Renal TransplantationDESYRENCT01817504
Systematic Transplantectomy Versus Conventional Care After Kidney Graft Failure
A study testing Systematic transplantectomy and Progressive reduction of immunosuppression in people with Renal Transplantation, run by Hospices Civils de Lyon at 9 sites in France.
Trial summary
Our hypothesis is early and systematic transplantectomy under a well-conducted immunosuppression is associated with a decreased risk of anti-HLA immunization against a conservative attitude including a gradual reduction of immunosuppression, with or without a transplantectomy performed for cause (clinical event). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Renal Transplantation
- What is being tested?
- Systematic transplantectomy and Progressive reduction of immunosuppression
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 9 sitesFrance
- Study dates
- Mar 2013to Nov 2021
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 Years.
- Patients affiliated to health protection system, social security in France or any similar regimen.
- Renal transplant patient with end-stage transplantation, regardless of the number of previous transplants.
- Patient receiving immunosuppressive protocol based on anticalcineurin or mTOR inhibitors
- Patient should have resume hemodialysis within 4 weeks
- Duration of transplantation more than one year
Show all 9Show fewer
- Patient with asymptomatic graft
- immunogenic potential residual >50% (calculated PIR during the re-dialysis)
- Patient not covered by any measure of legal protection.
Who cannot join
- Immunogenic potential residual <50%
- Graft infection uncontrolled by treatment
- Active infectious pathology
- Inflammatory graft
- Uncontrolled arterial hypertention
- Inflammatory syndrome of undetermined origin with CRP>50mg/l
Show all 13Show fewer
- Fever of unknown origin for more than 8 days T>38°C
- Contra-indication to surgery
- AVK treatment
- Patient candidate for a living donor within 12 months
- Monotherapy with calcineurin inhibitors or mTOR inhibitors
- Treatment directed against the humoral response in the 6 months preceding the recovery of dialysis (Rituximab IV-Ig or high doses)
- Presence of another transplant (pancreas, liver, heart, lung)
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
Service de Néphrologie et Transplantation Rénale, CHU Gabriel Montpied
Clermont-Ferrand, 63000
Service de Néphrologie -Dialyse-Transplantation, Hôpital Michallon
Grenoble, 38043
Transplantation Department, Hôpital Edourad Herriot
Lyon, 69003
Service de Néphrologie et Transplantation Rénale - Hôpital Lapeyronie
Montpellier, 34295
Institut de Transplantation, Urologie et Néphrologie - CHU Nantes
Nantes, 44093
Service de Néphrologie-Dialyse, Centre Hospitalier d'Annecy
Pringy, 74374
Service de Néphrologie, Dialyse et Transplantation Rénale, Hôpital Nord
Saint-Etienne, 42055
Service de Néphrologie et Transplantation Rénale - Nouvel Hôpital Civil
Strasbourg, 67091
Service de Néphrologie, Immunologie Clinique - CHU Bretonneau
Tours, 37044
About this study
Official title: Interest of Systematic Transplantectomy Versus Conventional Care After Kidney Graft Failure
Our hypothesis is early and systematic transplantectomy under a well-conducted immunosuppression is associated with a decreased risk of anti-HLA immunization against a conservative attitude including a gradual reduction of immunosuppression, with or without a transplantectomy performed for cause (clinical event).
Observation or Investigation Method Used :
Read more
The study is :
- multicenter
- prospective
- open
- randomized: patients are divided into two parallel groups:
- study group: transplantectomy within six weeks after return to dialysis, antiproliferatives stop at the start of dialysis, Maintenance anticalcineurin-based-immunosuppression without dose reduction up to two weeks after transplantectomy. Abrupt discontinuation of anticalcineurin two weeks after transplantectomy. Corticosteroids: 5mg per day until one month after transplantectomy then stop within one month.
- control group: No systematic transplantectomy. Antiproliferatives stop at the start of dialysis.Anticalcineurins half dose for 3 months, ¼ dose for 3 months and then stop. Corticosteroids:5 mg per day for 6 months, and then tapered and stop within 3 months.
In the case of transplantectomy for cause in the control group, immunosuppression will be continued at the maintenance dose during the current surgical procedure, and withdrawn two weeks later,similary to systematic transplantectomy.
- Conditions
- Renal Transplantation
- Being tested
- Systematic transplantectomy, Progressive reduction of immunosuppression
- Keywords
- Renal failure,, Transplantectomy, Immunosuppression, Sensitization
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systematic transplantectomyProcedure or surgery
Transplantectomy within two months after return to dialyse. Antiproliferatives stop at the start of dialysis. Maintenance basic immunosuppressive treatment without dose reduction up to two weeks after transplantectomy. Abrupt discontinuation of the basic immunosuppressive treatment ttwo weeks after transplantectomy. Maintenance corticosteroids at 5mg per day until one month after transplantectomy then stop corticosteroids within one month.
Progressive reduction of immunosuppressionProcedure or surgery
Progressive reduction of immunosuppression. Transplantectomy for cause only. Antiproliferatives withdrawn at the start of dialysis. Maintenance of anticalcineurin or mTOR inhibitors half dose for 3 months, ¼ dose for 3 months and then stop. Maintenance corticosteroids for 6 months up to 5 mg per day, and then soft stop in 3 months.
In case of transplantectomy by reason in the control group, basic immunosuppression will be continued at the maintenance dose during the current surgical procedure, and withdrawn two weeks later, similary to the strategy used in the study group.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Active comparator | The study group corresponds to systematic transplantectomy under immunosuppressive therapy within two months after return to dialysis, Receives: Procedure: Systematic transplantectomy |
| Control group | Other | The control group corresponds to progressive reduction of immunosuppression without systematic transplantectomy after return to dialysis Receives: Procedure: Progressive reduction of immunosuppression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti HLA Immunization assessed by Luminex assay
Evaluate the interest of a transplantectomy early (<2 months after return to dialysis) and systematic under immunosuppressive in renal transplant patients after loss of renal graft function in terms of anti-HLA immunization (measured by Luminex test) a year after loss of renal graft function and return to dialysis in the renal transplant patient.
Proportion of patients who developed HLA immunization (DSA)after systematic transplantectomy under immunosuppression versus progressive reduction of immunosuppression without transplantectomy
Measured: 12 months (M12)
Secondary outcomes (5)
Kinetics anti-HLA antibodies after transplantectomy
Determine the kinetics of new onset anti-HLA antibodies at D0, D15, D30, M3, M6, M9 after systematic or for cause transplantectomy and in the year following graft failure and the proportion of immunized patients during the first 6 months after dialysis. HLA antibodies will be assessed by Luminex test. The specificity of antibodies against HLA I or HLA II will be determined, as well as Mean Immunofluorescence Intensity in each case.
Measured: 12 months after inclusion
Morbidity and mortality after transplantectomy
Determine the morbidity and mortality after transplantectomy according to its indication, systematic or for cause (transplantectomy indications in the control group: persistent pain graft, unexplained fever, hematuria, inflammation or unexplained anemia ).
Measured: 12 months after inclusion
Measuring the impact of systematic transplantectomy on mortality, inflammation, nutritional status, anemia, hypertension and cardiovascular risk factors
The following parameters will be measured at D0, M1, M3, M6, M9 and M12 after return to dialysis during the first year after kidney graft failure: CRP, pre-albuminemia, albuminemia, BMI, hemoglobin, hematocrit, blood pressure, cholesterol, LDL cholesterol and triglyceride.
Measured: 12 months
Infectious comorbidity
The impact of early cessation of immunosuppression on infectious complications after kidney graft failure will assessed. For each patient, origin of infection, bacterial, viral, fungal, will determined. The total number of infection episodes during the first year will be analyzed in the two groups.
Measured: 12 months
Costs of two strategies
To evaluate the medico-economic impact of each conservation strategy in the management of patients who return to dialysis
Measured: 12 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionNov 2021
- Study completionNov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal TransplantationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuel MORELON, MD, Principal investigator, Transplantation Department, Hopital Edouard Herriot, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01817504
- Sponsor's protocol ID
- 2012.714
- Other IDs
- 2012-A00421-42
- Acronym
- DESYRE
- Status last verified
- Nov 2022
- First submitted
- 8 Mar 2013
- Last updated
- 21 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Systematic Transplantectomy Versus Conventional Care After Kidney Graft Failure
- ClinicalTrials.gov ID
- NCT01817504
- Acronym / sponsor ID
- DESYRE / 2012.714
- Conditions
- Renal Transplantation
- Keywords
- Renal failure,, Transplantectomy, Immunosuppression, Sensitization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Mar 2013 (actual)
- Primary completion
- Nov 2021 (actual)
- Study completion
- Nov 2021 (actual)
- First posted
- 25 Mar 2013 (estimated)
- 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.
