NCT02938611

Brief Summary

The main objective of this study is to evaluate the feasibility of estimating the prevalence of stage 4 and 5 chronic kidney disease in the Gard department of France from data obtained via laboratory databases. To verifiy if the demand for care thus authenticated by laboratory tests is adapted to nephrology care delivery, as recommended by the French High Authority of Health (HAS), laboratory data will be compared with those of patients seen by nephrologists in the department.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
3,375

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
recruiting

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 18, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 2016

Completed
2.2 years until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

March 10, 2025

Status Verified

March 1, 2025

Enrollment Period

6.9 years

First QC Date

October 18, 2016

Last Update Submit

March 7, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • The prevalence of chronic kidney disease stage > = 4 in the Gard according to laboratory data (raw number)

    from baseline (day 0) to 12 months

  • The prevalence of chronic kidney disease stage > = 4 in the Gard according to laboratory data (%)

    from baseline (day 0) to 12 months

Secondary Outcomes (3)

  • The percentage of patients with CKD stage >= 4 correctly reported by participating nephrologists

    from baseline (day 0) to 12 months

  • For each nephrologist participating in the study, the % of patients with stage >=4 chronic kidney disease who are correctly declared

    from baseline (day 0) to 12 months

  • The % of patients with chronic kidney disease stage > = 4 in the Gard according to laboratory data and who are not seen by a nephrologist

    from baseline (day 0) to 12 months

Study Arms (1)

The study population

Persons with stage \>=4 chronic kidney disease.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Persons with \>= stage 4 chronic kidney disease and residing in the Gard department of France.

You may qualify if:

  • chronic kidney disease (stage \>= 4)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

AIDER - Unité de Dialyse d'Alès

Alès, 30100, France

RECRUITING

AIDER - Unité de Dialyse de Nîmes, CHU Carémeau

Nîmes, 30029, France

NOT YET RECRUITING

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

NOT YET RECRUITING

Gardialyse

Nîmes, 30900, France

NOT YET RECRUITING

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 Officials

  • Olivier Moranne, MD, PhD

    Centre Hospitalier Universitaire de Nîmes

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2016

First Posted

October 19, 2016

Study Start

January 1, 2019

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

March 10, 2025

Record last verified: 2025-03

Locations