Chronic End Stage Renal Failure2ALTRNCT03934554
Improved Accessibility to the Renal Transplant List
An observational study of Chronic End Stage Renal Failure, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chronic End Stage Renal Failure
- How many people
- 125 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2018to 30 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients dialysed or not dialysed with end stage renal failure, eligible for a pre-transplant assessment
Who may be able to join
- 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
Who cannot join
- Patient already enrolled
- Patient having a pathology with a life expectancy of less than two years
- Patient with serious psychiatric disorders , or dementia.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Uh Montpellier
Montpellier, 34295
Coralie CHAMPION, ARC, 04 67 33 03 64 ext. 33, c-champion@chu-montpellier.fr
About this study
Official title: ARS Experimentation Project: Improving Accessibility to the Renal Transplantation List
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).
Read more
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:
- to organize multidisciplinary consultation meetings between transplant and dialysis professionals
- 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.
Read the 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
- Conditions
- Chronic End Stage Renal Failure
- Keywords
- Nephrology, Kidney transplant, Registration, Transplant waiting list
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patient dialysed or not dialysed acceding to a pre-transplant assessment for a registration on the national renal transplantation waiting list ( CRISTAL).
Number of patient dialysed or not dialysed acceding to a pre-transplant assessment for a registration on the national renal transplantation waiting list ( CRISTAL).
Measured: 1 year, up to the end of study
Secondary outcomes (11)
Number of files received by the nephrology department of Montpellier University Hospital on the COVOTEM platform
Number of files received by the nephrology department of Montpellier University Hospital on the COVOTEM platform
Measured: 1 year, up to the end of study
Number of dialysis patients who had a pre-transplant evaluation
Number of dialysis patients who had a pre-transplant evaluation
Measured: 1 year, up to the end of study
Number of non-dialysis patients who had a pre-transplant evaluation
Number of non-dialysis patients who had a pre-transplant evaluation
Measured: 1 year, up to the end of study
Number of patients on temporary or definitive contraindications
Number of patients on temporary or definitive contraindications
Measured: 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
Average period between the dialysis of the patient and the reception of the pre-registration file by the nephrology department of Montpellier University Hospital
Measured: 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
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
Measured: 1 year, up to the end of study
Average period between the reception of the pre-registration file
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)
Measured: 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)
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)
Measured: 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
Number of multidisciplinary consultation meetings performed without videoconferencing or videoconferencing between the dialysis center and Montpellier University Hospital Center
Measured: 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
Average period between the consultation appointment and the closing of the file (either a definitive inscription, a definitive contraindication, or a temporary contraindication > 4months
Measured: 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
Number of non-dialysis patients with renal insufficiency enrolled preemptively on the national renal transplantation waiting list
Measured: 1 year, up to the end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2019
- Study start1 Sep 2018
- Primary completion30 Nov 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic End Stage Renal FailureStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Sponsor
- Investigators
- Sylvie DELMAS, Doctor, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03934554
- Sponsor's protocol ID
- RECHMPL19_0138
- Acronym
- 2ALTR
- Status last verified
- Jun 2020
- First submitted
- 25 Apr 2019
- Last updated
- 5 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ARS Experimentation Project: Improving Accessibility to the Renal Transplantation List
- ClinicalTrials.gov ID
- NCT03934554
- Acronym / sponsor ID
- 2ALTR / RECHMPL19_0138
- Conditions
- Chronic End Stage Renal Failure
- Keywords
- Nephrology, Kidney transplant, Registration, Transplant waiting list
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- 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
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 30 Nov 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 2 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- to organize multidisciplinary consultation meetings between transplant and dialysis professionals
- 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
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
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients dialysed or not dialysed with end stage renal failure, eligible for a pre-transplant assessment
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Patient already enrolled
- Patient having a pathology with a life expectancy of less than two years
- Patient with serious psychiatric disorders , or dementia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
11 secondary outcomes
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 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
Time frame: 1 year, up to the end of study
Number of patients on temporary or definitive contraindications
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
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
Time frame: 1 year, up to the end of study
Average period between the reception of the pre-registration file
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)
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
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
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
Time frame: 1 year, up to the end of study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2020.
- Individual participant dataSharing planned: Undecided. NC
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sylvie DELMAS, Doctor principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic End Stage Renal Failure, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Moglie Le Quintrec, Professor (04 67 33 09 96, m-lequintrec-donnette@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2020.