The investigator hypothesize that the combined use of (1) non-invasive biomarkers in peripheral blood predicting anti-donor immunological activation or quiescence (2) interactive and actionable data analytics delivered at the bedside will promote safe clinical follow-up of kidney transplant patients with less need for invasive and induced risk surveillance by allograft protocol biopsies to assess allograft rejection in clinically stable kidney transplant patients. It is therefore proposed an European, multicenter, prospective randomized comparing two strategies of follow-up: in the first, biopsies are guided by biomarkers, in the second one, a routine biopsy is performed at M3. In both groups, a biopsy is performed at M12 and whenever considered necessary by the clinician.
The main objective of this study is to demonstrate the ability of use of non-invasive biomarkers to decrease the number of allograft biopsies during the first year after transplantation. 300 new transplanted patients in the 7 clinical transplant sites will be included in the prospective multicentre EU-TRAIN Impact study with centralized storage of samples in CHUN (blood mRNA), ICS (blood cellular assays), Saint -Louis Hospital (blood anti-HLA DSA, and non-HLA antibodies), INSERM (Biopsy mRNA). Recruitment of patients will start on the day of transplantation (d-8 for transplantation from living donors) and data/samples collected over the first year following transplantation. Realization of all the acts for the research are representing the usual medical practice (Standard Of Care: SOC) except six additional blood samples that will be collected and analyzed specifically for the research and additional analysis done specifically for the research on half of one of the two biopsy cores from the recipient. 3 additional blood samples from the living donor will also be collected and analyzed specifically for the research (timepoint of the sampling: anytime from 8 days to the day of transplant.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
342
Patients will follow a biomarker-guided strategy based on specific non-invasive biomarkers as defined in EUTRAIN-1 study on the basis of its detection and prediction capacities for rejection at M3 to decide whether a biopsy is performed. At M12 a routine biopsy is performed
Nantes Hospital
Nantes, France
Saint-Louis Hospital, Paris
Paris, Île-de-France Region, France
Necker Hospital, Paris
Paris, Île-de-France Region, France
Charité-Universitätsmedizin, Berlin
Berlin, Germany
Charité-Universitätsmedizin,
Berlin, Germany
Vall d'Hebron Hospital
Barcelona, Spain
Bellvitge University Hospital
Barcelona, Spain
Geneva University Hospitals
Geneva, Canton of Geneva, Switzerland
The rate of biopsies
comparison of the rate of biopsies performed during the first year in the Group of biomarkers guided biopsies vs. routine Group
Time frame: up to 12 months
Rate of immunosuppressant treatment modifications
Rate of immunosuppressant treatment modifications in both groups.
Time frame: 12month
Rate of complications due to performed biopsies
Rate of complications due to performed biopsies between both groups
Time frame: 12month
Type of biopsy-proven rejections between both groups
Type of biopsy-proven rejections between both groups at 12 months after transplantation
Time frame: 12month
Severity of biopsy-proven rejections between both groups
Severity of biopsy-proven rejections between both groups at 12 months after transplantation
Time frame: 12month
Outcome of biopsy-proven rejections between both groups
Outcome of biopsy-proven rejections between both groups at 12 months after transplantation
Time frame: 12month
Incidence of death
Incidence of death at 12 months after transplantation
Time frame: 12 months
Incidence of allograft loss
Incidence of allograft loss at 12 months after transplantation
Time frame: 12 months
Economic impact of implementing biomarkers in European Healthcare systems (cost/benefit)
Economic impact of implementing biomarkers in European Healthcare systems (cost/benefit) at 12 months after transplantation
Time frame: up to 12 months
Health-related Quality of life (QoL) of transplant patients after receiving a user-friendly reporting format from the EU-TRAIN report.
Health-related Quality of life (QoL) of transplant patients after receiving a user-friendly reporting format from the EU-TRAIN report.
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.