Clinical trial NCT04318405: Real Life Study on Iron Isomaltoside 1000 in the Treatment of ID in CKD, Heart Failure, ObGyn, IBD, Cancer and Elective Surgery (Real-CHOICE).
Official title: Iron Isomaltoside 1000 in Patients With Iron Deficiency or Iron Deficiency Anemia: a Multicentric, Prospective, Longitudinal, Observational Study in Switzerland.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Iron-Deficiency Anemia
Iron-Deficiency
Keywords: Iron isomaltoside 1000
Iron Derisomaltose 1000
Lead sponsor: Pierre Fabre Pharma AG
Sponsor class: INDUSTRY
First posted: 2020-03-24
Enrollment: 327
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.


Eligibility criteria: 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).

Primary outcomes:
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).
Secondary outcomes:
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).
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).
measure: Attitude of patients towards IIM treatment evaluated with questionnaire.
timeFrame: Complete observation time-frame (the total observation period of this study will amount to 90 months).
measure: Attitude of physicians towards IIM and IV iron treatment evaluated with questionnaire.
timeFrame: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
measure: Patient and disease profiles at baseline.
timeFrame: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
measure: Patient and disease profiles at baseline.
timeFrame: Baseline.
measure: Patient and disease profiles at baseline.
timeFrame: Baseline.
measure: Patient and disease profiles at baseline.
timeFrame: Baseline.
measure: Calculation of iron need based on IIM simplified dosing scheme.
timeFrame: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
measure: Calculation of iron need based on IIM simplified dosing scheme.
timeFrame: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
measure: Calculation of iron need based on IIM simplified dosing scheme.
timeFrame: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
measure: Calculation of iron need based on IIM simplified dosing scheme.
timeFrame: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
measure: Treatment sequence before IIM.
timeFrame: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
measure: Treatment sequence before IIM.
timeFrame: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
measure: Reason(s) for selection of IIM.
timeFrame: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
measure: Treatment with IIM.
timeFrame: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
measure: Treatment with IIM.
timeFrame: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
measure: Treatment with IIM.
timeFrame: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
measure: Treatment satisfaction of physician and patient upon treatment.
timeFrame: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
measure: Effectiveness of treatment with IIM: whole blood count changes.
timeFrame: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
measure: Effectiveness of treatment with IIM: whole blood count changes.
timeFrame: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
measure: Effectiveness of treatment with IIM: whole blood count changes.
timeFrame: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
measure: Effectiveness of treatment with IIM: whole blood count changes.
timeFrame: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
measure: Effectiveness of treatment with IIM: whole blood count changes.
timeFrame: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
measure: Effectiveness of treatment with IIM: total Hb increase.
timeFrame: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
measure: Effectiveness of treatment with IIM: serum ferritin increase.
timeFrame: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
measure: Effectiveness of treatment with IIM: serum ferritin increase.
timeFrame: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
measure: Effectiveness of treatment with IIM: serum ferritin increase.
timeFrame: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
measure: Effectiveness of treatment with IIM: serum ferritin increase.
timeFrame: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
measure: Effectiveness of treatment with IIM: CRP (C-reactive protein) status.
timeFrame: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
measure: Safety and tolerability of treatment with IIM, including frequency and severity of treatment-emergent AEs (Adverse Events) / ADRs (Adverse Drug Reactions).
timeFrame: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: 21
city: Basel
country: Switzerland
facility: 9
city: Bern
country: Switzerland
facility: 1
city: Biel
country: Switzerland
facility: 15
city: Brugg
country: Switzerland
facility: 19
city: Gossau
country: Switzerland
facility: 18
city: Kreuzlingen
country: Switzerland
facility: 11
city: Kreuzlingen
country: Switzerland
facility: 12
city: Kreuzlingen
country: Switzerland
facility: 8
city: Liestal
country: Switzerland
facility: 5
city: Opfikon
country: Switzerland
facility: 20
city: Rheinfelden
country: Switzerland
facility: 16
city: Sankt Gallen
country: Switzerland
facility: 13
city: Sion
country: Switzerland
facility: 7
city: Spreitenbach
country: Switzerland
facility: 6
city: St. Gallen
country: Switzerland
facility: 17
city: Steinach
country: Switzerland
facility: 14
city: Wettingen
country: Switzerland
facility: 10
city: Wohlen
country: Switzerland
facility: 3
city: Zürich
country: Switzerland
facility: 2
city: Zürich
country: Switzerland
facility: 4
Study officials:
References: