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

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ClinicalTrials.gov Identifier: NCT02938611
Recruitment Status : Not yet recruiting
First Posted : October 19, 2016
Last Update Posted : July 31, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

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.

Condition or disease
Renal Insufficiency, Chronic

Study Type : Observational
Estimated Enrollment : 3375 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Feasibility Study on Estimating the Prevalence and Management of Stage 4 Chronic Kidney Disease in Adults Via Laboratories and Nephrologists in the Gard, France
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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 ]
  2. The prevalence of chronic kidney disease stage > = 4 in the Gard according to laboratory data (%) [ Time Frame: from baseline (day 0) to 12 months ]

Secondary Outcome Measures :
  1. The percentage of patients with CKD stage >= 4 correctly reported by participating nephrologists [ Time Frame: from baseline (day 0) to 12 months ]
  2. 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 ]
  3. 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 ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.
Criteria

Inclusion Criteria:

  • chronic kidney disease (stage >= 4)

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02938611


Contacts
Contact: Olivier Moranne, MD, PhD +33.(0)4.66.68.31.49 olivier.moranne@chu-nimes.fr

Locations
France
AIDER - Unité de Dialyse d'Alès Not yet recruiting
Alès, France, 30100
Principal Investigator: Anne Wuillai, MD         
Sub-Investigator: Médérick Mohajer, MD         
Sub-Investigator: Farid Bellahsene, MD         
AIDER - Unité de Dialyse de Nîmes, CHU Carémeau Not yet recruiting
Nîmes Cedex 09, France, 30029
Principal Investigator: Laure Patrier, MD         
Sub-Investigator: Emilie Pambrun, MD         
CHU de Nîmes - Hôpital Universitaire Carémeau Not yet recruiting
Nîmes Cedex 09, France, 30029
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         
Gardialyse Not yet recruiting
Nîmes, France, 30900
Principal Investigator: Samir Boubenider, MD         
Sub-Investigator: Philippe Rousseau, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Study Director: Olivier Moranne, MD, PhD Centre Hospitalier Universitaire de Nîmes

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT02938611     History of Changes
Other Study ID Numbers: NIMAO/2016-06/OM-01
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: July 31, 2018
Last Verified: July 2018

Additional relevant MeSH terms:
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases