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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-A00421-42 | Other Identifier | ANSM |
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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:
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control group, immunosuppression will be continued at the maintenance dose during the current surgical procedure, and withdrawn two weeks later,similary to systematic transplantectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Active Comparator | The study group corresponds to systematic transplantectomy under immunosuppressive therapy within two months after return to dialysis, |
|
| Control group | Other | The control group corresponds to progressive reduction of immunosuppression without systematic transplantectomy after return to dialysis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Systematic transplantectomy | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 months (M12) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emmanuel MORELON, MD | Transplantation Department, Hopital Edouard Herriot, Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Néphrologie et Transplantation Rénale, CHU Gabriel Montpied | Clermont-Ferrand | 63000 | France | |||
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Progressive reduction of immunosuppression | Procedure | 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. |
|
| 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 ). | 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. | 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. | 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 | 12 months after inclusion |
| Service de Néphrologie -Dialyse-Transplantation, Hôpital Michallon |
| Grenoble |
| 38043 |
| France |
| Transplantation Department, Hôpital Edourad Herriot | Lyon | 69003 | France |
| Service de Néphrologie et Transplantation Rénale - Hôpital Lapeyronie | Montpellier | 34295 | France |
| Institut de Transplantation, Urologie et Néphrologie - CHU Nantes | Nantes | 44093 | France |
| Service de Néphrologie-Dialyse, Centre Hospitalier d'Annecy | Pringy | 74374 | France |
| Service de Néphrologie, Dialyse et Transplantation Rénale, Hôpital Nord | Saint-Etienne | 42055 | France |
| Service de Néphrologie et Transplantation Rénale - Nouvel Hôpital Civil | Strasbourg | 67091 | France |
| Service de Néphrologie, Immunologie Clinique - CHU Bretonneau | Tours | 37044 | France |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |