Real Life Study on Iron Isomaltoside 1000 in the Treatment of ID in CKD, Heart Failure, ObGyn, IBD, Cancer and Elective Surgery (Real-CHOICE).
Real-CHOICE
Iron Isomaltoside 1000 in Patients With Iron Deficiency or Iron Deficiency Anemia: a Multicentric, Prospective, Longitudinal, Observational Study in Switzerland.
1 other identifier
observational
327
1 country
21
Brief 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 with or without anemia in the real-world clinical setting after commercial availability of this product in Switzerland.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2020
Typical duration for all trials
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 12, 2020
CompletedFirst Posted
Study publicly available on registry
March 24, 2020
CompletedStudy Start
First participant enrolled
July 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2022
CompletedJuly 19, 2023
July 1, 2023
2.4 years
March 12, 2020
July 18, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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: 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.
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.
Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Effectiveness of treatment with IIM.
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.
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.
Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Patient and disease profiles at baseline.
Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
- +26 more secondary outcomes
Interventions
Observation of real-life treatment with iron isomaltoside 1000 / Iron Derisomaltose 1000
Eligibility Criteria
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.
You may qualify if:
- Legally capable male and female patients, aged ≥ 18 years (no upper limit);
- Written informed consent of the patient with regard to the pseudonymized documentation;
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
21
Basel, Switzerland
9
Basel, Switzerland
1
Bern, Switzerland
15
Biel, Switzerland
19
Brugg, Switzerland
18
Gossau, Switzerland
11
Kreuzlingen, Switzerland
12
Kreuzlingen, Switzerland
8
Kreuzlingen, Switzerland
5
Liestal, Switzerland
20
Opfikon, Switzerland
16
Rheinfelden, Switzerland
13
Sankt Gallen, Switzerland
17
Sankt Gallen, Switzerland
7
Sion, Switzerland
6
Spreitenbach, Switzerland
14
Steinach, Switzerland
10
Wettingen, Switzerland
3
Wohlen, Switzerland
2
Zurich, Switzerland
4
Zurich, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2020
First Posted
March 24, 2020
Study Start
July 10, 2020
Primary Completion
November 30, 2022
Study Completion
November 30, 2022
Last Updated
July 19, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share