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
About this trial
This is an interventional diagnostic trial for Chronic Kidney Diseases
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
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
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 Cacoub (unpublished) on the national health insurance database showed that iron deficiency was a poorly diagnosed and poorly treated comorbidity.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)
We'll reach out to this number within 24 hrs