Real Life Study on Iron Isomaltoside 1000 in the Treatment of ID in CKD, Heart Failure, ObGyn, IBD, Cancer and Elective Surgery (Real-CHOICE).

NCT ID: NCT04318405

Last Updated: 2023-07-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 327 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-07-10
• Study Completion Date: 2022-11-30

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.

Conditions

Iron-Deficiency Anemia; Iron-Deficiency

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Iron isomaltoside 1000

Observation of real-life treatment with iron isomaltoside 1000 / Iron Derisomaltose 1000

Intervention Type: DRUG

Other Intervention Names

Iron Derisomaltose 1000

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;

Exclusion Criteria

• 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.

• 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pierre Fabre Pharma AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

Switzerland

Other Identifiers

NIS-PFM-2019-2654

Identifier Type: -

Identifier Source: org_study_id