- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02938611
Feasibility of Estimating the Prevalence and Management of Stage 4 CKD the Gard, France (MRC-Gard)
March 7, 2025 updated by: Centre Hospitalier Universitaire de Nīmes
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
Conditions
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
- Name: Olivier Moranne, MD, PhD
- Phone Number: +33.(0)4.66.68.31.49
- Email: olivier.moranne@chu-nimes.fr
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
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIMAO/2016-06/OM-01
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.