NCT04123145

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 Cacoub (unpublished) on the national health insurance database showed that iron deficiency was a poorly diagnosed and poorly treated comorbidity.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).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,100

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 9, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 10, 2019

Completed
5 days until next milestone

Study Start

First participant enrolled

October 15, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
Last Updated

October 14, 2019

Status Verified

October 1, 2019

Enrollment Period

5 months

First QC Date

October 9, 2019

Last Update Submit

October 10, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • Complete blood iron status

    ferritin

    One day

  • Complete blood iron status

    Transferrin Saturation Factor

    One day

Study Arms (1)

CDK-ND

EXPERIMENTAL
Diagnostic Test: Iron status testing

Interventions

Iron status testingDIAGNOSTIC_TEST

Iron status testing

CDK-ND

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2019

First Posted

October 10, 2019

Study Start

October 15, 2019

Primary Completion

February 28, 2020

Study Completion

March 30, 2020

Last Updated

October 14, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share