Systematic Transplantectomy Versus Conventional Care After Kidney Graft Failure

  • STATUS
    Recruiting
  • End date
    Nov 14, 2023
  • participants needed
    118
  • sponsor
    Hospices Civils de Lyon
Updated on 14 June 2021
corticosteroids
immunosuppressive agents
dialysis
immunosuppressants
immunosuppression
graft failure
withdrawn

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, 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control group, immunosuppression will be continued at the maintenance dose during the current surgical procedure, and withdrawn two weeks later,similary to systematic transplantectomy.

Details
Condition Organ Transplantation, Renal transplant, Organ Transplant - Pediatric, Organ Transplant, Kidney Transplantation, kidney transplant, renal transplantation, kidney transplants
Treatment Systematic transplantectomy, Progressive reduction of immunosuppression
Clinical Study IdentifierNCT01817504
SponsorHospices Civils de Lyon
Last Modified on14 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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>38C
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)
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