Our hypothesis is early and systematic transplantectomy under a well-conducted immunosuppression is associated with a decreased risk of anti-HLA immunization against a conservative attitude including a gradual reduction of immunosuppression, with or without a transplantectomy performed for cause (clinical event).
Observation or Investigation Method Used :
The study is :
- multicenter
- prospective
- open
- randomized: patients are divided into two parallel groups:
- study group: transplantectomy within six weeks after return to dialysis, antiproliferatives stop at the start of dialysis, Maintenance anticalcineurin-based-immunosuppression without dose reduction up to two weeks after transplantectomy. Abrupt discontinuation of anticalcineurin two weeks after transplantectomy. Corticosteroids: 5mg per day until one month after transplantectomy then stop within one month.
- control group: No systematic transplantectomy. Antiproliferatives stop at the start of dialysis.Anticalcineurins half dose for 3 months, ¼ dose for 3 months and then stop. Corticosteroids:5 mg per day for 6 months, and then tapered and stop within 3 months.
In the case of transplantectomy for cause in the control group, immunosuppression will be continued at the maintenance dose during the current surgical procedure, and withdrawn two weeks later,similary to systematic transplantectomy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Active comparator | Procedure: Systematic transplantectomyThe study group corresponds to systematic transplantectomy under immunosuppressive therapy within two months after return to dialysis, |
| Control group | Other | Procedure: Progressive reduction of immunosuppressionThe control group corresponds to progressive reduction of immunosuppression without systematic transplantectomy after return to dialysis |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 Years.
- Patients affiliated to health protection system, social security in France or any similar regimen.
- Renal transplant patient with end-stage transplantation, regardless of the number of previous transplants.
- Patient receiving immunosuppressive protocol based on anticalcineurin or mTOR inhibitors
- Patient should have resume hemodialysis within 4 weeks
Key exclusion criteria (13 listed)
- Immunogenic potential residual <50%
- Graft infection uncontrolled by treatment
- Active infectious pathology
- Inflammatory graft
- Uncontrolled arterial hypertention
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 |
|---|---|---|
| Systematic transplantectomyTransplantectomy within two months after return to dialyse. Antiproliferatives stop at the start of dialysis. Maintenance basic immunosuppressive treatment without dose reduction up to two weeks after transplantectomy. Abrupt discontinuation of the basic immunosuppressive treatment ttwo weeks after transplantectomy. Maintenance corticosteroids at 5mg per day until one month after transplantectomy then stop corticosteroids within one month. | Procedure or surgery | Study group |
| Progressive reduction of immunosuppressionProgressive reduction of immunosuppression. Transplantectomy for cause only. Antiproliferatives withdrawn at the start of dialysis. Maintenance of anticalcineurin or mTOR inhibitors half dose for 3 months, ¼ dose for 3 months and then stop. Maintenance corticosteroids for 6 months up to 5 mg per day, and then soft stop in 3 months. In case of transplantectomy by reason in the control group, basic immunosuppression will be continued at the maintenance dose during the current surgical procedure, and withdrawn two weeks later, similary to the strategy used in the study group. | Procedure or surgery | Control group |
Primary outcome
Anti HLA Immunization assessed by Luminex assay
Time frame: 12 months (M12)
Evaluate the interest of a transplantectomy early (<2 months after return to dialysis) and systematic under immunosuppressive in renal transplant patients after loss of renal graft function in terms of anti-HLA immunization (measured by Luminex test) a year after loss of renal graft function and return to dialysis in the renal transplant patient. Proportion of patients who developed HLA immunization (DSA)after systematic transplantectomy under immunosuppression versus progressive reduction of immunosuppression without transplantectomy
5 secondary outcomes
Kinetics anti-HLA antibodies after transplantectomy
Time frame: 12 months after inclusion
Morbidity and mortality after transplantectomy
Time frame: 12 months after inclusion
Measuring the impact of systematic transplantectomy on mortality, inflammation, nutritional status, anemia, hypertension and cardiovascular risk factors
Time frame: 12 months
Infectious comorbidity
Time frame: 12 months
Costs of two strategies
Time frame: 12 months after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2022.
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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.
Emmanuel MORELON, MD principal investigator
Transplantation Department, Hopital Edouard Herriot, Hospices Civils de Lyon
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Systematic transplantectomy and Progressive reduction of immunosuppression in people with Renal Transplantation, run by Hospices Civils de Lyon at 9 sites 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 9 inclusion and 13 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: finished, as of the sponsor's last update on 21 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti HLA Immunization assessed by Luminex assay (time frame: 12 months (M12)). 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 21 Nov 2022.