Clinical trial · Observational
Real Life Study on Iron Isomaltoside 1000 in the Treatment of ID in CKD, Heart Failure, ObGyn, IBD, Cancer and Elective Surgery (Real-CHOICE).
Iron Isomaltoside 1000 in Patients With Iron Deficiency or Iron Deficiency Anemia: a Multicentric, Prospective, Longitudinal, Observational Study in Switzerland.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Iron-Deficiency | — | UNRESOLVED | — |
| Iron-Deficiency Anemia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Iron isomaltoside 1000 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Attitude of patients towards IV iron treatment evaluated with questionnaire.
- timeFrame
- 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).
- description
- 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.
Secondary outcomes (31)
- measure
- Effectiveness of treatment with IIM.
- timeFrame
- Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
- description
- Iron deficiency anemia (IDA): Hb (Hemoglobin) increase ≥ 1 g/dL.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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).
References
Publications (1)
- DERIVEDStute 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. PMID 40542212