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.

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.

Study Overview

• Status: Completed
• Conditions: Iron-Deficiency Anemia; Iron-Deficiency
• Intervention / Treatment: Drug: Iron isomaltoside 1000

• Study Type: Observational
• Enrollment (Actual): 327

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland
    • 21
  • Basel, Switzerland
    • 9
  • Bern, Switzerland
    • 1
  • Biel, Switzerland
    • 15
  • Brugg, Switzerland
    • 19
  • Gossau, Switzerland
    • 18
  • Kreuzlingen, Switzerland
    • 11
  • Kreuzlingen, Switzerland
    • 12
  • Kreuzlingen, Switzerland
    • 8
  • Liestal, Switzerland
    • 5
  • Opfikon, Switzerland
    • 20
  • Rheinfelden, Switzerland
    • 16
  • Sankt Gallen, Switzerland
    • 13
  • Sion, Switzerland
    • 7
  • Spreitenbach, Switzerland
    • 6
  • St. Gallen, Switzerland
    • 17
  • Steinach, Switzerland
    • 14
  • Wettingen, Switzerland
    • 10
  • Wohlen, Switzerland
    • 3
  • Zürich, Switzerland
    • 2
  • Zürich, Switzerland
    • 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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).

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: I am hesitant to be treated with IV iron.; I would consider IV iron treatment due to the physician ́s choice.; I would consider IV iron treatment due to its safety compared to other iron treatment options.; 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of treatment with IIM.	Iron deficiency anemia (IDA): Hb (Hemoglobin) increase ≥ 1 g/dL.	Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Effectiveness of treatment with IIM.	Iron deficiency without anemia (IDNA): Maintenance of baseline Hb-level and/or Hb above lower limit of normal (LLN).	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.	Taking into account baseline (BL) and follow-up (FU) answers. Questionnaire comprises the following questions: I am hesitant to be treated with IIM.; I would consider IIM treatment due to the physician ́s choice.; I would consider IIM treatment due to its safety compared to other iron treatment options.; I would consider IIM treatment due to its efficacy compared to other iron treatment options.; I would consider IIM treatment due to its specific dosing and administration schedule.	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.	Questionnaire comprises the following questions: I am hesitant to treat with IV iron.; I would consider IV iron treatment due to the patient ́s desire.; I would consider IV iron treatment due to its safety compared to other iron treatment options.; I would consider IV iron treatment due to its efficacy compared to other iron treatment options. And: I am hesitant to treat with IIM.; I would consider IIM treatment due to the patient ́s desire.; I would consider IIM treatment due to its safety compared to other iron treatment options.; I would consider IIM treatment due to its efficacy compared to other iron treatment options.; I would consider IIM treatment due to its specific dosing and administration schedule.	Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Patient and disease profiles at baseline.	Evaluation of kind of iron deficiency.	Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Patient and disease profiles at baseline.	Institution of diagnosis of IDA/IDNA.	Baseline.
Patient and disease profiles at baseline.	Etiology of iron deficiency.	Baseline.
Patient and disease profiles at baseline.	Method of iron need determination.	Baseline.
Calculation of iron need based on IIM simplified dosing scheme.	Evaluation of dosing intensity of IIM.	Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Calculation of iron need based on IIM simplified dosing scheme.	Calculated iron need.	Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Calculation of iron need based on IIM simplified dosing scheme.	Determined iron need.	Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Calculation of iron need based on IIM simplified dosing scheme.	Difference between administered IIM dose and calculated iron need.	Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Treatment sequence before IIM.	Dose intensities of administration.	Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Treatment sequence before IIM.	Dose intervals of administration.	Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Reason(s) for selection of IIM.	Reasons for treatment choice of IIM in current patient populations. Reasons could be: efficacy, safety profile, quality of life, patient's preference, physician's preference, comorbidities, convenient dosing, other.	Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Treatment with IIM.	Dose intensity of administration.	Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Treatment with IIM.	Mode of administration.	Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Treatment with IIM.	Duration of infusion.	Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Treatment satisfaction of physician and patient upon treatment.	Rate of physicians and patients with stability or positive change in satisfaction upon IIM treatment.	Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Effectiveness of treatment with IIM: whole blood count changes.	Red blood cell count	Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Effectiveness of treatment with IIM: whole blood count changes.	White blood cell count	Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Effectiveness of treatment with IIM: whole blood count changes.	Hemoglobin	Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Effectiveness of treatment with IIM: whole blood count changes.	Hematocrit	Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Effectiveness of treatment with IIM: whole blood count changes.	Platelets	Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Effectiveness of treatment with IIM: total Hb increase.	Hemoglobin	Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Effectiveness of treatment with IIM: serum ferritin increase.	Serum ferritin	Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Effectiveness of treatment with IIM: serum ferritin increase.	Transferrin saturation (TfS)	Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Effectiveness of treatment with IIM: serum ferritin increase.	Soluble transferrin receptor (sTfR)	Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Effectiveness of treatment with IIM: serum ferritin increase.	Phosphate level	Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Effectiveness of treatment with IIM: CRP (C-reactive protein) status.	CRP status.	Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Safety and tolerability of treatment with IIM, including frequency and severity of treatment-emergent AEs (Adverse Events) / ADRs (Adverse Drug Reactions).	Number of patients with: Treatment-emergent adverse events (maximum grade per patient),; Grade 3/4 treatment-emergent adverse drug reactions,; Grade 3/4 treatment-emergent serious adverse events,; Treatment-emergent serious adverse drug reactions,; Pre-treatment adverse events,; Pre-treatment serious adverse events,; Follow-up adverse events,; Follow-up serious adverse events.	Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).

Collaborators and Investigators

• Sponsor: Pierre Fabre Pharma AG

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2020
• Primary Completion (Actual): November 30, 2022
• Study Completion (Actual): November 30, 2022

Study Registration Dates

• First Submitted: March 12, 2020
• First Submitted That Met QC Criteria: March 19, 2020
• First Posted (Actual): March 24, 2020

Study Record Updates

• Last Update Posted (Actual): July 19, 2023
• Last Update Submitted That Met QC Criteria: July 18, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Iron isomaltoside 1000; Iron Derisomaltose 1000
• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Anemia, Hypochromic; Iron Metabolism Disorders; Anemia, Iron-Deficiency; Anemia; Iron Deficiencies; Physiological Effects of Drugs; Trace Elements; Micronutrients; Hematinics; Iron isomaltoside 1000; Iron
• Other Study ID Numbers: NIS-PFM-2019-2654

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No