Iron-Deficiency AnemiaReal-CHOICENCT04318405
Real Life Study on Iron Isomaltoside 1000 in the Treatment of ID in CKD, Heart Failure, ObGyn, IBD, Cancer and Elective Surgery (Real-CHOICE).
An observational study of Iron-Deficiency Anemia and Iron-Deficiency, run by Pierre Fabre Pharma AG at 21 sites in Switzerland.
Trial summary
Real-CHOICE - designed as a prospective, longitudinal, observational, non-interventional study - will investigate the attitude of patients and physicians towards IV (intravenous) iron therapy in general and IIM (iron isomaltoside 1000) treatment particularly before and after IIM treatment in iron deficient patients… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iron-Deficiency Anemia, Iron-Deficiency
- What is being tested?
- Iron isomaltoside 1000
- How many people
- 327 participants
- Where
- 21 sitesSwitzerland
- Study dates
- 10 Jul 2020to 30 Nov 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with iron deficiency (IDNA) or iron deficiency anemia (IDA) treated at the treating physician's discretion with IIM according to the Swiss SmPC for Monofer® in current practice.
Who may be able to join
- Legally capable male and female patients, aged ≥ 18 years (no upper limit);
- Written informed consent of the patient with regard to the pseudonymized documentation;
- The patients are not selected by specific inclusion or exclusion criteria, but by the indication listed in the Swiss SmPC (Summary of Product Characteristics) of Monofer®;
- Decision is taken to treat the patient with IIM in accordance with the current Swiss SmPC of Monofer® and by prescription; this decision is taken prior to and independent from the inclusion into the study.
Who cannot join
- Any contraindication regarding IIM treatment as specified in the Swiss SmPC of Monofer®;
- Retrospective observation of IIM infusion;
- Current or upcoming participation in an interventional clinical trial;
- Prior IV iron treatment or transfusion within 3 months prior to enrolment;
- Instable and/or untreated comorbidities potentially hampering the observation of the primary outcome parameter of this study;
- Prisoners or persons who are compulsorily detained (involuntarily incarcerated).
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
Switzerland21 sites
21
Basel
9
Basel
1
Bern
15
Biel
19
Brugg
18
Gossau
11
Kreuzlingen
12
Kreuzlingen
8
Kreuzlingen
5
Liestal
20
Opfikon
16
Rheinfelden
13
Sankt Gallen
17
Sankt Gallen
7
Sion
6
Spreitenbach
14
Steinach
10
Wettingen
3
Wohlen
2
Zurich
4
Zurich
About this study
Official title: Iron Isomaltoside 1000 in Patients With Iron Deficiency or Iron Deficiency Anemia: a Multicentric, Prospective, Longitudinal, Observational Study in Switzerland.
Real-CHOICE - designed as a prospective, longitudinal, observational, non-interventional study - will investigate the attitude of patients and physicians towards IV (intravenous) iron therapy in general and IIM (iron isomaltoside 1000) treatment particularly before and after IIM treatment in iron deficient patients with or without anemia in the real-world clinical setting after commercial availability of this product in Switzerland.
- Conditions
- Iron-Deficiency Anemia, Iron-Deficiency
- Being tested
- Iron isomaltoside 1000
- Keywords
- Iron isomaltoside 1000, Iron Derisomaltose 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.
Iron isomaltoside 1000Drug
Also called Iron Derisomaltose 1000
Observation of real-life treatment with iron isomaltoside 1000 / Iron Derisomaltose 1000
What is being measured
The primary outcome is the main question the study is designed to answer.
Attitude of patients towards IV iron treatment evaluated with questionnaire.
Rate of patients with stability or positive change in attitude.
Questionnaire comprises the following questions:
- I am hesitant to be treated with IV iron.
- I would consider IV iron treatment due to the physician ́s choice.
- I would consider IV iron treatment due to its safety compared to other iron treatment options.
- I would consider IV iron treatment due to its efficacy compared to other iron treatment options.
Measured: Change from baseline taking into account baseline (BL) and follow-up (FU) answers. Follow-up at the latest 12 weeks after observed dosing and before a potential subsequent dosing (if available based on clinical routine follow-up).
Secondary outcomes (31)
Effectiveness of treatment with IIM.
Iron deficiency anemia (IDA): Hb (Hemoglobin) increase ≥ 1 g/dL.
Measured: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Effectiveness of treatment with IIM.
Iron deficiency without anemia (IDNA): Maintenance of baseline Hb-level and/or Hb above lower limit of normal (LLN).
Measured: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Attitude of patients towards IIM treatment evaluated with questionnaire.
Taking into account baseline (BL) and follow-up (FU) answers.
Questionnaire comprises the following questions:
- I am hesitant to be treated with IIM.
- I would consider IIM treatment due to the physician ́s choice.
- I would consider IIM treatment due to its safety compared to other iron treatment options.
- I would consider IIM treatment due to its efficacy compared to other iron treatment options.
- I would consider IIM treatment due to its specific dosing and administration schedule.
Measured: Complete observation time-frame (the total observation period of this study will amount to 90 months).
Attitude of physicians towards IIM and IV iron treatment evaluated with questionnaire.
Questionnaire comprises the following questions:
- I am hesitant to treat with IV iron.
- I would consider IV iron treatment due to the patient ́s desire.
- I would consider IV iron treatment due to its safety compared to other iron treatment options.
- I would consider IV iron treatment due to its efficacy compared to other iron treatment options.
And:
- I am hesitant to treat with IIM.
- I would consider IIM treatment due to the patient ́s desire.
- I would consider IIM treatment due to its safety compared to other iron treatment options.
- I would consider IIM treatment due to its efficacy compared to other iron treatment options.
- I would consider IIM treatment due to its specific dosing and administration schedule.
Measured: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Patient and disease profiles at baseline.
Evaluation of kind of iron deficiency.
Measured: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Patient and disease profiles at baseline.
Institution of diagnosis of IDA/IDNA.
Measured: Baseline.
Patient and disease profiles at baseline.
Etiology of iron deficiency.
Measured: Baseline.
Patient and disease profiles at baseline.
Method of iron need determination.
Measured: Baseline.
Calculation of iron need based on IIM simplified dosing scheme.
Evaluation of dosing intensity of IIM.
Measured: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Calculation of iron need based on IIM simplified dosing scheme.
Calculated iron need.
Measured: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Calculation of iron need based on IIM simplified dosing scheme.
Determined iron need.
Measured: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Calculation of iron need based on IIM simplified dosing scheme.
Difference between administered IIM dose and calculated iron need.
Measured: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Treatment sequence before IIM.
Dose intensities of administration.
Measured: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Treatment sequence before IIM.
Dose intervals of administration.
Measured: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Reason(s) for selection of IIM.
Reasons for treatment choice of IIM in current patient populations. Reasons could be: efficacy, safety profile, quality of life, patient's preference, physician's preference, comorbidities, convenient dosing, other.
Measured: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Treatment with IIM.
Dose intensity of administration.
Measured: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Treatment with IIM.
Mode of administration.
Measured: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Treatment with IIM.
Duration of infusion.
Measured: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Treatment satisfaction of physician and patient upon treatment.
Rate of physicians and patients with stability or positive change in satisfaction upon IIM treatment.
Measured: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Effectiveness of treatment with IIM: whole blood count changes.
Red blood cell count
Measured: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Effectiveness of treatment with IIM: whole blood count changes.
White blood cell count
Measured: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Effectiveness of treatment with IIM: whole blood count changes.
Hemoglobin
Measured: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Effectiveness of treatment with IIM: whole blood count changes.
Hematocrit
Measured: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Effectiveness of treatment with IIM: whole blood count changes.
Platelets
Measured: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Effectiveness of treatment with IIM: total Hb increase.
Hemoglobin
Measured: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Effectiveness of treatment with IIM: serum ferritin increase.
Serum ferritin
Measured: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Effectiveness of treatment with IIM: serum ferritin increase.
Transferrin saturation (TfS)
Measured: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Effectiveness of treatment with IIM: serum ferritin increase.
Soluble transferrin receptor (sTfR)
Measured: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Effectiveness of treatment with IIM: serum ferritin increase.
Phosphate level
Measured: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Effectiveness of treatment with IIM: CRP (C-reactive protein) status.
CRP status.
Measured: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Safety and tolerability of treatment with IIM, including frequency and severity of treatment-emergent AEs (Adverse Events) / ADRs (Adverse Drug Reactions).
Number of patients with:
- Treatment-emergent adverse events (maximum grade per patient),
- Grade 3/4 treatment-emergent adverse drug reactions,
- Grade 3/4 treatment-emergent serious adverse events,
- Treatment-emergent serious adverse drug reactions,
- Pre-treatment adverse events,
- Pre-treatment serious adverse events,
- Follow-up adverse events,
- Follow-up serious adverse events.
Measured: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start10 Jul 2020
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
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
- 327 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Pharma AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04318405
- Sponsor's protocol ID
- NIS-PFM-2019-2654
- Acronym
- Real-CHOICE
- Status last verified
- Jul 2023
- First submitted
- 12 Mar 2020
- Last updated
- 19 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stute P, Krayenbuhl PA, Vavricka SR. Attitudes towards ferric derisomaltose among Swiss patients with iron deficiency and their treating physicians: the prospective, observational Real-CHOICE study. Arch Gynecol Obstet. 2025 Sep;312(3):909-918. doi: 10.1007/s00404-025-08085-5. Epub 2025 Jun 20.
PubMed 40542212
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron Isomaltoside 1000 in Patients With Iron Deficiency or Iron Deficiency Anemia: a Multicentric, Prospective, Longitudinal, Observational Study in Switzerland.
- ClinicalTrials.gov ID
- NCT04318405
- Acronym / sponsor ID
- Real-CHOICE / NIS-PFM-2019-2654
- Conditions
- Iron-Deficiency Anemia, Iron-Deficiency
- Keywords
- Iron isomaltoside 1000, Iron Derisomaltose 1000
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 327 participants (actual)
- Lead sponsor
- Pierre Fabre Pharma AGIndustry (pharma, biotech, devices)
- Study start
- 10 Jul 2020 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 24 Mar 2020 (actual)
- 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.
Real-CHOICE - designed as a prospective, longitudinal, observational, non-interventional study - will investigate the attitude of patients and physicians towards IV (intravenous) iron therapy in general and IIM (iron isomaltoside 1000) treatment particularly before and after IIM treatment in iron deficient patients with or without anemia in the real-world clinical setting after commercial availability of this product in Switzerland.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with iron deficiency (IDNA) or iron deficiency anemia (IDA) treated at the treating physician's discretion with IIM according to the Swiss SmPC for Monofer® in current practice.
Key inclusion criteria (4 listed)
- Legally capable male and female patients, aged ≥ 18 years (no upper limit);
- Written informed consent of the patient with regard to the pseudonymized documentation;
- The patients are not selected by specific inclusion or exclusion criteria, but by the indication listed in the Swiss SmPC (Summary of Product Characteristics) of Monofer®;
- Decision is taken to treat the patient with IIM in accordance with the current Swiss SmPC of Monofer® and by prescription; this decision is taken prior to and independent from the inclusion into the study.
Key exclusion criteria (6 listed)
- Any contraindication regarding IIM treatment as specified in the Swiss SmPC of Monofer®;
- Retrospective observation of IIM infusion;
- Current or upcoming participation in an interventional clinical trial;
- Prior IV iron treatment or transfusion within 3 months prior to enrolment;
- Instable and/or untreated comorbidities potentially hampering the observation of the primary outcome parameter of this study;
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: Iron Derisomaltose 1000Observation of real-life treatment with iron isomaltoside 1000 / Iron Derisomaltose 1000 | Drug | – |
Primary outcome
Attitude of patients towards IV iron treatment evaluated with questionnaire.
Time frame: Change from baseline taking into account baseline (BL) and follow-up (FU) answers. Follow-up at the latest 12 weeks after observed dosing and before a potential subsequent dosing (if available based on clinical routine follow-up).
Rate of patients with stability or positive change in attitude. Questionnaire comprises the following questions: 1. I am hesitant to be treated with IV iron. 2. I would consider IV iron treatment due to the physician ́s choice. 3. I would consider IV iron treatment due to its safety compared to other iron treatment options. 4. I would consider IV iron treatment due to its efficacy compared to other iron treatment options.
31 secondary outcomes
Effectiveness of treatment with IIM.
Time frame: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Effectiveness of treatment with IIM.
Time frame: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Attitude of patients towards IIM treatment evaluated with questionnaire.
Time frame: Complete observation time-frame (the total observation period of this study will amount to 90 months).
Attitude of physicians towards IIM and IV iron treatment evaluated with questionnaire.
Time frame: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Patient and disease profiles at baseline.
Time frame: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Patient and disease profiles at baseline.
Time frame: Baseline.
Patient and disease profiles at baseline.
Time frame: Baseline.
Patient and disease profiles at baseline.
Time frame: Baseline.
Calculation of iron need based on IIM simplified dosing scheme.
Time frame: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Calculation of iron need based on IIM simplified dosing scheme.
Time frame: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Calculation of iron need based on IIM simplified dosing scheme.
Time frame: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Calculation of iron need based on IIM simplified dosing scheme.
Time frame: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Treatment sequence before IIM.
Time frame: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Treatment sequence before IIM.
Time frame: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Reason(s) for selection of IIM.
Time frame: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Treatment with IIM.
Time frame: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Treatment with IIM.
Time frame: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Treatment with IIM.
Time frame: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Treatment satisfaction of physician and patient upon treatment.
Time frame: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Effectiveness of treatment with IIM: whole blood count changes.
Time frame: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Effectiveness of treatment with IIM: whole blood count changes.
Time frame: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Effectiveness of treatment with IIM: whole blood count changes.
Time frame: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Effectiveness of treatment with IIM: whole blood count changes.
Time frame: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Effectiveness of treatment with IIM: whole blood count changes.
Time frame: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Effectiveness of treatment with IIM: total Hb increase.
Time frame: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Effectiveness of treatment with IIM: serum ferritin increase.
Time frame: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Effectiveness of treatment with IIM: serum ferritin increase.
Time frame: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Effectiveness of treatment with IIM: serum ferritin increase.
Time frame: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Effectiveness of treatment with IIM: serum ferritin increase.
Time frame: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Effectiveness of treatment with IIM: CRP (C-reactive protein) status.
Time frame: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Safety and tolerability of treatment with IIM, including frequency and severity of treatment-emergent AEs (Adverse Events) / ADRs (Adverse Drug Reactions).
Time frame: Complete observation time-frame (the total observation period of this study per patient will amount to 3 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 19 Jul 2023.
- Derived from this study: PubMed 40542212Stute P, Krayenbuhl PA, Vavricka SR. Attitudes towards ferric derisomaltose among Swiss patients with iron deficiency and their treating physicians: the prospective, observational Real-CHOICE study. Arch Gynecol Obstet. 2025 Sep;312(3):909-918. doi: 10.1007/s00404-025-08085-5. Epub 2025 Jun 20.
- Individual participant dataSharing planned: No
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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.
21 sites 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 and Iron-Deficiency, run by Pierre Fabre Pharma AG at 21 sites in Switzerland.
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 6 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 19 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Switzerland. 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?
Attitude of patients towards IV iron treatment evaluated with questionnaire. (time frame: Change from baseline taking into account baseline (BL) and follow-up (FU) answers. Follow-up at the latest 12 weeks after observed dosing and before a potential subsequent dosing (if available based on clinical routine follow-up).). 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 NCT04318405, 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 19 Jul 2023.