Rejection Diagnosis in Kidney Transplants Patients — KTD-innov  

Kidney Transplantation Clinical Trial

Official title: Prospective KTD-innov Cohort of Kidney Transplants Patients

Status Completed

Clinical Trial Summary

Main objective: To constitute a prospective multicentre French cohort of kidney transplant recipients including clinical, biological and immunological evaluation combined with non-invasive biomarkers in peripheral blood and urine, and gene expression assessment in allograft biopsy in order to increase the performance of rejection diagnosis in kidney transplant patients.

the investigators hypothesise that the addition of non-invasive biomarkers and intragraft assessment of gene expression profiles will improve the diagnosis capacity of histology in kidney transplant recipients as it reveals pathophysiological pathways that are not captured by light microscopy.

Clinical Trial Description

Rejection currently represents the major cause of allograft failure worldwide, with immediate consequences for the patients in terms of mortality, morbidity and costs for the society. The field of transplantation lacks robust assessments for immune monitoring and diagnoses. Currently, light microscopy still represents the gold standard, which has clearly been identified as imperfect. Given those facts, success of clinical trials is impaired with space for improvement of current diagnosis standards that should eventually lead to improved outcomes for kidney transplant recipients.

This study will provide the investigators with prospective data of kidney transplant patient that will allow the improvement of rejection diagnosis and individual immune monitoring for precision medicine: improvement of rejection diagnosis, stage and assessment of response to therapy. In order to estimate for each patient a probability of rejection, The investigators will generate algorithms using traditional clinical, biological and histological data that will be enriched by tissue as well as blood and urine non-invasive immune biomarkers.

These algorithms will be encapsulated in a "user-friendly" web-based application with best in-class visualisation : the TransplanScreen will display individual information with comparative and predictive context for clinicians and patients and better interfacing and communication. It will include a comprehensive TransplanScreen report based on the algorithms and included in Electronic Medical Record databases (object-oriented). It aims to provide visual and contextual information to promote personalised decision making, addressing the demand of public health authorities for improving efficiency and quality of care.

The expected benefit for participants and society will be to reduce the financial burden of graft rejection for society.

The cohort will include n=750 kidney transplant recipients in 8 French centres : 3 Parisian ones: Necker hospital, Saint-Louis Hospital and Bichat hospital and 4 regional ones: CHU Nantes, Toulouse and Bordeaux, Montpellier and Lyon Hospitals. Bichat hospital will not be recruiting but will contribute to the research.

Vulnerable participants excluded.

Schedule for the study:

• inclusion period: 12 months

• participation period (treatment - follow-up): 12 months

• total duration of the study: 24 months

Exclusion period for participation in other studies, and justification: the participation to other minimal risks and constraints studies and observational non-interventional studies is allowed during this study. There is no exclusion period at the end of study. The participation to other interventional and observational non-interventional studies is allowed after the end of the study.

Number of enrolments expected per site and per month :

• Necker Hospital: 14 patients / month

• Saint-Louis Hospital: 8 patients / month

• CHU Nantes: 10 patients / month

• Lyon Hospitals: 9 patients / month

• CHU Toulouse: 13 patients / month

• CHU Bordeaux: 9 patients / month.

• CHU Montpelier: 8/month ;

Related Conditions & MeSH terms

• Graft Survival
• Kidney Transplantation
• Transplant Rejection

• NCT number: NCT03582436
• Study type: Observational
• Source: Assistance Publique - Hôpitaux de Paris
• Status: Completed
• Start date: June 25, 2018
• Completion date: March 18, 2021