Iron Deficiency AnemiaNCT01900197
Time to Relapse of Iron Deficiency Anemia After Standard Treatment With a New Intravenous Iron (Monofer®)
An observational study of Iron Deficiency Anemia, run by Pharmacosmos A/S at 1 site in Denmark.
Trial summary
The purpose of this study is to monitor and quality assure the efficacy and safety of Monofer® in a broad patient population when Monofer® is used according to the Monofer® label (SPC) in current practice and where standard routines are being followed. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Iron Deficiency Anemia
- What is being tested?
- 10% Iron Isomaltoside 1000
- How many people
- 391 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2013to Nov 2015
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with iron deficiency anemia treated on the doctor's dicretion with Monofer® as standard treatment according to current practice
Who may be able to join
- Patients with iron deficiency anemia treated on the doctor's discretion with Monofer® as standard treatment according to current practice
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Non-intervention Trial of the Time to Relapse of Iron Deficiency Anemia After Standard Treatment With a New Intravenous Iron (Monofer®)
The purpose of this study is to monitor and quality assure the efficacy and safety of Monofer® in a broad patient population when Monofer® is used according to the Monofer® label (SPC) in current practice and where standard routines are being followed.
Read the detailed description
The total duration of the study is approximately 21 months, which includes a 6 months enrolment period. The number of patient visits depends on the number of Monofer® treatment courses needed during the study period. Each patient can receive one or more treatment courses during 12 months after informed consent. The last blood test will be taken after the last Monofer® treatment course which might occur 13-15 months after Informed consent. Patients will only attend hospital visits planned as part of their standard treatment and they will receive treatment as a part of standard care and according to the doctor's discretion. Study termination will occur once the 12 months observational period has been completed for all patients and the last blood test has been collected from the last Monofer® treated patient in the study. Each treatment course can consist of one or more Monofer® administrations. For each administration of Monofer® either intravenous infusion or injection can be used. Pre- and post-treatment blood tests according to standard treatment are a part of the Monofer® treatment course.
DATA COLLECTION:
- Clinical data management will be performed in accordance with applicable standards and data cleaning procedures.
- The collected data will systematically be entered into an eCRF (MyEDC, Biostata). The source of information is the relevant laboratory results obtained from the patient record.
- The data will be evaluated by the Pharmacosmos A/S Medical Affairs team.
Laboratory assessments, i.e. anemia work-up/treatment evaluation, shall be a part of local standard practice. The protocol does not accept any additional samples outside current local standard practice to be taken.
- Conditions
- Iron Deficiency Anemia
- Being tested
- 10% Iron Isomaltoside 1000
- 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.
10% Iron Isomaltoside 1000Drug
Also called Monofer®
Administered according to local routines and product labeling in doses at the doctors discretion
| Study group | Role | What they receive |
|---|---|---|
| Iron deficiency anemia | Patients with iron deficiency anemia treated on the doctor's discretion with 10% Iron Isomaltoside 1000 (Monofer®) as standard treatment according to current practice Receives: Drug: 10% Iron Isomaltoside 1000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to relapse of iron deficiency anemia
Measured: From screening until 12 months
Secondary outcomes (1)
Number of ADRs
Measured: From screening until 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2013 (estimated)
- Study startAug 2013
- Primary completionNov 2015
- Study completionNov 2015
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 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 391 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Pharmacosmos A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioStata
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01900197
- Sponsor's protocol ID
- Monofer®-NIS-14
- Status last verified
- Feb 2016
- First submitted
- 11 Jul 2013
- Last updated
- 2 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Frigstad SO, Haaber A, Bajor A, Fallingborg J, Hammarlund P, Bonderup OK, Blom H, Rannem T, Hellstrom PM. The NIMO Scandinavian Study: A Prospective Observational Study of Iron Isomaltoside Treatment in Patients with Iron Deficiency. Gastroenterol Res Pract. 2017;2017:4585164. doi: 10.1155/2017/4585164. Epub 2017 Oct 22.
PubMed 29213281
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-intervention Trial of the Time to Relapse of Iron Deficiency Anemia After Standard Treatment With a New Intravenous Iron (Monofer®)
- ClinicalTrials.gov ID
- NCT01900197
- Acronym / sponsor ID
- Monofer®-NIS-14
- Conditions
- Iron Deficiency Anemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 391 participants (actual)
- Lead sponsor
- Pharmacosmos A/SIndustry (pharma, biotech, devices)
- Collaborators
- BioStata
- Study start
- Aug 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 16 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 purpose of this study is to monitor and quality assure the efficacy and safety of Monofer® in a broad patient population when Monofer® is used according to the Monofer® label (SPC) in current practice and where standard routines are being followed.
Detailed description
The total duration of the study is approximately 21 months, which includes a 6 months enrolment period. The number of patient visits depends on the number of Monofer® treatment courses needed during the study period. Each patient can receive one or more treatment courses during 12 months after informed consent. The last blood test will be taken after the last Monofer® treatment course which might occur 13-15 months after Informed consent. Patients will only attend hospital visits planned as part of their standard treatment and they will receive treatment as a part of standard care and according to the doctor's discretion. Study termination will occur once the 12 months observational period has been completed for all patients and the last blood test has been collected from the last Monofer® treated patient in the study. Each treatment course can consist of one or more Monofer® administrations. For each administration of Monofer® either intravenous infusion or injection can be used. Pre- and post-treatment blood tests according to standard treatment are a part of the Monofer® treatment course.
DATA COLLECTION:
- Clinical data management will be performed in accordance with applicable standards and data cleaning procedures.
- The collected data will systematically be entered into an eCRF (MyEDC, Biostata). The source of information is the relevant laboratory results obtained from the patient record.
- The data will be evaluated by the Pharmacosmos A/S Medical Affairs team.
Laboratory assessments, i.e. anemia work-up/treatment evaluation, shall be a part of local standard practice. The protocol does not accept any additional samples outside current local standard practice to be taken.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Iron deficiency anemia | – | Drug: 10% Iron Isomaltoside 1000Patients with iron deficiency anemia treated on the doctor's discretion with 10% Iron Isomaltoside 1000 (Monofer®) as standard treatment according to current practice |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with iron deficiency anemia treated on the doctor's dicretion with Monofer® as standard treatment according to current practice
Key inclusion criteria (1 listed)
- Patients with iron deficiency anemia treated on the doctor's discretion with Monofer® as standard treatment according to current practice
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| 10% Iron Isomaltoside 1000Also: Monofer®Administered according to local routines and product labeling in doses at the doctors discretion | Drug | Iron deficiency anemia |
Primary outcome
Time to relapse of iron deficiency anemia
Time frame: From screening until 12 months
1 secondary outcome
Number of ADRs
Time frame: From screening until 12 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 2 Mar 2016.
- Derived from this study: PubMed 29213281Frigstad SO, Haaber A, Bajor A, Fallingborg J, Hammarlund P, Bonderup OK, Blom H, Rannem T, Hellstrom PM. The NIMO Scandinavian Study: A Prospective Observational Study of Iron Isomaltoside Treatment in Patients with Iron Deficiency. Gastroenterol Res Pract. 2017;2017:4585164. doi: 10.1155/2017/4585164. Epub 2017 Oct 22.
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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?
An observational study of Iron Deficiency Anemia, 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 1 inclusion and 1 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 2 Mar 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 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.
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?
Time to relapse of iron deficiency anemia (time frame: From screening until 12 months). 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 NCT01900197, 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 2 Mar 2016.