Clinical trial NCT01817504: Systematic Transplantectomy Versus Conventional Care After Kidney Graft Failure
Official title: Interest of Systematic Transplantectomy Versus Conventional Care After Kidney Graft Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Transplantation
Keywords: Renal failure,
Transplantectomy
Immunosuppression
Sensitization
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2013-03-25
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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:

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control group, immunosuppression will be continued at the maintenance dose during the current surgical procedure, and withdrawn two weeks later,similary to systematic transplantectomy.


Eligibility criteria: 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)

Primary outcomes:
measure: Anti HLA Immunization assessed by Luminex assay
timeFrame: 12 months (M12)
Secondary outcomes:
measure: Kinetics anti-HLA antibodies after transplantectomy
timeFrame: 12 months after inclusion
measure: Morbidity and mortality after transplantectomy
timeFrame: 12 months after inclusion
measure: Measuring the impact of systematic transplantectomy on mortality, inflammation, nutritional status, anemia, hypertension and cardiovascular risk factors
timeFrame: 12 months
measure: Infectious comorbidity
timeFrame: 12 months
measure: Costs of two strategies
timeFrame: 12 months after inclusion
Other outcomes:
Locations:
city: Clermont-Ferrand Cedex
country: France
facility: Service de Néphrologie et Transplantation Rénale, CHU Gabriel Montpied
city: Grenoble Cedex
country: France
facility: Service de Néphrologie -Dialyse-Transplantation, Hôpital Michallon
city: Lyon
country: France
facility: Transplantation Department, Hôpital Edourad Herriot
city: Montpellier
country: France
facility: Service de Néphrologie et Transplantation Rénale - Hôpital Lapeyronie
city: Nantes
country: France
facility: Institut de Transplantation, Urologie et Néphrologie - CHU Nantes
city: Pringy
country: France
facility: Service de Néphrologie-Dialyse, Centre Hospitalier d'Annecy
city: Saint-Etienne
country: France
facility: Service de Néphrologie, Dialyse et Transplantation Rénale, Hôpital Nord
city: Strasbourg
country: France
facility: Service de Néphrologie et Transplantation Rénale - Nouvel Hôpital Civil
city: Tours
country: France
facility: Service de Néphrologie, Immunologie Clinique - CHU Bretonneau
Study officials:
affiliation: Transplantation Department, Hopital Edouard Herriot, Hospices Civils de Lyon
name: Emmanuel MORELON, MD
role: PRINCIPAL_INVESTIGATOR
References: