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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05514951
Other study ID # 2022-A00787-36
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date November 15, 2022
Est. completion date November 30, 2022

Study information

Verified date November 2022
Source Vifor Pharma
Contact Serge MAILLET
Phone + 33 1 80 04 16 39
Email serge.maillet@viforpharma.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Iron deficiency is defined by insufficient tissue iron stores and anemia is the ultimate stage of iron deficiency. Anemia should never be neglected in an elderly subject because it is associated with an increase in mortality, but also with a increased morbidity in terms of complications Apart from anemia, iron deficiency is common and constitutes a factor of poor prognosis in diseases chronic, all pathologies very frequently found in the elderly. It is the origin of the deterioration in the general condition of patients, their re-hospitalization or even the progression of their pathology. In this context where elderly patients also present a certain number of comorbidities including the pathologies mentioned previously, it is important to better diagnose the deficiency martial in the elderly patient.


Description:

Iron deficiency (MD) is defined by insufficient tissue iron stores. Since iron is essential for the synthesis of hemoglobin, when the iron deficiency no longer makes it possible to maintain a sufficient level of erythropoiesis, anemia appears: it is the ultimate stage of iron deficiency. Anemia is the most common haematological pathology encountered in geriatric practice. Its prevalence, in population generally ambulatory, is between 10 and 15% after the age of 65 and is greater than 20% beyond the age of 85. Anemia should never be neglected in an elderly subject because it is associated with an increase in mortality, but also with a increased morbidity in terms of complications heart disease, cognitive decline, frailty, hospitalizations, and impairment of quality of life. About a third of anemias elderly person is attributable to a deficiency in vitamin B9 or B12 or an iron deficiency. Apart from anemia, iron deficiency is common and constitutes a factor of poor prognosis in diseases chronic such as heart failure, kidney failure chronic or cancer, all pathologies very frequently found in the elderly. It is the origin of the deterioration in the general condition of patients, their re-hospitalization or even the progression of their pathology. In this context where elderly patients also present a certain number of comorbidities including the pathologies mentioned previously, it is important to better diagnose the deficiency martial in the elderly patient. This diagnosis is all the more important because, depending on the chronic pathology, data from the literature have shown that correcting the iron deficiency brings benefits to the patient by reducing the risk of recurrence of anemia, the prescription of erythropoietin and the use of transfusion for patients in oncology, gastroenterology and nephrology


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 900
Est. completion date November 30, 2022
Est. primary completion date November 30, 2022
Accepts healthy volunteers No
Gender All
Age group 75 Years and older
Eligibility Inclusion Criteria: - Any patient hospitalized in a geriatric unit (short geriatric stay, SSR) or seen on an outpatient basis (hospitalization day, consultation) - Affiliated patient or beneficiary of a social healthcare system - Patient having given written consent Exclusion Criteria: - Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by court order or administration

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Blood sampling
Blood sampling

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Vifor Pharma

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of patients diagnosed with iron deficiency on inclusion The diagnosis of iron deficiency will be made from the measurements of the ferritinemia and CST: Ferritinemia < 100 µg/L and/or CST < 20% Day 1
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