjects with a CRP above upper limit of normality must have a ferritin below 100 µg/L, whereas subjects with a CRP below or equal to upper limit of normality must have a ferritin below 30 µg/L
- Willingness to participate after signing informed consent
Who cannot join
- Patient judged by the physician to be in need of surgery due to Crohn´s disease or ulcerative colitis within the next 2 months
- Anaemia predominantly caused by factors other than IDA
- Iron overload or disturbance in utilisation of iron (e.g. haemochromatosis and haemosiderosis)
- Known hypersensitivity to any excipients of iron isomaltoside 1000
- History of multiple allergies
- Decompensated liver cirrhosis and/or known chronic viral hepatitis (defined as Alanine Aminotransferase (ALAT) > 3 times upper limit of normal)
Show all 19Show fewer
- Acute and/or chronic infections
- Body weight < 50 kg
- Rheumatoid arthritis with symptoms or signs of active joint inflammation
- Pregnancy and nursing. In order to avoid pregnancy, women have to be postmenopausal, surgically sterile, or use one of the following contraceptives during the whole study period and 5 days after the study has ended (i.e. 5 times plasma biological half-life of the investigational medicinal product): intrauterine devices and hormonal contraceptives (contraceptive pills, implants, transdermal patches, hormonal vaginal devices or injections with prolonged release)
- Blood transfusion within the previous 12 weeks
- Subjects with a history of asthma, allergic eczema, or other atopic allergy
- Planned elective surgery during the study
- Untreated Vitamin B12 or folate deficiency, defined as values below the lower reference range
- Participation in any other clinical study within 3 months prior to Screening
- IV iron treatment within 8 weeks prior to Screening
- Oral iron treatment within 1 week prior to Screening
- Erythropoiesis Stimulating Agent (ESA) treatment within 8 weeks prior to Screening
- Any other medical condition that, in the opinion of Investigator, may cause the subject to be unsuitable for the completion of the study or place the subject at potential risk from being in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Non-controlled, Safety Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Administered by a High Dosing Regimen in Subjects With Inflammatory Bowel Disease (PROMISE)
The study is a prospective, non-controlled, open-label multi-centre pilot safety study of iron isomaltoside 1000 (Monofer®) administered to subjects with anaemia and Inflammatory Bowel Disease (IBD). Based upon haemoglobin (Hb) level, the subjects are divided into two treatment groups, A and B. Depending on the body weight, subjects in Treatment Group A will receive a total dose of 1,500 mg or 2,000 mg IV iron isomaltoside 1000 as a single infusion, whereas subjects in Treatment Group B will receive a total dose of 2,500 mg or 3,000 mg IV iron isomaltoside 1000 divided into two administrations.
Read the detailed description
Subjects with a diagnosis of IBD (Crohn's disease or ulcerative colitis) and IDA ( Iron Deficiency Anaemia) with or without concomi-tant inflammation will be enrolled to receive a high dose of IV iron isomaltoside 1000.
- Conditions
- Inflammatory Bowel Disease
- Being tested
- Iron Isomaltoside 1000
- Keywords
- IBD, IDA, Subjects, diagnosis
- Medical subject headings
- Inflammatory Bowel Diseases, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron Isomaltoside 1000Drug
Also called Monofer
1500-3000mg IV depending on HB level, sex and body weight
| Study group | Role | What they receive |
|---|---|---|
| Group A Monofer | Experimental | Depending on the body weight, subjects in Treatment Group A will receive a total dose of 1,500 mg or 2,000 mg IV iron isomaltoside 1000 where 1,500 mg is administered as a single infusion and 2,000 mg is divided into 2 administrations: 1 administration of 1,500 mg at baseline and 1 administration of 500 mg 1 week later. All doses will be diluted in 100 ml normal saline (0.9 % sodium chloride) and administered by infusion over approximately 15 minutes. Receives: Drug: Iron Isomaltoside 1000 |
| Group B Monofer | Experimental | Depending on the body weight, Subjects in Treatment Group B will receive a total dose of 2,500 mg or 3,000 mg IV iron isomaltoside 1000 divided into 2 administrations; 1 administration of 1,500 mg and 8 weeks later a second administration of 1,000 mg or 1,500 mg.. All doses will be diluted in 100 ml normal saline (0.9 % sodium chloride) and administered by infusion over approximately 15 minutes. Receives: Drug: Iron Isomaltoside 1000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of the study is to evaluate the safety of a high IV iron dosing regimen of iron isomaltoside 1000 in subjects with IDA secondary to IBD.
