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

Renal Failure Clinical Trial

— TRACE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03234075
• Other study ID #: 69HCL17_0022
• Status: Recruiting
• Start date: January 1, 2018
• Est. completion date: January 1, 2023

Study information

• Verified date: January 2020
• Source: Hospices Civils de Lyon
• Contact: Myriam PASTURAL-THAUNAT, Dr
• Phone: 04 72 11 01 50
• Email: myriam.pastural-thaunat[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: January 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 84 Years

Eligibility

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.

Related Conditions & MeSH terms

• Renal Failure
• Renal Insufficiency

Intervention

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

Locations

Country	Name	City	State
France	Service de Transplantation, Groupement Hospitalier Edouard Herriot, Hospices Civils de Lyon	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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