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Study of the Prevalence of Iron Deficiency in Patients With Chronic Renal Failure But Non-Dialysis (CARENFER IRC-ND)

Primary Purpose

Chronic Kidney Diseases

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Iron status testing
Sponsored by
VIFORFRANCE
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Kidney Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient, male or female, over 18 years of age;
  • Patient present at the hospital on the day of the study (traditional hospitalization, week hospital, day hospital, or in consultation with CKD-ND);
  • Diagnosis of CKD-ND (glomerular filtration rate (GFR) > 15 mL/min/1.73 m²)
  • Patient with signed consent

Exclusion Criteria:

  • Protected patient: major under guardianship, tutorship or other legal protection, deprived of liberty by judicial or administrative decision;
  • Pregnant or breastfeeding woman;
  • Patient with dialysis

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    CDK-ND

    Arm Description

    Outcomes

    Primary Outcome Measures

    Complete blood iron status
    ferritin
    Complete blood iron status
    Transferrin Saturation Factor

    Secondary Outcome Measures

    Full Information

    First Posted
    October 9, 2019
    Last Updated
    October 10, 2019
    Sponsor
    VIFORFRANCE
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04123145
    Brief Title
    Study of the Prevalence of Iron Deficiency in Patients With Chronic Renal Failure But Non-Dialysis (CARENFER IRC-ND)
    Official Title
    Study of the Prevalence of Iron Deficiency in Patients With Chronic Renal Failure But Non-Dialysis (CARENFER IRC-ND)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 15, 2019 (Anticipated)
    Primary Completion Date
    February 28, 2020 (Anticipated)
    Study Completion Date
    March 30, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    VIFORFRANCE

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Despite its known prevalence, a recent study conducted with Prof. Cacoub (unpublished) on the national health insurance database showed that iron deficiency was a poorly diagnosed and poorly treated comorbidity. In patients with Chronic Kidney Disease but Non-Dialysis, the determination of Ferritinemia and Transferrin Saturation Factoris performed in only 30% and 10% of cases whereas they should be performed routinely in inflammatory situations and in case of anemia (HAS 2011, KDIGO 2012). The objective of this study is to obtain updated data on the prevalence of iron deficiency in France in patients with CKD-ND, applying the international recommendations and those of the French Health High Authority (determination of ferritinemia and Transferrin Saturation Factor).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Kidney Diseases

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    1100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    CDK-ND
    Arm Type
    Experimental
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Iron status testing
    Intervention Description
    Iron status testing
    Primary Outcome Measure Information:
    Title
    Complete blood iron status
    Description
    ferritin
    Time Frame
    One day
    Title
    Complete blood iron status
    Description
    Transferrin Saturation Factor
    Time Frame
    One day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patient, male or female, over 18 years of age; Patient present at the hospital on the day of the study (traditional hospitalization, week hospital, day hospital, or in consultation with CKD-ND); Diagnosis of CKD-ND (glomerular filtration rate (GFR) > 15 mL/min/1.73 m²) Patient with signed consent Exclusion Criteria: Protected patient: major under guardianship, tutorship or other legal protection, deprived of liberty by judicial or administrative decision; Pregnant or breastfeeding woman; Patient with dialysis

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Study of the Prevalence of Iron Deficiency in Patients With Chronic Renal Failure But Non-Dialysis (CARENFER IRC-ND)

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