Ignite Creation Date:
2024-05-06 @ 3:50 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04774575
Status:
COMPLETED
Last Update Posted:
2024-06-03
First Post:
2021-02-24
Brief Title:
Quantify the Benefits of Biomarkers in Routine Patient Care in Kidney Transplant Recipients
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Randomized Controlled Multicentre Trial to Quantify the Benefits of Biomarkers in Routine Patient Care in Kidney Transplant Recipients EU-TRAIN IMPACT Trial
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EUTRAIN IMPACT
Brief Summary:
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
Detailed Description:
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 datasamples 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None