Iron-deficiencyPhase 3NCT01895231
A Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Administered by Infusions to Iron-deficient Blood Donors
A Phase 3 study testing Iron isomaltoside 1000 (Monofer®) in people with Iron-deficiency, run by Pharmacosmos A/S at 1 site in Denmark.
Trial summary
The primary purpose of the study is to evaluate the effect of IV iron isomaltoside 1000 compared with placebo on Hb in first-time female donors with p-ferritin below 30 µg/L Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Iron-deficiency
- What is being tested?
- Iron isomaltoside 1000 (Monofer®)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 107 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2013to Dec 2016
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged ≥ 18 years
- First-time donor
- P-ferritin < 30 µg/L
- Willingness to participate and signed the informed consent form
Who cannot join
- Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis)
- Known hypersensitivity to any excipients in the investigational drug products
- History of drug related allergies
- History of severe asthma
- Decompensated liver cirrhosis and hepatitis (defined as 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))
Show all 13Show fewer
- Rheumatoid arthritis with symptoms or signs of active inflammation
- Subjects who are pregnant or nursing. In order to avoid pregnancy, women have to be postmenopausal (at least 12 months since last menstruation), surgically sterile, or use one of the following contraceptives 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: intrauterine devices and hormonal contraceptives (contraceptive pills, implants, transdermal patches, vaginal devices, or hormonal injections with prolonged release)
- Participation in any other clinical study where the study drug has not passed 5 half-lives prior to the screening
- Untreated vitamin B12 or folate deficiency
- Treated with other IV or oral iron products within 4 weeks prior to the screening
- Treated with Erythropoietin (EPO) within 4 weeks prior to the screening
- Any other medical condition that, in the opinion of the 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 Randomized, Prospective, Double-Blind, Comparative Placebo-Controlled Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Administered by Infusions to Iron-Deficient Blood Donors
The primary purpose of the study is to evaluate the effect of IV iron isomaltoside 1000 compared with placebo on Hb in first-time female donors with p-ferritin below 30 µg/L
Read the detailed description
At present, clinical efficacy and safety data is available for iron isomaltoside 1000 administered to patients with IDA requiring iron therapy. However, there is a need for clinical efficacy and safety data within iron deficiency without anaemia which is e.g. observed in blood donors. Thus, this study is planned to compare the efficacy and safety of parenteral iron isomaltoside 1000 with placebo in female blood donors with a p-ferritin below 30 µg/L.
- Conditions
- Iron-deficiency
- Being tested
- Iron isomaltoside 1000 (Monofer®), Placebo
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron isomaltoside 1000 (Monofer®)Drug
Also called Monofer®
PlaceboDrug
Also called 0.9 % saline
| Study group | Role | What they receive |
|---|---|---|
| Iron isomaltoside 1000 | Experimental | Monofer® 1000 mg IV infusion over 15 minutes Receives: Drug: Iron isomaltoside 1000 (Monofer®) |
| Placebo | Placebo comparator | 0.9 % saline Infusion over 15 min Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hb concentration
The primary endpoint is to measure and compare the change in Hb concentration from baseline to right before the third blood donation in the two study arms
Measured: From baseline and until t= 6 months
Secondary outcomes (11)
Change in Hb concentration
Change in Hb concentrations from baseline to right before second donation
Measured: From baseline and until t=3 months
Ability to complete 3 blood donations
Number of subjects who cannot complete three donations due to low Hb
Measured: From baseline and until t=6 months
Change in p-iron
Measured: From baseline and until week 12
Change in fatigue symptoms
Measured: From baseline and until week 12
Exercise tolerance
Change in exercise tolerance from baseline to 3 weeks after baseline measured by a two-step test on bike
Measured: From baseline to week 3
Number of adverse drug reactions
Measured: From screening and until t= 6 months
Change in p-ferritin
Measured: From baseline and until week 12
Change in Transferrin Saturation (TSAT)
Measured: From baseline until week 12
Change in reticulocyte count
Measured: From Baseline to week 12
Change in haematology parameters
Measured: From baseline and until t= 6 months
Change in RLS symptoms
Measured: From baseline and until t= 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron-deficiencyStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmacosmos A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Max Neeman
- Responsible party
- Sponsor
- Investigators
- Nørgaard, Principal investigator, RH Blodbanken
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01895231
- Sponsor's protocol ID
- P-Monofer-BD-02
- Status last verified
- Mar 2018
- First submitted
- 26 Jun 2013
- Last updated
- 15 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Prospective, Double-Blind, Comparative Placebo-Controlled Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Administered by Infusions to Iron-Deficient Blood Donors
- ClinicalTrials.gov ID
- NCT01895231
- Acronym / sponsor ID
- P-Monofer-BD-02
- Conditions
- Iron-deficiency
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Pharmacosmos A/SIndustry (pharma, biotech, devices)
- Collaborators
- Max Neeman
- Study start
- Jun 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 10 Jul 2013 (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 purpose of the study is to evaluate the effect of IV iron isomaltoside 1000 compared with placebo on Hb in first-time female donors with p-ferritin below 30 µg/L
Detailed description
At present, clinical efficacy and safety data is available for iron isomaltoside 1000 administered to patients with IDA requiring iron therapy. However, there is a need for clinical efficacy and safety data within iron deficiency without anaemia which is e.g. observed in blood donors. Thus, this study is planned to compare the efficacy and safety of parenteral iron isomaltoside 1000 with placebo in female blood donors with a p-ferritin below 30 µg/L.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iron isomaltoside 1000 | Experimental | Drug: Iron isomaltoside 1000 (Monofer®)Monofer® 1000 mg IV infusion over 15 minutes |
| Placebo | Placebo comparator | Drug: Placebo0.9 % saline Infusion over 15 min |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women aged ≥ 18 years
- First-time donor
- P-ferritin < 30 µg/L
- Willingness to participate and signed the informed consent form
Key exclusion criteria (13 listed)
- Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis)
- Known hypersensitivity to any excipients in the investigational drug products
- History of drug related allergies
- History of severe asthma
- Decompensated liver cirrhosis and hepatitis (defined as ALAT > 3 times upper limit of normal)
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®)Also: Monofer® | Drug | Iron isomaltoside 1000 |
| PlaceboAlso: 0.9 % saline | Drug | Placebo |
Primary outcome
Change in Hb concentration
Time frame: From baseline and until t= 6 months
The primary endpoint is to measure and compare the change in Hb concentration from baseline to right before the third blood donation in the two study arms
11 secondary outcomes
Change in Hb concentration
Time frame: From baseline and until t=3 months
Ability to complete 3 blood donations
Time frame: From baseline and until t=6 months
Change in p-iron
Time frame: From baseline and until week 12
Change in fatigue symptoms
Time frame: From baseline and until week 12
Exercise tolerance
Time frame: From baseline to week 3
Number of adverse drug reactions
Time frame: From screening and until t= 6 months
Change in p-ferritin
Time frame: From baseline and until week 12
Change in Transferrin Saturation (TSAT)
Time frame: From baseline until week 12
Change in reticulocyte count
Time frame: From Baseline to week 12
Change in haematology parameters
Time frame: From baseline and until t= 6 months
Change in RLS symptoms
Time frame: From baseline and until t= 6 months
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 15 Mar 2018.
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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.
Nørgaard principal investigator
RH Blodbanken
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®) in people with Iron-deficiency, 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 4 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: finished, as of the sponsor's last update on 15 Mar 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 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. 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 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?
Change in Hb concentration (time frame: From baseline and until t= 6 months). 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 15 Mar 2018.