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Completed

NCT Number: NCT02849964

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre d'Investigation Clinique, CHU de Besançon, Besançon, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Collaborators

  • Agence de La Biomédecine
  • Central Hospital, Nancy, France
  • Observatoire Régional de la Santé d'Alsace
  • University Hospital, Strasbourg, France

Registry information

Acronym: VIgIE

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 29, 2016
Registry last updated
Jul 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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