Evaluation of a New Regional Organization to Promote Access to Renal Transplantation (TRACE)

Promoting Access to Renal Transplantation: Impact of a Patient-centered Regional Organization

Patients with terminal chronic kidney disease (CRD) need renal function supplementation, namely dialysis or renal transplantation. Transplantation is the most efficient and cost-effective treatment. Early and equitable access to transplantation is a public health issue. Access to transplantation is facilitated by early and systematic information and assessment of patients for inclusion in the national waiting list for transplantation prior to the onset of dialysis, and by the development of transplantation from living donors. In France, there are wide disparities in access to national waiting list registration and transplantation. One of the causes of these inequalities in access would be the disparity in referral practices to a transplant medical and surgical team authorized to register the individual on the national waiting list.

The aim of the TRACE study is to evaluate the impact of a new regional organization promoting renal transplantation on access to renal transplantation.

Study Overview

• Status: Unknown
• Conditions: Renal Failure
• Intervention / Treatment: Other: Regional organization for promotion of renal transplantation

• Study Type: Observational
• Enrollment (Anticipated): 4000

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69003
    • Recruiting
    • Service de Transplantation, Groupement Hospitalier Edouard Herriot, Hospices Civils de Lyon
    • Contact: Myriam PASTURAL-THAUNAT, Dr; Phone Number: +33 04 72 11 01 50; Email: myriam.pastural-thaunat@chu-lyon.fr
    • Contact: Karine POYAU; Phone Number: +33 04 72 11 53 81; Email: karine.poyau@chu-lyon.fr
    • Principal Investigator: Myriam PASTURAL-THAUNAT, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 84 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The population participating in the study is composed of patients with a terminal Chronic Kidney Disease (CRD) requiring renal function supplementation.

Description

Inclusion Criteria:

• Patient older than 18 years and younger than 85 years.
• Entered in the French Network Epidemiology and Information in Nephrology register
• Renal function supplementation begun in 2013 -- 2014 (period before regional organization implementation) or in 2018 -- 2019 (period after regional organization implementation).

Exclusion Criteria:

- Patient followed in a Center of nephrology-dialysis or of Renal transplantation located outside French Auvergne Rhône Alpes or Center Regions.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control group; Patients supported without regional organization for promotion of renal transplantation Setting : French Auvergne Rhone Alpes region and French Center region
Intervention group; Patients supported with the regional organization for promotion of renal transplantation Setting : French Auvergne Rhone Alpes region	Other: Regional organization for promotion of renal transplantation; Early identification of candidates for renal transplantation; with the help of a care coordinator Inform all patients appropriately about the techniques of renal function supplementation; delivered by expert patients and a care coordinator Assist the nephrologists in patient graft pathway; Multidisciplinary assessment of patients in dedicated web-conferencing meetings bringing together nephrologists and transplant team (" WebRCP of kidney transplant orientation"); Helping to carry out the pre-graft assessments of patients by a care coordinator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative incidence rate of access to renal transplantation for patients with end-stage renal failure	Access to renal transplantation is defined by: Pre-emptive renal transplantation with living donor or deceased donor; Registration on the national waiting list for renal transplantation	At 24 months after initiation of renal function supplementation

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): January 1, 2023

Study Registration Dates

• First Submitted: July 26, 2017
• First Submitted That Met QC Criteria: July 26, 2017
• First Posted (Actual): July 31, 2017

Study Record Updates

• Last Update Posted (Actual): January 29, 2020
• Last Update Submitted That Met QC Criteria: January 27, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency
• Other Study ID Numbers: 69HCL17_0022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No