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

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.

Study Overview

• Status: Completed
• Conditions: Renal Insufficiency

• Study Type: Observational
• Enrollment (Actual): 6835

Contacts and Locations

Study Locations

• France
  • Besançon, France, 25030
    • Centre d'Investigation Clinique, CHU de Besançon
  • Chalon sur Saône, France, 73121
    • Hôpital William Morey, Néphrologie
  • Reims, France, 51100
    • CHU de Reims, Néphrologie
  • Vandoeuvre-les-Nancy, France, 54500
    • Centre d'Investigation Clinique CHU de Nancy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon
• Collaborators: University Hospital, Strasbourg, France; Central Hospital, Nancy, France; Agence de La Biomédecine; Observatoire Régional de la Santé d'Alsace
• Investigators: Principal Investigator: Elisabeth Monnet, MD, PhD, Centre d'Investigation Clinique, CHU Besançon; Principal Investigator: Carole Ayav, MD, Centre d'Investigation Clinique, CHU Nancy

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (ACTUAL): June 1, 2016
• Study Completion (ACTUAL): June 1, 2016

Study Registration Dates

• First Submitted: July 27, 2016
• First Submitted That Met QC Criteria: July 28, 2016
• First Posted (ESTIMATE): July 29, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): July 29, 2016
• Last Update Submitted That Met QC Criteria: July 28, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Incidence; Renal Replacement Therapy; Socioeconomic Factors; Clinical Practice Pattern
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Renal Insufficiency
• Other Study ID Numbers: VIgIE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO