Iron Deficiency AnaemiaPhase 3ProvideNCT02130063
IDA-01 A Randomised, Open-Label, Comparative Study of Intravenous Iron Isomaltoside 1000 (Monofer®) and Iron Sucrose
A Phase 3 study testing iron isomaltoside 1000 (Monofer®) and iron sucrose (Venofer®) in people with Iron Deficiency Anaemia, run by Pharmacosmos A/S at 1 site in United States.
Trial summary
The purpose of the trial is to evaluate and compare the effect of iron isomaltoside 1000 to iron sucrose in its ability to increase haemoglobin (Hb) in subjects with IDA when oral iron preparations are ineffective or cannot be used or where there is a clinical need to deliver iron rapidly. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iron Deficiency Anaemia
- What is being tested?
- iron isomaltoside 1000 (Monofer®) and iron sucrose (Venofer®)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 511 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Aug 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 having IDA caused by different aetiologies such as abnormal uterine bleeding, gastrointestinal diseases, cancer, bariatric procedures (gastric bypass operations), and other conditions leading to significant blood loss and with a documented history of intolerance or unresponsiveness to oral iron therapy for at least one month prior to study enrollment or where there at investigators judgment is a clinical need to deliver iron rapidly
- Hb < 11 g/dL
- TSAT < 20 %
- S-ferritin < 100 ng/mL
- Willingness to participate and signing the informed consent form
Who cannot join
- Anaemia predominantly caused by factors other than IDA (e.g. anaemia with untreated vitamin B12 or folate deficiency, haemolytic anaemia)
- Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis)
- Decompensated liver cirrhosis or active hepatitis (ALAT > 3 times upper limit of normal)
- Active acute or chronic infections (assessed by clinical judgement supplied with white blood cells (WBC) and C-reactive protein (CRP))
- Body weight < 50 kg
- Rheumatoid arthritis with symptoms or signs of active inflammation
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- Pregnant or nursing women. In order to avoid pregnancy, women have to be surgically sterile or use adequate contraception (e.g. intrauterine devices, hormonal contraceptives, or double barrier method) during the whole study period and after the study has ended for at least 5 times plasma biological half-life of the investigational medicinal product
- History of multiple allergies
- Known hypersensitivity to parenteral iron or any excipients in the investigational drug products
- Erythropoietin treatment within 8 weeks prior to the screening visit
- Other iron treatment or blood transfusion within 4 weeks prior to the screening visit
- Planned elective surgery during the study
- Participation in any other clinical study within 3 months prior to the 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, e.g. uncontrolled hypertension, unstable ischaemic heart disease, or uncontrolled diabetes mellitus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase III, Randomised, Open-Label, Comparative Study of Intravenous Iron Isomaltoside 1000 (Monofer®) and Iron Sucrose in Subjects With Iron Deficiency Anaemia and Who Are Intolerant or Unresponsive to Oral Iron Therapy or Who Need Iron Rapidly (PROVIDE)
The purpose of the trial is to evaluate and compare the effect of iron isomaltoside 1000 to iron sucrose in its ability to increase haemoglobin (Hb) in subjects with IDA when oral iron preparations are ineffective or cannot be used or where there is a clinical need to deliver iron rapidly.
Read the detailed description
IDA is highly prevalent in subjects with gastrointestinal diseases and cancer, menstruating or pregnant women, and subjects who have undergone bariatric procedure. IDA can have a substantial medical and quality of life (QoL) burden on the subjects and the treatment of these subjects includes controlling the bleeding and replenishing lost iron. Oral iron administration is often used in the clinical practice at many clinics; however, oral iron may not be tolerated by all subjects. Hence, there is a need for an alternative iron treatment in subjects, who do not tolerate oral iron.
This study is planned to compare the efficacy and safety of iron isomaltoside 1000 with another parenteral iron preparation (iron sucrose) in subjects with IDA and who are intolerant or unresponsive to oral iron therapy or who need iron rapidly.
- Conditions
- Iron Deficiency Anaemia
- Being tested
- iron isomaltoside 1000 (Monofer®), iron sucrose (Venofer®)
- Keywords
- IDA, Iron deficiency, iron deficiency anaemia and who are intolerant or unresponsive to oral iron therapy
- Medical subject headings
- Anemia, Iron-Deficiency, Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iron isomaltoside 1000 (Monofer®)Drug
iron sucrose (Venofer®)Drug
| Study group | Role | What they receive |
|---|---|---|
| iron isomaltoside 1000 (Monofer®) | Experimental | iron isomaltoside 1000 (Monofer®) Receives: Drug: iron isomaltoside 1000 (Monofer®) |
| iron sucrose (Venofer®) | Active comparator | iron sucrose (Venofer®) Receives: Drug: iron sucrose (Venofer®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With an Haemoglobin (Hb) Increase of ≥ 2 g/dL From Baseline at Any Time From Week 1 to Week 5
The primary efficacy endpoint of the trial was the count of subjects with an Hb increase of ≥ 2 g/dL from baseline at any time from week 1 to week 5. 'Any time' implied that if the endpoint was met at a time-point prior to or at week 5, the effect (increase of ≥ 2 g/dL) did not have to be maintained throughout the trial in order for a subject to be a responder.
Number of responders (i.e. a subject with increase in Hb ≥ 2 g/dL from baseline at any time from week 1 to week 5) and percentages according to number of subjects in the analysis set were summarised.
