Iron Deficiency AnemiaPhase 3NCT02172001
A Randomized, Double-blind, Comparative Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Against Placebo
A Phase 3 study testing Iron isomaltoside 1000 and Natrium Chloride 0,9% in people with Iron Deficiency Anemia, run by Pharmacosmos A/S at 1 site in United States.
Trial summary
The primary objective of the study is to evaluate and compare the effect of iron isomaltoside 1000 to placebo in its ability to increase haemoglobin (Hb) in subjects with IDA when oral iron preparations are ineffective or cannot be used. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iron Deficiency Anemia
- What is being tested?
- Iron isomaltoside 1000 and Natrium Chloride 0,9%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Mar 2015
- 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
- Men or women ≥ 18 years having IDA caused by different aetiologies* such as ab-normal uterine bleeding, gastrointestinal diseases (e.g. inflammatory bowel disease), cancer, preoperative anaemia (e.g. orthopaedic surgery), and other conditions leading to IDA and with a documented history of intolerance or unresponsiveness to oral iron therapy for at least one month* prior to study enrolment
- Hb < 11 g/dL
- TSAT < 20 %
- S-ferritin < 100 ng/mL
- Willingness to participate and signing the informed consent form (ICF)
Who cannot join
- Hb < 6 g/dL
- Anaemia predominantly caused by factors other than IDA (e.g. anaemia with untreat-ed vitamin B12 or folate deficiency, haemolytic anaemia)
- Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and hae-mosiderosis)
- 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
Show all 13Show fewer
- Pregnant or nursing women. In order to avoid pregnancy, women of childbearing po-tential have to use adequate contraception (e.g. intrauterine devices, hormonal contra-ceptives, or double barrier method) during the whole study period and 7 days after the last dosing
- 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 intravenous (IV) iron treatment or blood transfusion within 4 weeks prior to the screening visit
- Participation in any other interventional 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 ischemic heart disease, or uncontrolled diabetes mellitus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase III, Randomised, Double-blind, Comparative Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Against Placebo in Subjects With Iron Deficiency Anaemia and Who Are Intol-erant or Unresponsive to Oral Iron Therapy
The primary objective of the study is to evaluate and compare the effect of iron isomaltoside 1000 to placebo in its ability to increase haemoglobin (Hb) in subjects with IDA when oral iron preparations are ineffective or cannot be used.
Read the detailed description
IDA is highly prevalent in subjects and can have a substantial medical and quality of life (QoL) burden on the subjects and the treatment of these subjects includes 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 placebo in subjects with IDA and who are intolerant or unresponsive to oral iron therapy..
- Conditions
- Iron Deficiency Anemia
- Being tested
- Iron isomaltoside 1000, Natrium Chloride 0,9%
- Keywords
- IDA, Iron deficiency, iron deficiency anemia 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 1000Drug
Natrium Chloride 0,9%Drug
100 ml or 5 ml
| Study group | Role | What they receive |
|---|---|---|
| Iron isomaltoside 1000 | Experimental | Iron isomaltoside 1000. Dose: 1000 mg, 1500 mg or 2000 mg Receives: Drug: Iron isomaltoside 1000 |
| Placebo (NaCl 0,9%) | Placebo comparator | Sodium Chloride. Dose: 100 ml or 5 ml Receives: Drug: Natrium Chloride 0,9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with an Hb increase of ≥ 2 g/dL from baseline at any time from week 1 to week 5
Measured: Week 1 to 5
Secondary outcomes (1)
Time to Hb ≥ 2 g/dL
Measured: Week 1 to 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2014 (estimated)
- Primary completionMar 2015
Why it stopped: Study design not adequate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency AnemiaStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 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
- NCT02172001
- Sponsor's protocol ID
- P-Monofer-IDA-02
- Status last verified
- Mar 2016
- First submitted
- 21 Jun 2014
- Last updated
- 28 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomised, Double-blind, Comparative Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Against Placebo in Subjects With Iron Deficiency Anaemia and Who Are Intol-erant or Unresponsive to Oral Iron Therapy
- ClinicalTrials.gov ID
- NCT02172001
- Acronym / sponsor ID
- P-Monofer-IDA-02
- Conditions
- Iron Deficiency Anemia
- Keywords
- IDA, Iron deficiency, iron deficiency anemia and who are intolerant or unresponsive to oral iron therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study design not adequate
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Pharmacosmos A/SIndustry (pharma, biotech, devices)
- Primary completion
- Mar 2015 (actual)
- First posted
- 24 Jun 2014 (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 primary objective of the study is to evaluate and compare the effect of iron isomaltoside 1000 to placebo in its ability to increase haemoglobin (Hb) in subjects with IDA when oral iron preparations are ineffective or cannot be used.
Detailed description
IDA is highly prevalent in subjects and can have a substantial medical and quality of life (QoL) burden on the subjects and the treatment of these subjects includes 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 placebo in subjects with IDA and who are intolerant or unresponsive to oral iron therapy..
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 1000 | Experimental | Drug: Iron isomaltoside 1000Iron isomaltoside 1000. Dose: 1000 mg, 1500 mg or 2000 mg |
| Placebo (NaCl 0,9%) | Placebo comparator | Drug: Natrium Chloride 0,9%Sodium Chloride. Dose: 100 ml or 5 ml |
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 ab-normal uterine bleeding, gastrointestinal diseases (e.g. inflammatory bowel disease), cancer, preoperative anaemia (e.g. orthopaedic surgery), and other conditions leading to IDA and with a documented history of intolerance or unresponsiveness to oral iron therapy for at least one month* prior to study enrolment
- Hb < 11 g/dL
- TSAT < 20 %
- S-ferritin < 100 ng/mL
- Willingness to participate and signing the informed consent form (ICF)
Key exclusion criteria (13 listed)
- Hb < 6 g/dL
- Anaemia predominantly caused by factors other than IDA (e.g. anaemia with untreat-ed vitamin B12 or folate deficiency, haemolytic anaemia)
- Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and hae-mosiderosis)
- 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))
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 | Drug | Iron isomaltoside 1000 |
| Natrium Chloride 0,9%100 ml or 5 ml | Drug | Placebo (NaCl 0,9%) |
Primary outcome
Proportion of subjects with an Hb increase of ≥ 2 g/dL from baseline at any time from week 1 to week 5
Time frame: Week 1 to 5
1 secondary outcome
Time to Hb ≥ 2 g/dL
Time frame: Week 1 to 5
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2016.
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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 and Natrium Chloride 0,9% in people with Iron Deficiency Anemia, 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 13 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: withdrawn, as of the sponsor's last update on 28 Sep 2016. 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
Proportion of subjects with an Hb increase of ≥ 2 g/dL from baseline at any time from week 1 to week 5 (time frame: Week 1 to 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 28 Sep 2016.