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

• Conditions: Renal Failure
• Interventions: Other: Regional organization for promotion of renal transplantation

• Registration Number: NCT03234075
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-26
• Study First Submitted QC: 2017-07-26
• Study First Posted: 2017-07-31
• Study Start: 2018-01-01
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-27
• Last Update Posted: 2020-01-29
• Primary Completion: 2023-01-01
• Study Completion: 2023-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 4000

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).

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intervention group	Regional organization for promotion of renal transplantation	Patients supported with the regional organization for promotion of renal transplantation Setting : French Auvergne Rhone Alpes region

Primary Outcome Measures

Name	Time	Method
Cumulative incidence rate of access to renal transplantation for patients with end-stage renal failure	At 24 months after initiation of renal function supplementation	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

Trial Locations

Locations (1)

Service de Transplantation, Groupement Hospitalier Edouard Herriot, Hospices Civils de Lyon; 🇫🇷 Lyon, France