Clinical trial NCT02849964: Factors Related to Geographical Variation in the Incidence of End-stage Renal Failure: An Analysis in 5 French Regions
Official title: Factors Related to Geographical Variation in the Incidence of End-stage Renal Failure: An Analysis in 5 French Regions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Insufficiency
Keywords: Incidence
Renal Replacement Therapy
Socioeconomic Factors
Clinical Practice Pattern
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
Collaborators: name: Agence de La Biomédecine
name: Central Hospital, Nancy, France
name: University Hospital, Strasbourg, France
name: Observatoire Régional de la Santé d'Alsace
First posted: 2016-07-29
Enrollment: 6835
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: Factors associated with renal replacement therapy
timeFrame: Study period: 2010-2014
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: Centre d'Investigation Clinique, CHU de Besançon
city: Chalon sur Saône
country: France
facility: Hôpital William Morey, Néphrologie
city: Reims
country: France
facility: CHU de Reims, Néphrologie
city: Vandoeuvre-les-Nancy
country: France
facility: Centre d'Investigation Clinique CHU de Nancy
Study officials:
affiliation: Centre d'Investigation Clinique, CHU Besançon
name: Elisabeth Monnet, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre d'Investigation Clinique, CHU Nancy
name: Carole Ayav, MD
role: PRINCIPAL_INVESTIGATOR
References: