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

NCT02849964 | Completed

• 1 other identifier: VIgIE
• Study Type: observational
• Target: 6,835
• Locations: 1 country
• Sites: 4

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. 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. 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).

Conditions

Renal Insufficiency

Keywords

Incidence; Renal Replacement Therapy; Socioeconomic Factors; Clinical Practice Pattern

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

First time renal replacement therapy

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Transfer from another French administrative region
• Return to renal dialysis after graft rejection or a period without dialysis

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead
• Agence de La Biomédecine: collaborator
• Central Hospital, Nancy, France: collaborator
• University Hospital, Strasbourg, France: collaborator
• Observatoire Régional de la Santé d'Alsace: collaborator

Study Sites (4)

Centre d'Investigation Clinique, CHU de Besançon

Besançon, 25030, France

Location

Hôpital William Morey, Néphrologie

Chalon-sur-Saône, 73121, France

Location

CHU de Reims, Néphrologie

Reims, 51100, France

Location

Centre d'Investigation Clinique CHU de Nancy

Vandœuvre-lès-Nancy, 54500, France

Location

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Elisabeth Monnet, MD, PhD

  Centre d'Investigation Clinique, CHU Besançon

  PRINCIPAL INVESTIGATOR

• Carole Ayav, MD

  Centre d'Investigation Clinique, CHU Nancy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2016
• First Posted: July 29, 2016
• Study Start: September 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: July 29, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)