Status:
COMPLETED
Systematic Transplantectomy Versus Conventional Care After Kidney Graft Failure
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Renal Transplantation
Eligibility:
All Genders
18-75 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2021
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT01817504
Start Date
March 1 2013
End Date
November 1 2021
Last Update
November 21 2022
Active Locations (9)
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1
Service de Néphrologie et Transplantation Rénale, CHU Gabriel Montpied
Clermont-Ferrand, France, 63000
2
Service de Néphrologie -Dialyse-Transplantation, Hôpital Michallon
Grenoble, France, 38043
3
Transplantation Department, Hôpital Edourad Herriot
Lyon, France, 69003
4
Service de Néphrologie et Transplantation Rénale - Hôpital Lapeyronie
Montpellier, France, 34295