Improved Accessibility to the Renal Transplant List

NCT ID: NCT03934554

Last Updated: 2020-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

125 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-01

Study Completion Date

2020-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

In 2014, the "States General of Kidney" have allowed to assess the situation concerning the management of chronic kidney disease on the national territory. Ex-Languedoc-Roussillon has emerged as one of the French regions with a high dialysis / transplant ratio compared to other regions. Disparities in accessibility to the kidney transplant list were also very important. In the ex-Languedoc-Roussillon Region, the number of patients on the renal transplant list was lower than the national average (18.9 vs. 24.1%, respectively, according to the REIN 2015 report).

In 2015, the Regional Health Agency (ARS) ex-Languedoc-Roussillon, has published proposals to improve the healthcare of the patient in chronic end stage renal failure, and accessibility to the national waiting list for renal transplantation (CRISTAL).

To increase accessibility to the national waiting list for renal transplantation by improving the patient's healthcare, our project is based on the creation of a reinforced exchanges connexion between the hospital's nephrology services professionals, dialysis units and liberal nephrologists. This will include having regular meetings between dialysis nephrologists and CHU nephrologists. The proposals for this project were:

1. to organize multidisciplinary consultation meetings between transplant and dialysis professionals
2. to set up an exchange platform and communication tools built on the model of telemedicine (COVOTEM), common to the nephrology departments of the University Hospital Center, dialysis units.

This new device for the management of chronic end stage renal failure should increase the number of patients on the national renal transplantation waiting list. It should also make it possible to reduce the time between: firstly, the sending of the pre-registration file to the transplantation at Montpellier University Hospital and registration, and secondly between dialysis and registration.on waiting list.

The investigators hope that this experiment will increase the number of registrations on the National Kidney Transplantation Waitlist (CRISTAL). The implementation of this innovative tool should facilitate communication between nephrologists dialysis centers and nephrologists of CHU Montpellier, and accelerate the process of registration on the National Kidney Transplantation Waitlist.

If this platform proves to be easy to use and if the project's evaluation criteria show significant results, the platform could then be used to monitor patients in post-transplantation. Indeed, the data of patients who perform an alternating follow-up would be available for the referring nephrologists and for the transplant center. The further development of the platform would allow to create a mode of communication via this platform.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Main Objective: Evolution of the number of patients, dialysed or not dialysed in the ex-Languedoc-Roussillon Region, acceding during the year, to a pre-transplant assessment for a registration on the national renal transplantation waiting list ( CRISTAL).

Secondary Objectives:

* Evolution of patient waiting times for registration on the national renal transplantation waiting list (CRISTAL)
* For incident cases: Evolution of the time between dialysis, and the date of registration on the transplant waiting list or the date of decision of temporary or definitive contraindication by nephrologists CHU Montpellier .
* Evolution of the delays between the date of reception of the pre-registration file by the nephrology department of the University Hospital and the closing date of the file (either a definitive inscription, a definitive contraindication or a temporary contraindication \> 4 months)
* Evolution of the number of multidisciplinary consultation meetings performed without videoconferencing and videoconferencing between the dialysis center and Montpellier University Hospital
* Evaluation of exchanges between professionals involved in the course of care of the patient in chronic end stage renal failure

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic End Stage Renal Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Dialysis or non-dialysis patients with chronic renal insufficiency with a GFR \< 20ml / min eligible for transplant
* Patient wishing to start the registration process at the transplant
* Patient giving consent for the transmission of his data via an electronic platform

Exclusion Criteria

* Patient already enrolled
* Patient having a pathology with a life expectancy of less than two years
* Patient with serious psychiatric disorders , or dementia.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Aider Montpellier : Dr Chalabi Lofti

UNKNOWN

Sponsor Role collaborator

Aider Cèvennes et Confins Rhodaniens : Dr Mohajer Médérick

UNKNOWN

Sponsor Role collaborator

Aider Nîmes : Philippe LAN YUE WAH

UNKNOWN

Sponsor Role collaborator

Aider Lozère : Dr Hélène LERAY / Dr Cécile TURC-BARON

UNKNOWN

Sponsor Role collaborator

Aider Perpignan : Dr Ahmed RACHI

UNKNOWN

Sponsor Role collaborator

CHU de Nîmes : Pr Moranne Olivier

UNKNOWN

Sponsor Role collaborator

CH de Perpignan : Dr Vela Carlos

UNKNOWN

Sponsor Role collaborator

Centre d'Hémodialyse St Guilhem : Dr Argilès Angèl

UNKNOWN

Sponsor Role collaborator

Clinique Médipôle Perpignan : Dr DECOURT Alexandre

UNKNOWN

Sponsor Role collaborator

Clinique de Narbonne : Dr De Cornélissen François

UNKNOWN

Sponsor Role collaborator

GCS Help : Dr Maria Eugenia Noguera Gonzales

UNKNOWN

Sponsor Role collaborator

NephroCare Castelnau / Mas du Rochet / Lunel : Dr Basel Olivia

UNKNOWN

Sponsor Role collaborator

NephroCare Béziers : Dr Baron Emmanuel

UNKNOWN

Sponsor Role collaborator

NephroCare Nîmes / Bagnols : Dr Rousseau Philippe

UNKNOWN

Sponsor Role collaborator

Villeneuve les Béziers : Dr Baron Emmanuel

UNKNOWN

Sponsor Role collaborator

GCS eSanté : Sylvain Collet

UNKNOWN

Sponsor Role collaborator

University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sylvie DELMAS, Doctor

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Uh Montpellier

Montpellier, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Moglie Le Quintrec, Professor

Role: CONTACT

04 67 33 09 96

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Coralie CHAMPION, ARC

Role: primary

04 67 33 03 64 ext. 33

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RECHMPL19_0138

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Use of Predigraft in Kidney Transplant Patients
NCT04969757 ACTIVE_NOT_RECRUITING NA