Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Factors Related to Geographical Variation in the Incidence of End-stage Renal Failure: An Analysis in 5 French Regions (VIgIE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02849964
Recruitment Status : Completed
First Posted : July 29, 2016
Last Update Posted : July 29, 2016
Sponsor:
Collaborators:
Agence de La Biomédecine
Central Hospital, Nancy, France
University Hospital, Strasbourg, France
Observatoire Régional de la Santé d'Alsace
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

Brief Summary:

The REIN registry highlights significant disparities in the incidence of end-stage renal disease (ESRD) between regions, especially in the North East of France. According to the literature, the incidence of ESRD in an area could be related to contextual factors influencing the needs for dialysis or transplantation (age structure, prevalence of risk factors, socioeconomic and morbidity levels), as well as to primary and secondary care provision (general practitioners and nephrologists) and to practice patterns in nephrology.

The aims of this project are the following:

  1. to compare the incidence of renal replacement therapy (dialysis or preemptive transplantation) for ESRD between the "départements" and the "cantons" belonging to the 5 regions of Eastern France (Alsace, Lorraine, Champagne-Ardenne, Bourgogne and Franche-Comté), while taking into account differences in population sizes and spatial patterns of the data,
  2. to analyse the relations between incidence disparities and socioeconomic environment, geographic accessibility to primary and secondary care and medical practice patterns, after adjusting for morbidity and mortality rates (incidence of diabetes, cardiovascular mortality).

This project will enable a better understanding of the mechanisms involved in the spatial variations of ESRD incidence, while disentangling effects related to the need from effects related to service supply in different socio-economic contexts. It will be possible to identify a lack of equity in access to renal replacement therapy if, after adjusting for need indicators, there were variations of incidence of ESRD related to availability of service or to socioeconomic context. Highlighting such effects would lead to search for corrective measures in collaboration with the different stakeholders.


Condition or disease
Renal Insufficiency

Layout table for study information
Study Type : Observational
Actual Enrollment : 6835 participants
Observational Model: Ecologic or Community
Time Perspective: Retrospective
Official Title: Factors Related to Geographical Variation in the Incidence of End-stage Renal Failure: An Analysis in 5 French Regions
Study Start Date : September 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Failure

Group/Cohort
First time renal replacement therapy
Patients beginning renal replacement therapy by renal dialysis or preemptive kidney transplant.



Primary Outcome Measures :
  1. Factors associated with renal replacement therapy [ Time Frame: Study period: 2010-2014 ]
    Analysis of the association between renal replacement therapy incidence disparities and socioeconomic environment, geographic accessibility to primary and secondary care and medical practice patterns.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All person entering renal replacement therapy, either by renal dialysis or preemptive kidney transplant, between January 1st, 2010 and December 31, 2014, and residing in the study zone (5 northeastern administrative regions of France), found in the French REIN registry.
Criteria

Inclusion Criteria:

  • Age 18 and older
  • Resident of the 5 French administrative regions (Alsace, Bourgogne, Champagne-Ardenne, Franche-Comté, and Lorraine)
  • First renal replacement therapy by renal dialysis or preemptive kidney transplant between January 1st, 2010 and December 31, 2014
  • Found in the REIN registry

Exclusion Criteria:

  • Transfer from another French administrative region
  • Return to renal dialysis after graft rejection or a period without dialysis

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): NCT02849964


Locations
Layout table for location information
France
Centre d'Investigation Clinique, CHU de Besançon
Besançon, France, 25030
Hôpital William Morey, Néphrologie
Chalon sur Saône, France, 73121
CHU de Reims, Néphrologie
Reims, France, 51100
Centre d'Investigation Clinique CHU de Nancy
Vandoeuvre-les-Nancy, France, 54500
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Agence de La Biomédecine
Central Hospital, Nancy, France
University Hospital, Strasbourg, France
Observatoire Régional de la Santé d'Alsace
Investigators
Layout table for investigator information
Principal Investigator: Elisabeth Monnet, MD, PhD Centre d'Investigation Clinique, CHU Besançon
Principal Investigator: Carole Ayav, MD Centre d'Investigation Clinique, CHU Nancy

Layout table for additonal information
Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT02849964     History of Changes
Other Study ID Numbers: VIgIE
First Posted: July 29, 2016    Key Record Dates
Last Update Posted: July 29, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Centre Hospitalier Universitaire de Besancon:
Incidence
Renal Replacement Therapy
Socioeconomic Factors
Clinical Practice Pattern
Additional relevant MeSH terms:
Layout table for MeSH terms
Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic