Systematic Transplantectomy Versus Conventional Care After Kidney Graft Failure
- Conditions
- Renal Transplantation
- Interventions
- Procedure: Systematic transplantectomyProcedure: Progressive reduction of immunosuppression
- Registration Number
- NCT01817504
- Lead Sponsor
- Hospices Civils de Lyon
- Brief 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).
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control group, immunosuppression will be continued at the maintenance dose during the current surgical procedure, and withdrawn two weeks later,similary to systematic transplantectomy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 56
- 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
- Patient with asymptomatic graft
- immunogenic potential residual >50% (calculated PIR during the re-dialysis)
- Patient not covered by any measure of legal protection.
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Study group Systematic transplantectomy The study group corresponds to systematic transplantectomy under immunosuppressive therapy within two months after return to dialysis, Control group Progressive reduction of immunosuppression The control group corresponds to progressive reduction of immunosuppression without systematic transplantectomy after return to dialysis
- Primary Outcome Measures
Name Time Method Anti HLA Immunization assessed by Luminex assay 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
- Secondary Outcome Measures
Name Time Method Measuring the impact of systematic transplantectomy on mortality, inflammation, nutritional status, anemia, hypertension and cardiovascular risk factors 12 months 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.
Costs of two strategies 12 months after inclusion To evaluate the medico-economic impact of each conservation strategy in the management of patients who return to dialysis
Kinetics anti-HLA antibodies after transplantectomy 12 months after inclusion 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.
Infectious comorbidity 12 months 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.
Morbidity and mortality after transplantectomy 12 months after inclusion 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 ).
Trial Locations
- Locations (9)
Service de Néphrologie et Transplantation Rénale, CHU Gabriel Montpied
🇫🇷Clermont-Ferrand Cedex, France
Service de Néphrologie -Dialyse-Transplantation, Hôpital Michallon
🇫🇷Grenoble Cedex, France
Transplantation Department, Hôpital Edourad Herriot
🇫🇷Lyon, France
Service de Néphrologie et Transplantation Rénale - Hôpital Lapeyronie
🇫🇷Montpellier, France
Service de Néphrologie-Dialyse, Centre Hospitalier d'Annecy
🇫🇷Pringy, France
Institut de Transplantation, Urologie et Néphrologie - CHU Nantes
🇫🇷Nantes, France
Service de Néphrologie, Dialyse et Transplantation Rénale, Hôpital Nord
🇫🇷Saint-Etienne, France
Service de Néphrologie, Immunologie Clinique - CHU Bretonneau
🇫🇷Tours, France
Service de Néphrologie et Transplantation Rénale - Nouvel Hôpital Civil
🇫🇷Strasbourg, France