Measured: From baseline to week 5
Secondary outcomes (3)
Change in Hb Concentration
Measured: From baseline to week 2, 4 and 5
Change in Serum (s)-Ferritin Concentration
Measured: From baseline to week 1, 2, 4, and 5
Change in Transferrin Saturation (TSAT)
Measured: From baseline to week 1, 2, 4, and 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2014 (estimated)
- Study startMay 2014
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Iron Deficiency AnaemiaStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 511 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmacosmos A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioStata, ClinStar, LLC, Laboratory Corporation of America
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02130063
- Sponsor's protocol ID
- P-Monofer-IDA-01
- Acronym
- Provide
- Status last verified
- Aug 2015
- First submitted
- 28 Apr 2014
- Last updated
- 27 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomised, Open-Label, Comparative Study of Intravenous Iron Isomaltoside 1000 (Monofer®) and Iron Sucrose in Subjects With Iron Deficiency Anaemia and Who Are Intolerant or Unresponsive to Oral Iron Therapy or Who Need Iron Rapidly (PROVIDE)
- ClinicalTrials.gov ID
- NCT02130063
- Acronym / sponsor ID
- Provide / P-Monofer-IDA-01
- Conditions
- Iron Deficiency Anaemia
- Keywords
- IDA, Iron deficiency, iron deficiency anaemia and who are intolerant or unresponsive to oral iron therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 511 participants (actual)
- Lead sponsor
- Pharmacosmos A/SIndustry (pharma, biotech, devices)
- Collaborators
- BioStata, ClinStar, LLC, Laboratory Corporation of America
- Study start
- May 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 2 May 2014 (estimated)
- Results
- Posted 22 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the trial is to evaluate and compare the effect of iron isomaltoside 1000 to iron sucrose in its ability to increase haemoglobin (Hb) in subjects with IDA when oral iron preparations are ineffective or cannot be used or where there is a clinical need to deliver iron rapidly.
Detailed description
IDA is highly prevalent in subjects with gastrointestinal diseases and cancer, menstruating or pregnant women, and subjects who have undergone bariatric procedure. IDA can have a substantial medical and quality of life (QoL) burden on the subjects and the treatment of these subjects includes controlling the bleeding and replenishing lost iron. Oral iron administration is often used in the clinical practice at many clinics; however, oral iron may not be tolerated by all subjects. Hence, there is a need for an alternative iron treatment in subjects, who do not tolerate oral iron.
This study is planned to compare the efficacy and safety of iron isomaltoside 1000 with another parenteral iron preparation (iron sucrose) in subjects with IDA and who are intolerant or unresponsive to oral iron therapy or who need iron rapidly.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iron isomaltoside 1000 (Monofer®) | Experimental | Drug: iron isomaltoside 1000 (Monofer®)iron isomaltoside 1000 (Monofer®) |
| iron sucrose (Venofer®) | Active comparator | Drug: iron sucrose (Venofer®)iron sucrose (Venofer®) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men or women > 18 years having IDA caused by different aetiologies such as abnormal uterine bleeding, gastrointestinal diseases, cancer, bariatric procedures (gastric bypass operations), and other conditions leading to significant blood loss and with a documented history of intolerance or unresponsiveness to oral iron therapy for at least one month prior to study enrollment or where there at investigators judgment is a clinical need to deliver iron rapidly
- Hb < 11 g/dL
- TSAT < 20 %
- S-ferritin < 100 ng/mL
- Willingness to participate and signing the informed consent form
Key exclusion criteria (14 listed)
- Anaemia predominantly caused by factors other than IDA (e.g. anaemia with untreated vitamin B12 or folate deficiency, haemolytic anaemia)
- Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis)
- Decompensated liver cirrhosis or active hepatitis (ALAT > 3 times upper limit of normal)
- Active acute or chronic infections (assessed by clinical judgement supplied with white blood cells (WBC) and C-reactive protein (CRP))
- Body weight < 50 kg
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 1000 (Monofer®) | Drug | iron isomaltoside 1000 (Monofer®) |
| iron sucrose (Venofer®) | Drug | iron sucrose (Venofer®) |
Primary outcome
Number of Subjects With an Haemoglobin (Hb) Increase of ≥ 2 g/dL From Baseline at Any Time From Week 1 to Week 5
Time frame: From baseline to week 5
The primary efficacy endpoint of the trial was the count of subjects with an Hb increase of ≥ 2 g/dL from baseline at any time from week 1 to week 5. 'Any time' implied that if the endpoint was met at a time-point prior to or at week 5, the effect (increase of ≥ 2 g/dL) did not have to be maintained throughout the trial in order for a subject to be a responder. Number of responders (i.e. a subject with increase in Hb ≥ 2 g/dL from baseline at any time from week 1 to week 5) and percentages according to number of subjects in the analysis set were summarised.
3 secondary outcomes
Change in Hb Concentration
Time frame: From baseline to week 2, 4 and 5
Change in Serum (s)-Ferritin Concentration
Time frame: From baseline to week 1, 2, 4, and 5
Change in Transferrin Saturation (TSAT)
Time frame: From baseline to week 1, 2, 4, and 5
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 (Monofer®) and iron sucrose (Venofer®) in people with Iron Deficiency Anaemia, run by Pharmacosmos A/S at 1 site in United States.
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 14 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 27 Sep 2018. 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 United States. 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?
Yes. Results are posted in the registry (first posted 22 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Subjects With an Haemoglobin (Hb) Increase of ≥ 2 g/dL From Baseline at Any Time From Week 1 to Week 5 (time frame: From baseline to week 5). 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 27 Sep 2018.