Status:
COMPLETED
Real Life Study on Iron Isomaltoside 1000 in the Treatment of ID in CKD, Heart Failure, ObGyn, IBD, Cancer and Elective Surgery (Real-CHOICE).
Lead Sponsor:
Pierre Fabre Pharma AG
Conditions:
Iron-Deficiency Anemia
Iron-Deficiency
Eligibility:
All Genders
18+ years
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 gener...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
July 10 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 30 2022
Estimated Enrollment :
327 Patients enrolled
Trial Details
Trial ID
NCT04318405
Start Date
July 10 2020
End Date
November 30 2022
Last Update
July 19 2023
Active Locations (21)
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1
21
Basel, Switzerland
2
9
Basel, Switzerland
3
1
Bern, Switzerland
4
15
Biel, Switzerland