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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/22/2021.

Improved Accessibility to the Renal Transplant List

Clinicaltrials.gov identifier NCT03934554

Recruitment Status Recruiting

First Posted May 2, 2019

Last update posted June 5, 2020

Study Description

Brief summary:

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.

  • Condition or Disease:Chronic End Stage Renal Failure
  • Intervention/Treatment:
  • Phase: N/A
Detailed Description

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

Study Design
  • Study Type: Observational
  • Estimated Enrollment: 125 participants
  • Observational Model: Case-Only
  • Time Perspective: Prospective
  • Official Title: ARS Experimentation Project: Improving Accessibility to the Renal Transplantation List
  • Actual Study Start Date: September 2018
  • Estimated Primary Completion Date: November 2020
  • Estimated Study Completion Date: December 2020
Outcome Measures
  • Primary Outcome Measures: 1. Number of patient dialysed or not dialysed acceding to a pre-transplant assessment for a registration on the national renal transplantation waiting list ( CRISTAL). [ Time Frame: 1 year, up to the end of study ]
    Number of patient dialysed or not dialysed acceding to a pre-transplant assessment for a registration on the national renal transplantation waiting list ( CRISTAL).
  • Secondary Outcome Measures: 1. Average period between the dialysis of the patient and the reception of the pre-registration file by the nephrology department of Montpellier University Hospital [ Time Frame: 1 year, up to the end of study ]
    Average period between the dialysis of the patient and the reception of the pre-registration file by the nephrology department of Montpellier University Hospital
  • 2. Number of files received by the nephrology department of Montpellier University Hospital on the COVOTEM platform [ Time Frame: 1 year, up to the end of study ]
    Number of files received by the nephrology department of Montpellier University Hospital on the COVOTEM platform
  • 3. Number of dialysis patients who had a pre-transplant evaluation [ Time Frame: 1 year, up to the end of study ]
    Number of dialysis patients who had a pre-transplant evaluation
  • 4. Number of non-dialysis patients who had a pre-transplant evaluation [ Time Frame: 1 year, up to the end of study ]
    Number of non-dialysis patients who had a pre-transplant evaluation
  • 5. Number of patients on temporary or definitive contraindications [ Time Frame: 1 year, up to the end of study ]
    Number of patients on temporary or definitive contraindications
  • 6. Average period between the reception of the pre-registration file by the nephrology department of the University Hospital of Montpellier and the consultation appointment for registration [ Time Frame: 1 year, up to the end of study ]
    Average period between the reception of the pre-registration file by the nephrology department of the University Hospital of Montpellier and the consultation appointment for registration
  • 7. Average period between the reception of the pre-registration file [ Time Frame: 1 year, up to the end of study ]
    Average period between the reception of the pre-registration file by the nephrology department of the CHU of Montpellier and the closing of the file (either a definitive inscription, a definitive contraindication, or a temporary contraindication > 4months)
  • 8. Rate of participation of the centers in the experimentation (Number of files received by the nephrology department of the University Hospital Center of Montpellier per center) [ Time Frame: 1 year, up to the end of study ]
    Rate of participation of the centers in the experimentation (Number of files received by the nephrology department of the University Hospital Center of Montpellier per center)
  • 9. Number of multidisciplinary consultation meetings performed without videoconferencing or videoconferencing between the dialysis center and Montpellier University Hospital Center [ Time Frame: 1 year, up to the end of study ]
    Number of multidisciplinary consultation meetings performed without videoconferencing or videoconferencing between the dialysis center and Montpellier University Hospital Center
  • 10. Average period between the consultation appointment and the closing of the file (either a definitive inscription, a definitive contraindication, or a temporary contraindication > 4months [ Time Frame: 1 year, up to the end of study ]
    Average period between the consultation appointment and the closing of the file (either a definitive inscription, a definitive contraindication, or a temporary contraindication > 4months
  • 11. Number of non-dialysis patients with renal insufficiency enrolled preemptively on the national renal transplantation waiting list [ Time Frame: 1 year, up to the end of study ]
    Number of non-dialysis patients with renal insufficiency enrolled preemptively on the national renal transplantation waiting list
  • Biospecimen Retention: None Retained

    Two 9 mL EDTA (ethylenediaminetetraacetic acid) blood samples

Eligibility Criteria
  • Ages Eligible for Study: 18 to 90 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • Sampling Method: Non-Probability Sample
  • Study Population: Patients dialysed or not dialysed with end stage renal failure, eligible for a pre-transplant assessment
Criteria

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.

Contacts and Locations
Contacts

Contact: Moglie Le Quintrec, Professor 04 67 33 09 96 m-lequintrec-donnette@chu-montpellier.fr

Locations

France
Uh Montpellier
Montpellier

Sponsors and Collaborators

University Hospital, Montpellier

Aider Montpellier : Dr Chalabi Lofti

Aider Cèvennes et Confins Rhodaniens : Dr Mohajer Médérick

Aider Nîmes : Philippe LAN YUE WAH

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

Aider Perpignan : Dr Ahmed RACHI

CHU de Nîmes : Pr Moranne Olivier

CH de Perpignan : Dr Vela Carlos

Centre d’Hémodialyse St Guilhem : Dr Argilès Angèl

Clinique Médipôle Perpignan : Dr DECOURT Alexandre

Clinique de Narbonne : Dr De Cornélissen François

GCS Help : Dr Maria Eugenia Noguera Gonzales

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

NephroCare Béziers : Dr Baron Emmanuel

NephroCare Nîmes / Bagnols : Dr Rousseau Philippe

Villeneuve les Béziers : Dr Baron Emmanuel

GCS eSanté : Sylvain Collet

Investigators

Principal Investigator: Sylvie DELMAS, Doctor University Hospital, Montpellier

More Information
  • Responsible Party: University Hospital, Montpellier
  • ClinicalTrials.gov Identifier: NCT03934554 History of Changes
  • Other Study ID Numbers: RECHMPL19_0138
  • First Posted: May 2, 2019 Key Record Dates
  • Last Update Posted: June 5, 2020
  • Last Verified: June 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: Undecided
  • Plan Description: NC
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by University Hospital, Montpellier: Nephrology
    Kidney transplant
    Registration
    Transplant waiting list
  • Additional relevant MeSH terms: Kidney Failure, Chronic