type and incidence of adverse drug reactions (ADRs)
Measured: up to 16 weeks
Secondary outcomes (1)
To evaluate the efficacy of a high IV iron dosing regimen of iron isomaltoside 1000
obtain a target Hb (≥ 13 g/dL in men and ≥ 12g/dL in women)
Measured: up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2012 (estimated)
- Study startMay 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseaseStudies 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 3
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 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
- NCT01599702
- Sponsor's protocol ID
- P-Monofer-IBD-02
- Acronym
- IBD-02
- Status last verified
- Apr 2015
- First submitted
- 25 Apr 2012
- Last updated
- 29 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Non-controlled, Safety Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Administered by a High Dosing Regimen in Subjects With Inflammatory Bowel Disease (PROMISE)
- ClinicalTrials.gov ID
- NCT01599702
- Acronym / sponsor ID
- IBD-02 / P-Monofer-IBD-02
- Conditions
- Inflammatory Bowel Disease
- Keywords
- IBD, IDA, Subjects, diagnosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Pharmacosmos A/SIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 16 May 2012 (estimated)
- 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.
The study is a prospective, non-controlled, open-label multi-centre pilot safety study of iron isomaltoside 1000 (Monofer®) administered to subjects with anaemia and Inflammatory Bowel Disease (IBD). Based upon haemoglobin (Hb) level, the subjects are divided into two treatment groups, A and B. Depending on the body weight, subjects in Treatment Group A will receive a total dose of 1,500 mg or 2,000 mg IV iron isomaltoside 1000 as a single infusion, whereas subjects in Treatment Group B will receive a total dose of 2,500 mg or 3,000 mg IV iron isomaltoside 1000 divided into two administrations.
Detailed description
Subjects with a diagnosis of IBD (Crohn's disease or ulcerative colitis) and IDA ( Iron Deficiency Anaemia) with or without concomi-tant inflammation will be enrolled to receive a high dose of IV iron isomaltoside 1000.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A Monofer | Experimental | Drug: Iron Isomaltoside 1000Depending on the body weight, subjects in Treatment Group A will receive a total dose of 1,500 mg or 2,000 mg IV iron isomaltoside 1000 where 1,500 mg is administered as a single infusion and 2,000 mg is divided into 2 administrations: 1 administration of 1,500 mg at baseline and 1 administration of 500 mg 1 week later. All doses will be diluted in 100 ml normal saline (0.9 % sodium chloride) and administered by infusion over approximately 15 minutes. |
| Group B Monofer | Experimental | Drug: Iron Isomaltoside 1000Depending on the body weight, Subjects in Treatment Group B will receive a total dose of 2,500 mg or 3,000 mg IV iron isomaltoside 1000 divided into 2 administrations; 1 administration of 1,500 mg and 8 weeks later a second administration of 1,000 mg or 1,500 mg.. All doses will be diluted in 100 ml normal saline (0.9 % sodium chloride) and administered by infusion over approximately 15 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects with age ≥ 18 years
- Subjects diagnosed with IBD either in remission or active
- Hb < 12 g/dL for women and Hb < 13 g/dL for men
- Subjects with a CRP above upper limit of normality must have a ferritin below 100 µg/L, whereas subjects with a CRP below or equal to upper limit of normality must have a ferritin below 30 µg/L
- Willingness to participate after signing informed consent
Key exclusion criteria (19 listed)
- Patient judged by the physician to be in need of surgery due to Crohn´s disease or ulcerative colitis within the next 2 months
- Anaemia predominantly caused by factors other than IDA
- Iron overload or disturbance in utilisation of iron (e.g. haemochromatosis and haemosiderosis)
- Known hypersensitivity to any excipients of iron isomaltoside 1000
- History of multiple allergies
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 Isomaltoside 1000Also: Monofer1500-3000mg IV depending on HB level, sex and body weight | Drug | Group A Monofer, Group B Monofer |
Primary outcome
The primary objective of the study is to evaluate the safety of a high IV iron dosing regimen of iron isomaltoside 1000 in subjects with IDA secondary to IBD.
Time frame: up to 16 weeks
type and incidence of adverse drug reactions (ADRs)
1 secondary outcome
To evaluate the efficacy of a high IV iron dosing regimen of iron isomaltoside 1000
Time frame: up to 16 weeks
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 29 Apr 2015.
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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 3 study testing Iron Isomaltoside 1000 in people with Inflammatory Bowel Disease, 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 5 inclusion and 19 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 29 Apr 2015. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The primary objective of the study is to evaluate the safety of a high IV iron dosing regimen of iron isomaltoside 1000 in subjects with IDA secondary to IBD. (time frame: up to 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Apr 2015.