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

Pierre Fabre

Status: Completed

Conditions: Iron-Deficiency; Iron-Deficiency Anemia

Treatments: Drug: Iron isomaltoside 1000

Study type: Observational

Funder types: Industry

Identifiers

NCT04318405

NIS-PFM-2019-2654

Details and patient eligibility

About

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.

Enrollment: 327 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).