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

NCT ID: NCT02849964

Last Updated: 2016-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

6835 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Renal Insufficiency

Keywords

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Incidence Renal Replacement Therapy Socioeconomic Factors Clinical Practice Pattern

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

RETROSPECTIVE

Study Groups

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First time renal replacement therapy

Patients beginning renal replacement therapy by renal dialysis or preemptive kidney transplant.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Agence de La Biomédecine

OTHER_GOV

Sponsor Role collaborator

Central Hospital, Nancy, France

OTHER

Sponsor Role collaborator

University Hospital, Strasbourg, France

OTHER

Sponsor Role collaborator

Observatoire Régional de la Santé d'Alsace

UNKNOWN

Sponsor Role collaborator

Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elisabeth Monnet, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre d'Investigation Clinique, CHU Besançon

Carole Ayav, MD

Role: PRINCIPAL_INVESTIGATOR

Centre d'Investigation Clinique, CHU Nancy

Locations

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Centre d'Investigation Clinique, CHU de Besançon

Besançon, , France

Site Status

Hôpital William Morey, Néphrologie

Chalon-sur-Saône, , France

Site Status

CHU de Reims, Néphrologie

Reims, , France

Site Status

Centre d'Investigation Clinique CHU de Nancy

Vandœuvre-lès-Nancy, , France

Site Status

Countries

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France

Other Identifiers

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VIgIE

Identifier Type: -

Identifier Source: org_study_id