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

Iron-Deficiency Clinical Trial

— Real-CHOICE  

Official title:

Iron Isomaltoside 1000 in Patients With Iron Deficiency or Iron Deficiency Anemia: a Multicentric, Prospective, Longitudinal, Observational Study in Switzerland.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04318405
• Other study ID #: NIS-PFM-2019-2654
• Status: Completed
• Start date: July 10, 2020
• Est. completion date: November 30, 2022

Study information

• Verified date: July 2023
• Source: Pierre Fabre Pharma AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 327
• Est. completion date: November 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Iron-Deficiency
• Iron-Deficiency Anemia

Intervention

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

Locations

Country	Name	City	State
Switzerland	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	7	Sion
Switzerland	6	Spreitenbach
Switzerland	17	St. Gallen
Switzerland	14	Steinach
Switzerland	10	Wettingen
Switzerland	3	Wohlen
Switzerland	2	Zürich
Switzerland	4	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Pierre Fabre Pharma AG

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	Patient and disease profiles at baseline.	Institution of diagnosis of IDA/IDNA.	Baseline.
Secondary	Patient and disease profiles at baseline.	Etiology of iron deficiency.	Baseline.
Secondary	Patient and disease profiles at baseline.	Method of iron need determination.	Baseline.
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	Treatment with IIM.	Mode of administration.	Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Secondary	Treatment with IIM.	Duration of infusion.	Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).