Interest of Systematic Transplantectomy Versus Conventional Care After Kidney Graft Failure
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hospices Civils de Lyon
- Enrollment
- 56
- Locations
- 9
- Primary Endpoint
- Anti HLA Immunization assessed by Luminex assay
Study Overview
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:
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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.
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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control group, immunosuppression will be continued at the maintenance dose during the current surgical procedure, and withdrawn two weeks later,similary to systematic transplantectomy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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>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)
Arms & Interventions
Study group
The study group corresponds to systematic transplantectomy under immunosuppressive therapy within two months after return to dialysis,
Intervention: Systematic transplantectomy (Procedure)
Control group
The control group corresponds to progressive reduction of immunosuppression without systematic transplantectomy after return to dialysis
Intervention: Progressive reduction of immunosuppression (Procedure)
Outcomes
Primary Outcomes
Anti HLA Immunization assessed by Luminex assay
Time Frame: 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 Outcomes
- Measuring the impact of systematic transplantectomy on mortality, inflammation, nutritional status, anemia, hypertension and cardiovascular risk factors(12 months)
- Costs of two strategies(12 months after inclusion)
- Kinetics anti-HLA antibodies after transplantectomy(12 months after inclusion)
- Infectious comorbidity(12 months)
- Morbidity and mortality after transplantectomy(12 months after inclusion)