Systematic Transplantectomy Versus Conventional Care After Kidney Graft Failure
Condition: Renal Transplantation
Study type: Interventional

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      continued at the maintenance dose during the current surgical procedure, and withdrawn two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.
    


Intervention name(s): Systematic transplantectomy; Progressive reduction of immunosuppression
Intervention type(s): Procedure; Procedure
Intervention description(s): 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 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Renal failure,; Transplantectomy; Immunosuppression; Sensitization