Evaluation of a New Regional Organization to Promote Access to Renal Transplantation

NCT03234075 | Unknown

• 1 other identifier: 69HCL17_0022
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Renal Failure

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Interventions

Regional organization for promotion of renal transplantation OTHER

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

Intervention group

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Service de Transplantation, Groupement Hospitalier Edouard Herriot, Hospices Civils de Lyon

Lyon, 69003, France

RECRUITING

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

Central Study Contacts

Myriam PASTURAL-THAUNAT, Dr

CONTACT

04 72 11 01 50; myriam.pastural-thaunat@chu-lyon.fr

Karine POYAU

CONTACT

04 72 11 53 81; karine.poyau@chu-lyon.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2017
• First Posted: July 31, 2017
• Study Start: January 1, 2018
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: January 29, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)