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JOURNAL ONKOLOGIE – STUDIE
Real-CHOICE

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

Rekrutierend

NCT-Nummer:
NCT04318405

Studienbeginn:
Juni 2020

Letztes Update:
26.03.2021

Wirkstoff:
Iron isomaltoside 1000

Indikation (Clinical Trials):
Anemia, Anemia, Iron-Deficiency

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Pierre Fabre Pharma AG

Collaborator:
-

Kontakt

Studienlocations
(3 von 14)

Darmzentrum Portal10 Münster
Albersloher Weg 10
48153 Münster
DeutschlandRekrutierend» Google-Maps
Darmzentrum Portal10 Münster
Albersloher Weg 10
48153 Münster
DeutschlandRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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).

Studien-Rationale

Primary outcome:

1. Attitude of patients towards IV iron treatment evaluated with questionnaire. (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).):
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.



Secondary outcome:

1. Effectiveness of treatment with IIM. (Time Frame - Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).):
Iron deficiency anemia (IDA): Hb (Hemoglobin) increase ≥ 1 g/dL.

2. Effectiveness of treatment with IIM. (Time Frame - Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).):
Iron deficiency without anemia (IDNA): Maintenance of baseline Hb-level and/or Hb above lower limit of normal (LLN).

3. Attitude of patients towards IIM treatment evaluated with questionnaire. (Time Frame - Complete observation time-frame (the total observation period of this study will amount to 90 months).):
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.

4. Attitude of physicians towards IIM and IV iron treatment evaluated with questionnaire. (Time Frame - Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).):
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.

5. Patient and disease profiles at baseline. (Time Frame - Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).):
Evaluation of kind of iron deficiency.

6. Patient and disease profiles at baseline. (Time Frame - Baseline.):
Institution of diagnosis of IDA/IDNA.

7. Patient and disease profiles at baseline. (Time Frame - Baseline.):
Etiology of iron deficiency.

8. Patient and disease profiles at baseline. (Time Frame - Baseline.):
Method of iron need determination.

9. Calculation of iron need based on IIM simplified dosing scheme. (Time Frame - Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).):
Evaluation of dosing intensity of IIM.

10. Calculation of iron need based on IIM simplified dosing scheme. (Time Frame - Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).):
Calculated iron need.

11. Calculation of iron need based on IIM simplified dosing scheme. (Time Frame - Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).):
Determined iron need.

12. Calculation of iron need based on IIM simplified dosing scheme. (Time Frame - Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).):
Difference between administered IIM dose and calculated iron need.

13. Treatment sequence before IIM. (Time Frame - Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).):
Dose intensities of administration.

14. Treatment sequence before IIM. (Time Frame - Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).):
Dose intervals of administration.

15. Reason(s) for selection of IIM. (Time Frame - Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).):
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.

16. Treatment with IIM. (Time Frame - Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).):
Dose intensity of administration.

17. Treatment with IIM. (Time Frame - Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).):
Mode of administration.

18. Treatment with IIM. (Time Frame - Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).):
Duration of infusion.

19. Treatment satisfaction of physician and patient upon treatment. (Time Frame - Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).):
Rate of physicians and patients with stability or positive change in satisfaction upon IIM treatment.

20. Effectiveness of treatment with IIM: whole blood count changes. (Time Frame - Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).):
Red blood cell count

21. Effectiveness of treatment with IIM: whole blood count changes. (Time Frame - Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).):
White blood cell count

22. Effectiveness of treatment with IIM: whole blood count changes. (Time Frame - Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).):
Hemoglobin

23. Effectiveness of treatment with IIM: whole blood count changes. (Time Frame - Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).):
Hematocrit

24. Effectiveness of treatment with IIM: whole blood count changes. (Time Frame - Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).):
Platelets

25. Effectiveness of treatment with IIM: total Hb increase. (Time Frame - Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).):
Hemoglobin

26. Effectiveness of treatment with IIM: serum ferritin increase. (Time Frame - Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).):
Serum ferritin

27. Effectiveness of treatment with IIM: serum ferritin increase. (Time Frame - Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).):
Transferrin saturation (TfS)

28. Effectiveness of treatment with IIM: serum ferritin increase. (Time Frame - Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).):
Soluble transferrin receptor (sTfR)

29. Effectiveness of treatment with IIM: serum ferritin increase. (Time Frame - Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).):
Phosphate level

30. Effectiveness of treatment with IIM: CRP (C-reactive protein) status. (Time Frame - Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).):
CRP status.

31. Safety and tolerability of treatment with IIM, including frequency and severity of treatment-emergent AEs (Adverse Events) / ADRs (Adverse Drug Reactions). (Time Frame - Complete observation time-frame (the total observation period of this study per patient will amount to 3 months).):
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.

Geprüfte Regime

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

Quelle: ClinicalTrials.gov


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