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 Type
OBSERVATIONAL
Enrollment
327
Observation of real-life treatment with iron isomaltoside 1000 / Iron Derisomaltose 1000
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
...and 11 more locations
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: 1. I am hesitant to be treated with IV iron. 2. I would consider IV iron treatment due to the physician ́s choice. 3. I would consider IV iron treatment due to its safety compared to other iron treatment options. 4. I would consider IV iron treatment due to its efficacy compared to other iron treatment options.
Time frame: 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).
Effectiveness of treatment with IIM.
Iron deficiency anemia (IDA): Hb (Hemoglobin) increase ≥ 1 g/dL.
Time frame: 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).
Time frame: 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: 1. I am hesitant to be treated with IIM. 2. I would consider IIM treatment due to the physician ́s choice. 3. I would consider IIM treatment due to its safety compared to other iron treatment options. 4. I would consider IIM treatment due to its efficacy compared to other iron treatment options. 5. I would consider IIM treatment due to its specific dosing and administration schedule.
Time frame: 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: 1. I am hesitant to treat with IV iron. 2. I would consider IV iron treatment due to the patient ́s desire. 3. I would consider IV iron treatment due to its safety compared to other iron treatment options. 4. I would consider IV iron treatment due to its efficacy compared to other iron treatment options. And: 1. I am hesitant to treat with IIM. 2. I would consider IIM treatment due to the patient ́s desire. 3. I would consider IIM treatment due to its safety compared to other iron treatment options. 4. I would consider IIM treatment due to its efficacy compared to other iron treatment options. 5. I would consider IIM treatment due to its specific dosing and administration schedule.
Time frame: 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.
Time frame: 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.
Time frame: Baseline.
Patient and disease profiles at baseline.
Etiology of iron deficiency.
Time frame: Baseline.
Patient and disease profiles at baseline.
Method of iron need determination.
Time frame: Baseline.
Calculation of iron need based on IIM simplified dosing scheme.
Evaluation of dosing intensity of IIM.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Treatment with IIM.
Mode of administration.
Time frame: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Treatment with IIM.
Duration of infusion.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
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