Renal FailureTRACENCT03234075
Evaluation of a New Regional Organization to Promote Access to Renal Transplantation
An observational study of Renal Failure, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Renal Failure
- What is being tested?
- Regional organization for promotion of renal transplantation
- How many people
- 4,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2018to 1 Jan 2023
- 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 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population participating in the study is composed of patients with a terminal Chronic Kidney Disease (CRD) requiring renal function supplementation.
Who may be able to join
- 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).
Who cannot join
- Patient followed in a Center of nephrology-dialysis or of Renal transplantation located outside French Auvergne Rhône Alpes or Center Regions.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de Transplantation, Groupement Hospitalier Edouard Herriot, Hospices Civils de Lyon
Lyon, 69003
Myriam PASTURAL-THAUNAT, Dr, 04 72 11 01 50 ext. +33, myriam.pastural-thaunat@chu-lyon.fr
Karine POYAU, 04 72 11 53 81 ext. +33, karine.poyau@chu-lyon.fr
About this study
Official title: Promoting Access to Renal Transplantation: Impact of a Patient-centered Regional Organization
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.
- Conditions
- Renal Failure
- Being tested
- Regional organization for promotion of renal transplantation
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regional organization for promotion of renal transplantationOther
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
| Study group | Role | What they receive |
|---|---|---|
| Control group | Patients supported without regional organization for promotion of renal transplantation Setting : French Auvergne Rhone Alpes region and French Center region | |
| Intervention group | Patients supported with the regional organization for promotion of renal transplantation Setting : French Auvergne Rhone Alpes region Receives: Other: Regional organization for promotion of renal transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At 24 months after initiation of renal function supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2017
- Study start1 Jan 2018
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal FailureStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Other
- Time perspective
- Other
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03234075
- Sponsor's protocol ID
- 69HCL17_0022
- Acronym
- TRACE
- Status last verified
- Jan 2020
- First submitted
- 26 Jul 2017
- Last updated
- 29 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Access to Renal Transplantation: Impact of a Patient-centered Regional Organization
- ClinicalTrials.gov ID
- NCT03234075
- Acronym / sponsor ID
- TRACE / 69HCL17_0022
- Conditions
- Renal Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 31 Jul 2017 (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.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | –Patients supported without regional organization for promotion of renal transplantation Setting : French Auvergne Rhone Alpes region and French Center region |
| Intervention group | – | Other: Regional organization for promotion of renal transplantationPatients supported with the regional organization for promotion of renal transplantation Setting : French Auvergne Rhone Alpes region |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population participating in the study is composed of patients with a terminal Chronic Kidney Disease (CRD) requiring renal function supplementation.
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (1 listed)
- Patient followed in a Center of nephrology-dialysis or of Renal transplantation located outside French Auvergne Rhône Alpes or Center Regions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regional organization for promotion of renal transplantationEarly 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 | Other | Intervention group |
Primary outcome
Cumulative incidence rate of access to renal transplantation for patients with end-stage renal failure
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2020.
- Individual participant dataSharing planned: No
Related trials for Renal Failure
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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.
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 Renal Failure, run by Hospices Civils de Lyon 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 1 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 29 Jan 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 Myriam PASTURAL-THAUNAT, Dr (04 72 11 01 50 ext. +33, myriam.pastural-thaunat@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative incidence rate of access to renal transplantation for patients with end-stage renal failure (time frame: At 24 months after initiation of renal function supplementation). 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 29 Jan 2020.