Feasibility of Estimating the Prevalence and Management of Stage 4 CKD the Gard, France (MRC-Gard)

Feasibility Study on Estimating the Prevalence and Management of Stage 4 Chronic Kidney Disease in Adults Via Laboratories and Nephrologists in the Gard, France

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.

Study Overview

Status

Recruiting

Study Type

Observational

Enrollment (Estimated)

3375

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Alès, France, 30100
        • Recruiting
        • AIDER - Unité de Dialyse d'Alès
        • Principal Investigator:
          • Anne Wuillai, MD
        • Sub-Investigator:
          • Médérick Mohajer, MD
        • Sub-Investigator:
          • Farid Bellahsene, MD
      • Nîmes, France, 30900
        • Not yet recruiting
        • Gardialyse
        • Principal Investigator:
          • Samir Boubenider, MD
        • Sub-Investigator:
          • Philippe Rousseau, MD
      • Nîmes Cedex 09, France, 30029
        • Not yet recruiting
        • AIDER - Unité de Dialyse de Nîmes, CHU Carémeau
        • Principal Investigator:
          • Laure Patrier, MD
        • Sub-Investigator:
          • Emilie Pambrun, MD
      • Nîmes Cedex 09, France, 30029
        • Not yet recruiting
        • CHU de Nîmes - Hopital Universitaire Caremeau
        • Principal Investigator:
          • Olivier Moranne, MD, PhD
        • Sub-Investigator:
          • Pascal Reboul, MD
        • Sub-Investigator:
          • Sylvain Cariou, MD
        • Sub-Investigator:
          • Sophie Renaud, MD
        • Sub-Investigator:
          • Louis Marie Vernier, MD
        • Sub-Investigator:
          • Frédérique Vecina, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • chronic kidney disease (stage >= 4)

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
The study population
Persons with stage >=4 chronic kidney disease.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The prevalence of chronic kidney disease stage > = 4 in the Gard according to laboratory data (raw number)
Time Frame: from baseline (day 0) to 12 months
from baseline (day 0) to 12 months
The prevalence of chronic kidney disease stage > = 4 in the Gard according to laboratory data (%)
Time Frame: from baseline (day 0) to 12 months
from baseline (day 0) to 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
The percentage of patients with CKD stage >= 4 correctly reported by participating nephrologists
Time Frame: from baseline (day 0) to 12 months
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
Time Frame: from baseline (day 0) to 12 months
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
Time Frame: from baseline (day 0) to 12 months
from baseline (day 0) to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Olivier Moranne, MD, PhD, Centre Hospitalier Universitaire de Nīmes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

October 18, 2016

First Submitted That Met QC Criteria

October 18, 2016

First Posted (Estimated)

October 19, 2016

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 7, 2025

Last Verified

March 1, 2025

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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