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

Renal Insufficiency Clinical Trial

— VIgIE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02849964
• Other study ID #: VIgIE
• Status: Completed
• Phase: N/A
• First received: July 27, 2016
• Last updated: July 28, 2016
• Start date: September 2015
• Est. completion date: June 2016

Study information

• Verified date: July 2016
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6835
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Ecologic or Community, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Renal Insufficiency
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
France	Centre d'Investigation Clinique, CHU de Besançon	Besançon
France	Hôpital William Morey, Néphrologie	Chalon sur Saône
France	CHU de Reims, Néphrologie	Reims
France	Centre d'Investigation Clinique CHU de Nancy	Vandoeuvre-les-Nancy

Sponsors (5)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon	Agence de La Biomédecine, Central Hospital, Nancy, France, Centre Hospitalier Universitaire de Strasbourg, Observatoire Régional de la Santé d'Alsace

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No